Hycamtin

HYCAMTIN^® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

• •The recommended dosage is 2.3 mg/m²/day orally once daily for 5 consecutive days starting on Day 1 of a 21-day cycle. (
  2.1 Recommended Dosage

  The recommended dosage of HYCAMTIN capsules is 2.3 mg/m²/day orally once daily, with or without food, for 5 consecutive days, starting on Day 1 of a 21-day cycle. Round the dose to the nearest 0.25 mg and prescribe the minimum number of 1 mg and 0.25 mg capsules. Prescribe the same number of capsules for each of the 5 dosing days.

  Swallow capsules whole. Do not chew, crush, or divide the capsules.

  • If a dose of HYCAMTIN capsules is missed or vomiting occurs after taking a dose, do not administer an additional dose and take the next dose at the scheduled time.
  )
• •
  Renal Impairment:
  Reduce dose if creatinine clearance (CLcr) less than 50 mL/min. (
  2.3 Dosage Modifications for Renal Impairment

  • Reduce the dose of HYCAMTIN capsules in patients with the following creatinine clearance (CLcr), calculated with the Cockcroft-Gault method using ideal body weight.
  • •CLcr 30 to 49 mL/min: Administer 1.5 mg/m²/day.
  • •CLcr less than 30 mL/min: Administer 0.6 mg/m²/day.
  )

• •0.25 mg: opaque white to yellowish-white and imprinted with HYCAMTIN and 0.25 mg.
• •1 mg: opaque pink and imprinted with HYCAMTIN and 1 mg.

• •
  Lactation:
  Advise not to breastfeed. (
  8.2 Lactation

  Risk Summary

  There are no data on the presence of topotecan or its metabolites in human milk, or their effects on the breastfed infant or milk production. Lactating rats excrete high concentrations of topotecan into milk (

  see Data

  ). Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with HYCAMTIN and for 1 week after the last dose.

  Data

  Following intravenous administration of topotecan to lactating rats at a dose of 4.72 mg/m²(about twice the 1.5 mg/m²clinical intravenous dose based on BSA), topotecan was excreted into milk at concentrations up to 48-fold higher than those in plasma.
  )