Drugs Details

Drugs Info of Campath
Drugs Details
  • Drugs Type  : FDA
  • Date : 5th Jan 2015 03:33 am
  • Brand Name : Campath
  • Generic Name : alemtuzumab (Pronunciation: )
Descriptions

Campath (alemtuzumab) is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) directed against the 21-28 kD cell surface glycoprotein, CD52. Campath-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). The Campath-1H antibody has an approximate molecular weight of 150 kD. Campath is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product.

Campath is a sterile, clear, colorless, isotonic solution (pH 6.8-7.4) for injection. Each single use vial of Campath contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added.

What are the possible side effects of alemtuzumab (Campath)?

Some people receiving an alemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel hot or cold, nauseated, light-headed, sweaty, or have chest tightness or trouble breathing 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:

  • fever, sweating, chills, body aches, flu symptoms,...

Read All Potential Side Effects and See Pictures of Campath »

What are the precautions when taking alemtuzumab (Campath)?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/current infections (such as tuberculosis), bleeding/blood problems, cancer, kidney problems, heart problems, immune system problems (e.g., HIV), thyroid problems.

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

Read All Potential Precautions of Campath »

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

Indications

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Dosage Administration

Dosing Schedule And Administration

  • Administer as an IV infusion over 2 hours. Do not administer as intravenous push or bolus.
  • Recommended Dosing Regimen
    • Gradually escalate to the maximum recommended single dose of 30 mg. Escalation is required at initiation of dosing or if dosing is held ≥ 7 days during treatment. Escalation to 30 mg ordinarily can be accomplished in 3 – 7 days.
    • Escalation Strategy:
      • Administer 3 mg daily until infusion reactions are ≤ grade 2 [see ADVERSE REACTIONS].
      • Then administer 10 mg daily until infusion reactions are ≤ grade 2.
      • Then administer 30 mg/day three times per week on alternate days (e.g., Mon-Wed-Fri). The total duration of therapy, including dose escalation, is 12 weeks.
  • Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.

Recommended Concomitant Medications

  • Premedicate with diphenhydramine (50 mg) and acetaminophen (500-1000 mg) 30 minutes prior to first infusion and each dose escalation. Institute appropriate medical management (e.g. steroids, epinephrine, meperidine) for infusion reactions as needed [see BOXED WARNING, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
  • Administer trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week (or equivalent) as Pneumocystis jiroveci pneumonia (PCP) prophylaxis.
  • Administer famciclovir 250 mg BID or equivalent as herpetic prophylaxis.

Continue PCP and herpes viral prophylaxis for a minimum of 2 months after completion of Campath or until the CD4+ count is > 200 cells/^L, whichever occurs later [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

Dose Modification

  • Withhold Campath during serious infection or other serious adverse reactions until resolution.
  • Discontinue Campath for autoimmune anemia or autoimmune thrombocytopenia.
  • There are no dose modifications recommended for lymphopenia.

Dose Modification for Neutropenia or Thrombocytopenia [see WARNINGS AND PRECAUTIONS]

Hematologic Values Dose Modification*
ANC < 250/μL and/or platelet count ≤ 25,000/μL
For first occurrence: Withhold Campath therapy. Resume Campath at 30 mg when ANC ≥ 500/μL and platelet count ≥ 50,000/μL.
For second occurrence: Withhold Campath therapy. Resume Campath at 10 mg when ANC ≥ 500/μL and platelet count ≥ 50,000/μL.
For third occurrence: Discontinue Campath therapy.
≥ 50% decrease from baseline in patients initiating therapy with a baseline ANC ≤ 250/μL and/or a baseline platelet count ≤ 25,000/μL
For first occurrence: Withhold Campath therapy. Resume Campath at 30 mg upon return to baseline value(s).
For second occurrence: Withhold Campath therapy. Resume Campath at 10 mg upon return to baseline value(s).
For third occurrence: Discontinue Campath therapy.
*If the delay between dosing is ≥ 7 days, initiate therapy at Campath 3 mg and escalate to 10 mg and then to 30 mg as tolerated [see Dosing Schedule And Administration].

Preparation And Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, the vial should not be used. DO NOT SHAKE VIAL.

Use aseptic technique during the preparation and administration of Campath. Withdraw the necessary amount of Campath from the vial into a syringe.

  • To prepare the 3 mg dose, withdraw 0.1 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
  • To prepare the 10 mg dose, withdraw 0.33 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
  • To prepare the 30 mg dose, withdraw 1 mL in either a 1 mL or 3 mL syringe calibrated in 0.1 mL increments.

Inject syringe contents into 100 mL sterile 0.9% Sodium Chloride USP or 5% Dextrose in Water USP. Gently invert the bag to mix the solution. Discard syringe.

The vial contains no preservatives and is intended for single use only. DISCARD VIAL including any unused portion after withdrawal of dose.

Use within 8 hours after dilution. Store diluted Campath at room temperature (15-30°C) or refrigerated (2-8°C). Protect from light.

Incompatibilities

Campath is compatible with polyvinylchloride (PVC) bags and PVC or polyethylenelined PVC administration sets. Do not add or simultaneously infuse other drug substances through the same intravenous line.

How Supplied

Dosage Forms And Strengths

30 mg/1 mL single use vial

Storage And Handling

Campath (alemtuzumab) is supplied in single-use clear glass vials containing 30 mg of alemtuzumab in 1 mL of solution. Each carton contains three Campath vials (NDC 58468-0357-3) or one Campath vial (NDC 58468-0357-1).

Store Campath at 2-8°C (36-46°F). Do not freeze. If accidentally frozen, thaw at 2-8°C before administration. Protect from direct sunlight.

Manufactured and distributed by: Genzyme Corporation, Cambridge, MA 02142. Revised: Sep 2014

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

Side Effects

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Cytopenias [see WARNINGS AND PRECAUTIONS]
  • Infusion Reactions [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression/Infections [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions with Campath are: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (CMV viremia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety). The most common serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.

Clinical Trials Experience

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.

The data below reflect exposure to Campath in 296 patients with CLL of whom 147 were previously untreated and 149 received at least 2 prior chemotherapy regimens. The median duration of exposure was 11.7 weeks for previously untreated patients and 8 weeks for previously treated patients.

Lymphopenia

Severe lymphopenia and a rapid and sustained decrease in lymphocyte subsets occurred in previously untreated and previously treated patients following administration of Campath. In previously untreated patients, the median CD4+ was 0 cells/µL at one month after treatment and 238 cells/µL [25-75% interquartile range 115 to 418 cells/µL at 6 months post-treatment [see WARNINGS AND PRECAUTIONS].

Neutropenia

In previously untreated patients, the incidence of Grade 3 or 4 neutropenia was 42% with a median time to onset of 31 days and a median duration of 37 days. In previously treated patients, the incidence of Grade 3 or 4 neutropenia was 64% with a median duration of 28 days. Ten percent of previously untreated patients and 17% of previously treated patients received granulocyte colony stimulating factors.

Anemia

In previously untreated patients, the incidence of Grade 3 or 4 anemia was 12% with a median time to onset of 31 days and a median duration of 8 days. In previously treated patients, the incidence of Grade 3 or 4 anemia was 38%. Seventeen percent of previously untreated patients and 66% of previously treated patients received either erythropoiesis stimulating agents, transfusions or both.

Thrombocytopenia

In previously untreated patients, the incidence of Grade 3 or 4 thrombocytopenia was 14% with a median time to onset of 9 days and a median duration of 14 days. In previously treated patients, the incidence of Grade 3 or 4 thrombocytopenia was 52% with a median duration of 21 days. Autoimmune thrombocytopenia was reported in 2% of previously treated patients with one fatality.

Infusion reactions

Infusion reactions, which included pyrexia, chills, hypotension, urticaria, and dyspnea, were common. Grade 3 and 4 pyrexia and/or chills occurred in approximately 10% of previously untreated patients and in approximately 35% of previously treated patients. The occurrence of infusion reactions was greatest during the initial week of treatment and decreased with subsequent doses of Campath. All patients were pretreated with antipyretics and antihistamines; additionally, 43% of previously untreated patients received glucocorticoid pre-treatment.

Infections

In the study of previously untreated patients, patients were tested weekly for CMV using a PCR assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy. CMV infection occurred in 16% (23/147) of previously untreated patients; approximately one-third of these infections were serious or life threatening. In studies of previously treated patients in which routine CMV surveillance was not required, CMV infection was documented in 6% (9/149) of patients; nearly all of these infections were serious or life threatening.

Other infections were reported in approximately 50% of patients across all studies. Grade 3 - 5 sepsis ranged from 3% to 10% across studies and was higher in previously treated patients. Grade 3 - 4 febrile neutropenia ranged from 5 to 10% across studies and was higher in previously treated patients. Infection-related fatalities occurred in 2% of previously untreated patients and 16% of previously treated patients. There were 198 episodes of other infection in 109 previously untreated patients; 16% were bacterial, 7% were fungal, 4% were other viral, and in 73%, the organism was not identified.

Cardiac

Cardiac dysrhythmias occurred in approximately 14% of previously untreated patients. The majority were tachycardias and were temporally associated with infusion; dysrhythmias were Grade 3 or 4 in 1% of patients.

Previously Untreated Patients

Table 1 contains selected adverse reactions observed in 294 patients randomized (1:1) to receive Campath or chlorambucil as first line therapy for B-CLL. Campath was administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks. The median duration of therapy was 11.7 weeks with a median weekly dose of 82 mg (25-75% interquartile range: 69 mg - 90 mg).

Table 1

Per Patient Incidence of Selected1 Adverse Reactions in Treatment Naive B-CLL Patients
    Campath
(n=147)
Chlorambucil
(n=147)
All Grades2 % Grades 3-4 % All Grades % Grades 3-4 %
Blood and Lymphatic System Disorders Lymphopenia 97 97 9 1
Neutropenia 77 42 51 26
Anemia 76 13 54 18
Thrombocytopenia 71 13 70 14
General Disorders and Administration Site Conditions Pyrexia 69 10 11 1
Chills 53 3 1 0
Infections and Infestations CMV viremia3 55 4 8 0
CMV infection 16 5 0 0
Other infections 74 21 65 10
Skin and Subcutaneous Tissue Disorders Urticaria 16 2 1 0
Rash 13 1 4 0
Erythema 4 0 1 0
Vascular Disorders Hypotension 16 1 0 0
Hypertension 14 5 2 1
Nervous System Disorders Headache 14 1 8 0
Tremor 3 0 1 0
Respiratory, Thoracic and Mediastinal Disorders Dyspnea 14 4 7 3
Gastrointestinal Disorders Diarrhea 10 1 4 0
Psychiatric Disorders Insomnia 10 0 3 0
Anxiety 8 0 1 0
Cardiac Disorders Tachycardia 10 0 1 0
1Adverse reactions occurring at a higher relative frequency in the Campath arm
2NCI CTC version 2.0 for adverse reactions; NCI CTCAE version 3.0 for laboratory values
3CMV viremia (without evidence of symptoms) includes both cases of single PCR positive test results and of confirmed CMV viremia ( ≥ 2 occasions in consecutive samples 1 week apart). For the latter, ganciclovir (or equivalent) was initiated per protocol.
Previously Treated Patients

Additional safety information was obtained from 3 single arm studies of 149 previously treated patients with CLL administered 30 mg Campath intravenously three times weekly for 4 to 12 weeks (median cumulative dose 673 mg [range 2 - 1106 mg]; median duration of therapy 8.0 weeks). Adverse reactions in these studies not listed in Table 1 that occurred at an incidence rate of > 5% were fatigue, nausea, emesis, musculoskeletal pain, anorexia, dysesthesia, mucositis, and bronchospasm.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Using an ELISA assay, anti-human antibodies (HAHA) were detected in 11 of 133 (8.3%) previously untreated patients. In addition, two patients were weakly positive for neutralizing activity. Limited data suggest that the anti-Campath antibodies did not adversely affect tumor response. Four of 211 (1.9%) previously-treated patients were found to have antibodies to Campath following treatment.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Campath with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions were identified during post-approval use of Campath. 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 Campath exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal connection to Campath.

Fatal infusion reactions: [see WARNINGS AND PRECAUTIONS].

Cardiovascular: congestive heart failure, cardiomyopathy, decreased ejection fraction (some patients had been previously treated with cardiotoxic agents).

Immune disorders: Goodpasture's syndrome, Graves' disease, aplastic anemia, Guillain Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, serum sickness, fatal transfusion associated Graft versus Host Disease.

Infections: Epstein-Barr Virus (EBV) including EBV-associated lymphoproliferative disorder, progressive multifocal leukoencephalopathy (PML), re-activation of latent viruses.

Metabolic: tumor lysis syndrome

Neurologic: optic neuropathy

Read the Campath (alemtuzumab) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No formal drug interaction studies have been performed with Campath.

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

Learn More »

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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Cytopenias

Severe, including fatal, autoimmune anemia and thrombocytopenia, and prolonged myelosuppression have been reported in patients receiving Campath.

In addition, hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have been reported after treatment with Campath at the recommended dose. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.

Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia) [see DOSAGE AND ADMINISTRATION]. No data exist on the safety of Campath resumption in patients with autoimmune cytopenias or marrow aplasia [see ADVERSE REACTIONS].

Infusion Reactions

Adverse reactions occurring during or shortly after Campath infusion include pyrexia, chills/rigors, nausea, hypotension, urticaria, dyspnea, rash, emesis, and bronchospasm. In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Monitor for the signs and symptoms listed above and withhold infusion for Grade 3 or 4 infusion reactions [see ADVERSE REACTIONS].

The following serious, including fatal, infusion reactions have been identified in postmarketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Initiate Campath according to the recommended dose-escalation scheme [see DOSAGE AND ADMINSTRATION]. Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion reactions as needed [see DOSAGE AND ADMINISTRATION]. If therapy is interrupted for 7 or more days, reinstitute Campath with gradual dose escalation [see DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS].

Immunosuppression/Infections

Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections [see ADVERSE REACTIONS]. Administer PCP and herpes viral prophylaxis during Campath therapy and for a minimum of 2 months after completion of Campath or until the CD4+ count is ≥ 200 cells/µL, whichever occurs later [see DOSAGE AND ADMINISTRATION]. Prophylaxis does not eliminate these infections.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia (defined as polymerase chain reaction (PCR) positive CMV in ≥ 2 consecutive samples obtained 1 week apart) [see ADVERSE REACTIONS]. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia [see DOSAGE AND ADMINISTRATION].

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.1

In patients receiving Campath as initial therapy, recovery of CD4+ counts to ≥ 200 cells/µL occurred by 6 months post-treatment; however at 2 months post-treatment, the median was 183 cells/µL. In previously treated patients receiving Campath, the median time to recovery of CD4+ counts to ≥ 200 cells/µ.L was 2 months; however, full recovery (to baseline) of CD4+ and CD8+ counts may take more than 12 months [see BOXED WARNING and ADVERSE REACTIONS].

Laboratory Monitoring

Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL [see ADVERSE REACTIONS].

Immunization

The safety of immunization with live viral vaccines following Campath therapy has not been studied. Do not administer live viral vaccines to patients who have recently received Campath. The ability to generate an immune response to any vaccine following Campath therapy has not been studied.

REFERENCES

1 American Association of Blood Banks, America's Blood Centers, American Red Cross. Circular of Information for the Use of Human Blood and Blood Components. July 2002.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term studies in animals have been performed to establish the carcinogenic or mutagenic potential of Campath, or to determine its effects on fertility in males or females.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Campath. IgG antibodies, such as Campath, can cross the placental barrier. It is not known whether Campath can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Campath should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Excretion of Campath in human breast milk has not been studied; it is not known whether this drug is excreted in human milk. IgG antibodies, such as Campath, can be excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Campath, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the elimination half-life of Campath and the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

Geriatric Use

Of 147 previously untreated B-CLL patients treated with Campath, 35% were ≥ age 65 and 4% were ≥ age 75. Of 149 previously treated patients with B-CLL, 44% were ≥ 65 years of age and 10% were ≥ 75 years of age. Clinical studies of Campath did not include sufficient number of subjects age 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

OverDose

Across all clinical experience, the reported maximum single dose received was 90 mg. Bone marrow aplasia, infections, or severe infusions reactions occurred in patients who received a dose higher than recommended.

One patient received an 80 mg dose by IV infusion and experienced acute bronchospasm, cough, and dyspnea, followed by anuria and death. Another patient received two 90 mg doses by IV infusion one day apart during the second week of treatment and experienced a rapid onset of bone marrow aplasia.

There is no known specific antidote for Campath overdosage. Treatment consists of drug discontinuation and supportive therapy.

ContrainDications

None

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

Clinical Pharamacology

Mechanism Of Action

Campath binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of Campath to the leukemic cells.

Pharmacodynamics

Cardiac Electrophysiology

The effect of multiple doses of alemtuzumab (12 mg/day for 5 days) on the QTc interval was evaluated in a single-arm study in 53 patients without malignancy. No large changes in the mean QTc interval (i.e., > 20 ms) were detected in the study. A mean increase in heart rate of 22 to 26 beats/min was observed for at least 2 hours following the initial infusion of alemtuzumab. This increase in heart rate was not observed with subsequent doses.

Pharmacokinetics

Campath pharmacokinetics were characterized in a study of 30 previously treated B-CLL patients in whom Campath was administered at the recommended dose and schedule. Campath pharmacokinetics displayed nonlinear elimination kinetics. After the last 30 mg dose, the mean volume of distribution at steady-state was 0.18 L/kg (range 0.1 to 0.4 L/kg). Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i.e., loss of CD52 receptors in the periphery). After 12 weeks of dosing, patients exhibited a seven-fold increase in mean AUC. Mean half-life was 11 hours (range 2 to 32 hours) after the first 30 mg dose and was 6 days (range 1 to 14 days) after the last 30 mg dose.

Comparisons of AUC in patients ≥ 65 years (n=6) versus patients < 65 years (n=15) suggested that no dose adjustments are necessary for age. Comparisons of AUC in female patients (n=4) versus male patients (n=17) suggested that no dose adjustments are necessary for gender.

The pharmacokinetics of Campath in pediatric patients have not been studied. The effects of renal or hepatic impairment on the pharmacokinetics of Campath have not been studied.

Clinical Studies

Previously Untreated B-CLL Patients

Campath was evaluated in an open-label, randomized (1:1) active-controlled study in previously untreated patients with B-CLL, Rai Stage I-IV, with evidence of progressive disease requiring therapy. Patients received either Campath 30 mg IV 3 times/week for a maximum of 12 weeks or chlorambucil 40 mg/m PO once every 28 days, for a maximum of 12 cycles.

Of the 297 patients randomized, the median age was 60 years, 72% were male, 99% were Caucasian, 96% had a WHO performance status 0-1, 23% had maximum lymph node diameter ≥ 5cm, 34% were Rai Stage III/IV, and 8% were treated in the U.S.

Patients randomized to receive Campath experienced longer progression free survival (PFS) compared to those randomized to receive chlorambucil (median PFS 14.6 months vs. 11.7 months, respectively). The overall response rates were 83% and 55% (p < 0.0001) and the complete response rates were 24% and 2% (p < 0.0001) for Campath and chlorambucil arms, respectively. The Kaplan-Meier curve for PFS is shown in Figure 1.

Figure 1: Progression Free Survival in Previously Untreated B-CLL Patients1

Progression Free Survival in Previously Untreated B-CLL Patients - Illustration

1 Log-rank test adjusted for Rai Stage (I-II vs. III-IV).

Previously Treated B-CLL Patients

Campath was evaluated in three multicenter, open-label, single arm studies of 149 patients with B-CLL previously treated with alkylating agents, fludarabine, or other chemotherapies. Patients were treated with the recommended dose of Campath, 30 mg intravenously, three times per week for up to 12 weeks. Partial response rates of 21 to 31% and complete response rates of 0 to 2% were observed.

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

Patient Information

Cytopenias

Advise patients to report any signs or symptoms such as bleeding, easy bruising, petechiae or purpura, pallor, weakness or fatigue [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Infusion Reactions

Advise patients of the signs and symptoms of infusion reactions and of the need to take premedications as prescribed [see WARNINGS AND PRECAUTIONS and overall ADVERSE REACTIONS].

Infections

Advise patients to immediately report symptoms of infection (e.g. pyrexia) and to take prophylactic anti-infectives for PCP (trimethoprim/sulfamethoxazole DS or equivalent) and for herpes virus (famciclovir or equivalent) as prescribed [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Advise patients that irradiation of blood products is required [see WARNINGS AND PRECAUTIONS].

Advise patients that they should not be immunized with live viral vaccines if they have recently been treated with Campath [see WARNINGS AND PRECAUTIONS].

Advise male and female patients with reproductive potential to use effective contraceptive methods during treatment and for a minimum of 6 months following Campath therapy [see Nonclinical Toxicology].

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.

 

ALEMTUZUMAB - INJECTION

 

(AL-em-TOOZ-oo-mab)

 

COMMON BRAND NAME(S): Campath

 

WARNING: This medication may cause very serious (rarely fatal) blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat, dark urine.

This medication may also cause very serious (rarely fatal) infusion-related reactions. (See also Side Effects section.)

Your doctor will monitor you closely to decrease the risk of these serious side effects.

 

USES: Alemtuzumab is used to treat a certain type of leukemia (B-cell chronic lymphocytic leukemia, also known as B-CLL). This medication works by stopping the growth of cancer cells.

Alemtuzumab is also used to treat a certain type of multiple sclerosis (relapsing-remitting multiple sclerosis-MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using alemtuzumab and each time you receive treatment with this drug. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection into a vein by a health care professional. The dosage and treatment schedule is based on your medical condition and response to treatment. If you are using this medication to treat B-cell chronic lymphocytic leukemia, your doctor will increase your dose slowly to decrease the risk of side effects.

Before you receive this medication, your doctor will direct you to take other medications (e.g., acetaminophen, diphenhydramine) to help prevent side effects. Your doctor should also prescribe other medications (e.g., antibiotics, antiviral medications) to help prevent infection in your body. Use these additional medications exactly as prescribed by your doctor.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Fever, chills, dizziness, muscle stiffness, nausea, vomiting, headache, diarrhea, mild rash/itching, tiredness, or trouble breathing may occur during or after the infusion. These reactions occur more often during the first week of treatment. Tell your doctor or pharmacist immediately if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Mouth sores, loss of appetite, shaking (tremor), stomach/abdominal pain, constipation, drowsiness, cough, increased sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 immediately if any of these serious side effects occur: shortness of breath, mental/mood changes (e.g., depression, anxiety), bone pain, muscle pain/spasm, unusual weakness, swelling ankles/feet, yellowing skin/eyes, change in the amount of urine, painful urination, numbness/tingling of arms/legs, pain/redness/swelling of arms/legs/injection site.

Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, trouble breathing, chest/jaw/left arm pain, irregular heartbeat, seizures, confusion, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Campath (alemtuzumab) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/current infections (such as tuberculosis), bleeding/blood problems, cancer, kidney problems, heart problems, immune system problems (e.g., HIV), thyroid problems.

This drug may make you dizzy or drowsy. 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.

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

Before receiving a blood transfusion, tell your doctor that you are using this medication.

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

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of child-bearing age should use reliable forms of birth control (such as condoms, birth control pills) during and after treatment with this medication. Talk with your doctor for more details and to discuss the risks and benefits of treatment with this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended during treatment and for at least 3 to 4 months after treatment with this drug. 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 weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

 

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. Symptoms of overdose may include: trouble breathing, change in the amount of urine.

 

NOTES: Laboratory and/or medical tests (such as complete blood count, kidney function, thyroid function, blood pressure) should be performed periodically during and after treatment is completed 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 immediately to establish a new dosing schedule.

 

STORAGE: Not applicable. This medication is given in a hospital or 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: Campath

Generic Name: alemtuzumab (Pronunciation: )

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

What is alemtuzumab (Campath)?

Alemtuzumab is an antibody made from animal DNA.

Alemtuzumab is used to treat chronic B-cell lymphocytic leukemia.

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

What are the possible side effects of alemtuzumab (Campath)?

Some people receiving an alemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel hot or cold, nauseated, light-headed, sweaty, or have chest tightness or trouble breathing 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:

  • fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;
  • pale or yellowed skin, dark colored urine, confusion or weakness;
  • easy bruising, unusual bleeding (nosebleed, bleeding gums), purple or red pinpoint spots under your skin;
  • cough with yellow or green mucus, wheezing;
  • tired feeling, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • swelling, warmth, redness, tingling, itching, or oozing of the skin;
  • vision problems, changes in your behavior, seizure (convulsions); or
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Less serious side effects include:

  • nausea, vomiting, diarrhea, loss of appetite;
  • sleep problems (insomnia);
  • headache, anxiety;
  • joint or muscle pain; or
  • mild itching or rash.

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 Campath (alemtuzumab) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about alemtuzumab (Campath)?

You should not receive alemtuzumab if you are allergic to it.

Before you receive alemtuzumab, tell your doctor if you have any type of infection, if you are allergic to mouse or hamster proteins, or if you have regular blood transfusions.

Alemtuzumab can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Serious and sometimes fatal infections may occur during treatment with alemtuzumab. Call your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, weakness, confusion, easy bruising or bleeding (nosebleed, bleeding gums), feeling light-headed or short of breath, rapid heart rate, pale or yellowed skin, or dark colored urine.

Do not receive a "live" vaccine while using alemtuzumab. The vaccine may not work as well during this time, and may not fully protect you from disease.

You may be given other medications together with alemtuzumab to help prevent infection or certain side effects. Take these medicines for the full prescribed length of time.

You should not breast-feed while you are receiving alemtuzumab.

Side Effects Centers
  • Campath

Patient Detailed How Take

What should I discuss with my health care provider before receiving alemtuzumab (Campath)?

You should not receive alemtuzumab if you are allergic to it.

To make sure alemtuzumab is safe for you, tell your doctor if you have any of these other conditions:

  • any type of bacterial, fungal, or viral infection (including herpes, cytomegalovirus, HIV, or AIDS);
  • if you are allergic to mouse or hamster proteins; or
  • if you have regular blood transfusions.

FDA pregnancy category C. It is not known whether alemtuzumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while receiving this medication.

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

How is alemtuzumab given (Campath)?

Alemtuzumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Alemtuzumab must be given slowly, and the IV infusion can take up to up to 2 hours to complete.

This medication is usually given for a total or 12 weeks. You may receive the medication every day or 3 days per week, depending on any side effects that occur.

If you have stopped receiving alemtuzumab for longer than 7 days for any reason, you may need to restart the medication at a lower dose.

You may be given an antibiotic and other medications to help prevent certain side effects of alemtuzumab. Take these medicines for the full prescribed length of time, which may include at least 2 months after you stop receiving alemtuzumab.

Alemtuzumab can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Side Effects Centers
  • Campath

Patient Detailed Avoid Taking

What happens if I miss a dose (Campath)?

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

What happens if I overdose (Campath)?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving alemtuzumab (Campath)?

Do not receive a "live" vaccine while receiving alemtuzumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What other drugs will affect alemtuzumab (Campath)?

There may be other drugs that can interact with alemtuzumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. 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 alemtuzumab.


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.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 9/27/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Campath

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