Drugs Details

Drugs Info of Vibativ
Drugs Details
  • Drugs Type  : FDA
  • Date : 19th Jun 2015 04:26 am
  • Brand Name : Vibativ
  • Generic Name : (telavancin) Lyophilized Powder for Intravenous Use
Descriptions

VIBATIV contains telavancin hydrochloride (Figure 1), a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin.

The chemical name of telavancin hydrochloride is vancomycin,N3''-[2-(decylamino)ethyl]-29-[[(phosphono-methyl)-amino]-methyl]- hydrochloride. Telavancin hydrochloride has the following chemical structure:

Figure 1: Telavancin Hydrochloride

VIBATIV® (telavancin) Structural Formula Illustration

Telavancin hydrochloride is an off-white to slightly colored amorphous powder with the empirical formula C80H106Cl2N11O27P•xHCl (where x = 1 to 3) and a free-base molecular weight of 1755.6. It is highly lipophilic and slightly soluble in water.

VIBATIV is a sterile, preservative-free, white to slightly colored lyophilized powder containing telavancin hydrochloride (equivalent to either 250 mg or 750 mg of telavancin as the free base) for intravenous use. The inactive ingredients are Hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin) (2500 mg per 250 mg telavancin, 7500 mg per 750 mg telavancin), mannitol (312.5 mg per 250 mg telavancin, 937.5 mg per 750 mg telavancin), and sodium hydroxide and hydrochloric acid used in minimal quantities for pH adjustment. When reconstituted, it forms a clear to slightly colored solution with a pH of 4.5 (4.0 to 5.0).

What are the possible side effects of telavancin (Vibativ)?

Some people receiving a telavancin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your doctor right away if you feel itchy or tingly, or have a red rash on your upper body during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • drowsiness, confusion, mood changes, increased...

Read All Potential Side Effects and See Pictures of Vibativ »

What are the precautions when taking telavancin for injection (Vibativ)?

See also Warning section.

Before using telavancin, tell your doctor or pharmacist if you are allergic to it; or to vancomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Telavancin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs...

This monograph has been modified to include the generic and brand name in many instances.

Indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known.

Complicated Skin And Skin Structure Infections

VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).

HABP/VABP

VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilatorassociated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable.

Dosage Administration

Complicated Skin And Skin Structure Infections

The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥ 18 years of age by intravenous infusion once every 24 hours for 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical progress.

Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

The recommended dosing for VIBATIV is 10 mg/kg administered over a 60-minute period in patients ≥ 18 years of age by intravenous infusion once every 24 hours for 7 to 21 days. The duration of therapy should be guided by the severity of the infection and the patient's clinical progress.

Patients With Renal Impairment

Because telavancin is eliminated primarily by the kidney, a dosage adjustment is required for patients whose creatinine clearance is ≤ 50 mL/min, as listed in Table 1 [see CLINICAL PHARMACOLOGY].

Table 1: Dosage Adjustment in Adult Patients with Renal Impairment

Creatinine Clearancea (CrCl) (mL/min) VIBATIV Dosage Regimen
> 50 10 mg/kg every 24 hours
30-50 7.5 mg/kg every 24 hours
10- < 30 10 mg/kg every 48 hours
aCalculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if it is less than IBW.

There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl < 10 mL/min), including patients undergoing hemodialysis.

Preparation And Administration

250 mg vial

Reconstitute the contents of a VIBATIV 250 mg vial with 15 mL of 5% Dextrose Injection, USP; Sterile Water for Injection, USP; or 0.9% Sodium Chloride Injection, USP. The resultant solution has a concentration of 15 mg/mL (total volume of approximately 17.0 mL).

750 mg vial

Reconstitute the contents of a VIBATIV 750 mg vial with 45 mL of 5% Dextrose Injection, USP; Sterile Water for Injection, USP; or 0.9% Sodium Chloride Injection, USP. The resultant solution has a concentration of 15 mg/mL (total volume of approximately 50.0 mL).

To minimize foaming during product reconstitution, allow the vacuum of the vial to pull the diluent from the syringe into the vial. Do not forcefully inject the diluent into the vial. Do not forcefully shake the vial and do not shake final infusion solution.

The following formula can be used to calculate the volume of reconstituted VIBATIV solution required to prepare a dose:

Telavancin dose (mg) = 10 mg/kg or 7.5 mg/kg x patient weight (in kg) (see Table 1)

Volume of reconstituted solution (mL) = Telavancin dose (mg)/ 15 mg/mL

For doses of 150 to 800 mg, the appropriate volume of reconstituted solution must be further diluted in 100 to 250 mL prior to infusion. Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final concentration of 0.6 to 8 mg/mL. Appropriate infusion solutions include: 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP. The dosing solution should be administered by intravenous infusion over a period of 60 minutes.

Reconstitution time is generally under 2 minutes, but can sometimes take up to 20 minutes. Mix thoroughly to reconstitute and check to see if the contents have dissolved completely. Parenteral drug products should be inspected visually for particulate matter prior to administration. Discard the vial if the vacuum did not pull the diluent into the vial.

Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparing the final intravenous solution. Studies have shown that the reconstituted solution in the vial should be used within 12 hours when stored at room temperature or within 7 days under refrigeration at 2 to 8°C (36 to 46°F). The diluted (dosing) solution in the infusion bag should be used within 12 hours when stored at room temperature or used within 7 days when stored under refrigeration at 2 to 8°C (36 to 46°F). However, the total time in the vial plus the time in the infusion bag should not exceed 12 hours at room temperature and 7 days under refrigeration at 2 to 8°C (36 to 46°F). The diluted (dosing) solution in the infusion bag can also be stored at -30 to -10°C (-22 to 14°F) for up to 32 days.

VIBATIV is administered intravenously. Because only limited data are available on the compatibility of VIBATIV with other IV substances, additives or other medications should not be added to VIBATIV single-use vials or infused simultaneously through the same IV line. If the same intravenous line is used for sequential infusion of additional medications, the line should be flushed before and after infusion of VIBATIV with 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or Lactated Ringer's Injection, USP.

How Supplied

Dosage Forms And Strengths

VIBATIV is supplied in single-use vials containing either 250 or 750 mg telavancin as a sterile, lyophilized powder.

Storage And Handling

Cartons of 10 individually packaged 250 mg single-dose vials (NDC 62847-002-01)
Cartons of 10 individually packaged 750 mg single-dose vials (NDC 62847-001-01)

Store original packages at refrigerated temperatures of 2 to 8°C (35 to 46 °F). Excursions to ambient temperatures (up to 25 °C (77 °F)) are acceptable. Avoid excessive heat.

Manufactured by: Theravance Biopharma Antibiotics, Inc. Marketed by: Theravance Biopharma US, Inc., South San Francisco, CA 94080. Revised: December 2014


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following serious adverse reactions are also discussed elsewhere in the labeling:

  • Nephrotoxicity [See WARNINGS AND PRECAUTIONS]
  • Infusion-related reactions [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

Complicated Skin and Skin Structure Infections

The two Phase 3 cSSSI clinical trials (Trial 1 and Trial 2) for VIBATIV included 929 adult patients treated with VIBATIV at 10 mg/kg IV once daily. The mean age of patients treated with VIBATIV was 49 years (range 18-96). There was a slight male predominance (56%) in patients treated with VIBATIV, and patients were predominantly Caucasian (78%).

In the cSSSI clinical trials, < 1% (8/929) patients who received VIBATIV died and < 1% (8/938) patients treated with vancomycin died. Serious adverse events were reported in 7% (69/929) of patients treated with VIBATIV and most commonly included renal, respiratory, or cardiac events. Serious adverse events were reported in 5% (43/938) of vancomycin-treated patients, and most commonly included cardiac, respiratory, or infectious events. Treatment discontinuations due to adverse events occurred in 8% (72/929) of patients treated with VIBATIV, the most common events being nausea and rash (~1% each). Treatment discontinuations due to adverse events occurred in 6% (53/938) of vancomycin-treated patients, the most common events being rash and pruritus (~1% each).

The most common adverse events occurring in ≥ 10% of VIBATIV-treated patients observed in the VIBATIV Phase 3 cSSSI trials were taste disturbance, nausea, vomiting, and foamy urine.

Table 4 displays the incidence of treatment-emergent adverse drug reactions reported in ≥ 2% of patients treated with VIBATIV possibly related to the drug.

Table 4: Incidence of Treatment-Emergent Adverse Drug Reactions Reported in ≥ 2% of VIBATIV or Vancomycin Patients Treated in cSSSI Trial 1 and Trial 2

  VIBATIV
(N=929)
Vancomycin
(N=938)
Body as a Whole
  Rigors 4% 2%
Digestive System
  Nausea 27% 15%
  Vomiting 14% 7%
  Diarrhea 7% 8%
Metabolic and Nutritional
  Decreased appetite 3% 2%
Nervous System
  Taste disturbance* 33% 7%
Renal System
  Foamy urine 13% 3%
* Described as a metallic or soapy taste.

HABP/VABP

Two randomized, double-blind Phase 3 trials (Trial 1 and Trial 2) for VIBATIV included 1,503 adult patients treated with VIBATIV at 10 mg/kg IV once daily or vancomycin at 1 g IV twice daily. The mean age of patients treated with VIBATIV was 62 years (range 18-100). In patients treated with VIBATIV, 69% of the patients were white and 65% were male. In the combined VIBATIV group, 29% were VAP and 71% were HAP patients.

Table 5 summarizes deaths using Kaplan-Meier estimates at Day 28 as stratified by baseline creatinine clearance categorized into four groups. Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for HABP/VABP had increased mortality observed versus vancomycin in both the trials.

Table 5: 28-Day Mortality (Kaplan-Meier Estimates) Stratified by Baseline Creatinine Clearance — All-Treated Analysis Population

View Enlarged Table

Serious adverse events were reported in 31% of patients treated with VIBATIV and 26% of patients who received vancomycin. Treatment discontinuations due to adverse events occurred in 8% (60/751) of patients who received VIBATIV, the most common events being acute renal failure and electrocardiogram QTc interval prolonged (~1% each). Treatment discontinuations due to adverse events occurred in 5% (40/752) of vancomycin-patients, the most common events being septic shock and multi-organ failure ( < 1%).

Table 6 displays the incidence of treatment-emergent adverse drug reactions reported in ≥ 5% of HABP/VABP patients treated with VIBATIV possibly related to the drug.

Table 6: Incidence of Treatment-Emergent Adverse Drug Reactions Reported in ≥ 5% of VIBATIV or Vancomycin Patients Treated in HABP/VABP Trial 1 and Trial 2

  VIBATIV (N=751) Vancomycin (N=752)
Nausea 5% 4%
Vomiting 5% 4%
Renal Failure Acute 5% 4%

Nephrotoxicity

Complicated Skin and Skin Structure Infections

In cSSSI trials, the incidence of renal adverse events indicative of renal impairment (increased serum creatinine, renal impairment, renal insufficiency, and/or renal failure) was 30/929 (3%) of VIBATIV-treated patients compared with 10/938 (1%) of vancomycin-treated patients. In 17 of the 30 VIBATIV-treated patients, these adverse events had not completely resolved by the end of the trials, compared with 6 of the 10 vancomycin-treated patients. Serious adverse events indicative of renal impairment occurred in 11/929 (1%) of VIBATIVtreated patients compared with 3/938 (0.3%) of vancomycin-treated patients. Twelve patients treated with VIBATIV discontinued treatment due to adverse events indicative of renal impairment compared with 2 patients treated with vancomycin.

Increases in serum creatinine to 1.5 times baseline occurred more frequently among VIBATIV-treated patients with normal baseline serum creatinine (15%) compared with vancomycin-treated patients with normal baseline serum creatinine (7%).

Fifteen of 174 (9%) VIBATIV-treated patients ≥ 65 years of age had adverse events indicative of renal impairment compared with 16 of 755 patients (2%) < 65 years of age [see Use In Specific Populations].

Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

In the HABP/VABP trials, the incidence of renal adverse events (increased serum creatinine, renal impairment, renal insufficiency, and/or renal failure) was 10% for VIBATIV vs. 8% for vancomycin. Of the patients who had at least one renal adverse event, 54% in each treatment group recovered completely, recovered with sequelae, or were improving from the renal AE at the last visit. Three percent of VIBATIV-treated patients and 2% of vancomycintreated patients experienced at least one serious renal adverse event. Renal adverse events resulted in discontinuation of study medication in 14 VIBATIV-treated patients (2%) and 7 vancomycin-treated patients (1%).

Increases in serum creatinine to 1.5 times baseline occurred more frequently among VIBATIV-treated patients (16%) compared with vancomycin-treated patients (10%).

Forty-four of 399 (11.0%) VIBATIV-treated patients ≥ 65 years of age had adverse events indicative of renal impairment compared with 30 of 352 patients (8%) < 65 years of age [see Use In Specific Populations].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIBATIV. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious hypersensitivity reactions have been reported after first or subsequent doses of VIBATIV, including anaphylactic reactions. It is unknown if patients with hypersensitivity reactions to vancomycin will experience cross-reactivity to telavancin. [see Hypersensitivity Reactions]

Read the Vibativ (telavancin for injection) Side Effects Center for a complete guide to possible side effects

Interactions

Drug-Laboratory Test Interactions

Effects of Telavancin on Coagulation Test Parameters

Telavancin binds to the artificial phospholipid surfaces added to common anticoagulation ests, thereby interfering with the ability of the coagulation complexes to assemble on the surface of the phospholipids and promote clotting in vitro. These effects appear to depend on the type of reagents used in commercially available assays. Thus, when measured shortly after completion of an infusion of VIBATIV, increases in the PT, INR, aPTT, and ACT have been observed. These effects dissipate over time, as plasma concentrations of telavancin decrease.

Urine Protein Tests

Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g., pyrogallol red-molybdate). However, microalbumin assays are not affected and can be used to monitor urinary protein excretion during VIBATIV treatment.

Read the Vibativ Drug Interactions Center for a complete guide to possible interactions


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Increased Mortality In Patients With HABP/VABP And Pre-existing Moderate To Severe Renal Impairment (CrCl ≤ 50 mL/min)

In the analysis of patients (classified by the treatment received) in the two combined HABP/VABP trials with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min), all-cause mortality within 28 days of starting treatment was 95/241 (39%) in the VIBATIV group, compared with 72/243 (30%) in the vancomycin group. All-cause mortality at 28 days in patients without pre-existing moderate/severe renal impairment (CrCl > 50 mL/min) was 86/510 (17%) in the VIBATIV group and 92/510 (18%) in the vancomycin group. Therefore, VIBATIV use in patients with baseline CrCl ≤ 50 mL/min should be considered only when the anticipated benefit to the patient outweighs the potential risk [see ADVERSE REACTIONS, Clinical Trials Experience and Clinical Trials, HABP/VABP].

Decreased Clinical Response In Patients With cSSSI And Pre-existing Moderate/Severe Renal Impairment (CrCl ≤ 50 mL/min)

In a subgroup analysis of the combined cSSSI trials, clinical cure rates in the VIBATIVtreated patients were lower in patients with baseline CrCl ≤ 50 mL/min compared with those with CrCl > 50 mL/min (Table 2). A decrease of this magnitude was not observed in vancomycin-treated patients. Consider these data when selecting antibacterial therapy for use in patients with cSSSI and with baseline moderate/severe renal impairment.

Table 2: Clinical Cure by Pre-existing Renal Impairment - Clinically Evaluable Population

  VIBATIV%
(n/N)

Vancomycin%
(n/N)

cSSSI Trials
CrCl > 50 mL/min 87.0% (520/598) 85.9% (524/610)
CrCl ≤ 50 mL/min 67.4% (58/86) 82.7% (67/81)

Nephrotoxicity

In both the HABP/VABP trials and the cSSSI trials, renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction (pre-existing renal disease, diabetes mellitus, congestive heart failure, or hypertension). The renal adverse event rates were also higher in patients who received concomitant medications known to affect kidney function (e.g., non-steroidal antiinflammatory drugs, ACE inhibitors, and loop diuretics).

Monitor renal function (i.e., serum creatinine, creatinine clearance) in all patients receiving VIBATIV. Values should be obtained prior to initiation of treatment, during treatment (at 48- to 72-hour intervals or more frequently, if clinically indicated), and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, and CLINICAL PHARMACOLOGY].

In patients with renal dysfunction, accumulation of the solubilizer hydroxypropyl-betacyclodextrin can occur [see Patients with Renal Impairment and CLINICAL PHARMACOLOGY].

Pregnant Women And Women Of Childbearing Potential

Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. VIBATIV caused adverse developmental outcomes in 3 animal species at clinically relevant doses. This raises concern about potential adverse developmental outcomes in humans.

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment [see Use In Specific Populations].

Coagulation Test Interference

Although telavancin does not interfere with coagulation, it interfered with certain tests used to monitor coagulation (Table 3), when conducted using samples drawn 0 to 18 hours after VIBATIV administration for patients being treated once every 24 hours. Blood samples for these coagulation tests should be collected as close as possible prior to a patient's next dose of VIBATIV. Blood samples for coagulation tests unaffected by VIBATIV may be collected at any time [see DRUG INTERACTIONS].

For patients who require aPTT monitoring while being treated with VIBATIV, a non phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.

Table 3: Coagulation Tests Affected and Unaffected by Telavancin

Affected by Telavancin Unaffected by Telavancin
Prothrombin time/international normalized ratio Thrombin time
Activated partial thromboplastin time Whole blood (Lee-White) clotting time
Activated clotting time Platelet aggregation study
Coagulation based factor X activity assay Chromogenic anti-factor Xa assay
  Functional (chromogenic) factor X activity assay
Bleeding time
D-dimer
Fibrin degradation products

No evidence of increased bleeding risk has been observed in clinical trials with VIBATIV. Telavancin has no effect on platelet aggregation. Furthermore, no evidence of hypercoagulability has been seen, as healthy subjects receiving VIBATIV have normal levels of D-dimer and fibrin degradation products.

Hypersensitivity Reactions

Serious and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. Discontinue VIBATIV at first sign of skin rash, or any other sign of hypersensitivity. Telavancin is a semi-synthetic derivative of vancomycin; it is unknown if patients with hypersensitivity reactions to vancomycin will experience crossreactivity to telavancin. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin [see Postmarketing Experience].

Infusion-Related Reactions

VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome”-like reactions including: flushing of the upper body, urticaria, pruritus, or rash. Stopping or slowing the infusion may result in cessation of these reactions.

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the flora of the colon and may permit overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin- producing strains of C. difficile cause increased morbidity and mortality, since these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Development Of Drug-Resistant Bacteria

Prescribing VIBATIV in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibacterial drugs, use of VIBATIV may result in overgrowth of nonsusceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken.

QTc Prolongation

In a study involving healthy volunteers, doses of 7.5 and 15 mg/kg of VIBATIV prolonged the QTc interval [see CLINICAL PHARMACOLOGY]. Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. Patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy were not included in clinical trials of VIBATIV. Use of VIBATIV should be avoided in patients with these conditions.

Patient Counseling Information

See Medication Guide.

Use During Pregnancy and By Women of Childbearing Potential

Women of childbearing potential (those who have not had: complete absence of menses for at least 24 months or medically confirmed menopause, medically confirmed primary ovarian failure, a history of hysterectomy, bilateral oophorectomy, or tubal ligation) should:

  • Be informed about the potential risk of fetal harm if VIBATIV is used during pregnancy
  • Have a pregnancy test prior to administration of VIBATIV
  • If not pregnant, use effective contraceptive methods to prevent pregnancy during VIBATIV treatment
  • Notify their prescribing physician/ healthcare provider if they become pregnant during VIBATIV treatment
Pregnancy Registry

There is a pregnancy registry that monitors pregnancy outcomes in women exposed to VIBATIV during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-855-6338479.

Diarrhea

Diarrhea is a common problem caused by antibiotics that usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having received the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Correct Use of Antibacterial Drugs

Patients should be counseled that antibacterial drugs including VIBATIV should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When VIBATIV is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of immediate treatment, and (2) increase the likelihood that the bacteria will develop resistance and will not be treatable by VIBATIV or other antibacterial drugs in the future.

Common Adverse Effects

Patients should be informed about the common adverse effects of VIBATIV including diarrhea, taste disturbance, nausea, vomiting, headache, and foamy urine. Patients should be instructed to inform their healthcare provider if they develop any unusual symptom, or if any known symptom persists or worsens. Patients should be instructed to inform their healthcare provider of any other medications they are currently taking with VIBATIV, including over-the-counter medications.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to determine the carcinogenic potential of telavancin have not been performed.

Neither mutagenic nor clastogenic potential of telavancin was found in a battery of tests including: assays for mutagenicity (Ames bacterial reversion), an in vitro chromosome aberration assay in human lymphocytes, and an in vivo mouse micronucleus assay.

Telavancin did not affect the fertility or reproductive performance of adult male rats (exposed to telavancin for at least 4 weeks prior to mating) or female rats (exposed to telavancin for at least 2 weeks prior to mating).

Male rats given telavancin for 6 weeks, at exposures similar to those measured in clinical studies, displayed altered sperm parameters that were reversible following an 8-week recovery period.

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category C

Pregnancy Exposure Registry

There is a pregnancy registry that monitors pregnancy outcomes in women exposed to VIBATIV during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the VIBATIV pregnancy registry by calling 1-855633- 8479.

Fetal Risk Summary

All pregnancies have a background risk of birth defects (about 3%), pregnancy loss (about 15%), or other adverse outcomes regardless of drug exposure.

There are no data on VIBATIV use in pregnant women. In 3 animal species, VIBATIV exposure during pregnancy at clinically relevant doses caused reduced fetal weights and increased rates of digit and limb malformations in offspring. These data raise concern about potential adverse developmental outcomes in humans (see Data).

Clinical Considerations

Given the lack of human data and the risks suggested by animal data, avoid using VIBATIV in pregnant women unless the benefits to the patient outweigh the potential risks to thefetus.

Data

Human Data

There are no data on human pregnancies exposed to VIBATIV.

Animal Data

In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively. These doses resulted in exposure levels approximately 1- to 2-fold the human exposure (AUC) at the maximum clinical recommended dose. Malformations observed at < 1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). Additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. Fetal body weights were decreased in rats.

In a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same AUC as observed at the maximum clinical dose) from the start of organogenesis through lactation. Offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. Brachymelia was also observed. Developmental milestones and fertility of the pups were unaffected.

Nursing Mothers

It is not known whether telavancin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VIBATIV is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of VIBATIV in pediatric patients has not been studied.

Geriatric Use

Of the 929 patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of cSSSI, 174 (19%) were ≥ 65 years of age and 87 (9%) were ≥ 75 years of age. In the cSSSI trials, lower clinical cure rates were observed in patients ≥ 65 years of age compared with those < 65 years of age. Overall, treatment-emergent adverse events occurred with similar frequencies in patients ≥ 65 (75% of patients) and < 65 years of age (83% of patients). Fifteen of 174 (9%) patients ≥ 65 years of age treated with VIBATIV had adverse events indicative of renal impairment compared with 16 of 755 (2%) patients < 65 years of age [see WARNINGS AND PRECAUTIONS, Clinical Trials].

Of the 749 HABP/VABP patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of HABP/VABP, 397 (53%) were ≥ 65 years of age and 230 (31%) were ≥ 75 years of age. Treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients ≥ 65 years of age than in those < 65 years of age in both treatment groups.

Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

The mean plasma AUC values of telavancin were similar in healthy young and elderly subjects. Dosage adjustment for elderly patients should be based on renal function [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].

Patients With Renal Impairment

The HABP/VABP and cSSSI trials included patients with normal renal function and patients with varying degrees of renal impairment. Patients with underlying renal dysfunction or risk factors for renal dysfunction had a higher incidence of renal adverse events [see WARNINGS AND PRECAUTIONS].

In the HABP/VABP studies higher mortality rates were observed in the VIBATIV-treated patients with baseline CrCl ≤ 50 mL/min. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment should be considered only when the anticipated benefit to the patient outweighs the potential risk [see WARNINGS AND PRECAUTIONS].

VIBATIV-treated patients in the cSSSI studies with baseline creatinine clearance ≤ 50 mL/min had lower clinical cure rates. Consider these data when selecting antibacterial therapy in patients with baseline moderate/severe renal impairment (CrCl ≤ 50 mL/min) [see WARNINGS AND PRECAUTIONS].

Dosage adjustment is required in patients with ≤ 50 mL/min renal impairment [see DOSAGE AND ADMINISTRATION]. There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl < 10 mL/min), including patients receiving hemodialysis [see OVERDOSAGE, CLINICAL PHARMACOLOGY].

Hydroxypropyl-beta-cyclodextrin is excreted in urine and may accumulate in patients with renal impairment. Serum creatinine should be closely monitored and, if renal toxicity is suspected, an alternative agent should be considered [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Patients With Hepatic Impairment

The HABP/VABP and cSSSI trials included patients with normal hepatic function and with hepatic impairment. No dosage adjustment is recommended in patients with mild or moderate hepatic impairment [see CLINICAL PHARMACOLOGY].


This monograph has been modified to include the generic and brand name in many instances.

OverDose

In the event of overdosage, VIBATIV should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function. Following administration of a single dose of VIBATIV 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of hemodialysis. However, no information is available on the use of hemodialysis to treat an overdosage [see CLINICAL PHARMACOLOGY].

The clearance of telavancin by continuous venovenous hemofiltration (CVVH) was evaluated in an in vitro study [see Nonclinical Toxicology]. Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate. However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdosage is unknown.

ContrainDications

Intravenous Unfractionated Heparin Sodium

Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Known Hypersensitivity To VIBATIV

VIBATIV is contraindicated in patients with known hypersensitivity to telavancin.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Telavancin is an antibacterial drug [see Microbiology].

Pharmacodynamics

The antimicrobial activity of telavancin appears to best correlate with the ratio of area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) for Staphylococcus aureus based on animal models of infection. Exposure-response analyses of the clinical trials support the dose of 10 mg/kg every 24 hours.

Cardiac Electrophysiology

The effect of telavancin on cardiac repolarization was assessed in a randomized, double-blind, multiple-dose, positive-controlled, and placebo-controlled, parallel study (n=160). Healthy subjects received VIBATIV 7.5 mg/kg, VIBATIV 15 mg/kg, positive control, or placebo infused over 60 minutes once daily for 3 days. Based on interpolation of the data from VIBATIV 7.5 mg/kg and 15 mg/kg, the mean maximum baseline-corrected, placebocorrected QTc prolongation at the end of infusion was estimated to be 12-15 msec for VIBATIV 10 mg/kg and 22 msec for the positive control (Table 7). By 1 hour after infusion the maximum QTc prolongation was 6-9 msec for VIBATIV and 15 msec for the positive control.

Table 7: Mean and Maximum QTcF Changes from Baseline Relative to Placebo

  QTcF1 Change from Baseline
Mean (Upper 90% Confidence Limit2) msec Maximum (Upper 90% Confidence Limit) msec
VIBATIV 7.5 mg/kg 4.1 (7) 11.6 (16)
VIBATIV 15 mg/kg 4.6 (8) 15.1 (20)
Positive Control 9.5 (13) 21.6 (26)
1 Fridericia corrected
2Upper CL from a 2-sided 90% CI on difference from placebo (msec)

ECGs were performed prior to and during the treatment period in patients receiving VIBATIV 10 mg/kg in 3 cSSSI studies to monitor QTc intervals. In these trials, 214 of 1029 (21%) patients allocated to treatment with VIBATIV and 164 of 1033 (16%) allocated to vancomycin received concomitant medications known to prolong the QTc interval and known to be associated with definite or possible risk of torsades de pointes. The incidence of QTc prolongation > 60 msec was 1.5% (15 patients) in the VIBATIV group and 0.6% (6 patients) in the vancomycin group. Nine of the 15 VIBATIV patients received concomitant medications known to prolong the QTc interval and definitely or possibly associated with a risk of torsades de pointes, compared with 1 of the 6 patients who received vancomycin. A similar number of patients in each treatment group ( < 1%) who did not receive a concomitant medication known to prolong the QTc interval experienced a prolongation > 60 msec from baseline. In a separate analysis, 1 patient in the VIBATIV group and 2 patients in the vancomycin group experienced QTc > 500 msec. No cardiac adverse events were ascribed to prolongation of the QTc interval. In the Phase 3 HABP/VABP studies, the incidence of QTc prolongation > 60 msec or mean value > 500 msec was 8% (52 patients) in the telavancin group and 7% (48 patients) in the vancomycin group.

Pharmacokinetics

The mean pharmacokinetic parameters of telavancin (10 mg/kg) after a single and multiple 60-minute intravenous infusions (10 mg/kg every 24 hours) are summarized in Table 8.

Table 8: Pharmacokinetic Parameters of Telavancin in Healthy Adults, 10 mg/kg

  Single Dose
(n=42)
Multiple Dose
(n=36)
Cmax (mcg/mL) 93.6 ±14.2 108 ± 26
AUC0-∞(mcg•hr/mL) 747 ± 129 -1
AUC0-24h (mcg•hr/mL) 666 ± 107 780 ± 125
t½ (hr) 8.0 ± 1.5 8.1 ± 1.5
Cl (mL/hr/kg) 13.9 ± 2.9 13.1 ± 2.0
Vss (mL/kg) 145 ± 23 133 ± 24
Cmax maximum plasma concentration
AUC area under concentration-time course
t½ terminal elimination half-life
Cl clearance
Vss apparent volume of distribution at steady state
1 Data not available

In healthy young adults, the pharmacokinetics of telavancin administered intravenously were linear following single doses from 5 to 12.5 mg/kg and multiple doses from 7.5 to 15 mg/kg administered once daily for up to 7 days. Steady-state concentrations were achieved by the third daily dose.

Distribution

Telavancin binds to human plasma proteins, primarily to serum albumin, in a concentration-independent manner. The mean binding is approximately 90% and is not affected by renal or hepatic impairment.

Concentrations of telavancin in pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) were measured through collection of bronchoalveolar lavage fluid at various times following administration of VIBATIV 10 mg/kg once daily for 3 days to healthy adults. Telavancin concentrations in ELF and AM exceeded the MIC90 for S. aureus (0.5 mcg/mL) for at least 24 hours following dosing.

Concentrations of telavancin in skin blister fluid were 40% of those in plasma (AUC0-24hr ratio) after 3 daily doses of 7.5 mg/kg VIBATIV in healthy young adults.

Metabolism

No metabolites of telavancin were detected in in vitro studies using human liver microsomes, liver slices, hepatocytes, and kidney S9 fraction. None of the following recombinant CYP 450 isoforms were shown to metabolize telavancin in human liver microsomes: CYP 1A2, 2C9, 2C19, 2D6, 3A4, 3A5, 4A11. The clearance of telavancin is not expected to be altered by inhibitors of any of these enzymes.

In a mass balance study in male subjects using radiolabeled telavancin, 3 hydroxylated metabolites were identified with the predominant metabolite (THRX-651540) accounting for < 10% of the radioactivity in urine and < 2% of the radioactivity in plasma. The metabolic pathway for telavancin has not been identified.

Excretion

Telavancin is primarily eliminated by the kidney. In a mass balance study, approximately 76% of the administered dose was recovered from urine and < 1% of the dose was recovered from feces (collected up to 216 hours) based on total radioactivity.

Specific Populations

Geriatric Patients

The impact of age on the pharmacokinetics of telavancin was evaluated in healthy young (range 21-42 years) and elderly (range 65-83 years) subjects. The mean CrCl of elderly subjects was 66 mL/min. Age alone did not have a clinically meaningful impact on the pharmacokinetics of telavancin [see Use In Specific Populations].

Pediatric Patients

The pharmacokinetics of telavancin in patients less than 18 years of age have not been studied.

Gender

The impact of gender on the pharmacokinetics of telavancin was evaluated in healthy male (n=8) and female (n=8) subjects. The pharmacokinetics of telavancin were similar in males and females. No dosage adjustment is recommended based on gender.

Renal Impairment

The pharmacokinetics of telavancin were evaluated in subjects with normal renal function and subjects with varying degrees of renal impairment following administration of a single dose of telavancin 7.5 mg/kg (n=28). The mean AUC0-« values were approximately 13%, 29%, and 118% higher for subjects with CrCl > 50 to 80 mL/min, CrCl 30 to 50 mL/min, and CrCl < 30 mL/min, respectively, compared with subjects with normal renal function. Dosage adjustment is required in patients with CrCl ≤ 50 mL/min [see DOSAGE AND ADMINISTRATION].

Creatinine clearance was estimated from serum creatinine based on the Cockcroft-Gault formula:

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)

*Use actual body weight if < ideal body weight (IBW)

IBW (male) = 50 kg + 0.9 kg/cm over 152 cm height

IBW (female) = 45.5 kg + 0.9 kg/cm over 152 cm height

Following administration of a single dose of VIBATIV 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of hemodialysis. The effects of peritoneal dialysis have not been studied.

Following a single intravenous dose of VIBATIV 7.5 mg/kg, the clearance of hydroxypropylbeta- cyclodextrin was reduced in subjects with renal impairment, resulting in a higher exposure to hydroxypropyl-beta-cyclodextrin. In subjects with mild, moderate, and severe renal impairment, the mean clearance values were 38%, 59%, and 82% lower, respectively, compared with subjects with normal renal function. Multiple infusions of VIBATIV may result in accumulation of hydroxypropyl-beta-cyclodextrin.

Hepatic Impairment

The pharmacokinetics of telavancin were not altered in subjects with moderate hepatic impairment (n= 8, Child-Pugh B) compared with healthy subjects with normal hepatic function matched for gender, age, and weight. The pharmacokinetics of telavancin have not been evaluated in patients with severe hepatic impairment (Child-Pugh C).

Drug Interactions

In Vitro

The inhibitory activity of telavancin against the following CYP 450 enzymes was evaluated in human liver microsomes: CYP 1A2, 2C9, 2C19, 2D6, and 3A4/5. Telavancin inhibited CYP 3A4/5 at potentially clinically relevant concentrations. Upon further evaluation in a Phase 1 clinical trial, telavancin was found not to inhibit the metabolism of midazolam, a sensitive CYP3A substrate (see below).

Midazolam

The impact of telavancin on the pharmacokinetics of midazolam (CYP 3A4/5 substrate) was evaluated in 16 healthy adult subjects following administration of a single dose of VIBATIV 10 mg/kg, intravenous midazolam 1 mg, and both. The results showed that telavancin had no impact on the pharmacokinetics of midazolam and midazolam had no effect on the pharmacokinetics of telavancin.

Aztreonam

The impact of telavancin on the pharmacokinetics of aztreonam was evaluated in 11 healthy adult subjects following administration of a single dose of VIBATIV 10 mg/kg, aztreonam 2 g, and both. Telavancin had no impact on the pharmacokinetics of aztreonam and aztreonam had no effect on the pharmacokinetics of telavancin. No dosage adjustment of telavancin or aztreonam is recommended when both drugs are coadministered.

Piperacillin-tazobactam

The impact of telavancin on the pharmacokinetics of piperacillin-tazobactam was evaluated in 12 healthy adult subjects following administration of a single dose of VIBATIV 10 mg/kg, piperacillin-tazobactam 4.5 g, and both. Telavancin had no impact on the pharmacokinetics of piperacillin-tazobactam and piperacillin-tazobactam had no effect on the pharmacokinetics of telavancin. No dosage adjustment of telavancin or piperacillintazobactam is recommended when both drugs are coadministered.

Microbiology

Telavancin is a semisynthetic, lipoglycopeptide antibiotic. Telavancin exerts concentration-dependent, bactericidal activity against Gram-positive organisms in vitro, as demonstrated by time-kill assays and MBC/MIC (minimum bactericidal concentration/minimum inhibitory concentration) ratios using broth dilution methodology. In vitro studies demonstrated a telavancin post-antibiotic effect ranging from 1 to 6 hours against S. aureus and other Gram-positive pathogens.

Mechanism of Action

Telavancin inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II. Telavancin also binds to the bacterial membrane and disrupts membrane barrier function.

Interactions with Other Antibacterial Drugs

In vitro investigations demonstrated no antagonism between telavancin and amikacin, aztreonam, cefepime, ceftriaxone, ciprofloxacin, gentamicin, imipenem, meropenem, oxacillin, piperacillin/tazobactam, rifampin, and trimethoprim/sulfamethoxazole when tested in various combinations against telavancin-susceptible staphylococci, streptococci, and enterococci. This information is not available for other bacteria.

Cross-Resistance

Some vancomycin-resistant enterococci have a reduced susceptibility to telavancin. There is no known cross-resistance between telavancin and other classes of antibacterial drugs.

Antibacterial Activity

Telavancin has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections as described in the Indications and Usage section [see INDICATIONS AND USAGE]:

Facultative Gram-Positive Microorganisms

Staphylococcus aureus (including methicillin-resistant isolates)
Enterococcus faecalis (vancomycin-susceptible isolates only)
Streptococcus agalactiae
Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Streptococcus pyogenes

Greater than 90% of the following microorganisms exhibit an in vitro MIC less than or equal to the telavancin-susceptible breakpoint for organisms of similar genus shown in Table 9. The safety and effectiveness of telavancin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Facultative Gram-Positive Microorganisms

Enterococcus faecium (vancomycin-susceptible isolates only)
Staphylococcus haemolyticus

Streptococcus dysgalactiae
subsp. equisimilis
Staphylococcus epidermidis

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide cumulative results of the in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antimicrobial drug.

Dilution Technique

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure [see REFERENCES]. Standardized procedures are based on a broth dilution method or equivalent with standardized inoculum concentrations and standardized concentrations of telavancin powder. The test method treats telavancin as a water-insoluble agent. Dimethyl sulfoxide is used as solvent and diluent, and the cation-adjusted Mueller Hinton Broth test medium is supplemented with polysorbate 80 to a final concentration of 0.002%. Telavancin should not be tested by the agar dilution method. The MIC values should be interpreted according to the criteria provided in Table 9.

Diffusion Technique

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure requires the use of standardized inoculum concentrations [see REFERENCES]. This procedure uses paper disks impregnated with 30 mcg of telavancin to test the susceptibility of microorganisms to telavancin. The disk diffusion interpretive criteria are provided in Table 9.

Table 9: Susceptibility Interpretive Criteria for Telavancin

  Susceptibility Interpretive Criteria1
Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion Zone Diameter (mm)
S I R S I R
Staphylococcus aureus (including methicillin-resistant isolates) ≤ 0.12 -- -- ≥ 15 -- --
Streptococcus pyogenes Streptococcus agalactiae ≤ 0.12 -- -- ≥ 15 -- --
Streptococcus anginosus group ≤ 0.06     ≥ 15    
Enterococcus faecalis (vancomycin-susceptible isolates only) ≤ 0.25 -- -- ≥ 15 -- --
1 The current absence of resistant isolates precludes defining any results other than “susceptible.” Isolates yielding results other than susceptible should be subjected to additional testing.

A report of “susceptible” indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound in the blood reaches the concentrations usually achievable.

Quality Control

Standardized susceptibility test procedures require the use of laboratory control microorganisms to monitor the performance of the supplies and reagents used in the assay, and the techniques of the individuals performing the test [see REFERENCES]. Standard telavancin powder should provide the range of values noted in Table 10.

Quality control microorganisms are specific strains of organisms with intrinsic biological properties relating to resistance mechanisms and their genetic expression within bacteria; the specific strains used for microbiological quality control are not clinically significant.

Table 10: Acceptable Quality Control Ranges for Telavancin to be used in Validation of Susceptibility Test Results

  Acceptable Quality Control Ranges
Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion Zone Diameter (mm)
Enterococcus faecalis ATCC 29212 0.03 - 0.12 Not applicable
Staphylococcus aureus ATCC 29213 0.03 - 0.12 Not applicable
Staphylococcus aureus ATCC 25923 Not applicable 16-20
Streptococcus pneumoniae ATCC 496191 0.004 - 0.015 17-24
1 This organism may be used for validation of susceptibility test results when testing Streptococcus spp. other than S. pneumoniae

Animal Toxicology And/Or Pharmacology

Two-week administration of telavancin in rats produced minimal renal tubular vacuolization with no changes in BUN or creatinine. These effects were not seen in studies conducted in dogs for similar duration. Four weeks of treatment resulted in reversible elevations in BUN and/or creatinine in association with renal tubular degeneration that further progressed following 13 weeks of treatment.

These effects occurred at exposures (based on AUCs) that were similar to those measured in clinical trials.

The potential effects of continuous venovenous hemofiltration (CVVH) on the clearance of telavancin were examined in an in vitro model using bovine blood. Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate [see OVERDOSAGE].

Clinical Trials

Complicated Skin And Skin Structure Infections

Adult patients with clinically documented complicated skin and skin structure infections (cSSSI) were enrolled in two randomized, multinational, multicenter, double-blinded trials (Trial 1 and Trial 2) comparing VIBATIV (10 mg/kg IV every 24 hours) with vancomycin (1 g IV every 12 hours) for 7 to 14 days. Vancomycin dosages could be adjusted per site-specific practice. Patients could receive concomitant aztreonam or metronidazole for suspected Gram-negative and anaerobic infection, respectively. These trials were identical in design, enrolling approximately 69% of their patients from the United States.

The trials enrolled adult patients with cSSSI with suspected or confirmed MRSA as the primary cause of infection. The all-treated efficacy (ATe) population included all patients who received any amount of study medication according to their randomized treatment group and were evaluated for efficacy. The clinically evaluable population (CE) included patients in the ATe population with sufficient adherence to the protocol.

The ATe population consisted of 1,794 patients. Of these, 1,410 (79%) patients were clinically evaluable (CE). Patient baseline infection types were well-balanced between treatment groups and are presented in Table 11.

Table 11: Baseline Infection Types in Patients in cSSSI Trials 1 and 2 - ATe Population

  VIBATIV
(N=884)1
Vancomycin
(N=910)1
Type of infection
Major Abscess 375 (42.4%) 397 (43.6%)
Deep/Extensive Cellulitis 309 (35.0%) 337 (37.0%)
Wound Infection 139 (15.7%) 121 (13.3%)
Infected Ulcer 45 (5.1%) 46 (5.1%)
Infected Burn 16 (1.8%) 9 (1.0%)
1 Includes all patients randomized, treated, and evaluated for efficacy

The primary efficacy endpoints in both trials were the clinical cure rates at a follow-up (Test of Cure) visit in the ATe and CE populations. Clinical cure rates in Trials 1 and 2 are displayed for the ATe and CE population in Table 12.

Table 12: Clinical Cure at Test-of-Cure in cSSSI Trials 1 and 2 - ATe and CE Populations

View Enlarged Table

The cure rates by pathogen for the microbiologically evaluable (ME) population are presented in Table 13.

Table 13: Clinical Cure Rates at the Test-of-Cure for the Most Common Pathogens in cSSSI Trials 1 and 2 - ME Population1

  VIBATIV
% (n/N)
Vancomycin
% (n/N)
Staphylococcus aureus(MRSA) 87.0% (208/239) 85.9% (225/262)
Staphylococcus aureus(MSSA) 82.0% (132/161) 85.1% (131/154)
Enterococcus faecalis 95.6% (22/23) 80.0% (28/35)
Streptococcus pyogenes 84.2% (16/19) 90.5% (19/21)
Streptococcus agalactiae 73.7% (14/19) 86.7% (13/15)
Streptococcus anginosus group 76.5% (13/17) 100.0% (9/9)

1 The ME population included patients in the CE population who had Gram-positive pathogens isolated at baseline and had central identification and susceptibility of the microbiological isolate(s).

In the two cSSSI trials, clinical cure rates were similar across gender and race. Clinical cure rates in the VIBATIV clinically evaluable (CE) population were lower in patients ≥ 65 years of age compared with those < 65 years of age. A decrease of this magnitude was not observed in the vancomycin CE population. Clinical cure rates in the VIBATIV CE population < 65 years of age were 503/581 (87%) and in those ≥ 65 years were 88/122 (72%). In the vancomycin CE population clinical cure rates in patients < 65 years of age were 492/570 (86%) and in those ≥ 65 years was 111/137 (82%). Clinical cure rates in the VIBATIV-treated patients were lower in patients with baseline CrCl ≤ 50 mL/min compared with those with CrCl > 50 mL/min. A decrease of this magnitude was not observed in the vancomycin-treated patients [see WARNINGS AND PRECAUTIONS].

HABP/VABP

Adult patients with hospital-acquired and ventilator-associated pneumonia were enrolled in two randomized, parallel-group, multinational, multicenter, double-blinded trials of identical design comparing VIBATIV (10 mg/kg IV every 24 hours) with vancomycin (1 g IV every 12 hours) for 7 to 21 days. Vancomycin dosages could be adjusted for body weight and/or renal function per local guidelines. Patients could receive concomitant aztreonam or metronidazole for suspected Gram-negative and anaerobic infection, respectively. The addition of piperacillin/tazobactam was also permitted for coverage of Gram-negative organisms if resistance to aztreonam was known or suspected. Patients with known or suspected infections due to methicillin-resistant Staphylococcus aureus were enrolled in the studies.

Of the patients enrolled across both trials, 64% were male and 70% were white. The mean age was 63 years. At baseline, more than 50% were admitted to an intensive care unit, about 23% had chronic obstructive pulmonary disease, about 29% had ventilator-associated pneumonia and about 6% had bacteremia. Demographic and baseline characteristics were generally well-balanced between treatment groups; however, there were differences between HABP/VABP Trial 1 and HABP/VABP Trial 2 with respect to a baseline history of diabetes mellitus (31% in Trial 1, 21% in Trial 2) and baseline renal insufficiency (CrCl ≤ 50 mL/min) (36% in Trial 1, 27% in Trial 2).

All-cause mortality was evaluated because there is historical evidence of treatment effect for this endpoint. This was a protocol pre-specified secondary endpoint. The 28-day all-cause mortality outcomes (overall and by baseline creatinine clearance categorization) in the group of patients who had at least one baseline Gram-positive respiratory pathogen are shown in Table 14. This group of patients included those who had mixed Gram-positive/Gramnegative infections.

Table 14: All-Cause Mortality at Day 28 in Patients with at least One Baseline Gram- Positive Pathogen

    Trial 1 Trial 2
VIBATIV Vancomycin VIBATIV Vancomycin
All Patients Mortalitya 28.7% 24.3% 24.3% 22.3%
N=187 N=180 N=224 N=206
Difference (95% CI) 4.4% (-4.7%, 13.5%) 2.0% (-6.1%, 10%)
CrCl ≤ 50 mL/min Mortalitya 41.8% 35.4% 43.9% 29.6%
N=63 N=68 N=53 N=58
Difference (95% CI) 6.4% (-10.4, 23.2) 14.3% (-3.6, 32.2)
CrCl > 50 mL/min Mortalitya 22.0% 17.6% 18.2% 19.3%
N=124 N=112 N=171 N=148
Difference (95% CI) 4.4% (-5.9, 14.7) -1.1% (-9.8, 7.6)
aMortality rates are based on Kaplan-Meier estimates at Study Day 28. There were 84 patients (5.6%) whose survival statuses were not known up to 28 days after initiation of study drug and were considered censored at the last day known to be alive. Thirty-five of these patients were treated with VIBATIV and 45 were treated with vancomycin.

The protocol-specified analysis included clinical cure rates at the TOC (7 to 14 days after the last dose of study drug) in the co-primary All-Treated (AT) and Clinically Evaluable (CE) populations (Table 15). Clinical cure was determined by resolution of signs and symptoms, no further antibacterial therapy for HABP/VABP after end-of-treatment, and improvement or no progression of baseline radiographic findings. However, the quantitative estimate of treatment effect for this endpoint has not been established.

Table 15: Clinical Response Rates in Trials 1 and 2 - AT and CE Populations

  Trial 1 Trial 2
VIBATIV Vancomycin VIBATIV Vancomycin
ATa 57.5% (214/372) 59.1% (221/374) 60.2% (227/377) 60.0% (228/380)
Difference (95% CI) -1.6% (-8.6%, 5.5%) 0.2% (-6.8%, 7.2%)
CEb 83.7% (118/141) 80.2% (138/172) 81.3% (139/171) 81.2% (138/170)
Difference (95% CI) 3.5% (-5.1%, 12.0%) 0.1% (-8.2%, 8.4%)
aAll-Treated (AT) Population: Patients who received at least one dose of study medication
bClinically Evaluable (CE) Population: Patients who were clinically evaluable

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement, CLSI document M100-S24, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2014.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

VIBATIV®
(vy-'ba-tiv)
(telavancin) for Injection

Read this Medication Guide before you receive VIBATIV. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about VIBATIV?

VIBATIV can cause serious side effects, including:

  • Increased risk of death. VIBATIV was associated with an increased risk of death compared to vancomycin in people who already had kidney problems and were treated for bacterial pneumonia that you can get when you are in the hospital.
  • New or worsening kidney problems. Your healthcare provider should do a blood test to check your kidneys before you start, while you receive, and after you stop receiving VIBATIV.
  • VIBATIV may harm your unborn baby. Women who can become pregnant should have a blood pregnancy test before receiving VIBATIV.
    • Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if VIBATIV is the right medicine for you.
    • Women who can become pregnant should use effective birth control (contraception) while receiving VIBATIV.
    • If you become pregnant while receiving VIBATIV, tell your healthcare provider right away. Talk to your healthcare provider about taking part in the VIBATIV Pregnancy Registry. This is a study to learn how VIBATIV affects pregnancy and babies. You can enroll in this registry by calling 1-855-633-8479.

What is VIBATIV?

VIBATIV is a prescription antibacterial medicine used alone, or with other medicines, to treat adults with certain types of germs (bacteria) that cause:

  • Serious skin infections
  • Hospital-Acquired Bacterial Pneumonia (HABP)
  • Ventilator-Associated Bacterial Pneumonia (VABP)

It is not known if VIBATIV is safe or effective in children under 18 years of age.

Who should not take VIBATIV?

Do not take VIBATIV if you:

  • are allergic to telavancin or any of the ingredients in VIBATIV. See the end of this Medication Guide for a complete list of ingredients in VIBATIV.

What should I tell my healthcare provider before receiving VIBATIV?

Before you receive VIBATIV, tell your healthcare provider if you:

  • have had a serious allergic reaction to VIBATIV or vancomycin
  • have kidney problems
  • have diabetes
  • have or have had heart problems, including QTc prolongation or a family history of it
  • have high blood pressure
  • have any other medical conditions
  • are breastfeeding or plan to breastfeed. It is not known if VIBATIV passes into breast milk. You and your healthcare provider should decide if you will breastfeed while receiving VIBATIV.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. VIBATIV and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

  • a Non-Steroidal Anti-Inflammatory Drug (NSAID)
  • certain blood pressure medicines called ACE Inhibitors or ARBs
  • water pills (diuretics)
  • a blood thinner
  • medicine to control your heart rate or rhythm (antiarrhythmics)

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive VIBATIV?

  • VIBATIV is given by your healthcare provider through a needle placed into your vein (IV infusion) slowly over 1 hour, 1 time each day, for 7 to 21 days.
  • Do not stop receiving VIBATIV unless your healthcare provider tells you to, even if you feel better.
  • Your healthcare provider will do blood tests before you start and while you receive VIBATIV.

What are the possible side effects of VIBATIV?

VIBATIV may cause serious side effects, including:

See “What is the most important information I should know about VIBATIV?”

  • Serious allergic reactions. Allergic reactions can happen in people who take VIBATIV, even after only one dose. Stop taking VIBATIV and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
    • hives
    • trouble breathing or swallowing
    • swelling of the lips, tongue, face
    • throat tightness, hoarseness
    • rapid heartbeat
    • faint
  • Infusion-related reactions. People who receive VIBATIV too quickly can have a certain type of skin reaction called “Red-man Syndrome”. Signs and symptoms of Red-man Syndrome can include:
    • red color (flushing)
    • rash
    • itching
  • Problems with the electrical system of your heart (QTc prolongation). Tell your healthcare provider right away if you have a change in your heartbeat such as a fast or irregular heartbeat or if you had a fainting episode.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of VIBATIV include:

  • change in your sense of taste
  • nausea
  • vomiting
  • foamy urine
  • diarrhea

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of VIBATIV. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VIBATIV?

  • Store VIBATIV in the original package
  • Keep VIBATIV refrigerated between 350F to 460F (20C to 80C)
  • Keep out of heat

Keep VIBATIV and all medicines out of the reach of children.

General Information about the safe and effective use of VIBATIV.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIBATIV for a condition for which it is not prescribed.

This Medication Guide summarizes the most important information about VIBATIV. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about VIBATIV that is written for health professionals.

For more information, go to www.vibativ.com or call 1-855-633-8479.

What are the ingredients in VIBATIV?

Active ingredient: telavancin hydrochloride

Inactive ingredients: hydroxypropylbetadex, Ph. Eur (hydroxypropyl-beta-cyclodextrin), mannitol, sodium hydroxide and hydrochloric acid


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

TELAVANCIN - INJECTION

 

(TEL-a-VAN-sin)

 

COMMON BRAND NAME(S): Vibativ

 

WARNING: Adults with moderate to severe kidney disease who are using telavancin to treat serious lung infections may be at an increased risk for death. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for lung infections, with your doctor.

Telavancin may cause or worsen kidney problems. Problems are more likely to occur if you have heart failure, kidney disease, diabetes, or high blood pressure, or if you take certain medications (see also Drug Interactions section). Kidney function tests must be performed before you start treatment, during treatment, and after you finish treatment to check for kidney problems. Tell your doctor right away if you have any symptoms of kidney problems such as a change in the amount of urine.

This drug may cause harm to an unborn baby if used during pregnancy. Women of childbearing age should have a pregnancy test before starting this medication. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

 

USES: This medication is an antibiotic used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using telavancin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually once a day. It should be injected slowly over 60 minutes. The dosage and length of treatment is based on your weight, medical condition, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Flushing of the upper body may occur if this medication is injected too fast ("red man syndrome"). Tell your doctor immediately if this occurs. The infusion of this medication may need to be slowed or stopped.

Metallic/soapy taste, nausea, vomiting, or foamy urine may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Vibativ (telavancin for injection) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before using telavancin, tell your doctor or pharmacist if you are allergic to it; or to vancomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Telavancin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using telavancin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using telavancin safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Telavancin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that may affect the kidneys (including NSAIDs such as ibuprofen).

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This medication may interfere with certain laboratory tests (including coagulation tests such as PT/INR/APPT, urine protein tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: See also Warning section.

Laboratory and/or medical tests (such as kidney function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

 

Patient Detailed Side Effect

Brand Names: Vibativ

Generic Name: telavancin (Pronunciation: TEL a VAN sin)

  • What is telavancin (Vibativ)?
  • What are the possible side effects of telavancin (Vibativ)?
  • What is the most important information I should know about telavancin (Vibativ)?
  • What should I discuss with my health care provider before using telavancin (Vibativ)?
  • How is telavancin given (Vibativ)?
  • What happens if I miss a dose (Vibativ)?
  • What happens if I overdose (Vibativ)?
  • What should I avoid while using telavancin (Vibativ)?
  • What other drugs will affect telavancin (Vibativ)?
  • Where can I get more information?

What is telavancin (Vibativ)?

Telavancin is an antibiotic that treats infection caused by bacteria.

Telavancin is used to treat severe skin infections.

Telavancin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of telavancin (Vibativ)?

Some people receiving a telavancin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your doctor right away if you feel itchy or tingly, or have a red rash on your upper body during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain, loss of appetite;
  • chills or shivering;
  • headache, dizziness;
  • foamy appearance in your urine;
  • unusual or unpleasant taste in your mouth;
  • vaginal itching or discharge;
  • mild skin rash or itching; or
  • redness or pain around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Vibativ (telavancin for injection) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about telavancin (Vibativ)?

Before using this medication, tell your doctor if you are pregnant. You may need a pregnancy test to determine whether you are pregnant before you start using telavancin.

If you are not pregnant before you start using telavancin, use effective birth control to prevent pregnancy during treatment. Any woman who could possibly become pregnant should use birth control during treatment with telavancin.

If you are a woman using telavancin, you are considered able to become pregnant unless you have ovarian failure, have had a tubal ligation or hysterectomy, or have been in menopause or not had a menstrual period in 2 years.

Telavancin can be harmful to the kidneys, and this effect is increased when telavancin is used together with other medicines that can harm the kidneys. Before using telavancin, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, a diuretic (water pill), or any other injected antibiotics.

If you have kidney disease, you may need a dose adjustment or special tests to safely use telavancin.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Telavancin will not treat a viral infection such as the common cold or flu.

Call your doctor right away if you have a serious side effect such as watery or bloody diarrhea, confusion, thirst, swelling, feeling short of breath, or urinating less than usual or not at all

Side Effects Centers
  • Vibativ

Patient Detailed How Take

What should I discuss with my health care provider before using telavancin (Vibativ)?

You should not use this medication if you are allergic to it.

If you have kidney disease, you may need a dose adjustment or special tests to safely use telavancin.

FDA pregnancy category C. It is not known whether telavancin is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant. You may need a pregnancy test to determine whether you are pregnant before you start using telavancin.

Your name may need to be listed on a pregnancy registry if you use telavancin while you are pregnant. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether telavancin had any effect on the baby.

If you are not pregnant before you start using telavancin, use effective birth control to prevent pregnancy during treatment. Any woman who could possibly become pregnant should use birth control during treatment with telavancin.

If you are a woman using telavancin, you are considered able to become pregnant unless you have ovarian failure, have had a tubal ligation or hysterectomy, or have been in menopause or not had a menstrual period in 2 years.

It is not known whether telavancin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is telavancin given (Vibativ)?

Telavancin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Telavancin must be given slowly through an IV infusion, and can take at least 1 hour to complete.

This medication is usually given once every 24 hours for 7 to 14 days. Follow your doctor's instructions.

Telavancin powder must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Telavancin will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your kidney function will need to be checked with blood tests on a regular basis. Do not miss any follow-up visits to your doctor.

Telavancin can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using telavancin.

Store telavancin powder in the refrigerator. Do not freeze.

After mixing telavancin with a diluent, you may store the mixture in the refrigerator and use it within 72 hours. Do not freeze.

Mixed medicine may also be stored at room temperature, but you must then use it within 4 hours after mixing.

Do not use the mixed medication if it has changed colors or has any particles in it. Mix a new dose.

Side Effects Centers
  • Vibativ

Patient Detailed Avoid Taking

What happens if I miss a dose (Vibativ)?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose (Vibativ)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, increased thirst, vomiting, swelling, and urinating less than usual or not at all.

What should I avoid while using telavancin (Vibativ)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What other drugs will affect telavancin (Vibativ)?

Telavancin can be harmful to the kidneys, and this effect is increased when telavancin is used together with other medicines that can harm the kidneys. Before using telavancin, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, a diuretic (water pill), or any other injected antibiotics.

Tell your doctor about all other medications you use, especially:

  • arsenic trioxide (Trisenox);
  • droperidol (Inapsine);
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
  • an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);
  • anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace);
  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
  • migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
  • narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).

This list is not complete and there may be other drugs that can interact with telavancin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about telavancin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI