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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
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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).
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RECENT MAJOR CHANGES
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Warnings and Precautions (5.3) 3/2009
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INDICATIONS AND USAGE
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Campath is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) (1).
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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).
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DOSAGE FORMS AND STRENGTHS
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30 mg/1 mL single use vial (3).
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CONTRAINDICATIONS
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None (4).
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WARNINGS AND PRECAUTIONS
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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).
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ADVERSE REACTIONS
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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
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 08/2009 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Schedule and Administration
2.2 Recommended Concomitant Medications
2.3 Dose Modification
2.4 Preparation and Administration
2.5 Incompatibilities
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cytopenias
5.2 Infusion Reactions
5.3 Immunosuppression/Infections
5.4 Laboratory Monitoring
5.5 Immunization
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC |
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