Tigecare Use In Pregnancy & Lactation

Pregnancy: Tigecycline, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy.
There are no available data on the risk of major birth defects or miscarriage following the use of Tigecycline during pregnancy. Administration of intravenous tigecycline in pregnant rats and rabbits during the period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 and 1 times the human exposure at the recommended clinical dose in rats and rabbits, respectively. Advise the patient of the potential risk to the fetus if Tigecycline is used during the second or third trimester.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Lactation: Risk Summary: There are no data on the presence of tigecycline in human milk; however, tetracycline class antibacterial drugs are present in breast milk. It is not known whether tigecycline has an effect on the breastfed infant or on milk production. Tigecycline has low oral bioavailability; therefore, infant exposure is expected to be low. Tigecycline is present in rat milk with little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Tigecycline and any potential adverse effects on the breastfed child from Tigecycline or from the underlying maternal condition.
Clinical Considerations: Because of the theoretical risk of dental discoloration and inhibition of bone growth, avoid breastfeeding if taking Tigecycline for longer than three weeks. A lactating woman may also consider interrupting breastfeeding and pumping and discarding breastmilk during administration of Tigecycline and for 9 days (approximately 5 half-lives) after the last dose in order to minimize drug exposure to a breastfed infant.