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Drug Description

(altretamine) Capsules 50 mg


  • HEXALEN® (altretamine) capsules should only be given under the supervision of a physician experienced in the use of antineoplastic agents.
  • Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of HEXALEN® (altretamine) capsules, and as clinically indicated (see ADVERSE REACTIONS).
  • Because of the possibility of HEXALEN® (altretamine) capsules-related neurotoxicity, neurologic examination should be performed regularly during HEXALEN® capsules administration (see ADVERSE REACTIONS).

    HEXALEN® (altretamine) capsules, is a synthetic cytotoxic antineoplastic s-triazine derivative. HEXALEN® capsules contain 50 mg of altretamine for oral administration. Inert ingredients include lactose, anhydrous and calcium stearate. Altretamine, known chemically as N,N,N',N',N“,N”-hexamethyl-1,3,5-triazine-2,4,6-triamine, has the following structural formula:

    HEXALEN® (altretamine)  Structural Formula Illustration

    Its empirical formula is C9H18N6 with a molecular weight of 210.28. Altretamine is a white crystalline powder, melting at 172°± 1°C. Altretamine is practically insoluble in water but is increasingly soluble at pH 3 and below.

    Indications & Dosage


    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 combination.


    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:

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

    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


    Where does ovarian cancer occur? See Answer
    Side Effects



    With continuous high-dose daily HEXALEN® (altretamine) capsules, nausea and vomiting of gradual onset occur frequently. Although in most instances these symptoms are controllable with anti-emetics, at times the severity requires HEXALEN® (altretamine) capsules dose reduction or, rarely, discontinuation of HEXALEN® (altretamine) capsules therapy. In some instances, a tolerance of these symptoms develops after several weeks of therapy. The incidence and severity of nausea and vomiting are reduced with moderate-dose administration of HEXALEN® (altretamine) capsules. In 2 clinical studies of single-agent HEXALEN® (altretamine) capsules utilizing a moderate, intermittent dose and schedule, only 1 patient (1%) discontinued HEXALEN® (altretamine) capsules due to severe nausea and vomiting.


    Peripheral neuropathy and central nervous system symptoms (mood disorders, disorders of consciousness, ataxia, dizziness, vertigo) have been reported. They are more likely to occur in patients receiving continuous high-dose daily HEXALEN (altretamine) ® (altretamine) capsules than moderate-dose HEXALEN® (altretamine) capsules administered on an intermittent schedule. Neurologic toxicity has been reported to be reversible when therapy is discontinued. Data from a randomized trial of HEXALEN® (altretamine) capsules and cisplatin plus or minus pyridoxine in ovarian cancer indicated that pyridoxine significantly reduced neurotoxicity; however, it adversely affected response duration suggesting that pyridoxine should not be administered with HEXALEN® (altretamine) capsules and/or cisplatin (1).


    HEXALEN® (altretamine) capsules causes mild to moderate dose-related myelosuppression. Leukopenia below 3000 WBC/mm³occurred in <15% of patients on a variety of intermittent or continuous dose regimens. Less than 1% had leukopenia below 1000 WBC/mm³. Thrombocytopenia below 50,000 platelets/mm³was seen in <10% of patients. When given in doses of 8-12 mg/kg/day over a 21 day course, nadirs of leukocyte and platelet counts were reached by 3-4 weeks, and normal counts were regained by 6 weeks. With continuous administration at doses of 6-8 mg/kg/day, nadirs are reached in 6-8 weeks (median).

    Data in the following table are based on the experience of 76 patients with ovarian cancer previously treated with a cisplatin-based combination regimen who received single-agent HEXALEN® (altretamine) capsules. In one study, HEXALEN® (altretamine) capsules, 260 mg/m²/day, was administered for 14 days of a 28 day cycle. In another study, HEXALEN® (altretamine) capsules, 6-8 mg/kg/day, was administered for 21 days of a 28 day cycle.


    Adverse Experiences %Patients
    Nausea and Vomiting 33  
      Mild to Moderate   32
      Severe   1
    Increased Alkaline Phosphatase 9  
    Peripheral Sensory Neuropathy 31  
      Mild   22
      Moderate to Servere   9
    Anorexia and Fatigue 1  
    Seizures 1  
    Leukopenia 5  
      WBC 2000-2999/mm³   4

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