ld be obtained at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia is observed on therapy. CD4+ counts should be assessed after treatment until recovery to ³ 200 cells/mL. (See WARNINGS and ADVERSE REACTIONS.)
Drug/Laboratory Interactions:
No formal drug interaction studies have been performed with Campath. An immune response to Campath may interfere with subsequent diagnostic serum tests that utilize antibodies.
Immunization:
Patients who have recently received Campath, should not be immunized with live viral vaccines, due to their immunosuppression. The safety of immunization with live viral vaccines following Campath therapy has not been studied. The ability to generate a primary or anamnestic humoral response to any vaccine following Campath therapy has not been studied.
Immunogenicity:
Four (1.9%) of 211 patients eva luated for development of an immune response were found to have antibodies to Campath. The data reflect the percentage of patients whose test results were considered positive for antibody to Campath in a kinetic enzyme immunoassay, and are highly dependent on the sensitivity and specificity of the assay. The observed incidence of antibody positivity may be influenced by several additional factors including sample handling, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to Campath with the incidence of antibodies to other products may be misleading. Patients who develop hypersensitivity to Campath may have allergic or hypersensitivity reactions to other monoclonal antibodies.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
No long-term studies in animals have been performed to establish the carcinogenic or mutagenic potential of Campath, or to determine its effects on fertility in males or females. Women of childbearing potential and men of reproductive potential should use effective contraceptive methods during treatment and for a minimum of 6 months following Campath therapy.
Pregnancy Category C:
Animal reproduction studies have not been conducted with Campath. It is not known whether Campath can affect reproductive capacity or cause fetal harm when administered to a pregnant woman. However, human IgG is known to cross the placental barrier and therefore Campath may cross the placental barrier and cause fetal B and T lymphocyte depletion. Campath should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Excretion of Campath in human breast milk has not been studied. Because many drugs including human IgG are excreted in human milk, breast-feeding should be discontinued during treatment and for at least 3 months following the last dose of Campath.
Pediatric Use:
The safety and effectiveness of Campath in children have not been established.
Geriatric Use:
Of the 149 patients with B-CLL enrolled in the three clinical studies, 66 (44%) were 65 and over, while 15 (10%) were 75 and over. Substantial differences in safety and efficacy related to age were not observed; however the size of the database is not sufficient to exclude important differences.
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ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the ra |
