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Altretamine Pregnancy and Breastfeeding Warnings

Altretamine is also known as: Hexalen

Altretamine Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity at doses 2 and 10 times the human dose. Animal fertility studies also have shown some effects on males at doses of 120 and 450 mg/m2/day including reduced fertility; decreased spermatogenesis; a possible dominant lethal mutagenic effect; and atrophy of testes, seminal vesicles, and the ventral prostate. Adverse fertility effects have not been observed with female animals. There are no controlled data in human pregnancy. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug may cause fetal damage when administered to a pregnant woman. US FDA pregnancy category: D Comments: -Women of childbearing potential should be advised to use effective contraception to avoid becoming pregnant while taking this drug due to the potential hazard to the fetus. -Based on animal studies, this drug may cause fertility impairment in males.

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Altretamine Breastfeeding Warnings

Breastfeeding is not recommended during treatment. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Hexalen Capsules (altretamine)." US Bioscience, West Conshohoken, PA.

References for breastfeeding information

  1. "Product Information. Hexalen Capsules (altretamine)." US Bioscience, West Conshohoken, PA.

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