Tigilyn Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of Tigecycline (Tigilyn) in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. As it is known for tetracycline class antibiotics, Tigecycline (Tigilyn) may also induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in fetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes. Tigecycline (Tigilyn) should not be used during pregnancy unless the clinical condition of the woman requires treatment with Tigecycline (Tigilyn).
Breastfeeding: It is unknown whether Tigecycline (Tigilyn) metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of Tigecycline (Tigilyn) metabolites in milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Tigecycline (Tigilyn) therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: Tigecycline (Tigilyn) did not affect mating or fertility in rats at exposures up to 4.7 times the human daily dose based on AUC. In female rats, there were no compound-related effects on ovaries or oestrus cycles at exposures up to 4.7 times the human daily dose based on AUC.