Page 7 - 2020 Catalog
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Carmustine for Injection, USP

             AP-rated to BiCNU®*

             QU ALIT Y  Y OU  C AN TRUS T.


             SA VINGS   Y OU C AN SEE.




















                                                                                           NDC number - 70710-1525-09














        INDICATION: 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
        IMPORTANT SAFETY INFORMATION:
       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. Do not administer a repeat course of carmustine for
        injection, USP until blood counts recover.
       Pulmonary Toxicity:
       •  Carmustine for injection, USP causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m  cumulative dose are at signifi cantly higher risk than those receiving
                                                                         2
        less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood.
        CONTRAINDICATIONS                                        ADVERSE REACTIONS
        •  Carmustine for injection, USP is contraindicated in patients with previous hypersensitivity to   •  Most common adverse reactions (>1%) are nausea, vomiting, renal toxicity, pneumonitis, pulmonary
         carmustine for injection, USP or its components.         toxicity, myelosuppression.
        WARNINGS AND PRECAUTIONS                                 To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc, Pennington, NJ
        •  Administration Reactions: Extravasation may occur; monitor infusion site closely during administration.  08534 at +1-877-993-8779 or FDA at +1-800-FDA-1088 or www.fda.gov/medwatch.
        •  Carcinogenicity: Potentially carcinogenic to humans. Monitor patient periodically for such signs   DRUG INTERACTIONS
         and apprise the patient of the symptoms for which they need to seek medical help.    – Cimetidine: Increased myelosuppression with concomitant use.
        •  Ocular Toxicity: Has occurred when administered via unapproved intraarterial intracarotid route.    – Phenobarbital: Induces carmustine metabolism, reducing exposure. May lead to reduced effi cacy.
        •  Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential     – Phenytoin: Carmustine for injection, USP may reduce the effi cacy of phenytoin.
         risk to a fetus and to avoid pregnancy.                 USE IN SPECIFIC POPULATIONS
                                                                 • Advise lactating females not to breastfeed.


        PLEASE SEE IMPORTANT PRESCRIBING INFORMATION ON THE NEXT PAGE.
        You are encouraged to report negative side effects of prescription drugs to the FDA.
        Visit MedWatch (www.fda.gov/medwatch) or call 1-800-FDA-1088.
                                                                                             www.zydususa.com
       *AP-rated to BiCNU . BiCNU  is a registered trademark of Emcure Pharmaceuticals Limited.
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