Erlotinib Pregnancy and Breastfeeding Warnings

Erlotinib is also known as: Tarceva

Erlotinib Pregnancy Warnings

Use is not recommended in women who are pregnant or contemplating pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. AU TGA pregnancy category: C US FDA pregnancy category: D Comments: Encourage use of adequate methods of contraception in females during therapy and for at least two weeks following the last dose.

Animal studies have shown maternal toxicity including embryo-fetal lethality and abortion during organogenesis at plasma levels higher than achieved at therapeutic doses. In animal studies where the drug was given prior to mating through the first week of pregnancy, an increase in early resorptions which resulted in a decrease in the number of live fetuses has been reported. Animal studies have shown no teratogenicity during organogenesis. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

Erlotinib Breastfeeding Warnings

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

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