Finished product reference
Carmustine
Injection, Powder, for Solution · Parenteral · 100 mg
- List code
- 219
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 .
What it is and how it works
Mechanism of Action 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.
Indications
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. - 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 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
Dosage and administration (summary)
Recommended Dosage: As a single agent, 150 to 200 mg/m 2 carmustine for injection, USP 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. Dosage The recommended dose of carmustine for injection, USP as a single agent in previously untreated patients is 150 to 200 mg/m 2 intravenously every 6 weeks. Administer as a single dose or divided into daily injections such as 75 to 100 mg/m 2 on two successive days.
Contraindications
Carmustine for injection, USP is contraindicated in patients with previous hypersensitivity to carmustine for injection, USP or its components. Hypersensitivity
Warnings and precautions
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.
Pregnancy
Pregnancy Risk Summary Carmustine for injection, USP can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals [ see Data ].
Storage and supply
Storage and Handling 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).
Source: Carmustine (Carmustine) — US FDA prescribing information, 2025-11-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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