Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 100mg
wafers
- 7.7mg
Brain Tumors, Multiple Myeloma, Hodgkin's Disease, NHL
BiCNU
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (5)
- adenovirus types 4 and 7 live, oral
carmustine decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- influenza virus vaccine quadrivalent, adjuvanted
carmustine decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
carmustine decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- palifermin
palifermin increases toxicity of carmustine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- tofacitinib
carmustine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (34)
- acalabrutinib
acalabrutinib, carmustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and carmustine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- bendamustine
bendamustine, carmustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- busulfan
busulfan, carmustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- carboplatin
carboplatin, carmustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- chlorambucil
carmustine, chlorambucil. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- cholera vaccine
carmustine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- cimetidine
cimetidine, carmustine. Mechanism: decreasing metabolism. Use Caution/Monitor. Enhanced myelotoxicity.
- cisplatin
carmustine, cisplatin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- cyclophosphamide
carmustine, cyclophosphamide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- dacarbazine
carmustine, dacarbazine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- dengue vaccine
carmustine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
carmustine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- dichlorphenamide
dichlorphenamide and carmustine both decrease serum potassium. Use Caution/Monitor.
- digoxin
carmustine decreases levels of digoxin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. It is prudent to closely monitor patients for loss of clinical efficacy of digoxin while receiving antineoplastic therapy.
- ethotoin
carmustine decreases levels of ethotoin by unknown mechanism. Use Caution/Monitor.
- fingolimod
carmustine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- fosphenytoin
carmustine decreases levels of fosphenytoin by unknown mechanism. Use Caution/Monitor.
- hydroxyurea
carmustine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ifosfamide
carmustine, ifosfamide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- influenza A (H5N1) vaccine
carmustine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza virus vaccine (H5N1), adjuvanted
carmustine decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- isavuconazonium sulfate
carmustine and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
carmustine, lomustine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- meningococcal group B vaccine
carmustine decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, carmustine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
carmustine and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- phenytoin
carmustine decreases levels of phenytoin by unknown mechanism. Use Caution/Monitor.
- siponimod
siponimod and carmustine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
carmustine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- streptozocin
carmustine, streptozocin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- thiotepa
carmustine, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- trastuzumab
trastuzumab, carmustine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, carmustine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
Minor (2)
- vitamin A
vitamin A, carmustine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
- vitamin E
vitamin E, carmustine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
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
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
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.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%)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| carmustine intravenous - | 100 mg vial |  | |
| carmustine intravenous - | 100 mg vial |  | |
| carmustine intravenous - | 100 mg vial |  | |
| BiCNU intravenous - | 100 mg vial |  | |
| BiCNU intravenous - | 100 mg vial |  | |
| BiCNU intravenous - | 100 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
carmustine intravenous
CARMUSTINE - INJECTION
(kar-MUS-teen)
COMMON BRAND NAME(S): BiCNU
WARNING: Carmustine may cause serious bleeding/blood problems. This effect can cause anemia, lower your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Your doctor will check you closely during and for at least 6 weeks after treatment to lessen the chance of serious side effects. Tell your doctor right away if you develop symptoms such as easy bruising/bleeding, unusual tiredness, signs of infection (such as sore throat that doesn't go away, fever, chills).This medication may also cause very serious (possibly fatal) lung problems. The risk increases after receiving higher total doses and can occur years after treatment. Tell your doctor right away if you develop symptoms such as cough that doesn't go away, shortness of breath, chest pain, unusual weakness/tiredness.
USES: This medication is used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). Carmustine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.
HOW TO USE: This medication is given by slow injection into a vein by a health care professional. It is given as directed by your doctor, usually every 6 weeks. The dosage is based on your medical condition, body size, and response to treatment.
SIDE EFFECTS: See also Warning section.Nausea, vomiting, loss of appetite, headache, flushing, eye redness, or pain at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), vision changes.People who are treated with this medication may rarely get other cancers. Consult your doctor for more details.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using carmustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, current/recent/returning infection, kidney disease, liver problems, lung disease.Carmustine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be at greater risk for developing serious lung problems after receiving this medication.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using carmustine. Carmustine may harm an unborn baby. Women should ask about reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 6 months after stopping treatment. Men should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: nalidixic acid.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood count, kidney/liver/lung function) should be done while you are using this medication. Keep all medical and lab appointments.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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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.
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