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Trastuzumab Pregnancy and Breastfeeding Warnings

Trastuzumab is also known as: Herceptin

Trastuzumab Pregnancy Warnings

Use should be avoided. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -Advise women of the potential hazard to the fetus. -Women of childbearing potential should use effective contraception during treatment and for 7 months after the last dose.

Animal studies showed no evidence of harm to the fetus or impairment of fertility. The drug crossed the placental barrier. There are no adequate or well-controlled studies in pregnant women. Post marketing reports showed cases of oligohydramnios which resulted in impairment of fetal renal growth and/or function, pulmonary hypoplasia including fatalities, skeletal abnormalities, and neonatal death. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves at http://www.herceptinpregnancyregistry.com/. 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.

Trastuzumab Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: Breastfeeding should be avoided during therapy and for 7 months after the last dose.

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