CARMUSTINE- carmustine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARMUSTINE (UNII: U68WG3173Y) (CARMUSTINE - UNII:U68WG3173Y)

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 is contraindicated in patients with previous hypersensitivity to Carmustine for Injection or its components. Risk Summary Carmustine for Injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animals [see Data] . Limited available data with Carmustine for Injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Carmustine was embryotoxic in rats an

Product summary:

Carmustine for Injection, USP. Each package includes a vial containing 100 mg carmustine and a vial containing 3 mL sterile diluent. NDC 23155-649-41 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). The recommended storage of unopened Carmustine for Injection vials provides a stable product for up to 3 years. Compatibility/ Incompatibility with Containers The intravenous solution is unstable in polyvinyl chloride container. DO NOT USE PVC Containers . Administer Carmustine for Injection solution from the glass bottles or polypropylene container only. Ensure the polypropylene containers used are PVC free and DEHP free. Important Note Carmustine for Injection, USP has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The Carmustine for Injection will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the Carmustine for Injection is suitable for use and should be refrigerated immediately.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CARMUSTINE - CARMUSTINE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARMUSTINE FOR
INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CARMUSTINE FOR
INJECTION, USP.
CARMUSTINE FOR INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1977
WARNING: MYELOSUPPRESSION AND PULMONARY TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• SUPPRESSION OF MARROW FUNCTION, NOTABLY THROMBOCYTOPENIA AND
LEUKOPENIA, IS THE
MOST COMMON AND SEVERE OF THE TOXIC EFFECTS OF CARMUSTINE FOR
INJECTION. MONITOR
BLOOD COUNTS. (5, 6).
• PULMONARY TOXICITY FROM CARMUSTINE FOR INJECTION APPEARS TO BE
DOSE RELATED.
PATIENTS RECEIVING GREATER THAN 1400 MG/M CUMULATIVE DOSE ARE AT
SIGNIFICANTLY HIGHER
RISK THAN THOSE RECEIVING LESS (5, 6).
INDICATIONS AND USAGE
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 (1)
Multiple myeloma-in combination with prednisone (1)
Relapsed or refractory Hodgkin's lymphoma in combination with other
approved drugs (1)
Relapsed or refractory Non-Hodgkin's lymphomas in combination with
other approved drugs (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage: As a single agent, 150 to 200 mg/m Carmustine for
Injection intravenously
every 6 weeks as a single dose or divided into daily injections such
as 75 to 100 mg/m on 2 successive
days. Adjust dose for combination therapy or in patients with reduced
bone marrow reserve (2.1)
Administer reconstituted solution only as a slow intravenous infusion
over at least 2 hours. (2.2)
DOSAGE FORMS AND STRENGTHS
For injection: 100 mg of carmustine lyophilized powder in a
single-dose vial for reconstitution and a vial
containing 3mL sterile