Stivarga Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Women of childbearing potential must be informed that regorafenib may cause foetal harm.
Women of childbearing potential and men should ensure effective contraception during treatment and up to 8 weeks after completion of therapy.
Pregnancy: There are no data on the use of regorafenib in pregnant women.
Based on its mechanism of action regorafenib is suspected to cause foetal harm when administered during pregnancy. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Stivarga should not be used during pregnancy unless clearly necessary and after careful consideration of the benefits for the mother and the risk to the foetus.
Breast-feeding: It is unknown whether regorafenib or its metabolites are excreted in human milk.
In rats, regorafenib or its metabolites are excreted in milk. A risk to the breast-fed child cannot be excluded. Regorafenib could harm infant growth and development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding must be discontinued during treatment with Stivarga.
Fertility: There are no data on the effect of Stivarga on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).