Carmustine

Carmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma-in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.

The mechanism of action of carmustine is not fully understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. The metabolites may contribute to antitumor activity and toxicities of carmustine.

Recommended Dosage: As a single agent, 150 to 200 mg/m 2 Carmustine for Injection intravenously every 6 weeks as a single dose or divided into daily injections such as 75 to 100 mg/m 2 on 2 successive days. Adjust dose for combination therapy or in patients with reduced bone marrow reserve. Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours.

Hypersensitivity. Carmustine for Injection is contraindicated in patients with previous hypersensitivity to Carmustine for Injection or its components.

Boxed warning (myelosuppression and pulmonary toxicity): Myelosuppression Carmustine for Injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections,. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose. Administration Reactions: Extravasation may occur, monitor infusion site closely during administration. Carcinogenicity: Potentially carcinogenic to humans. Monitor patient periodically for such signs and apprise the patient of the symptoms for which they need to seek medical help. Ocular Toxicity: Has occurred when administered via unapproved intraarterial intracarotid route. Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy.

The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression Pulmonary toxicity Administration Reactions Carcinogenicity Ocular Toxicity The following adverse reactions associated with the use of Carmustine for Injection were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders Tachycardia and chest pain.

Cimetidine: Increased myelosuppression with concomitant use. Phenobarbital: Induces carmustine metabolism, reducing exposure. May lead to reduced efficacy. Phenytoin: Carmustine for Injection may reduce the efficacy of phenytoin.

Store product and diluent in a refrigerator (2°-8°C, 36°-46°F). Stability Store the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials in a refrigerator (2°-8°C, 36°-46°F). Important Note Carmustine for Injection, USP has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. If this is evident, the Carmustine for Injection is suitable for use and should be refrigerated immediately. The recommended storage of unopened Carmustine for Injection vials provides a stable product for up to 3 years.