Select therapeutic use:

Prostate and other male cancers:

Indications for: TOPOSAR

Refractory testicular tumors after appropriate radiation, surgery, and other chemotherapy.

Adult Dosage:

Give by slow IV infusion over 30–60mins. Range 50–100mg/m2 per day on days 1 through 5 to 100mg/m2 per day on days 1, 3, and 5. Repeat course every 3 to 4 weeks after recovery from any toxicity. Renal impairment (CrCl 15–50mL/min): reduce dose to 75%; (CrCl <15mL/min): see literature. Consider dose reduction with existing myelosuppression due to previous radiation or chemotherapy.

Children Dosage:

Not established.

Boxed Warning:

Should be administered under the supervision of an experienced physician in cancer chemotherapy. Severe myelosuppression.

TOPOSAR Warnings/Precautions:

Monitor for myelosuppression; obtain CBCs with differential, platelets, hemoglobin at baseline, prior to each subsequent dose, during and after therapy. Withhold dose if platelet count <50,000/mm3 or ANC <500/mm3. Renal impairment. Hypoalbuminemia. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

TOPOSAR Classification:

Topoisomerase inhibitor.

TOPOSAR Interactions:

Potentiated by cyclosporine. Additive toxicity with radiation, other cytotoxic therapies.

Adverse Reactions:

Hypersensitivity/infusion reactions (eg, fever/chills, hypotension, bronchospasm), GI upset, anorexia, mucositis, myelosuppression (esp neutropenia, thrombocytopenia; may be fatal), alopecia, fever, infections, peripheral neurotoxicity; rare: acute leukemia; others.

How Supplied:

Multi-dose vials (5mL, 25mL, 50mL)—1

Respiratory and thoracic cancers:

Indications for: TOPOSAR

First-line treatment of small cell lung cancer.

Adult Dosage:

Give by slow IV infusion over 30–60mins. Range 35mg/m2 per day for 4 days to 50mg/m2 per day for 5 days. Repeat course every 3 to 4 weeks after recovery from any toxicity. Renal impairment (CrCl 15–50mL/min): reduce dose to 75%; (CrCl <15mL/min): see literature. Consider dose reduction with existing myelosuppression due to previous radiation or chemotherapy.

Children Dosage:

Not established.

Boxed Warning:

Should be administered under the supervision of an experienced physician in cancer chemotherapy. Severe myelosuppression.

TOPOSAR Warnings/Precautions:

Monitor for myelosuppression; obtain CBCs with differential, platelets, hemoglobin at baseline, prior to each subsequent dose, during and after therapy. Withhold dose if platelet count <50,000/mm3 or ANC <500/mm3. Renal impairment. Hypoalbuminemia. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

TOPOSAR Classification:

Topoisomerase inhibitor.

TOPOSAR Interactions:

Potentiated by cyclosporine. Additive toxicity with radiation, other cytotoxic therapies.

Adverse Reactions:

Hypersensitivity/infusion reactions (eg, fever/chills, hypotension, bronchospasm), GI upset, anorexia, mucositis, myelosuppression (esp neutropenia, thrombocytopenia; may be fatal), alopecia, fever, infections, peripheral neurotoxicity; rare: acute leukemia; others.

How Supplied:

Multi-dose vials (5mL, 25mL, 50mL)—1