HEXALEN (altretamine) ® (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
DOSAGE AND ADMINISTRATION
HEXALEN® (altretamine) capsules is administered orally. Doses are calculated on the basis
of body surface area.
HEXALEN® (altretamine) 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® (altretamine)
capsules bioavailability or pharmacokinetics has not been evaluated.
HEXALEN® (altretamine) capsules should be temporarily discontinued (for 14 days or longer)
and subsequently restarted at 200 mg/m²/day for any of the following situations:
Gastrointestinal intolerance unresponsive to symptomatic measures;
White blood count <2000/mm³or granulocyte count <1000/mm³;
Platelet count <75,000/mm³;
If neurologic symptoms fail to stabilize on the reduced dose schedule, HEXALEN® (altretamine)
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
HEXALEN® (altretamine) capsules is available in 50 mg clear, hard gelatin
capsules imprinted with the following inscription:
Bottles of 100 capsules
Store up to 25°C (77°F); excursions permitted to 15° to 30°C
(59° to 86°F).
1. Wiernik PH, et al. Hexamethylmelamine and Low or Moderate
Dose Cisplatin With or Without Pyridoxine for Treatment of Advanced Ovarian Carcinoma: A Study of the Eastern Cooperative Oncology Group. Cancer Invest.
1992; 10(1): 1-9.
2. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines
and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing Society;
3. U.S. Department of Health and Human Services. Recommendations
for the Safe Handling of Parenteral Antineoplastic Drugs. Washington DC: Division
of Safety, National Institutes of Health; 1983 Public Health Service publication
4. AMA Council on Scientific Affairs. Guidelines for Handling
Parenteral Antineoplastics. JAMA. 1985; 253:1590-1591.
5. National Study Commission on Cytotoxic Exposure. Recommendations
for Handling Cytotoxic Agents. Boston, MA: Available from Louis P. Jeffrey,
Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College
of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115;
6. Clinical Oncological Society of Australia: Guidelines and
Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia.
7. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic
Agents: A Report from the Mount Sinai Medical Center. CA Cancer J Clin. 1983;33:258-263.
8. American Society of Hospital Pharmacists. ASHP Technical
Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J of Hosp
Pharm. 1990; 47:1033-1049.
9. OSHA Work Practice Guidelines. Controlling Occupational Exposure
to Hazardous Drugs. Am J Health Syst Pharm. 1996;53:1669-1685
HEXALEN® (altretamine) capsules is a registered trademark
of MGI PHARMA, INC., Manufactured by: AAI Development Services, An aaiPharma®
Company, 1726 North 23rd St. Wilmington, North Carolina 28405. Manufactured
for: MGI PHARMA, INC. Bloomington, Minnesota 55437. For Medical Inquiries call:
1-800-562-5580. Revision Date November, 2003. FDA revision date: 7/11/2001