Tepmetko Use In Pregnancy & Lactation

Contraception in males and females: Pregnancy testing is recommended in women of childbearing potential prior to initiating treatment with TEPMETKO.
Women of childbearing potential should use effective contraception during TEPMETKO treatment and for at least 1 week after the last dose.
Male patients with female partners of childbearing potential should use barrier contraception during TEPMETKO treatment and for at least 1 week after the last dose.
Pregnancy: There are no clinical data on the use of TEPMETKO in pregnant women. Studies in animals have shown teratogenicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on the mechanism of action and findings in animals TEPMETKO can cause foetal harm when administered to pregnant women.
TEPMETKO should not be used during pregnancy, unless the clinical condition of the woman requires treatment with tepotinib. Women of childbearing potential or male patients with female partners of childbearing potential should be advised of the potential risk to a foetus.
Breast-feeding: There are no data regarding the secretion of tepotinib or its metabolites in human milk or its effects on the breast-fed infant or milk production. Breast-feeding should be discontinued during treatment with TEPMETKO and for one week after final dose.
Fertility: No human data on the effect of TEPMETKO on fertility are available. No morphological changes in male or female reproductive organs were seen in the repeat-dose toxicity studies in rats and dogs (see Pharmacology: Toxicology: Preclinical safety data under Actions).