Telbivudine Pregnancy Warnings
Telbivudine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Telbivudine is only recommended for use during pregnancy when benefit outweighs risk.
Animal studies have shown that telbivudine crosses the placenta. A pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to telbivudine. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).
Telbivudine Breastfeeding Warnings
There are no data on the excretion of telbivudine into human milk. It is excreted into rat milk. The manufacturer advises against breast-feeding during telbivudine therapy.
