Bosentan Testing and Patient Counseling Reporting Form Instructions
- October 27, 2023
- Bosentan
Table of Contents
Bosentan Testing and Patient Counseling Reporting Form
Instructions for Prescribers
This form may be used every month to confirm the completion of both liver and pregnancy tests on a single form. Completion of required tests and patient counseling must be confirmed with the Bosentan REMS for bosentan to be dispensed to your patient.
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This form may be completed online at www.BosentanREMSProgram.com, by calling the Contact Center at 1-866-359-2612 or by faxing at
1- 800-730-8231. -
Your patient will not receive a call from the Bosentan REMS during a given month if completion of tests and counseling for that month have been confirmed.
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If this form is not submitted, your patient will receive a call from the Bosentan REMS each month during treatment to confirm completion of required tests and counseling on the risks associated with treatment with bosentan.
Use this form to:
- Report that a patient has been counseled on the risk of hepatotoxicity.
- Report pretreatment and monthly liver test completion for a patient in the Bosentan REMS.
- Report that a female of reproductive potential (as defined in the Prescriber Guide) has been counseled on the risk of embryo-fetal toxicity, as appropriate for the reproductive potential status as defined in the Prescriber Guide.
- Report pretreatment and monthly pregnancy test completion (including the final test one month following bosentan discontinuation) for a female of reproductive potential in the Bosentan REMS.
If you have questions, require additional information, or need additional copies of Bosentan REMS documents, visit www.BosentanREMSProgram.com, or call the Bosentan REMS at 1-866-359-2612.
Prescriber Information (All fields required)
First Name: Last Name: NPI#:
Phone: Fax: Email:
Patient Information (All fields required)
First Name: Last Name:
Date of Birth (MM/DD/YYYY): Zip Code: Gender:
- Male
- Female
Is this patient a Female of Reproductive Potential?
(as defined in the Prescriber Guide)
- Yes
- No
Confirm Liver Test Completed
For all patients: Complete this section to confirm the completion of a liver
test
Monthly liver test has been completed
By checking the above box, you attest that a liver test has been completed for
the patient indicated on this form.
Confirm Pregnancy Test Completed
For females of reproductive potential: Complete this section to confirm the
completion of a pregnancy test
Monthly pregnancy test has been completed
By checking the above box, you attest that a pregnancy test has been completed
for the patient indicated on this form.
Acknowledgement of Patient Counseling
- Patient has been counseled this month on the risks associated with bosentan treatment and the Bosentan REMS requirements
By checking the above box, you attest that this patient has been counseled
this month on the risks of hepatotoxicity and embryo-fetal toxicity,
as appropriate for the reproductive potential status as defined in the
Prescriber Guide.
Signature
By signing below, you signify that the appropriate test(s) and/or counseling
indicated above have been completed for this patient.
Signature: Date:
Print Name:
Submitted by: Prescriber Designee Prescriber
Please Note: A certified prescriber or prescriber designee may complete and submit this form on behalf of the certified prescriber of record. The certified prescriber of record is responsible for monitoring, evaluating, and managing each patient under their care.