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carmustine (Rx)Brand and Other Names:BiCNU, Gliadel

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

powder for injection

  • 100mg

wafers

  • 7.7mg
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Brain Tumors, Multiple Myeloma, Hodgkin's Disease, NHL

BiCNU

  • 150-200 mg/m² IV (single dose or divided 2 days) q6Weeks OR 
  • 75-100 mg/m²/day IV for 2 days q6Weeks

Adjunct to Surgery in Patients with Recurrent Glioblastoma Multiforme

Gliadel

  • Up to 8 wafers placed in surgical resection cavity of brain

Adjunct to Surgery & Radiation in Patients with Maligmant Glioma

Gliadel

  • Up to 8 wafers placed in surgical resection cavity of brain

Intracranial Malignancies (Orphan)

Orphan indication sponsor

  • Direct Therapeutics, Inc; 460 Seaport Court, Suite 220; Redwood, CA 94063

Renal Impairment

CrCl 46-80 mL/min: Administer 80% of regular dose

CrCl 31-45 mL/min: Administer 75% of regular dose

CrCl ≤ 30 mL/min: Not recommended

Hepatic Impairment

Dose adjustment may be necessary; not studied

Other Indications & Uses

Off-label: Mycosis fungoides

Safety & efficacy not established

BiCNU

Brain Tumors, Multiple Myeloma, Hodgkin's Disease, NHL

150-200 mg/m² IV (single dose or divided 2 days) q6Weeks OR 

75-100 mg/m²/day IV for 2 days q6Weeks

Monitor CBC, pulmonary function, LFTs, renal function

Gliadel

Adjunct to Surgery in Patients with Recurrent Glioblastoma Multiforme

Up to 8 wafers placed in surgical resection cavity of brain

Monitor CBC, pulmonary function, LFTs, renal function

Adjunct to Surgery & Radiation in Patients with Maligmant Glioma

Up to 8 wafers placed in surgical resection cavity of brain

Monitor CBC, pulmonary function, LFTs, renal function

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Interactions

Interaction Checker

carmustine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Convulsions (19%)

            Hemiplegia (19%)

            Headache (15%)

            Metabolic disorder (14%)

            Somnolence (14%)

            Fever (12%)

            1-10%

            Confusion (10%)

            Aphasia (9%)

            Nausea (8%)

            Vomiting (8%)

            Pain (7%)

            Rash (5%)

            Abscess (4%)

            Cranial edema (4%)

            ICP elevation (4%)

            Meningitis (4%)

            Hyperglycemia (3%)

            HTN (3%)

            Constipation (2%)

            Diarrhea (2%)

            Dizziness (2%)

            Depression (2%)

            Frequency Not Defined

            Greater myelotoxicity reported when coadministered with cimetidine

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Bone marrow suppression (notably thrombocytopenia and leukopenia) is the most common and severe of the toxic effects that may result from carmustine administration. It may contribute to bleeding and infections. Monitor blood counts for at least 6 weeks after a dose. Do not give recommended dosage more frequently than every 6 weeks. Adjust dose based on nadir blood counts from prior dose

            Pulmonary toxicity is dose related. Risk increases with cumulative doses > 1400 mg/m², history of lung disease and duration of therapy. Delayed cases of pulmonary fibrosis that can result in death have been reported 15 years after administration in children

            Contraindications

            Hypersensitivity

            Cautions

            Do not give more frequently than q6-8wk due to delayed myelosuppression

            Risk of irreversible pulmonary fibrosis on long-term treatment

            Injection site reactions may occur during administration; rapid infusion may cause burning along the vein and flushing of skin

            Extravasation risk, monitor closely during infusion

            Intra-arterial administration may cause ocular toxicity

            Monitor renal function regularly during treatment

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Alkylates and crosslinks DNA and RNA intefering with normal DNA function; may also inhibit enzyme processes by carbamylation of aminoacids in protein

            Pharmacokinetics

            Half-life elimination: 1.4 min (initial); 22 min (secondary)

            Vd: 3.25 L/kg

            Distribution: Readily crosses blood-brain barrier

            Clearance: 56 mL/min/kg

            Excretion: Urine (60-70%)

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            Administration

            IV Incompatibilities

            Solution: D5W (may be used in shorter time periods)

            Additive: sodium bicarbonate

            Y-site: allopurinol

            IV Compatibilities

            Solution: NS

            Y-site: amifostine, aztreonam, cefepime, etoposide PO4, filgrastim, fludarabine, gemcitabine, granisetron, melphalan, ondansetron, piperacillin/tazobactam, sargramostim, teniposide, thiotepa, vinorelbine

            IV Preparation

            Initially dilute with 3 mL of supplied diluent (dehydrated alcohol); further dilute aseptically with 27 mL SWI to result in a concentration of 3.3 mg/mL in 10% alcohol

            Standard dilution: dose/150-500 mL D5W or NS

            IV Administration

            Significant absorption to PVC containers; should be administered in either glass or Excel container

            Infuse over 1-2 hr

            High dose carmustine: maximum rate of infusion <3 mg/sq.meter/min to avoid excessive flushing, agitation, & hypotension; infusions should run over at least 2 hr

            Extravasation Management

            Elevate extremity

            Inject long-acting dexamethasone or by hyaluronidase throughout tissue with a 25- to 37-gauge needle

            Apply warm, moist compresses

            Storage

            Store intact vials under refrigeration

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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