Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Genzyme Europe BV Gooimeer 10 1411 DD Naarden Netherlands
MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.
MabCampath should be administered under the supervision of a physician experienced in the use of cancer therapy.
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. However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).
Median duration of treatment was 11.7 weeks for first-line patients and 9.0 weeks for previously treated patients.
Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored. If a patient improves (i.e. achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored. Therapy should be discontinued if there is evidence of disease progression.
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).
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
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.
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.
Patients have received repeated unit doses of up to 240 mg of MabCampath. The frequency of grade 3 or 4 adverse events, such as fever, hypotension and anaemia, may be higher in these patients. There is no known specific antidote for MabCampath. Treatment consists of discontinuation of MabCampath and supportive therapy.
Unopen vial: 3 years.
Reconstituted solution: MabCampath contains no antimicrobial preservative. MabCampath should be used within 8 hours after dilution. Solutions may be stored at 15°C-30°C or refrigerated. This can only be accepted if preparation of the solution takes place under strictly aseptic conditions and the solution is protected from light.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.
Pack size: carton of 3 vials.
The vial contents should be inspected for particulate matter and discolouration prior to administration. If particulate matter is present or the concentrate is coloured, then the vial should not be used.
MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light. The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. The bag should be inverted gently to mix the solution. Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line (see section 4.5).
Caution should be exercised in the handling and preparation of the MabCampath solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. Women who are pregnant or trying to become pregnant should not handle MabCampath.
Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of by incineration.
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