MABCAMPATH
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Package(a):
AMPOULES (solution for infusion): 3 x 3 ml x 10 mg/ml.
This package has been discontinued.
Dosage(a):
Prepare the solution according to instructions. All doses should be administered by intravenous infusion over approximately 2 hours. Patients should be premedicated with an appropriate antihistamine and analgesic prior to the first dose at each escalation and prior to subsequent infusions. Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment. During the first week of treatment, administer in escalating doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated. Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks. In most patients, dose escalation to 30 mg can be accomplished in 3-7 days. However, if acute severe adverse reactions (especially hypotension, rigors, fever or bronchospasm) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated prior to further escalation. The majority of major responses have been achieved with treatment durations of 4-12 weeks. Once a patient meets all laboratory and clinical criteria for a complete response, discontinue and monitor the patient. If a partial response or stable disease is achieved and then reaches a plateau without further improvement for 4 weeks or more, discontinue treatment and monitor the patient. Therapy should be discontinued if there is evidence of disease progression. In the event of serious infection or severe haematological toxicity discontinue until the event resolves. It is recommended to discontinue when platelet count falls to <25,000 microliters or whose absolute neutrophil count (ANC) drops to <250 microliters. May reinstitute after the infection or toxicity has resolved. The recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy: Children and adolescents (below 17 years of age): No studies have been conducted. Elderly (over 65 years of age): Recommendations are as stated above for adults. Patients should be monitored carefully.
Prescribing Restrictions:
Package(b):
VIALS (solution for infusion): 3 x 1 ml x 30 mg/ml.
Dosage(b):
Prepare the solution according to instructions. All doses should be administered by intravenous infusion over approximately 2 hours. Patients should be premedicated with an appropriate antihistamine and analgesic prior to the first dose at each escalation and prior to subsequent infusions. Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment. During the first week of treatment, administer in escalating doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated. Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks. In most patients, dose escalation to 30 mg can be accomplished in 3-7 days. However, if acute severe adverse reactions (especially hypotension, rigors, fever or bronchospasm) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated prior to further escalation. The majority of major responses have been achieved with treatment durations of 4-12 weeks. Once a patient meets all laboratory and clinical criteria for a complete response, discontinue and monitor the patient. If a partial response or stable disease is achieved and then reaches a plateau without further improvement for 4 weeks or more, discontinue treatment and monitor the patient. Therapy should be discontinued if there is evidence of disease progression. In the event of serious infection or severe haematological toxicity discontinue until the event resolves. It is recommended to discontinue when platelet count falls to <25,000 microliters or whose absolute neutrophil count (ANC) drops to <250 microliters. May reinstitute after the infection or toxicity has resolved. The recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy: Children and adolescents (below 17 years of age): No studies have been conducted. Elderly (over 65 years of age): Recommendations are as stated above for adults. Patients should be monitored carefully.
Prescribing Restrictions: None
Indications:
Treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.
Contra-Indications:
Hypersensitivity or anaphylactic reactions to alemtuzumab, to murine proteins or to any of the excipients, active systemic infections, HIV infections, active secondary malignancies, pregnancy, lactation, renal or hepatic impairment.
Special Precautions:
Patients with ischaemic heart disease, angina and/or in patients receiving antihypertensive medication. As transient grade 3 or 4 neutropenia commonly occurs after 5-6 weeks, hematological monitoring of patients is indicated. It is recommended that patients be premedicated with an oral antihistamine and analgesic 30 minutes prior to first treatment at 3 mg, at each subsequent dose escalation, and thereafter, if clinically indicated. The recommended premedication is 50 mg diphenhydramine and 500 mg paracetamol. It is highly recommended that anti-infective prophylaxis (trimethoprim/sulfamethoxazole or other prophylaxis against PCP and an effective oral anti-herpes agent, such as famciclovir), should be initiated while on therapy and administered up to a minimum of 2 months following cessation of treatment. Complete blood counts and platelet counts should be obtained at regular intervals during therapy.
Pregnancy and lactation: Males and females of childbearing capacity should use effective contraceptive measures during treatment and for 6 months following therapy. See prescribing information for full details.
Side Effects:
Acute adverse reactions, which may occur during initial dose escalation due to the release of cytokines, include hypotension, rigors, fever, shortness of breath, chills and rashes. If these events are moderate to severe, then dosing should continue at the same level prior to each dose escalation, with appropriate premedication, until each dose is well tolerated. If therapy is withheld for more than 7 days, reinstitute with gradual dose escalation. Transient hypotension may occur.
Drug Interactions:
No formal drug interaction studies have been performed. It is recommended not to start therapy within 3 weeks of other chemotherapeutic agents. Patients should not receive live viral vaccines in, at least, the 12 months following therapy.
