Temsirolimus Pregnancy and Breastfeeding Warnings

Temsirolimus is also known as: Torisel

Temsirolimus Pregnancy Warnings

US and UK: Use should be avoided during pregnancy unless the benefit for the mother outweighs the risk to the fetus. AU: Use should be avoided. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Women should be advised to avoid pregnancy throughout treatment and for 3 months after therapy discontinuation. Men with partners of childbearing potential should be encouraged to use reliable methods of contraception during and for 3 months after therapy.

This drug may cause fetal harm based on its mechanism of action. Animal studies have shown embryofetal and intrauterine toxicities at human sub-therapeutic exposures. Embryofetal adverse effects included increased mortality, reduced fetal weights, incomplete/reduced ossifications, omphalocele, bifurcated sternebrae, and notched ribs. Fertility effects observed in animals included decreased pre- and post-implantation losses, decreased sperm concentration and motility, decreased reproductive organ weights, and testicular tubular degeneration. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. 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.

Temsirolimus Breastfeeding Warnings

The main metabolite is excreted in the milk of lactating rats.

US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. AU and UK: Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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