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Bicnu Generic Name & Formulations
Legal Class
Rx
General Description
Carmustine 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Alkylating agent.
How Supplied
Single-use vial—1 (w. 3mL sterile diluent)
Manufacturer
Bicnu Indications
Indications
Palliative therapy as a single agent or in established combination therapy for brain tumors (glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, metastatic brain tumors).
Bicnu Dosage and Administration
Adult
Pretreat with antiemetics. Give by slow IV infusion over at least 2hrs. Previously untreated patients as a single agent: Initially 150–200mg/m2 every 6 weeks. May give as one single dose or divided into daily injections (eg, 75–100mg/m2) on 2 consecutive days. Adjust subsequent doses based on hematologic response (see full labeling). In combination therapy: adjust doses accordingly (see full labeling).
Children
Not established.
Bicnu Contraindications
Not Applicable
Bicnu Boxed Warnings
Boxed Warning
Myelosuppression. Pulmonary toxicity.
Bicnu Warnings/Precautions
Warnings/Precautions
Monitor CBCs weekly for >6 weeks after each dose. Do not give repeat doses until platelets are >100,000/mm3 and leukocytes are 4000/mm3. Perform pulmonary function tests prior to and during therapy. History of lung disease. Patients with baseline <70% of the predicted forced vital capacity or carbon monoxide diffusing capacity, and cumulative doses >1400mg/m2 increase risk of pulmonary toxicity. Monitor liver and renal function prior to and periodically during treatment. Ocular toxicity via unapproved intraarterial intracarotid route. Elderly. Embryo-fetal toxicity. Pregnancy: avoid. Females of reproductive potential should use effective contraception during and for at least 6 months after therapy; in males (during and for at least 3 months after therapy). Nursing mothers: not recommended.
Bicnu Pharmacokinetics
See Literature
Bicnu Interactions
Interactions
Increased myelosuppression with concomitant cimetidine. Antagonized by phenobarbital. May antagonize serum phenytoin levels.
Bicnu Adverse Reactions
Adverse Reactions
Nausea, vomiting, nephrotoxicity, pneumonitis, pulmonary toxicity, myelosuppression; delayed pulmonary fibrosis, secondary malignancies (monitor). Inj site reactions: intensive flushing of the skin and suffusion of the conjunctiva related to rapid IV infusion.
Bicnu Clinical Trials
See Literature
Bicnu Note
Not Applicable
Bicnu Patient Counseling
See Literature
Bicnu Generic Name & Formulations
Legal Class
Rx
General Description
Carmustine 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Alkylating agent.
How Supplied
Single-use vial—1 (w. 3mL sterile diluent)
Manufacturer
Bicnu Indications
Indications
Palliative therapy as single agent or in established combination therapy in multiple myeloma (in combination with prednisone), relapsed or refractory Hodgkin's or Non-Hodgkin's lymphomas (in combination with other approved drugs).
Bicnu Dosage and Administration
Adult
Pretreat with antiemetics. Give by slow IV infusion over at least 2hrs. Previously untreated patients as a single agent: Initially 150–200mg/m2 every 6 weeks. May give as one single dose or divided into daily injections (eg, 75–100mg/m2) on 2 consecutive days. Adjust subsequent doses based on hematologic response (see full labeling). In combination therapy: adjust doses accordingly (see full labeling).
Children
Not established.
Bicnu Contraindications
Not Applicable
Bicnu Boxed Warnings
Boxed Warning
Myelosuppression. Pulmonary toxicity.
Bicnu Warnings/Precautions
Warnings/Precautions
Monitor CBCs weekly for >6 weeks after each dose. Do not give repeat doses until platelets are >100,000/mm3 and leukocytes are 4000/mm3. Perform pulmonary function tests prior to and during therapy. History of lung disease. Patients with baseline <70% of the predicted forced vital capacity or carbon monoxide diffusing capacity, and cumulative doses >1400mg/m2 increase risk of pulmonary toxicity. Monitor liver and renal function prior to and periodically during treatment. Ocular toxicity via unapproved intraarterial intracarotid route. Elderly. Embryo-fetal toxicity. Pregnancy: avoid. Females of reproductive potential should use effective contraception during and for at least 6 months after therapy; in males (during and for at least 3 months after therapy). Nursing mothers: not recommended.
Bicnu Pharmacokinetics
See Literature
Bicnu Interactions
Interactions
Increased myelosuppression with concomitant cimetidine. Antagonized by phenobarbital. May antagonize serum phenytoin levels.
Bicnu Adverse Reactions
Adverse Reactions
Nausea, vomiting, nephrotoxicity, pneumonitis, pulmonary toxicity, myelosuppression; delayed pulmonary fibrosis, secondary malignancies (monitor). Inj site reactions: intensive flushing of the skin and suffusion of the conjunctiva related to rapid IV infusion.
Bicnu Clinical Trials
See Literature
Bicnu Note
Not Applicable
Bicnu Patient Counseling
See Literature
