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Regorafenib Pregnancy and Breastfeeding Warnings

Regorafenib is also known as: Stivarga

Regorafenib Pregnancy Warnings

Embryo-fetal development animal studies observed a total loss of pregnancy at doses as low as 1 to 1.6 mg/kg. Animal studies also reported delayed ossification in fetuses with dose-dependent increases in skeletal malformations, cardiovascular malformations, external abnormalities, diaphragmatic hernia, and dilation of the renal pelvis. In addition, ventricular septal defects and significant adverse effects on the urinary system (including missing kidney/ureter; small, deformed and malpositioned kidney; and hydronephrosis) were found. Results from animal studies indicated that regorafenib can impair male (tubular atrophy and degeneration in the testes, atrophy in the seminal vesicle, and cellular debris and oligospermia in the epididymides) and female (necrotic corpora lutea in the ovaries) fertility. There are no controlled data in human pregnancy. 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.

FDA pregnancy category: D Use of regorafenib should be avoided. Females and males should use adequate methods of contraception during treatment and for 2 months after the last dose.

Regorafenib Breastfeeding Warnings

A decision should be made to discontinue breast-feeding 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 The effects in the nursing infant are unknown.

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