Mekinist Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in females: Female patients of reproductive potential must be advised to use effective methods of contraception during treatment with trametinib and for 16 weeks after stopping treatment.
Use with dabrafenib may render hormonal contraceptives less effective and therefore an alternative method of contraception, such as a barrier method, should be used when trametinib is used in combination with dabrafenib. Refer to the Full Prescribing Information of dabrafenib for further information.
Pregnancy: There are no adequate and well-controlled studies of trametinib in pregnant women. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Non Clinical Safety Data under Actions ). Trametinib should not be administered to pregnant women. If trametinib is used during pregnancy, or if the patient becomes pregnant while taking trametinib, the patient should be informed of the potential hazard to the fetus.
Breast-feeding: It is not known whether trametinib is excreted in human milk. Because many medicinal products are excreted in human milk, a risk to the breast-feeding infant cannot be excluded. Trametinib should not be administered to breast-feeding mothers. A decision should be made whether to discontinue breast-feeding or discontinue trametinib, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data in humans for trametinib as monotherapy or in combination with dabrafenib. In animals, no fertility studies have been performed, but adverse effects were seen on female reproductive organs (see Pharmacology: Toxicology: Non-Clinical Safety Data under Actions). Trametinib may impair fertility in humans.
Men taking trametinib in combination with dabrafenib: Effects on spermatogenesis have been observed in animals given dabrafenib. Male patients taking trametinib in combination with dabrafenib should be informed of the potential risk for impaired spermatogenesis, which may be irreversible. Refer to the dabrafenib SmPC for further information.