Hexalen
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Questions & Answers
Side Effects & Adverse Reactions
See boxed Warnings.
Concurrent administration of HEXALEN® capsules and antidepressants of the monoamine oxidase (MAO) inhibitor class may cause severe orthostatic hypotension. Four patients, all over 60 years of age, were reported to have experienced symptomatic hypotension after 4 to 7 days of concomitant therapy with HEXALEN® capsules and MAO inhibitors.
HEXALEN® capsules causes mild to moderate myelosuppression and neurotoxicity. Blood counts and a neurologic examination should be performed prior to the initiation of each course of therapy and the dose of HEXALEN® capsules adjusted as clinically indicated (see Dosage and Administration).
HEXALEN® capsules has been shown to be embryotoxic and teratogenic in rats and rabbits when given at doses 2 and 10 times the human dose. HEXALEN® capsules may cause fetal damage when administered to a pregnant woman. If HEXALEN® capsules is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
HEXALEN® (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.
History
There is currently no drug history available for this drug.
Other Information
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:
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.
Sources
Hexalen Manufacturers
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Eisai Inc.
![Hexalen (Altretamine) Capsule [Eisai Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hexalen | Eisai Inc.
HEXALEN® capsules is administered orally. Doses are calculated on the basis of body surface area.
HEXALEN® 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® capsules bioavailability or pharmacokinetics has not been evaluated.
HEXALEN® capsules should be temporarily discontinued (for 14 days or longer) and subsequently restarted at 200 mg/m2/day for any of the following situations:
1) Gastrointestinal intolerance unresponsive to symptomatic measures;
2) White blood count <2000/mm3 or granulocyte count <1000/mm3;
3) Platelet count <75,000/mm3;
4) Progressive neurotoxicity.If neurologic symptoms fail to stabilize on the reduced dose schedule, HEXALEN® 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.
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