HEXALEN (altretamine) 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.

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

HEXALEN 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 bioavailability or pharmacokinetics has not been evaluated.

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

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

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

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published (2-8). There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HEXALEN is available in 50 mg clear, hard gelatin capsules imprinted with the following inscription: USB 001.

Bottles of 100 capsules (NDC 58063-0001-70)

Stored at controlled room temperature 15° to 30° C (59° to 86°F).

REFERENCES

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