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ALEMBIC-BOSENTAN is a brand name for Bosentan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Hepatic/Biliary/Pancreatic Bosentan has been associated with a reversible, dose-related increase in aspartate aminotransferase (AST) and alanine aminotransferase (ALT), accompanied in some cases by elevated bilirubin. Increases in liver enzymes usually occurred within the first 26 weeks following initiation of treatment and returned to pretreatment levels without sequelae within a few days to 9 weeks, either spontaneously or after dose reduction or discontinuation.
These increases may also occur late in treatment. In the post-marketing period, rare cases of unexplained hepatic cirrhosis were reported after prolonged (> 12 months) therapy with bosentan in patients with multiple co-morbidities and drug therapies.
There have also been rare reports of liver failure. The contribution of bosentan in these cases could not be excluded. In at least one case the initial presentation (after > 20 months of treatment) included pronounced elevations in aminotransferases and bilirubin levels accompanied by non-specific symptoms, all of which resolved slowly over time after discontinuation of bosentan.
This case reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of treatment and the treatment algorithm, which includes stopping Alembic-Bosentan with a rise of aminotransferases accompanied by signs or symptoms of liver dysfunction.
Liver transaminase levels must be measured prior to initiation of treatment and subsequently at monthly intervals. , aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 times the upper limit of normal (ULN), particularly when the total bilirubin is increased to greater than 2 times the ULN, is contraindicated (see CONTRAINDICATIONS).
Management of Patients with Increased Liver Transaminases:
ALT/AST levels Treatment and monitoring recommendations are as follows: > 3 and ≤ 5 x ULN Confirm by another liver function test; if confirmed, reduce the daily dose or stop treatment, monitor aminotransferase levels at least every 2 weeks.
If the aminotransferase levels return to pretreatment values consider continuing or reintroducing Alembic-Bosentan as appropriate (see Reintroduction of treatment below). > 5 and ≤ 8 x ULN Confirm by another liver function test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Once the aminotransferase levels return to pretreatment values consider reintroducing Alembic-Bosentan (see Reintroduction of treatment below). > 8 x ULN Treatment must be stopped and reintroduction of Alembic-Bosentan is not to be considered.
______________________________________________________________________________ Alembic-Bosentan Page 5 of 42 In the case of elevations of aminotransferases accompanied by clinical symptoms of liver injury (such as nausea, vomiting, fever, abdominal pain, jaundice or unusual lethargy or fatigue) or of increases in bilirubin ≥ 2 x ULN, treatment must be stopped and reintroduction of Alembic-Bosentan is not to be considered.
Reintroduction of treatment Reintroduction of treatment with Alembic-Bosentan should only be considered if the potential benefits of treatment with Alembic-Bosentan outweigh the potential risks and when aminotransferase levels are within pretreatment values.
Alembic-Bosentan is to be reintroduced at the starting dose and aminotransferase levels must then be checked within 3 days after reintroduction, then again after further 2 weeks, and thereafter according to the recommendations above.
General Pulmonary veno-occlusive disease Cases of pulmonary edema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease. Consequently, should signs of pulmonary edema occur when Alembic-Bosentan is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.
In the post-marketing period there have been rare reports of pulmonary edema in patients treated with bosentan who had a suspected diagnosis of pulmonary veno-occlusive disease. 5 years. In this study there was one new safety finding that was not previously observed in the pulmonary arterial hypertension studies.
This was an early increased incidence of hospitalization due to worsening of chronic heart failure with no difference in mortality between bosentan and placebo-treated patients. At the end of the study, there was no difference in overall hospitalizations for heart failure or in mortality between bosentan and placebo-treated patients.
This effect was observed during the first 4–8 weeks of treatment with bosentan and could have been the result of fluid retention. In this trial, fluid retention was reflected by early weight gain, decreased hemoglobin concentration, and increased incidence of leg edema.
In the placebo-controlled trials with pulmonary arterial hypertension patients, peripheral edema and decreased hemoglobin concentrations were reported with no evidence for increased incidence of early hospitalization due to clinical worsening.
, leg edema, weight gain). Should this occur, starting treatment with diuretics or increasing the existing dose of diuretics is recommended. Treatment with diuretics is recommended in patients with evidence of fluid retention before the start of treatment with bosentan.
9 g/dL overall average), which is likely due to hemodilution. In placebo- controlled studies […]