Indications
Carmustine for Injection 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) Carmustine for injection 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 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.
Contraindications
Hypersensitivity (4) Carmustine for Injection is contraindicated in patients with previous hypersensitivity to carmustine or its components. Carmustine for Injection is contraindicated in patients with previous hypersensitivity to carmustine or its components.
Warnings and precautions
Administration Reactions: Extravasation may occur; monitor infusion site closely during administration (5.3) 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. (5.4) Ocular Toxicity: Has occurred when administered via unapproved intraarterial intracarotid route. (5.5) Embryo-Fetal toxicity: Can cause fetal harm.
Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. (5.6)
5.1
At a glance
- Brand name
- Carmustine
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Penn Life
- Status
- Prescription
- FDA approval
- 2 Apr 2019
- Application
- ANDA209278-001