BICNU Rx

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.

Boxed Warning:

Myelosuppression. Pulmonary toxicity.

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.

Pharmacological Class:

Alkylating agent.

Interactions:

Increased myelosuppression with concomitant cimetidine. Antagonized by phenobarbital. May antagonize serum phenytoin levels.

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.

Boxed Warning:

Myelosuppression. Pulmonary toxicity.

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.

Pharmacological Class:

Alkylating agent.

Interactions:

Increased myelosuppression with concomitant cimetidine. Antagonized by phenobarbital. May antagonize serum phenytoin levels.

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)