"The findings, published online April 4 and in the May issue of Obstetrics Gynecology, should reassure physicians who are reluctant to prescribe HT in these patients out of concern it might increase the risk for recurrence and reduce surviv"...
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;
- Progressive neurotoxicity.
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 or appropriate.
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; 1999:32-41.
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 NIH 83-2621.
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; 1987.
6. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983;1:426-428.
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: 7/11/2001This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/29/2016
Additional Hexalen Information
Hexalen - User Reviews
Hexalen User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.