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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.
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
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.
There is currently no drug history available for this drug.
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.