ists of drug discontinuation and supportive therapy.
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DOSAGE AND ADMINISTRATION
Campath should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.
Dosing Schedule and Administration:
Campath therapy should be initiated at a dose of 3 mg administered as a 2 hour IV infusion daily. (See ADVERSE EVENTS.) When the Campath 3 mg daily dose is tolerated (e.g., infusion-related toxicities are £ Grade 2), the daily dose should be escalated to 10 mg and continued until tolerated. When the 10 mg dose is tolerated, the maintenance dose of Campath 30 mg may be initiated. The maintenance dose of Campath is 30 mg/day administered three times per week on alternate days (i.e., Monday, Wednesday, and Friday) for up to 12 weeks. In most patients, escalation to 30 mg can be accomplished in 3 - 7 days. Dose escalation to the recommended maintenance dose of 30 mg administered three times per week is required. Single doses of Campath greater than 30 mg or cumulative weekly doses of greater than 90 mg should not be administered since higher doses are associated with an increased incidence of pancytopenia. (See BOXED WARNING.) Campath should be administered intravenously only. The infusion should be administered over a 2 hour period. DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.
Recommended Concomitant Medications:
Premedication should be given prior to the first dose, at dose escalations, and as clinically indicated. The premedication used in clinical studies was diphenhydramine 50 mg and acetaminophen 650 mg administered 30 minutes prior to Campath infusion. In cases where severe infusion-related events occur, treatment with hydrocortisone 200 mg was used in decreasing the infusion-related events.
Patients should receive anti-infective prophylaxis to minimize the risks of serious opportunistic infections. (See BOXED WARNING.) The anti-infective regimen used on Study 1 consisted of trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week and famciclovir or equivalent 250 mg twice a day (BID) upon initiation of Campath therapy. Prophylaxis should be continued for 2 months after completion of Campath therapy or until the CD4+ count is ³ 200 cells/mL, whichever occurs later.
Dose Modification and Reinitiation of Therapy:
Campath therapy should be discontinued during serious infection, serious hematologic toxicity, or other serious toxicity until the event resolves. (See WARNINGS.) Campath therapy should be permanently discontinued if evidence of autoimmune anemia or thrombocytopenia appears. Table 3 includes recommendations for dose modification for severe neutropenia or thrombocytopenia.
Table 3: Dose Modification and Reinitiation of Therapy for Hematologic Toxicity
Hematologic Toxicity Dose Modification and Reinitiation of Therapy
For first occurrence of ANC < 250/mL and/or platelet count £ 25,000/mL Withhold Campath therapy. When ANC ³ 500/mL and platelet count ³ 50,000/mL, resume Campath therapy at same dose. If delay between dosing is ³ 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/mL and/or platelet count £ 25,000/mL Withhold Campath therapy. When ANC ³ 500/mL and platelet count ³ 50,000/mL, resume Campath therapy at 10 mg. If delay between dosing is ³ 7 days, initiate therapy at Campath 3 mg and escalate t |
