MABCAMPATH

What it is

MabCampath is a recombinant DNA-derived humanised monoclonal antibody directed against the 21–28 kD cell surface glycoprotein, CD52. Each vial contains 30 mg/mL alemtuzumab as a concentrated solution for infusion. All doses are administered by intravenous infusion over approximately 2 hours.

Approved indications

— B-cell chronic lymphocytic leukaemia (B-CLL).

Dosing overview

During the first week of treatment, MabCampath should be administered 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.

Key safety warnings

MabCampath can result in serious, and in some instances fatal, infusion reactions. Patients should be carefully monitored during infusions and MabCampath discontinued if indicated. Acute adverse reactions which may occur during initial dose escalation due to the release of cytokines include hypotension, chills/rigors, fever, shortness of breath and rashes. Additional reactions include nausea, urticaria, vomiting, fatigue, dyspnoea, headache, pruritus, diarrhoea and bronchospasm. Profound lymphocyte depletion, an expected pharmacological effect of MabCampath, inevitably occurs and may be prolonged. CD4 and CD8 T-cell counts begin to rise from weeks 8–12 during treatment and continue to recover for several months following the discontinuation of treatment. In patients receiving MabCampath as first line therapy, the median time to recovery of CD4+ counts to ≥200 cells/μL occurred by 6 months post-treatment, however at 2 months post-treatment the median was 183 cells/μL. In previously treated patients receiving MabCampath, the median time to reach a level of 200 cells/μL is 2 months following last infusion with MabCampath but may take more than 12 months to approximate pretreatment levels. Serious, sometimes fatal bacterial, viral, fungal and protozoan infections have been reported in patients receiving MabCampath therapy. Anti-infective prophylaxis (for example trimethoprim/sulfamethoxazole 1 tablet twice daily, 3 times weekly, or other prophylaxis against Pneumocystis jirovecii pneumonia and an effective oral anti-herpes agent, such as famciclovir 500 mg twice daily) should be initiated while on therapy and for a minimum of 2 months following completion of treatment with MabCampath or until the CD4+ count has recovered to 200 cells/μL or greater, whichever is the later. Serious and, in rare instances fatal, pancytopenia, autoimmune idiopathic thrombocytopenia and autoimmune haemolytic anaemia have occurred in patients receiving MabCampath. Single doses of MabCampath greater than 30 mg or cumulative doses greater than 90 mg per week should not be administered because these doses are associated with a higher incidence of pancytopenia.

Contraindications

MabCampath is contraindicated in hypersensitivity or anaphylactic reactions to alemtuzumab, to murine proteins or to any of the excipients. MabCampath is contraindicated in patients with active systemic infections. MabCampath is contraindicated in patients infected with HIV. MabCampath is contraindicated in patients with active secondary malignancies. MabCampath is contraindicated in pregnancy. MabCampath is contraindicated in breast-feeding.

Regulatory history

MabCampath alemtuzumab 30 mg/mL concentrate solution for infusion vial was first listed on the ARTG on 10 May 2006.