Press Release Prescribing Information
Campath® Alemtuzumab - For Intravenous Use Only
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As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) - See Things in a Whole New Light: Campath First Line - Campath® Alemtuzumab For Intravenous Use Only
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Dosing and Administration

Recommended concomitant medications


Dosing schedule



Dose modification and reinitiation of therapy for hematologic toxicity

Hematologic Toxicity Dose Modification and Reinitiation of Therapy
For first occurrence of ANC <250/µL and/or platelet count ≤25,000/µL Withhold Campath therapy. When ANC ≥500/µL and platelet count ≥50,000/µL, resume Campath therapy at same dose. If delay between dosing is ≥7 days, initiate therapy at Campath 3 mg and escalate to 10 mg and then to 30 mg as tolerated.
For second occurrence of ANC <250/µL and/or platelet count ≤25,000/µL Withhold Campath therapy. When ANC ≥500/µL and platelet count ≥50,000/µL, resume Campath therapy at 10 mg. If delay between dosing is ≥7 days, initiate therapy at Campath 3 mg and escalate to 10 mg only.
For third occurrence of ANC <250/µL and/or platelet count ≤25,000/µL Discontinue Campath therapy permanently.
For a decrease of ANC and/or platelet count to ≤50% of the baseline value in patients initiating therapy with a baseline ANC ≤500/µL and/or a baseline platelet count ≤25,000/µL Withhold Campath therapy. When ANC and/or platelet count return to baseline value(s), resume 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.
Indication and Important Safety Information

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

WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS (5.1)].

Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].

Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].

The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.

Please see Full Prescribing Information (PDF).