"The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
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: 7/11/2001
Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.
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