Hexalen (Altretamine) - Indications and Dosage

INDICATIONS and USAGE

HEXALEN^® (altretamine) capsules is indicated for use as a single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination.

DOSAGE AND ADMINISTRATION

HEXALEN^® capsules is administered orally. Doses are calculated on the basis of body surface area.

HEXALEN^® capsules may be administered either for 14 or 21 consecutive days in a 28 day cycle at a dose of 260 mg/m²/day. The total daily dose should be given as 4 divided oral doses after meals and at bedtime. There is no pharmacokinetic information supporting this dosing regimen and the effect of food on HEXALEN^® capsules bioavailability or pharmacokinetics has not been evaluated.

HEXALEN^® capsules should be temporarily discontinued (for 14 days or longer) and subsequently restarted at 200 mg/m²/day for any of the following situations:

1. Gastrointestinal intolerance unresponsive to symptomatic measures;
2. White blood count <2000/mm³ or granulocyte count <1000/mm³;
3. Platelet count <75,000/mm³;
4. Progressive neurotoxicity.

If neurologic symptoms fail to stabilize on the reduced dose schedule, HEXALEN^® capsules should be discontinued indefinitely.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published (2-9). There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

HEXALEN^® (altretamine) capsules is available in 50 mg clear, hard gelatin capsules imprinted with the following inscription:

•  USB 001.
•  Bottles of 100 capsules
•  (NDC 58063-001-70)

Store up to 25ºC (77ºF); excursions permitted to 15° to 30°C (59° to 86°F).