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Campath® Alemtuzumab - For Intravenous Use Only - illuminating possibilites
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As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
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Dosing and Administration

Recommended concomitant medications


Premedicate with diphenhydramine (50 mg) and acetaminophen (500 mg to 1000 mg) 30 minutes prior to first infusion and each dose escalation. Institute appropriate medical management (eg, steroids, epinephrine, meperidine) for infusion reactions as needed.

Administer trimethoprim/sulfamethoxazole DS twice daily (BID) 3 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/µL, whichever occurs later.

Dosing schedule

Treat for 12 weeks (36 doses) as recommended for maximum bone marrow clearance

Treat for 12 weeks (36 doses) as recommended for maximum bone marrow clearance
*Dose escalation can take up to 3 to 7 days to accomplish.

Dose modification

Dose Modification for Neutropenia or Thrombocytopenia

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
ANC=absolute neutrophil count.
If the delay between dosing is ≥7 days, initiate Campath therapy at 3 mg and escalate to 10 mg and then to 30 mg as tolerated.
Indications & Usage

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

Important safety information
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.

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.

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.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. 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.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

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

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. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see full Prescribing Information (PDF).