Can pregnant women use Tolvaptan?

Available data on the use of Tolvaptan tablets (Tolvaptan) in pregnant women are insufficient to determine whether there is a risk of drug-related adverse developmental outcomes. Tolvaptan did not cause any developmental toxicity in rats or rabbits at exposures approximately 2.8 times and 0.8 times the maximum recommended human dose (MRHD) of 60 mg once daily in patients with congestive heart failure (CHF).

At doses causing significant maternal toxicity, effects were observed on embryo-fetal development in both species. In rats, CHF patients experienced reduced fetal weight and delayed fetal ossification at 11-fold exposure based on AUC. In rabbits, the incidence of miscarriage, embryo-fetal death, fetal microphthalmia, palpebral distosis, cleft palate, brachycephaly, and skeletal malformations is approximately 1.6 times higher than in patients with congestive heart failure. There are no data on the presence of tolvaptan or its metabolites in breast milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants, including electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion, women are advised not to breastfeed during treatment with tolvaptan.

Tolvaptan tablets have been marketed in China and have entered the scope of Class B medical insurance. The price paid by medical insurance is relatively cheap, but the reimbursement ratio is different in different regions, and the price after reimbursement will be different. Domestic pharmacies or hospitals will sell this drug, and the original drug of tolvaptan tablets is also on the market overseas. There are also generic tolvaptan tablets produced in other countries. The price of Indian pharmaceutical factory production specifications15mg*4 tablets per box is around RMB 800 (the price may fluctuate due to the exchange rate). The ingredients of foreign generic drugs are basically the same as those of domestic and foreign original drugs.