Carmustine
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
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 until blood counts recover. Pulmonary Toxicity Carmustine for Injection 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. Monitor blood counts. (5, 6). • Pulmonary toxicity from Carmustine for Injection appears to be dose related.
Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less (5, 6).
Dosing in kidney impairment
Do not administer a repeat course of Carmustine for Injection, USP until circulating blood elements have returned to acceptable levels (platelets above 100 Gi/L, leukocytes above 4 Gi/L and absolute neutrophil count above 1 Gi/L). The usual interval between courses is 6 weeks. Evaluate renal function prior to administration and periodically during treatment.
For patients with compromised renal function, monitor for toxicity more frequently. Discontinue Carmustine for Injection, USP if the creatinine clearance is less than 10 mL/min. Do not administer Carmustine for Injection, USP to patients with compromised renal function. Monitor transaminases and bilirubin periodically during treatment. [see Adverse Reactions ]. 2.2 Preparation and Administration of Intravenous Solution Dissolve Carmustine for Injection, USP with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP).
Preparation and administration
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Preparation and Administration of Intravenous Solution Dissolve Carmustine for Injection, USP with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP). Aseptically add 27 mL Sterile Water for Injection, USP. Each mL of resulting solution contains 3.3 mg of Carmustine for Injection in 10% ethanol. Such solutions should be protected from light.
The reconstituted solution is a clear, colorless to yellowish solution. Once reconstituted, the solution must be further diluted with Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Examine reconstituted vials for crystal formation prior to use. If crystals are observed, they may be re-dissolved by warming the vial to room temperature with agitation.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After reconstitution as recommended, Carmustine for Injection is stable for 24 hours under refrigeration (2°-8°C, 36°-46°F) in glass container. Examine reconstituted vials for crystal formation prior to use.
If crystals are observed, they may be redissolved by warming the vial to room temperature with agitation. Vials reconstituted as directed and further diluted with 500 mL Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, in glass or polypropylene containers to a concentration of 0.2 mg/mL, should be stored at room temperature, protected from light and utilized within 8 hours.
These solutions are also stable 24 hours under refrigeration (2°-8°C, 36°-46°F) and an additional 6 hours at room temperature protected from light. Administer reconstituted solution by slow intravenous infusion over at least two hours. Administration of Carmustine for Injection over a period of less than two hours can lead to pain and burning at the site of injection.
Monitor the injected area during the administration. The rate of administration of the intravenous infusion should not be more than 1.66 mg/m 2 /min. See Section 16.2 for important instructions on the storage and handling of the injection. Carmustine for Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 The lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose vial.
Discard unused portion. Accidental contact of reconstituted Carmustine for Injection, USP with the skin has caused transient hyperpigmentation of the affected areas. Wear impervious gloves to minimize the risk of dermal exposure impervious gloves when handling vials containing Carmustine for Injection. Immediately wash the skin or mucosa thoroughly with soap and water if Carmustine for Injection lyophilized material or solution contacts the skin or mucosa 1 .
Drug interactions
Check carmustine against a medication listLabel text (3 paragraphs)
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 may reduce the efficacy of phenytoin. (7.2)
7.1 Effect of other drugs on Carmustine for Injection 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. Consider alternative drugs to phenobarbital.
7.2 Effect of Carmustine for Injection on other drugs Phenytoin: Carmustine for Injection when coadministered with phenytoin may reduce phenytoin serum concentrations. Consider alternative drugs to phenytoin.
Contraindications
Hypersensitivity (4) Carmustine for Injection is contraindicated in patients with previous hypersensitivity to Carmustine for Injection or its components.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Carmustine for Injection 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 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 for the mother and possible risks to the fetus when prescribing Carmustine for Injection 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.
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 1400 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…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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