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Approximately 11% of patients treated with bosentan experience elevations in hepatic aminotransferases (ALT and AST) to at least 3 times the upper limit of normal (ULN), with bilirubin elevation observed in a small number of cases. Serum aminotransferase levels must be measured. If elevated hepatic aminotransferases are accompanied by clinical signs of hepatotoxicity or if bilirubin is ≥ 2 times the ULN, bosentan should be discontinued. Initiation of bosentan treatment should be avoided in patients with baseline aminotransferase levels greater than 3 times the ULN.
Based on animal data, bosentan may cause fetal harm when administered to pregnant women. It is contraindicated during pregnancy. Women of reproductive potential must rule out pregnancy before treatment, and use two reliable methods of contraception during treatment and for one month after discontinuing treatment. Pregnancy testing should be performed monthly.
Due to the risks of hepatotoxicity and birth defects, bosentan is only available through a restricted program called the Bosentan REMS Program. As part of this program, prescribing physicians, patients, and pharmacies must be enrolled in the program.
Bosentan may cause fluid retention. If clinically significant fluid retention occurs, it should be evaluated and may require management or discontinuation of bosentan.
If signs of pulmonary edema appear, the possibility of associated pulmonary venous occlusive disease should be considered, and the need to discontinue bosentan should be evaluated.
Decreased sperm count has been observed in patients receiving bosentan treatment.
Bosentan treatment can cause dose-related reductions in hemoglobin and hematocrit. It is recommended to check hemoglobin concentration 1 month and 3 months after starting treatment, and then every 3 months thereafter.
FDA，2025.07
Lucius Pharmaceuticals (Lao) LTD. (Lucius Pharmaceuticals), with its manufacturing campus in Laos located in the capital city of Vientiane in 2020, officially begins its great journey to make effective and affordable medicines available to people in need around the world...More
Lucius Pharmaceutical Co., Ltd., was established in 2020 in Vientiane, the capital of Laos. It aims to offer safe, effective, and affordable medicines globally. With a factory spanning 25,000 square meters, the company manufactures 200+ generic drugs in diverse therapeutic fields.
Address:No.26 Thongmang village, Xaythany district, Vientiane Capital, Laos
E-mail:laoslucius@gmail.com
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