FDA

Carmustine

Approved 12 Mar 2021InjectionInjectable

The FDA lists this product in 13 strengths and forms.

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.

Contraindications

Hypersensitivity ( 4 ) 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 )

5.1Myelosuppression

Bone marrow toxicity is a dose-limiting, common and severe toxic effect of carmustine occurring 4 to 6 weeks after drug administration (thrombocytopenia occurs at about 4 weeks post-administration persisting for 1 to 2 weeks; leukopenia occurs at 5 to 6 weeks after a dose of carmustine persisting for 1 to 2 weeks; thrombocytopenia is generally more severe than leukopenia; anemia is less frequent and less severe compared to thrombocytopenia and/or leukopenia) Complete blood count should therefore be monitored weekly for at least six weeks after a dose.

At a glance

Brand name: Carmustine
Route: Injection
Dosage form: Injectable
Applicant: Hengrui Pharma
Status: Discontinued
FDA approval: 12 Mar 2021
Application: ANDA211202-001

Indications

Warnings and precautions

Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. ( 5.6 )

5.1Myelosuppression

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Carmustine 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 use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Carmustine was embryotoxic in rats and rabbits and teratogenic in rats (thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area.

Consider the benefits and risks of carmustine for the mother and possible risks to the fetus when prescribing carmustine to a pregnant woman. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Intraperitoneal (IP) administration of carmustine to pregnant rats 14 days prior to mating and during the period of organogenesis at cumulative doses ≥26 mg/kg (158 mg/m 2 ), approximately 0.1 times the maximum cumulative human dose of 1,400 mg/m 2 , resulted in pre-implantation loss, increased resorptions (including completely resorbed litters), and reduced the number of live births in the presence of maternal toxicity.

Carmustine administered IP to pregnant rats during the period of organogenesis at cumulative doses ≥4 mg/kg (24 mg/m 2 ), approximately 0.02 times the maximum cumulative human dose based on a mg/m 2 basis, resulted in reduced fetal weight and various malformations, which included thoracoabdominal closure defects, neural tube defects, and eye defects, including microphthalmia/anophthalmia, and skeletal anomalies in the skull, sternebra, vertebrae and ribs, and reduced skeletal ossification) in the presence of maternal toxicity.

Embryo-fetal death was observed at cumulative doses ≥8 mg/kg (48 mg/m 2 ), approximately 0.03 times the maximum cumulative human dose on a mg/ m 2 basis. Intravenous (IV) administration of carmustine to rats at a cumulative dose of 50 mg/kg (300 mg/ m 2 ), approximately 0.2 times the maximum cumulative human dose on a mg/m 2 basis, during the last quarter of pregnancy resulted in the death of offspring within 4 months.

Carmustine administered IV to rabbits during the period of organogenesis resulted in spontaneous abortions in mothers and growth defects in the fetus, mainly at cumulative doses ≥13 mg/kg (156 mg/m 2 ), approximately 0.1 times the maximum cumulative human dose on a mg/ m 2 basis.

Carmustine

Indications

Contraindications

Warnings and precautions

5.1Myelosuppression

At a glance

Two medicines in one question?

Carmustine

Indications

Contraindications

Warnings and precautions

5.1Myelosuppression

At a glance

Two medicines in one question?

5.2Pulmonary Toxicity Cases

5.3Administration Reactions

5.4Carcinogenicity

5.5Ocular Toxicity

5.6Embryo-Fetal Toxicity

Interactions

7.1Effects of Other Drugs on Carmustine Cimetidine:

7.2Effects of Carmustine on Other Drugs Phenytoin:

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information