User Manual Q&AAnswer
Jan 14, 2025 - 08:13 PM
To enroll in the Bosentan REMS program, there are several requirements that need to be met. These requirements include:
1. Understanding the risks: Before starting treatment with bosentan, all patients must be counseled on the risks of liver problems and, for females, the risk of serious birth defects.
2. Liver function monitoring: All patients, regardless of gender, must undergo liver tests before starting bosentan treatment and continue to get monthly liver tests while taking the medication. Your prescriber will monitor your liver and may adjust or stop your treatment if there are signs of liver problems.
3. Pregnancy avoidance for females: Females who can get pregnant have additional requirements in the REMS. They must be counseled on the risk of serious birth defects before their first prescription and each month thereafter. They also need to complete a pregnancy test before starting bosentan treatment, monthly during treatment, and one month after ending treatment.
4. Confirmation of testing and counseling: Before receiving bosentan, all patients must be contacted by the Bosentan REMS or the pharmacy to confirm that the required liver tests and counseling have been completed.
It is important to note that these are just the general requirements for enrolling in the Bosentan REMS program. For more specific information and guidance, it is recommended to consult the Bosentan REMS program software user guide or visit the official website at www.BosentanREMSProgram.com.
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