infection during MabCampath treatment and for at least 2 months following completion of treatment.
Transient grade 3 or 4 neutropenia occurs very commonly by weeks 5-8 following initiation of treatment. Transient grade 3 or 4 thrombocytopenia occurs very commonly during the first 2 weeks of therapy and then begins to improve in most patients. Therefore, haematological monitoring of patients is indicated. If a severe haematological toxicity develops, MabCampath treatment should be interrupted until the event resolves. Treatment may be reinstituted following resolution of the haematological toxicity (see section 4.2). MabCampath should be permanently discontinued if autoimmune anaemia or autoimmune thrombocytopenia appears.
Complete blood counts and platelet counts should be obtained at regular intervals during MabCampath therapy and more frequently in patients who develop cytopenias.
It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice. However, if retreatment is considered, it may be prudent to confirm the presence of CD52 expression. In data available from first line patients treated with MabCampath, loss of CD52 expression was not observed around the time of disease progression or death.
Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric monoclonal antibodies.
Medicinal products for the treatment of hypersensitivity reactions, as well as preparedness to institute emergency measures in the event of reaction during administration is necessary (see section 4.2).
Males and females of childbearing potential should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy (see sections 4.6 and 5.3).
No studies have been conducted which specifically address the effect of age on MabCampath disposition and toxicity. In general, older patients (over 65 years of age) tolerate cytotoxic therapy less well than younger individuals. Since CLL occurs commonly in this older age group, these patients should be monitored carefully (see section 4.2). In the studies in first line and previously treated patients no substantial differences in safety and efficacy related to age were observed; however the sizes of the databases are limited.
4.5 Interaction with other medicinal products and other forms of interaction
Although no formal drug interaction studies have been performed with MabCampath, there are no known clinically significant interactions of MabCampath with other medicinal products. Because MabCampath is a recombinant humanized protein, a P450 mediated drug-drug interaction would not be expected. However, it is recommended that MabCampath should not be given within 3 weeks of other chemotherapeutic agents.
Although it has not been studied, it is recommended that patients should not receive live viral vaccines in, at least, the 12 months following MabCampath therapy. The ability to generate a primary or anamnestic humoral response to any vaccine has not been studied.
4.6 Pregnancy and lactation
Pregnancy
MabCampath is contraindicated during pregnancy. Human IgG is known to cross the placental barrier; MabCampath may cross the placental barrier as well and thus potentially cause foetal B and T cell lymphocyte depletion. Animal reproduction studies have not been conducted with MabCampath. It is not known if MabCampath can cause foetal harm when administered to |
