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CAMPATH (alemtuzumab) Injection
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CAMPATH safely and effectively. See full prescribing information for CAMPATH.
CAMPATH ®(alemtuzumab)
Injection for intravenous use
Initial U.S. Approval: 2001
WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS
See full prescribing information for complete boxed warning.
Serious, including fatal, cytopenias, infusion reactions and infections can occur (5.1 – 5.3).
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Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia (2.1).
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Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion reactions (5.2).
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Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections (2.2, 5.3).
INDICATIONS AND USAGE
Campath is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) (1).
DOSAGE AND ADMINISTRATION
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Administer as an IV infusion over 2 hours (2.1).
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Escalate to recommended dose of 30 mg/day three times per week for 12 weeks (2.1).
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Premedicate with oral antihistamine and acetaminophen prior to dosing (2.2).
DOSAGE FORMS AND STRENGTHS
30 mg/1 mL single use vial (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Cytopenias:
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Obtain complete blood counts (CBC) and platelet counts at weekly intervals during therapy and CD4 counts after therapy until recovery to ≥ 200 cells/µL (5.4).
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Discontinue for autoimmune or severe hematologic adverse reactions (5.1).
Infections:
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Campath induces severe and prolonged lymphopenia and increases risk of infection. If a serious infection occurs, withhold treatment until infection resolves (5.3).
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Do not administer live viral vaccines to patients who have recently received Campath (5.5).
ADVERSE REACTIONS
Most common adverse reactions (≥ 10%): cytopenias, infusion reactions, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4-CAMPATH (1-877-422-6728) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 10/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICTIONS AND USAGE
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Schedule and Administration
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Administer as an IV infusion over 2 hours. Do not administer as intravenous push or bolus.
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Recommended Dosing Regimen
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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.
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Escalation Strategy:
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Administer 3 mg daily until infusion reactions are ≤ grade 2 [see ADVERSE REACTIONS (6.1)].
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Then administer 10 mg daily until infusion reactions are ≤ grade 2.
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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.
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Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.
2.2 Recommended Concomitant Medications
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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 (5.2) and ADVERSE REACTIONS (6.1)].
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Administer trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week (or equivalent) as Pneumocystis jiroveci pneumonia (PCP) prophylaxis.
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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/µL, whichever occurs later [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.3)].
2.3 Dose Modification
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Withhold Campath during serious infection or other serious adverse reactions until resolution.
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Discontinue Campath for autoimmune anemia or autoimmune thrombocytopenia.
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There are no dose modifications recommended for lymphopenia.
2.4 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.
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To prepare the 3 mg dose, withdraw 0.1 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
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To prepare the 10 mg dose, withdraw 0.33 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
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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.
2.5 Incompatibilities
Campath is compatible with polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets. Do not add or simultaneously infuse other drug substances through the same intravenous line.
3 DOSAGE FORMS AND STRENGTHS
30 mg/1 mL single use vial
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 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 (2.3)]. No data exist on the safety of Campath resumption in patients with autoimmune cytopenias or marrow aplasia [see ADVERSE REACTIONS (6.1)].
5.2 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 (6.1)].
The following serious, including fatal, infusion reactions have been identified in post-marketing 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 ADMINISTRATION (2)]. Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g., glucocorticoids, epinephrine, meperidine) for infusion |
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