rmination of the effectiveness of Campath is based on overall response rates. (See CLINICAL STUDIES.) Comparative, randomized trials demonstrating increased survival or clinical benefits such as improvement in disease-related symptoms have not yet been conducted.
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CONTRAINDICATIONS
Campath is contraindicated in patients who have active systemic infections, underlying immunodeficiency (e.g., seropositive for HIV), or known Type I hypersensitivity or anaphylactic reactions to Campath or to any one of its components.
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WARNINGS (See BOXED WARNING.)
Infusion-Related Events:
Campath has been associated with infusion-related events including hypotension, rigors, fever, shortness of breath, bronchospasm, chills, and/or rash. In order to ameliorate or avoid infusion-related events, patients should be premedicated with an oral antihistamine and acetaminophen prior to dosing and monitored closely for infusion-related adverse events. In addition, Campath should be initiated at a low dose with gradual escalation to the effective dose. Careful monitoring of blood pressure and hypotensive symptoms is recommended especially in patients with ischemic heart disease and in patients on antihypertensive medications. If therapy is interrupted for 7 or more days, Campath should be reinstituted with gradual dose escalation. (See ADVERSE EVENTS and DOSAGE AND ADMINISTRATION.)
Immunosuppression/Opportunistic Infections:
Campath induces profound lymphopenia. A variety of opportunistic infections have been reported in patients receiving Campath therapy (see ADVERSE EVENTS, Infections). If a serious infection occurs, Campath therapy should be interrupted and may be reinitiated following the resolution of the infection.
Anti-infective prophylaxis is recommended upon initiation of therapy and for a minimum of 2 months following the last dose of Campath or until CD4+ counts are ³ 200 cells/mL. The median time to recovery of CD4+ counts to ³ 200/mL was 2 months, however, full recovery (to baseline) of CD4+ and CD8+ counts may take more than 12 months. (See BOXED WARNING and DOSAGE AND ADMINISTRATION.
Because of the potential for Graft versus Host Disease (GVHD) in severely lymphopenic patients, irradiation of any blood products administered prior to recovery from lymphopenia is recommended.
Hematologic Toxicity:
Severe, prolonged, and in rare instances fatal, myelosuppression has occurred in patients with leukemia and lymphoma receiving Campath. Bone marrow aplasia and hypoplasia were observed in the clinical studies at the recommended dose. The incidence of these complications increased with doses above the recommended dose. In addition, severe and fatal autoimmune anemia and thrombocytopenia were observed in patients with CLL. Campath should be discontinued for severe hematologic toxicity (see Table 3 Dose Modification and Reinitiation of Therapy for Hematologic Toxicity) or in any patient with evidence of autoimmune hematologic toxicity. Following resolution of transient, non-immune myelosuppression, Campath may be reinitiated with caution. (See DOSAGE AND ADMINISTRATION.) There is no information on the safety of resumption of Campath in patients with autoimmune cytopenias or marrow aplasia. (See ADVERSE REACTIONS.)
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PRECAUTIONS
Laboratory Monitoring:
Complete blood counts (CBC) and platelet counts shou |
