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Carmustine is a brand name for Carmustine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION 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.
1) Administer reconstituted solution only as a slow intravenous infusion over at least 2 hours. 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. 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 (6) ]. 2 Preparation and Administration of Intravenous Solution Dissolve carmustine for injection, USP with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP).
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. Nephrotoxicity Progressive azotemia, decrease in kidney size, renal failure Nervous System Disorders Headaches, encephalopathy, and seizures Pulmonary Toxicity Pneumonitis, interstitial lung disease Reproductive System and Breast Disorders Gynecomastia Skin and Subcutaneous Tissue Disorders Burning sensation, hyperpigmentation, swelling, pain, erythema, skin necrosis, alopecia, allergic reaction Vascular Disorders Veno-occlusive disease.
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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. 4) Ocular Toxicity: Has occurred when administered via unapproved intraarterial intracarotid route.
5) Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to avoid pregnancy. 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) ].
, leukopenia and neutropenia) has been reported when carmustine was combined with cimetidine [see Drug Interactions (7) ]. 2 Pulmonary Toxicity Cases of fatal pulmonary toxicity with carmustine for injection, USP have been reported.
Pulmonary toxicity characterized by pulmonary infiltrates and/or fibrosis has been reported to occur from 9 days to 43 months after treatment with carmustine for injection, USP and related nitrosoureas. Pulmonary toxicity from carmustine for injection, USP is dose-related.
Patients receiving greater than 1400 mg/m 2 cumulative dose are at significantly higher risk than those receiving less. However, there have been reports of pulmonary fibrosis in patients receiving lower total doses. Interstitial fibrosis (with lower doses) occurred rarely.
4 CONTRAINDICATIONS Carmustine for injection, USP is contraindicated in patients with previous hypersensitivity to carmustine for injection, USP or its components. Hypersensitivity
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Aseptically add 27 mL Sterile Water for Injection, USP. 3 mg of carmustine for injection, USP 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, USP 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.
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, USP 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.
2 for important instructions on the storage and handling of the injection. Carmustine for injection, USP 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 via.
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, USP lyophilized material or solution contacts the skin or mucosa 1 .
Additionally, delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients who received carmustine for injection, USP (in cumulative doses ranging from 770 to 1800 mg/m 2 combined with cranial radiotherapy for intracranial tumors) in childhood and early adolescence.
Other risk factors include past history of lung disease and duration of treatment. Baseline pulmonary function studies should be conducted along with frequent pulmonary function tests during treatment. Patients with a baseline below 70% of the predicted forced vital capacity (FVC) or carbon monoxide diffusing capacity (DLCO) are particularly at risk.
3 Administration Reactions Injection site reactions may occur during the administration of carmustine for injection, USP. Rapid intravenous infusion of carmustine for injection, USP may produce intensive flushing of the skin and suffusion of the conjunctiva within 2 hours, lasting about 4 hours.
It is also associated with burning at the site of injection although true thrombosis is rare. Given the possibility of extravasation, close monitoring of the infusion site for possible infiltration during drug administration is recommended.
A specific treatment for extravasation reactions is unknown at this time. 4 Carcinogenicity Long-term use of nitrosoureas, such as carmustine for injection, USP, has been reported to be associated with the development of secondary malignancies.
1) ] . Nitrosourea therapy, such as carmustine for injection, USP, has carcinogenic potential in humans. Patients treated with carmustine for injection, USP should be monitored long-term for development of second malignancies. 5 Ocular Toxicity Carmustine for injection, USP has been administered through an intraarterial intracarotid route; this procedure is investigational and has been associated with ocular toxicity.
Safety and effectiveness of the intraarterial route have not been established. 6 Embryo-Fetal Toxicity Carmustine was embryotoxic in rats and rabbits and teratogenic in rats when given in doses lower than the maximum cumulative human dose based on body surface area.
There are no adequate and well-controlled studies in pregnant women. 3 ) ]. Advise females of reproductive potential to use highly effective contraception during and after treatment with carmustine for injection, USP for at least 6 months after therapy.
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