hese 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
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) ] .
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
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) ] .
Dose Modification for Neutropenia or Thrombocytopenia [see WARNINGS AND PRECAUTIONS (5.1)] Hematologic Values Dose ModificationIf 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 DOSAGE AND ADMINISTRATION (2.1) ].
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.
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.
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 on |
