CARMUSTINE
CARMUSTINE · KIT · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CARMUSTINE is a kit containing carmustine. Manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
Key Facts
- Brand Name
- CARMUSTINE
- Generic Name
- CARMUSTINE
- NDC Code (Product)
23155-649- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA017422
- Marketing Start
- 10/01/2019
Recall History
Bristol-myers Squibb Company
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 (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 & Administration
2 DOSAGE AND ADMINISTRATION 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 (2.1) Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours. (2.2) 2.1 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. Lower the dose when carmustine for injection, USP is used with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted. Administer carmustine for injection, USP for the duration according to the established regimen. Premedicate each dose with anti-emetics. Adjust doses subsequent to the initial dose according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment: Nadir After Prior Dos…
Contraindications
4 CONTRAINDICATIONS Carmustine for injection, USP is contraindicated in patients with previous hypersensitivity to carmustine for injection, USP or its components. Hypersensitivity
Drug Interactions
7 DRUG INTERACTIONS Cimetidine: Increased myelosuppression with concomitant use. (7.1) Phenobarbital: Induces carmustine metabolism, reducing exposure. May lead to reduced efficacy. (7.1) Phenytoin: Carmustine for injection, USP may reduce the efficacy of phenytoin. (7.2) 7.1 Effects of other drugs on carmustine for injection, USP Cimetidine: Greater myelosuppression (e.g., leukopenia and neutropenia) has been reported when oral cimetidine has been coadministered with carmustine. Consider alternative drugs to cimetidine. Phenobarbital: Phenobarbital induces the metabolism of carmustine and may compromise antitumor activity of carmustine for injection, USP. Consider alternative drugs to phenobarbital. 7.2 Effects of carmustine for injection, USP on other drugs Phenytoin: Carmustine for injection, USP when coadministered with phenytoin may reduce phenytoin serum concentrations. Consider alternative drugs to phenytoin.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Pulmonary toxicity [see Warnings and Precautions (5.2) ] Administration Reactions [see Warnings and Precautions (5.3) ] Carcinogenicity [see Warnings and Precautions (5.4) ] Ocular Toxicity [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of carmustine for injection, USP 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. Eye Disorders Conjunctival edema, conjunctival hemorrhage, blurred vision and loss of depth perception Gastrointestinal Toxicity Nausea, vomiting, anorexia, and diarrhea Hepatotoxicity Increased transaminase, increased alkaline phosphatase, increased bilirubin levels Infections and Infestations Opportunistic infection (including with fatal outcome). Neoplasms Benign, Malignant and Unspecified (including c…
Frequently Asked Questions
What is CARMUSTINE used for?
CARMUSTINE contains CARMUSTINE. It is a kit taken as directed. Consult your doctor for specific uses.
Is CARMUSTINE a controlled substance?
CARMUSTINE is not classified as a controlled substance by the DEA.
What is the generic name for CARMUSTINE?
The generic name for CARMUSTINE is CARMUSTINE. There are 10 other brand versions of CARMUSTINE.
What is the NDC code for CARMUSTINE ?
The NDC (National Drug Code) for CARMUSTINE is 23155-649, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..