medicinal products
Premedications
Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).
Prophylactic antibiotics
Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment (see section 4.4).
Dose modification guidelines
There are no dose modifications recommended for severe lymphopenia given the mechanism of action of MabCampath.
In the event of serious infection or severe haematological toxicity MabCampath should be interrupted until the event resolves. It is recommended that MabCampath should be interrupted in patients whose platelet count falls to < 25,000/μl or whose absolute neutrophil count (ANC) drops to < 250/μl. MabCampath may be reinstituted after the infection or toxicity has resolved. MabCampath should be permanently discontinued if autoimmune anaemia or autoimmune thrombocytopenia appears. The following table outlines the recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy:
Haematologic values
Dose modification*
ANC < 250/μl and/or platelet count 25,000/μl
For first occurrence
Withhold MabCampath therapy. Resume MabCampath at 30 mg when ANC 500/μl and platelet count 50,000/μl.
For second occurrence
Withhold MabCampath therapy. Resume MabCampath at 10 mg when ANC 500/μl and platelet count 50,000/μl.
For third occurrence
Discontinue MabCampath 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 MabCampath therapy. Resume MabCampath at 30 mg upon return to baseline value(s).
For second occurrence
Withhold MabCampath therapy. Resume MabCampath at 10 mg upon return to baseline value(s).
For third occurrence
Discontinue MabCampath therapy.
*If the delay between dosing is 7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg and then to 30 mg as tolerated
Special populations
Elderly (over 65 years of age)
Recommendations are as stated above for adults. Patients should be monitored carefully (see section 4.4).
Patients with renal or hepatic impairment
No studies have been conducted.
Paediatric population
The safety and efficacy of MabCampath in children aged less than 17 years of age have not been established. No data are available.
Method of administration
The MabCampath solution must be prepared according to the instructions provided in section 6.6. All doses should be administered by intravenous infusion over approximately 2 hours.
4.3 Contraindications
- Hypersensitivity to alemtuzumab, to murine proteins or to any of the excipients.
- Active systemic infections.
- HIV.
- Active second malignancies.
- Pregnancy.
4.4 Special warnings and precautions for use
Acute adverse reactions, which may occur during initial dose escalation and some of which may be 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, diarr |
