pharmacopeia
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Boxed 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. [ see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [ see Dosage and Administration (2.1) ]. 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 2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . 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, USP. Monitor blood counts. (5, 6). Pulmonary toxicity from carmustine for injection, USP appears to be dose related.

Mechanism of action

Sourced from openFDA

The mechanism of action of carmustine is not fully understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators.

Indications

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  • 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.ICD-10: C90.00

Contraindications

Sourced from openFDA
  • Carmustine for injection, USP is contraindicated in patients with previous hypersensitivity to carmustine for injection, USP or its components.contraindicated

Dosage & administration

Sourced from openFDA

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 Dose Percentage of Prior Dose to be Given Leukocytes/mm 3 Platelets/mm 3 >4000 >100,000 100% 3000-3999 75,000-99,999 100% 2000-2999 25,000-74,999 70% <2000 <25,000 50% The hematologic toxicity can be delayed and cumulative. Monitor blood counts weekly.

Warnings & precautions

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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 Myelosuppression Bone marrow toxicity is a dose-limiting, common and severe toxic effect of carmustine for injection, USP occurring 4-6 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 for injection, USP 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. Repeat doses of carmustine for injection, USP should not be given more frequently than every six weeks. The bone marrow toxicity of carmustine for injection, USP is cumulative and therefore the dosage adjustment must be considered on the basis of nadir blood counts from prior dose [see Adverse Reactions (6) ].

Adverse reactions

Sourced from openFDA

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 cysts and polyps) Acute leukemia, bone marrow dysplasias.

Use in specific populations

Sourced from openFDA

Lactation: Advise lactating females not to breastfeed (8.2) 8.1 Pregnancy Risk Summary Carmustine for injection, USP 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, USP 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 injection, USP for the mother and possible risks to the fetus when prescribing carmustine for injection, USP 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 2-4% and 15-20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Distribution Carmustine crosses the blood-brain barrier. Levels of radioactivity in the CSF are greater than or equal to 50% of those measured concurrently in plasma.

Overdosage

Sourced from openFDA

The main result of overdose is myeloablation. No proven antidotes have been established for carmustine for injection, USP overdosage.

Approval history

Sourced from openFDA
  • Mar 7, 1977NDANDA017422Avet Lifesciences
  • Sep 23, 1996NDANDA020637Azurity
  • Sep 11, 2018ANDAANDA210179Navinta Llc
  • Oct 16, 2018ANDAANDA211229Amneal
  • Apr 2, 2019ANDAANDA209278Penn Life
  • Oct 22, 2020ANDAANDA213207Dr Reddys
  • Mar 12, 2021ANDAANDA211202Hengrui Pharma
  • Aug 2, 2021ANDAANDA213460Meitheal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,543 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use50011%
  2. 2Febrile Neutropenia3778.3%
  3. 3Myelodysplastic Syndrome2906.4%
  4. 4Disease Progression2876.3%
  5. 5Thrombocytopenia2445.4%
  6. 6Pyrexia2375.2%
  7. 7Mucosal Inflammation2074.6%
  8. 8Neutropenia2054.5%
  9. 9Pneumonia1954.3%
  10. 10Drug Ineffective1894.2%
  11. 11Infection1743.8%
  12. 12Acute Myeloid Leukaemia1723.8%
  13. 13Sepsis1583.5%
  14. 14Diarrhoea1563.4%
  15. 15Product Use In Unapproved Indication1523.3%

Literature

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Recent PubMed references pinned to Carmustine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 273 ClinicalTrials.gov registrations naming Carmustine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Carmustine work?
The mechanism of action of carmustine is not fully understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators.
What is Carmustine used for?
According to FDA labeling, Carmustine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Carmustine?
Carmustine is classified as Nitrosoureas, Alkylating Drug, Alkylating Activity, Decreased DNA Integrity, Decreased DNA Replication.
What are the brand names for Carmustine?
Carmustine is marketed under brand names including BiCNU, Gliadel.
What are the contraindications for Carmustine?
Carmustine labeling lists contraindications including: Carmustine for injection, USP is contraindicated in patients with previous hypersensitivity to carmustine for injection, USP or its components.. Always consult the full prescribing information and a clinician.
Note. Data for carmustine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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