Drugs Details

Drugs Info of Navelbine
Drugs Details
  • Drugs Type  : FDA
  • Date : 3rd Jul 2015 04:52 am
  • Brand Name : Navelbine
  • Generic Name : vinorelbine (Pronunciation: vin OR el been)
Descriptions

NAVELBINE (vinorelbine tartrate) is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:

 

NAVELBINE® (vinorelbine tartrate) Structural Formula Illustration

C45H54N4O82C4H6O6      M.W. 1079.12.

 

NAVELBINE Injection is a sterile nonpyrogeinc aqueous solution. Each milliliter of solution contains 10 mg vinorelbine tartrate in Water for Injection. The pH of NAVELBINE Injection is approximately 3.5.

 

What are the possible side effects of vinorelbine (Navelbine)?

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:

  • signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • cough, bronchospasm (wheezing, chest tightness, trouble breathing);
  • severe constipation, stomach pain, bloody or black stools;
  • pale skin, feeling light-headed or short of breath,...

Read All Potential Side Effects and See Pictures of Navelbine »

What are the precautions when taking vinorelbine tartrate (Navelbine)?

Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.

Vinorelbine can...

Read All Potential Precautions of Navelbine »

Indications

NAVELBINE is indicated:

  • In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • As a single agent, for the treatment of patients with metastatic NSCLC

Dosage Administration

Recommended Dose

In Combination with Cisplatin 100 mg/m²
  • The recommended dose of NAVELBINE is 25 mg/m² administered as an intravenous injection or infusion over 6 to 10 minutes on days 1, 8, 15 and 21 of a 28 day cycle in combination with cisplatin 100 mg/m² on day 1 only of each 28 day cycle.
In Combination with Cisplatin 120 mg/m²
  • The recommended dose of NAVELBINE is 30 mg/m² administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m² on days 1 and 29, then every 6 weeks.
Single-Agent

The recommended dose of NAVELBINE is 30 mg/m² administered intravenously over 6 to 10 minutes once a week.

Dose Modifications

Hematologic Toxicity

[see WARNINGS AND PRECAUTIONS]

Hold or decrease the dose of NAVELBINE in patients with decreasedneutrophil counts using the following schema.

 

NEUTROPHILS ON DAY OF TREATMENT (CELLS/MM³) PERCENTAGE OF STARTING DOSE OF NAVELBINE
≥ 1,500 100%
1,000 to 1,499 50%
< 1,000 Do not administer NAVELBINE. Repeat neutrophil count in one week. If three consecutive weekly doses are held because Neutrophil count is < 1,000 cells/mm³, discontinue NAVELBINE
Note : For patients who experience fever and/or sepsis while neutrophil count is < 1,500 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of NAVELBINE should be:
> 1,500 75%
1,000 to 1,499 37.5%
< 1,000 Do not administer NAVELBINE. Repeat neutrophil count in one week.

 

Hepatic Impairment/Toxicity

[see WARNINGS AND PRECAUTIONS and Use In Specific Populations]

Reduce NAVELBINE dose in patients with elevated serum total bilirubin concentration according to the following schema:

 

SERUM TOTAL BILIRUBIN CONCENTRATION (MG/DL) PERCENTAGE OF STARTING DOSE OF NAVELBINE
≤ 2.0 100%
2.1 to 3.0 50%
> 3.0 25%

 

Concurrent Hematologic Toxicity and Hepatic Impairment

In patients with both hematologic toxicity and hepatic impairment, administer the lower of the doses based on the corresponding starting dose of NAVELBINE determined from the above schemas.

Neurologic Toxicity

[see WARNINGS AND PRECAUTIONS] Discontinue NAVELBINE for NCICTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathycausing constipation.

Preparation And Administration

Preparation of NAVELBINE

Dilute NAVELBINE in either a syringe or intravenous bag using one of the recommended solutions.

Syringe

Dilute to a concentration between 1.5 and 3 mg/mL. The following solutions may be used for dilution:

  • 5% Dextrose Injection, USP
  • 0.9% Sodium Chloride Injection, USP
Intravenous Bag

Dilute to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:

  • 5% Dextrose Injection, USP
  • 0.9% Sodium Chloride Injection, USP
  • 0.45% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.45% Sodium Chloride Injection, USP
  • Ringer's Injection, USP
  • Lactated Ringer's Injection, USP
Stability

Diluted NAVELBINE may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).

Administration

Administer diluted NAVELBINE over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of one of the solutions.

NAVELBINE must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE is injected.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, NAVELBINE should not be administered.

Management of Suspected Extravasation
  • If NAVELBINE leakage into surrounding tissue occurs or is suspected, immediately stop administration of NAVELBINE and initiate appropriate management measures in accordance with institutional policies. [seeWARNINGS AND PRECAUTIONS]

Procedures For Proper Handling And Disposal

Handle and dispose NAVELBINE consistent with recommendations for the handling and disposal of hazardous drugs2 .

Exercise caution in handling and preparing the solution of NAVELBINE. The use of gloves is recommended. If the solution of NAVELBINE contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.

Avoid contamination of the eye with NAVELBINE. If exposure occurs, flush the eyes with water immediately and thoroughly.

How Supplied

Dosage Forms And Strengths

NAVELBINE Injection

Clear colorless to pale yellow solution in single use vials:

1 mL (10 mg/ 1 mL)
5 mL (50 mg/ 5 mL)

Storage And Handling

NAVELBINE Injection is a clear, colorless to pale yellow aqueous solution available in single-dose vials with royal blue caps, individually packaged in a carton as:

10 mg/1 mL (NDC 64370-532-01).
50 mg/5 mL (NDC 64370-532-02).

Store the vials at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE. Unopened vials of NAVELBINE are stable at 25°C (77°F) for up to 72 hours.

NAVELBINE is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

REFERENCES

1. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Manufactured by: Pierre Fabre Médicament 45 place Abel Gance -92100 Boulogne –FRANCE. Distributed by: Pierre Fabre Pharmaceuticals, Inc. Parsippany, NJ 07054. Revised: 03/2014

Side Effects

The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the label:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity and Respiratory Failure [see WARNINGS ANDPRECAUTIONS]
  • Constipation and Bowel Obstruction [see WARNINGS ANDPRECAUTIONS]
  • Extravasation Tissue Injury [see WARNINGS AND PRECAUTIONS]
  • Neurologic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under varying designs and in different patient populations, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

Single Agent

The data below reflect exposure to NAVELBINE as a single agent administered at a dose of 30 mg/m² on a weekly basis to 365 patients enrolled in 3 controlled studies for metastatic NSCLC and advanced breast cancer. The population included 143 previously untreated metastatic NSCLC patients (Study 3) who received a median of 8 doses of NAVELBINE. The patients were aged 32 to 79 (median 61 years), 71% were male, 91% Caucasian, 48% had adenocarcinoma histology. The data also reflect exposure to NAVELBINE in 222 patients with previously treated advancedbreast cancer who received a median of 10 doses of NAVELBINE. NAVELBINE is not indicated for the treatment of breast cancer.

Selected adverse reactions reported in these studies are provided in Tables 1 and 2. The most common adverse reactions ( ≥ 20%) of single agent NAVELBINE were leukopenia, neutropenia, anemia, Aspartateaminotransferase (AST) elevation, nausea, vomiting, constipation, asthenia, injection site reaction, and peripheral neuropathy. The most common ( ≥ 5%) Grade 3 or 4 adverse reactions were neutropenia, leukopenia, anemia, increased total bilirubin, AST elevation, injection site reaction and asthenia. Approximately 49% of NSCLC patients treated with Navelbine experienced at least one dose reduction due to an adverse reaction. Thirteen percent of patients discontinued NAVELBINE due to adverse reactions. The most frequent adverse reactions leading to NAVELBINE discontinuation were asthenia, dyspnea, nausea, constipation, anorexia, myasthenia and fever.

Table 1: Hematologic Adverse Reactions Experienced in > 5% of Patients Receiving NAVELBINE*†

    ALL PATIENTS
(N=365)
NSCLC
(N= 143)
Laboratory Hematologic
Neutropenia < 2,000 cells/mm³ 90% 80%
< 500 cells/mm³ 36% 29%
Leukopenia < 4,000 cells/mm³ 92% 81%
< 1,000 cells/mm³ 15% 12%
Thrombocytopenia < 100,000 cells/mm³ 5% 4%
Anaemia < 11 g/dl 83% 77%
< 8 g/dl 9% 1%
Hospitalizations due to neutropenic complications 9% 8%
*Grade based on modified criteria from the National Cancer Institute version 1. 
†Patients with NSCLC had not received prior chemotherapy. The majority of the remaining patients had received prior chemotherapy.

 

Table 2: Non-hematologic Adverse Reactions Experienced in ≥ 5% of Patients Receiving NAVELBINE*†

  ALL GRADES GRADES 3+4
ALL PATIENTS NSCLC ALL PATIENTS NSCLC
Laboratory
Hepatic
  AST increased (n=346) 67% 54% 6% 3%
  bilirubin increased (n=351) 13% 9% 7% 5%
Clinical
  Nausea 44% 34% 2% 1%
  Asthenia 36% 27% 7% 5%
  Constipation 35% 29% 3% 2%
  Injection site reaction 28% 38% 2% 5%
  Injection site pain 16% 13% 2% 1%
  Neuropathy peripheral} 25% 20% < 2% 1%
  Vomiting 20% 15% 2% 1%
  Diarrhea 17% 13% 1% 1%
  Alopecia 12% 12% <1% 1%
  Phlebitis 7% 10% <1% 1%
  Dyspnea 7% 3% 3% 2%
* Grade based on modified criteria from the National Cancer Institute version 1. 
‡ Incidence of paresthesia plus hypesthesia. 
†Patients with NSCLC had not received prior chemotherapy. The majority of the remaining patients had received prior chemotherapy.

 

Myelosuppression: In clinical trials, Grade 3-4 neutropenia, anemia, andthrombocytopenia occurred in 69%, 9% and 1%, respectively of patients receiving single-agent NAVELBINE. Neutropenia is the major dose-limiting toxicity.

Neurotoxicity: neurotoxicity was most commonly manifested as constipation, paresthesia, hypersthesia, and hyporeflexia. Grade 3 and 4 neuropathy was observed in 1% of the patients receiving single-agent NAVELBINE.

Injection site reactions: Injection site reactions, including erythema, pain at injection site, and vein discoloration, occurred in approximately one third of patients; 5% were severe. Phlebitis (chemical phlebitis) along the veinproximal to the site of injection was reported in 10% of patients.

Cardiovascular toxicity: Chest pain occurred in 5% of patients; myocardial infarction occurred in less than 0.1% of patients.

Pulmonary Toxicity and Respiratory Failure: Dyspnea (shortness of breath) was reported in 3% of patients; it was severe in 2%. Interstitialpulmonary changes were documented.

Other: Hemorrhagic cystitis and the syndrome of inappropriate ADH secretion were each reported in < 1% of patients.

In Combination with Cisplatin

Table 3 presents the incidence of selected adverse reactions, occurring in ≥ 10% of NAVELBINE treated patients reported in a randomized trial comparing the combination of NAVELBINE 25 mg/m² administered every week of each 28-day cycle and cisplatin 100 mg/m² administered on day 1 of each 28-day cycle versus cisplatin alone at the same dose and schedule in patients with previously untreated NSCLC (Study 1).

Patients randomized to NAVELBINE plus cisplatin received a median of 3 cycles of treatment and those randomized to cisplatin alone received a median of 2 cycles of treatment. Thirty-Five percent of the eligible patients in the combination arm required treatment discontinuation due to an adverse reaction compared to 19% in the cisplatin alone arm. The incidence of Grade 3 and 4 neutropenia was significantly higher in the NAVELBINE plus cisplatin arm (82%) compared to the cisplatin alone arm (5%). Four patients in the NAVELBINE plus cisplatin arm died of neutropenic sepsis. Seven additional deaths were reported in the combination arm: 2 from cardiac ischemia, 1cerebrovascular accident, 1 multisystem failure due to an overdose of NAVELBINE, and 3 from febrile neutropenia.

Table 3: Adverse Reactions Experienced by ≥ 10% of Patients on NAVELBINE plus Cisplatin versus Single-Agent Cisplatin*

LABORATORY NAVELBINE 25MG/M² PLUS CISPLATIN 100 MG/M² (N=212) CISPLATIN 100MG/M² (N=210)
ALL GRADES GRADES 3+4 ALL GRADES GRADES 3+4
Hematologic
  Neutropenia 89% 82% 26% 5%
  Anemia  89% 24% 72% < 8%
  Leukopenia 88% 58% 31% < 1%
  Thrombocytopenia 29% 5% 21% < 2%
  Febrile neutropenia N/A* 11% N/A* 0%
Renal
  Blood creatinine increased 37% 4% 28% < 5%
Clinical
  Malaise/Fatigue/Lethargy 67% 12% 49% 8%
  Vomiting 60% 13% 60% 14%
  Nausea 58% 14% 57% 12%
  Decreased apetite 46% 0% 37% 0%
  Constipation 35% 3% 16% 1%
  Alopecia 34% 0% 14% 0%
  Weight decreased 34% 1% 21% < 1%
  Fever without infection 20% 2% 4% 0%
  Hearing impaired 18% 4% 18% < 4%
  Injection site reaction 17% < 1% 1% 0%
  Diarrhea 17% < 3% 11% < 2%
  Paraesthesia 17% < 1% 10% < 1%
  Taste alterations 17% 0% 15% 0%
  Peripheral numbness 11% 2% 7% < 1%
  Myalgia/Arthralgia 12% < 1% 3% < 1%
  Phlebitis/Thrombosis/Embolism 10% 3% <1% < 1%
  Weakness 12% < 3% 7% 2%
  Infection 11% < 6% <1% < 1%
  Respiratory tract infection 10% < 5% 3% 3%
*Graded according to the standard SWOG criteria version 1. 
*Categorical toxicity grade not specified

 

Table 4 presents the incidence of selected adverse reactions, occurring in ≥ 10% of NAVELBINE treated patients reported in a randomized trial of NAVELBINE plus cisplatin, vindesine plus cisplatin and NAVELBINE alone in patients with stage III or IV NSCLC who had not received prior chemotherapy. A total of 604 patients received either NAVELBINE 30 mg/m² every week plus cisplatin 120 mg/m² on Day 1 and Day 29, then every 6 weeks thereafter (N=207), vindesine 3 mg/m² for 6 weeks, then every other week thereafter plus cisplatin 120 mg/m² on Days 1 and Day 29, then every 6 weeks thereafter (N=193) or NAVELBINE 30mg/m² every week (N=204).

Patients randomized to NAVELBINE plus cisplatin received a median of 15 weeks of treatment, vindesine plus cisplatin 12 weeks and NAVELBINE received 13 weeks. Study discontinuation due to an adverse reaction was required in 27, 22 and 10% of the patients randomized to NAVELBINE plus cisplatin, vindesine plus cisplatin and cisplatin alone arms, respectively. Grade 3 and 4 neutropenia was significantly greater in the NAVELBINE plus cisplatin arm (78%) compared to vindesine plus cisplatin (48%) and NAVELBINE alone (53%). Neurotoxicity, including peripheral neuropathy and constipation was reported in 44% (Grades 34, 7%) of the patients receiving NAVELBINE plus cisplatin, 58% (Grades 3-4, 17%) of the patients receiving vindesine and cisplatin and 44% (Grades 3-4, 8.5%) of the patients receiving NAVELBINE alone.

Table 4: Adverse Reactions Experienced by ≥ 10 % of Patients from a Comparative Trial of NAVELBINE Plus Cisplatin versus Vindesine Plus Cisplatin versus Single-Agent NAVELBINE*

View Enlarged Table

 

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of NAVELBINE. Because these reactions 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.

Infections and infestations: pneumonia

Immune system disorders: anaphylactic reaction, pruritus, urticaria,angioedema

Nervous system disorders: loss of deep tendon reflexes, muscularweakness, gait disturbance, headache

Ear and labyrinth disorders: vestibular disorder, hearing impaired

Cardiac disorders: tachycardia

Respiratory disorders: pulmonary edema

Vascular disorders: pulmonary embolism, deep vein thrombosis,hypertension, hypotension, flushing, vasodilatation

Gastrointestinal disorders: mucosal inflammation, dysphagia, pancreatitis

Skin disorders: generalized cutaneous reactions (rash)

Musculoskeletal and connective tissue disorders: jaw pain, myalgia,arthralgia

General disorders and administration site conditions: injection site rash, urticaria, blistering, sloughing of skin

Injury, poisoning and procedural complications: radiation recall phenomenon, dermatitis, esophagitis

Laboratory abnormalities: electrolyte imbalance including hyponatremia

Other: tumor pain, back pain, abdominal pain

Interactions

CYP3A Inhibitors

Exercise caution in patients concurrently taking drugs known to inhibit drugmetabolism by hepatic cytochrome P450 isoenzymes in the CYP3A subfamily. Concurrent administration of NAVELBINE with an inhibitor of this metabolic pathway may cause an earlier onset and/or an increased severity of adverse reactions.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Myelosuppression

Myelosuppression manifested by neutropenia, anemia and thrombocytopeniaoccur with NAVELBINE® as a single agent and in combination with cisplatin[see ADVERSE REACTIONS]. Neutropenia is the major dose-limiting toxicity with NAVELBINE. Grade 3-4 neutropenia occurred in 53% of patients treated with NAVELBINE at 30 mg/m² per week. Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with NAVELBINE administered at 30 mg/m² per week, neutropenia resulted in hospitalizations for pyrexia and/or sepsis in 8% of patients. Death due to sepsis occurred in 1% of patients. Neutropenia nadirs occur between 7 and 10 days after dosing with neutropenia count recovery usually occurring within the following 7 to 14 days.

Monitor complete blood counts prior to each dose of NAVELBINE. Do not administer NAVELBINE to patients with neutrophil counts < 1,000 cells/mm³. Adjustments in the dosage of NAVELBINE should be based on neutrophil counts obtained on the day of treatment [see DOSAGE AND ADMINISTRATION].

Hepatic Toxicity

Drug-induced liver injury manifest by elevations of aspartate aminotransferase and bilirubin can occur in patients receiving NAVELBINE alone or in combination with cytotoxic agents. Assess hepatic function prior to initiation of NAVELBINE and periodically during treatment. Reduce the dose of NAVELBINE for patients who develop elevations in total bilirubin > 2 times upper limit of normal [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].

Severe Constipation And Bowel Obstruction

Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation occur with NAVELBINE administration. Institute a prophylacticbowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus, considering adequate dietary fiber intake, hydration, and routine use of stool softeners.

Extravasation And Tissue Injury

Extravasation of NAVELBINE can result in severe irritation, local tissue necrosis and/or thrombophlebitis. If signs or symptoms of extravasation occur, immediately stop administration of NAVELBINE and institute recommended management procedures. [see DOSAGE AND ADMINISTRATION and ADVERSE REACTION]

Neurologic Toxicity

Sensory and motor neuropathies, including severe neuropathies, occur in patients receiving NAVELBINE. Monitor patients for new or worsening signs and symptoms of neuropathy such as paresthesia, hyperesthesia, hyporeflexia and muscle weakness while receiving NAVELBINE. Discontinue NAVELBINE for NCI CTCAE Grade 2 or greater neuropathy [see DOSAGE AND ADMINISTRATION and ADVERSE REACTION]

Pulmonary Toxicity And Respiratory Failure

Pulmonary toxicity, including severe acute bronchospasm, interstitialpneumonitis, acute respiratory distress syndrome (ARDS) occurs with use of NAVELBINE. Interstitial pneumonitis and ARDS included fatalities. The mean time to onset of interstitial pneumonitis and ARDS after vinorelbine administration was one week (range 3 to 8 days) [see ADVERSE REACTIONS].

Interrupt NAVELBINE in patients who develop unexplained dyspnea, or have any evidence of pulmonary toxicity. Permanently discontinue NAVELBINE for confirmed interstitial pneumonitis or ARDS.

Embryo-Fetal Toxicity

NAVELBINE can cause fetal harm when administered to a pregnant woman. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during therapy with NAVELBINE [see Use In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

The carcinogenic potential of NAVELBINE has not been studied. Vinorelbine has been shown to affect chromosome number and possibly structure in vivo (polyploidy in bone marrow cells from Chinese hamsters and a positive micronucleus test in mice). It was not mutagenic in the Ames test and gave inconclusive results in the mouse lymphoma TK Locus assay.

Vinorelbine did not affect fertility to a statistically significant extent when administered to rats on either a once-weekly (9 mg/m², approximately one third the human dose) or alternate-day schedule (4.2 mg/m², approximately 0.14 times the human recommended dose) prior to and during mating. In male rats, administration of vinorelbine twice weekly for 13 or 26 weeks at dose levels of 2.1 and 7.2 mg/m² (approximately 0.07 and 0.24 times the recommended human dose), respectively, resulted in decreasedspermatogenesis and prostate/seminal vesicle secretion.

Use In Specific Population

Pregnancy

Pregnancy Category D

Risk Summary

NAVELBINE can cause fetal harm when administered to a pregnant woman. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus.

Animal Data

In a mouse embryofetal development study, administration of a single dose of vinorelbine at a dose level of 9 mg/m² or greater (approximately 0.33 times the recommended human dose based on body surface area) was embryotoxic and fetotoxic. Vinorelbine was embryotoxic and fetotoxic to pregnant rabbits when administered every 6 days during the period of organogenesis at doses of 5.5 mg/m² (approximately 0.18 times the recommended human dose based on body surface area) or greater. At doses that did not cause maternal toxicity in either species, vinorelbine administration resulted in reduced fetal weight and delayed ossification.

Nursing Mothers

It is not known whether this drug is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from vinorelbine, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of NAVELBINE in pediatric patients have not been established. Results from a single-arm study of NAVELBINE administered at the dose of 33.75 mg/m² (for 35 patients) or at the dose of 30mg/m² (for 11 patients) every week during 6 weeks followed by 2 weeks of rest was evaluated (courses of 8 weeks). Forty-six patients age 1 to 25 (median 11 years) with recurrent solid malignant tumors, includingrhabdomyosarcoma or undifferentiated sarcoma (N=21 patients),neuroblastoma (N= 4 patients), and central nervous system (CNS) tumors (N=21 patients) were enrolled. The most significant grade 3 or 4 hematological adverse reactions were neutropenia (70%) and anemia (33%). The most significant grade 3 or 4 nonhematological toxicity adverse reactions were motor (15%) or cranial (13%) neuropathy, hypoxia (13%) and dyspnea (11%). Objective tumor response was observed in 2 out of 21 patients with rhabdomyosarcoma or undifferentiated sarcoma. No objective tumor response was observed in patients with CNS tumors (N=21) or neuroblastoma (N=4).

Geriatric Use

Of the 769 number of patients who received NAVELBINE alone and NAVELBINE in combination with Cisplatin in studies 1, 2 and 3, 247 patients were 65 years of age or older. No overall differences in safety, efficacy and pharmacokinetic parameters were observed between these patients and younger patients. [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

The influence of hepatic impairment on the pharmacokinetics of NAVELBINE has not been evaluated, but the liver plays an important role in themetabolism of NAVELBINE. Elevations of aspartate aminotransferase occur in > 60% of the patients receiving NAVELBINE alone (6% Grade 3-4). Therefore, exercise caution in patients with hepatic impairment. Reduce the dose of NAVELBINE for patients with bilirubin elevation [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Females And Males Of Reproductive Potential

Contraception

Females

NAVELBINE can cause fetal harm when administered to a pregnant woman [see Use In Specific Populations]. Advise female patients of reproductive potential to use highly effective contraception during therapy with NAVELBINE.

Males

NAVELBINE may damage spermatozoa [see Nonclinical Toxicology]. Males with female sexual partners of reproductive potential should use highly effective contraception during and for 3 months after therapy with NAVELBINE.

Fertility

Males

Based on animal findings, NAVELBINE may cause decreased fertility in males [see Nonclinical Toxicology]

OverDose

There is no known antidote for overdoses of NAVELBINE. Overdoses involving quantities up to 10 times the recommended dose (30 mg/m²) have been reported. The toxicities described were consistent with those listed in the ADVERSE REACTIONS section including paralytic ileus, stomatitis, andesophagitis. Bone marrow aplasia, sepsis, and paresis have also been reported. Fatalities have occurred following overdose of NAVELBINE. If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors, and antibiotics should be instituted as deemed necessary by the physician.

ContrainDications

None

Clinical Pharamacology

Mechanism Of Action

Vinorelbine is a vinca alkaloid that interferes with microtubule assembly. The antitumor activity of vinorelbine is thought to be due primarily to inhibition ofmitosis at metaphase through its interaction with tubulin. Vinorelbine may also interfere with: 1) amino acid, cyclic AMP, and glutathione metabolism, 2) calmodulin-dependent Ca++-transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis. Vinorelbine inhibited mitoticmicrotubule formation in intact mouse embryo tectal plates at a concentration of 2 μM inducing a blockade of cells at metaphase, but produced depolymerization of axonal microtubules at a concentration 40 μM, suggesting a modest selectivity of vinorelbine for mitotic microtubules.

Pharmacokinetics

The pharmacokinetics of vinorelbine were studied in 49 patients who received doses of 30 mg/m² administered as 15-to 20-minute constant-rate infusions. Vinorelbine concentrations in plasma decay in a triphasic manner. The terminal phase half-life averages 27.7 to 43.6 hours and the mean plasma clearance ranges from 0.97 to 1.26 L/hr/kg.

Distribution

Steady-state volume of distribution (VSS) values range from 25.4 to 40.1 L/kg. Vinorelbine demonstrated high binding to human platelets and lymphocytes. The free fraction was approximately 0.11 in human plasma over a concentration range of 234 to 1169 ng/mL. The binding to plasma constituents in cancer patients ranged from 79.6% to 91.2%. Vinorelbine binding was not altered in the presence of cisplatin, 5-fluorouracil, or doxorubicin.

Metabolism

Vinorelbine undergoes substantial hepatic elimination in humans, with large amounts recovered in feces. Two metabolites of vinorelbine have been identified in human blood, plasma, and urine; vinorelbine N-oxide and deacetylvinorelbine. Deacetylvinorelbine has been demonstrated to be the primary metabolite of vinorelbine in humans, and has been shown to possess antitumor activity similar to vinorelbine. Therapeutic doses of vinorelbine (30 mg/m²) yield very small, if any, quantifiable levels of either metabolite in blood or urine. The metabolism of vinorelbine is mediated by hepatic cytochrome P450 isoenzymes in the CYP3A subfamily.

Excretion

After intravenous administration of radioactive vinorelbine, approximately 18% and 46% of administered radioactivity was recovered in urine and feces, respectively. In a different study, 10.9% ± 0.7% of a 30-mg/m² intravenous dose was excreted as parent drug in urine.

Specific Populations

Elderly: Age has no effect on the pharmacokinetics (CL, V SS and t1/2 ) of vinorelbine.

Drug Interactions

The pharmacokinetics of vinorelbine are not influenced by the concurrent administration of cisplatin.

Clinical Studies

Combination Use With Cisplatin

The safety and efficacy of NAVELBINE in combination with cisplatin was evaluated in two randomized, multicenter trials.

Cisplatin 100mg/m²

Study 1 was a randomized, multicenter, open-label trial of NAVELBINE plus cisplatin and cisplatin alone for the treatment of stage IV or stage IIIb NSCLC patients with malignant pleural effusion or multiple lesions in more than onelobe of the ipsilateral lung who had not received prior chemotherapy. A total of 432 patients were randomized 1:1 to receive either NAVELBINE 25 mg/m² on Day 1 then every week of each 28-day cycle with cisplatin 100 mg/m² administered on Day 1 of each 28-day cycle (N=214) or cisplatin 100 mg/m² on Day 1 of each 28-day cycle (N=218).

Patient demographics and disease characteristics were similar between arms. Of the overall study population, the median age was 64 (range 33-84), 66% were male, 80% were Caucasian, 92% had stage IV disease and 8% stage IIIB, 53% had adenocarcinoma, 21% squamous cell, 14% large cell histology. The major efficacy outcome measure was overall survival. The efficacy results are presented in Table 7 and Figure 1.

Table 7: Efficacy Results (Study 1)

  NAVELBINE PLUS CISPLATIN 
(N=214)
CISPLATIN ALONE
(N=218)
Overall Survival
Median Survival in months (95% CI) 7.8
(6.9, 9.6 )
6.2
(5.4, 7.7)
Unstratified log-rank p-value 0.01
Overall Response rate (ORR)
Evaluable patients ORR (95% CI) N = 206 
19% (14%, 25%)
N=209 
8% (5%, 13% )
Chi-square test p-value < 0.001

 

Figure 1 : Overall Survival NAVELBINE/Cisplatin versus Single-Agent Ciplatin

Overall Survival NAVELBINE/Cisplatin versus Single-Agent Ciplatin - Illustration

 

Cisplatin 120mg/m²

Study 2 was a randomized, 3-arm, open-label, multicenter trial of NAVELBINE plus cisplatin, vindesine plus cisplatin and NAVELBINE alone for the treatment of patients with stage III or IV NSCLC who had not received prior chemotherapy. The study was conducted in Europe. A total of 612 patients were randomized 1:1:1 to receive NAVELBINE 30 mg/m² every week of a 6week cycle plus cisplatin 120 mg/m² on Day 1 and Day 29, then every 6 weeks thereafter (N=206); and vindesine 3 mg/m² for 6 weeks, then every other week thereafter plus cisplatin 120 mg/m² on Days 1 and Day 29, then every 6 weeks thereafter (N=200) or NAVELBINE 30mg/m² every week of a 6-week cycle (N=206). The main efficacy outcome measure was to compare overall survival between NAVELBINE plus cisplatin and vindesine plus cisplatin. The other efficacy outcome measure was to compare overall survival in the better of the two combination regimens to that of NAVELBINE alone.

Patient demographics were in general similar between arms: the median age of the overall population was 60 years (range 30 to 75), 90% were male, 78% had WHO performance status of 0 or 1. Tumor characteristics were in general similar with the exception of histologic subtype of NSCLC. Adenocarcinoma was the histologic subtype in 32% of patients in the NAVELBINE plus cisplatin arm, 40% of patients in vindesine plus cisplatin arm and 28% of patients on the NAVELBINE alone arm. Ten percent of the patients had stage IIIA disease, 28% stage IIIB and 50% stage IV. Twelve percent of the patients had received prior surgery or radiotherapy.

The efficacy results of Study 2 are presented in Table 8.

Table 8: Efficacy Results (Study 2)

  NAVELBINE ALONE 
(N=206)
NAVELBINE PLUS CISPLATIN
(N=206)
VINDESINE PLUS CISPLATIN 
(N=200)
Median survival in months (99.5% CI) 7.2 
(5.4-9.1)
9.2 
(7.4-11.1)
7.4 
(6.1-9.1)
Unstratified log-rank p-value n/a1 0.087
0.05   n/a
Overall Response (ORR) N=205 N=203 N=198
Evaluable Patients 14% 
(10%, 20%)
28% 
(22%, 35%)
19% 
(14%, 25% )
ORR (95% CI)      
Chi-square test p-value n/a 0.03
< 0.001 n/a
1n/a = not applicable

 

Single Agent

The safety and efficacy of NAVELBINE as a single agent was evaluated in one randomized multi-center trial.

Study 3 was a randomized, open-label clinical trial of NAVELBINE or 5-Fluorouracil (5-FU) plus leucovorin (LV) in patients with Stage IV NSCLC who had not received prior chemotherapy A total of 211 patients were randomized 2:1 to receive NAVELBINE 30 mg/m² weekly of a 8-week cycle (N=143) or 5-FU 425 mg/m² bolus intravenously plus LV 20 mg/m² bolus intravenously daily for 5 days of a 4-weeks cycle (N=68).

Patient demographics and disease characteristics were in general similar between arms. In the overall population, the median age was 61 years (range 32 -83), 74% were male, 88% were Caucasian, 46% had adenocarcinoma histology. Fifty percent of the patients had Karnofsky performance status ≥ 90 in the NAVELBINE arm compared to 38% in the 5-FU and LV arm.

The primary efficacy outcome of the study was overall survival. The median survival time was 30 weeks versus 22 weeks for patients receiving NAVELBINE versus 5-FU/LV, respectively (P=0.06). Partial objective responses were observed in 11.1% (95% CI=6.2%, 17.9%) and 3.5% (95% CI=0.4%, 11.9%) of patients who received NAVELBINE and 5-FU/LV, respectively.

Patient Information

Inform patients of the following:

  • Myelosuppression 
    Advise patients to contact a healthcare provider for new onset fever, or symptoms of infection [see WARNINGS AND PRECAUTIONS]
  • Constipation and bowel obstruction 
    Advise patients to follow a diet rich in fibers, drink fluids to stay well hydrated and use stool softeners to avoid constipation. Contact a health care provider for severe constipation, new onset abdominal pain, nausea and vomiting [see WARNINGS AND PRECAUTIONS]
  • Neurologic toxicity 
    Advise patients to contact a health care provider for new onset or worsening of numbness, tingling, decrease sensation or muscle weakness [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity 
    Advise patients to contact a healthcare provider for new onset or worsening of shortness of breath, cough, wheezing or other new pulmonary symptoms [see WARNINGS AND PRECAUTIONS]
  • Females and Males of Reproductive Potential
    • NAVELBINE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use highly effective contraception during treatment with NAVELBINE, and to contact their healthcare provider if they become pregnant, or if pregnancy is suspected [see WARNINGS AND PRECAUTIONS andUse In Specific Populations].
    • NAVELBINE may damage sperm. Advise males to use highly effective contraception during and for 3 months after therapy [seeUse in Specific Population and Nonclinical Toxicology].
    • NAVELBINE, may cause decreased fertility in males [seeNonclinical Toxicology].

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.

 

VINORELBINE - INJECTION

 

(vye-nor-ELL-bean)

 

COMMON BRAND NAME(S): Navelbine

 

WARNING: This medication must be given only by injection into a vein (intravenously-IV) by a trained healthcare professional. Deaths have occurred with medications similar to vinorelbine that were injected into the spine.

Vinorelbine can lower your blood cell counts (bone marrow suppression) and lower your ability to fight an infection. Your doctor will follow your blood counts closely. Tell your doctor immediately if you develop any signs of an infection such as fever, chills, or persistent sore throat.

If this medication accidentally leaks out of your vein into surrounding tissue, the skin and/or muscle may be severely damaged. Tell your doctor immediately if you have pain, redness, swelling, or discoloration at the injection site.

 

USES: Vinorelbine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.

 

HOW TO USE: Vinorelbine is given by injection only into a vein by a healthcare professional. It is usually given over 6-10 minutes, once a week, or as directed by your doctor. The dosage is based on your medical condition, response to therapy, and body size.

If this medication comes into contact with your skin, wash your skin immediately and completely with soap and water. If vinorelbine gets into your eyes, flush them immediately and completely with water, and contact the doctor.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, fatigue, constipation, diarrhea, dizziness, muscle aches, joint pain, or irritation at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

To prevent constipation, eat a diet adequate in fiber and drink plenty of water. Your doctor may also prescribe a laxative (such as a stool softener) to help prevent constipation.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling/pain in the hands or feet, decreased reflexes, mouth sores, easy bruising/bleeding, weakness, new or increased trouble breathing, cough, severe constipation, stomach/abdominal pain, blood in the urine, mental/mood changes.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: 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 Navelbine (vinorelbine tartrate) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.

Vinorelbine can sometimes cause a serious skin reaction that looks likes a severe sunburn when given after radiation treatment (radiation recall). The reaction usually develops on the skin area previously treated with radiation within days to months after vinorelbine treatment. Throat problems can also be part of radiation recall with vinorelbine. Tell your doctor immediately if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. Your doctor may prescribe medication to treat your symptoms. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug may damage sperm and decrease fertility in men. Men with female partners of childbearing age should use reliable forms of birth control (such as condoms) during treatment and for 3 months after treatment with this medication.

This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby. Women of childbearing age should use reliable form(s) of birth control during treatment with this drug and for some time afterwards. Consult your doctor for more details.

It is not known if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. 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: mitomycin, drugs affecting liver enzymes that remove vinorelbine from your body (such as azole antifungals, including itraconazole; macrolide antibiotics, including erythromycin; cimetidine; rifamycins, including rifabutin; St. John's wort; certain anti-seizure medicines, including carbamazepine; aprepitant).

 

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: Laboratory and/or medical tests (e.g., complete blood counts, liver function tests) should 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.

 

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Navelbine

Generic Name: vinorelbine (Pronunciation: vin OR el been)

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

What is vinorelbine (Navelbine)?

 

Vinorelbine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vinorelbine is used to treat non-small cell lung cancer.

Vinorelbine is sometimes used in combination with other cancer medications.

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

What are the possible side effects of vinorelbine (Navelbine)?

 

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:

  • signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • cough, bronchospasm (wheezing, chest tightness, trouble breathing);
  • severe constipation, stomach pain, bloody or black stools;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • numbness, burning, pain, or tingly feeling;
  • problems with vision, hearing, speech, balance, or daily activities;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • pain, burning, redness, swelling, or skin changes where the IV needle was placed.

Less serious side effects may include:

  • temporary hair loss;
  • jaw pain, joint or muscle pain;
  • tumor pain;
  • weight loss;
  • nausea, vomiting, diarrhea, loss of appetite; or
  • feeling dizzy, weak, or tired.

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 Navelbine (vinorelbine tartrate) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about vinorelbine (Navelbine)?

 

You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

Do not use vinorelbine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vinorelbine, tell your doctor if you have liver disease, bone marrow suppression, a nerve disorder, or if you have received radiation therapy or other cancer treatments.

Vinorelbine is sometimes used in combination with other cancer medications.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vinorelbine is injected.

Vinorelbine can lower blood cells that help your body fight infections. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with vinorelbine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving vinorelbine (Navelbine)?

 

You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • liver disease;
  • bone marrow suppression;
  • a nerve disorder; or
  • if you have received radiation therapy or other cancer treatments.

FDA pregnancy category D. Vinorelbine can cause harm to an unborn baby or cause birth defects.Before you receive vinorelbine, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether vinorelbine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are being treated with vinorelbine.

How is vinorelbine given (Navelbine)?

 

Vinorelbine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion.

Vinorelbine is usually given once every 7 days. You may also receive the medication once every 6 weeks. Follow your doctor's instructions.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Vinorelbine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

Patient Detailed Avoid Taking

What happens if I miss a dose (Navelbine)?

 

Call your doctor for instructions if you miss an appointment for your vinorelbine injection.

What happens if I overdose (Navelbine)?

 

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

Overdose symptoms may include white patches or sores in your mouth or throat, painful swallowing, heartburn, severe constipation, and stomach pain.

What should I avoid while receiving vinorelbine (Navelbine)?

 

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with vinorelbine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Talk to your doctor about ways to avoid constipation while being treated with vinorelbine.

What other drugs will affect vinorelbine (Navelbine)?

 

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

  • conivaptan (Vaprisol);
  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • an antidepressant such as nefazodone;
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • cancer medicines such as cisplatin (Platinol), carboplatin (Paraplatin), mitomycin (Mutamycin), or oxaliplatin (Elixatin);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with vinorelbine. 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 doctor or pharmacist can provide more information about vinorelbine.


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.

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