Important Safety Information

Verify dosage using body surface area. Do not exceed a single dose of 4 mg intravenously.

Recommended Dosage for Ovarian Cancer

The recommended dosage of HYCAMTIN for injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity.

Recommended Dosage for Small Cell Lung Cancer (SCLC)

The recommended dosage of HYCAMTIN for injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.

Recommended Dosage for Cervical Cancer

The recommended dosage of HYCAMTIN for injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3, in combination with cisplatin 50 mg/m2 on Day 1, of a 21-day cycle.

Dosage Modifications for Adverse Reactions

Hematologic

Do not administer subsequent cycles of HYCAMTIN for injection until neutrophils recover to greater than 1,000/mm3, platelets recover to greater than 100,000/mm3, and hemoglobin levels recover to greater than or equal to 9 g/dL (with transfusion if necessary).

For HYCAMTIN for injection as a single agent, reduce the dose to 1.25 mg/m2/day for:

• neutrophil counts of less than 500/mm3 or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose
• platelet counts less than 25,000/mm3 during previous cycle

For HYCAMTIN for injection in combination with cisplatin, reduce the dose to 0.6 mg/m2/day (and further to 0.45 mg/m2 if necessary) for:

• febrile neutropenia (defined as neutrophil counts less than 1,000/mm3 with temperature of greater than or equal to 38.0°C (100.4°F) or administer G-CSF starting no sooner than 24 hours following the last dose
• platelet counts less than 25,000/mm3 during previous cycle

Dosage Modification for Renal Impairment

For HYCAMTIN for injection as a single agent, reduce the dose to 0.75 mg/m2/day for patients with creatinine clearance (CLcr) of 20 to 39 mL/min (calculated with the Cockcroft-Gault method using ideal body weight) [see Clinical Pharmacology (12.3)].

Preparation and Intravenous Administration

• Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit.

Preparation

• Reconstitute each 4 mg vial of HYCAMTIN for injection with 4 mL Sterile Water for Injection, USP.
• Dilute the appropriate volume of the reconstituted solution in either 0.9% Sodium Chloride Intravenous Infusion, USP or 5% Dextrose in Water Injection, USP.

Stability

• Because the vials contain no preservative, use contents immediately after reconstitution. Discard any unused portion.
• Store reconstituted product diluted for infusion at approximately 20°C to 25°C (68°F to 77°F) protected from light for no more than 24 hours. Discard after 24 hours.

HYCAMTIN for injection is a cytotoxic drug. Follow applicable handling and disposal procedures.1