Drug Name:
BICNU Rx

Generic Name and Formulations:
Carmustine 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Company:
Bristol-Myers Squibb
Therapeutic Use:
Indications for BICNU:
Palliative therapy as a single agent or in established combination therapy for brain tumors (glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, metastatic brain tumors).
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.
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.
Interactions:
Increased myelosuppression with concomitant cimetidine. Antagonized by phenobarbital. May antagonize serum phenytoin levels.
Pharmacological Class:
Alkylating agent.
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.
How Supplied:
Single-use vial—1 (w. 3mL sterile diluent)
Indications for BICNU:
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).
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.
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.
Interactions:
Increased myelosuppression with concomitant cimetidine. Antagonized by phenobarbital. May antagonize serum phenytoin levels.
Pharmacological Class:
Alkylating agent.
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.
How Supplied:
Single-use vial—1 (w. 3mL sterile diluent)
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