carmustine (Rx)

Brand and Other Names:BiCNU, Gliadel
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

powder for injection

  • 100mg

wafers

  • 7.7mg

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

Recurrent Glioblastoma

Indicated for recurrent glioblastoma as an adjunct to surgery

Gliadel

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

Maligmant Glioma

Indicated for newly-diagnosed high-grade glioma as an adjunct to surgery and radiation

Gliadel

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

Orphan Designations

Intracranial malignancies

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

Conditioning treatment prior to hematopoietic progenitor cell transplantation

  • Sponsor
    • Adienne S.A.; Via Zurigo, 46 6900 Lugano Switzerland

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

Recurrent Glioblastoma

Up to 8 wafers placed in surgical resection cavity of brain

Monitor CBC, pulmonary function, LFTs, renal function

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

and carmustine

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      Serious - Use Alternative

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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

            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:

            Infections: Opportunistic infections (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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            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

            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; complete blood count should be monitored weekly for at least six weeks after each dose

            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

            Ocular toxicity associated with intracarotid route (investigational); safety and efficacy not established

            Associated with moderate to high emetic potential; administer antiemetics to prevent nausea and vomiting

            Monitor liver function tests periodically during therapy; reversible increases (rare) in bilirubin, alkaline phosphatase levels, and transaminases reported

            Wafer implant associated with intracranial hypertension; brain edema reported in patients with newly diagnosed glioma; monitor closely for intracranial hypertension related to brain edema, inflammation, or necrosis of brain tissues surrounding resection; in refractory cases, removing the wafer may be necessary

            Meningitis reported in patients with recurrent glioma receiving wafer implants; monitor postoperatively for signs/symptoms of meningitis and CNS infection

            Renal failure, decreased kidney size, and progressive azotemia reported in patients receiving low or large cumulative doses or prolonged treatment; monitor renal function periodically

            Long-term use associated with development of secondary malignancies (acute leukemia and bone marrow dysplasias)

            Wafer implants associated with seizures; treatment-emergent seizures reported within 5 days of surgery; initiate optimal anti-seizure therapy prior to surgery

            Impaired neurosurgical wound healing, including wound dehiscence, delayed healing, and subdural, subgleal or wound effusions associated with wafer implant treatment; cerebrospinal fluid leaks also reported; monitor for impaired neurosurgical wound healing following surgery

            Avoid pregnancy

            Contraception

            • Advise female patients to avoid pregnancy during therapy because of risk of fetal harm
            • Advise female patients of reproductive potential to use highly effective contraception during and for up to six months after completion of treatment
            • Advise males with female sexual partners of reproductive potential to use effective contraception during therapy and for at least three months after final dose of carmustine

            Fertility

            • Based on nonclinical findings, male fertility may be compromised by therapy
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            Pregnancy & Lactation

            Pregnancy

            Therapy can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women

            Animal data

            • Drug is embryotoxic and teratogenic in rats at exposures less than exposure at recommended human dose based on body surface area (BSA) and embryotoxic in rabbits at exposures similar to exposures at the recommended human dose based on BSA; advise pregnant women of potential risk to a fetus
            • Verify pregnancy status of females of reproductive potential prior to therapy
            • Therapy can cause fetal harm when administered to a pregnant woman.
            • Advise females of reproductive potential to use effective contraception for 6 months after therapy
            • Based on its mechanism of action, advise males with female partners of reproductive potential to use effective contraception for 3 months following therapy
            • Carmustine caused testicular degeneration in animals; advise male patients of potential risk of infertility

            Lactation

            No data are available regarding presence of drug or metabolites in human milk or effects on breastfed child or on milk production; because of potential for serious adverse reactions in breastfed children from therapy, advise women not to breastfeed following treatment and for at least 7 days after treatment

            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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.