Bosentan Patient Enrollment Form Instructions

Bosentan Patient Enrollment Form Instructions

Instructions

For immediate patient enrollment, please go to www.BosentanREMSProgram.com. Scan the Quick Response (QR) code to complete the form online. The patient must complete this form with the prescriber. To submit this form via fax or mail, please complete all required fields below and fax to 1 800-730-8231 or mail to the Bosentan REMS, 200 Pinecrest Plaza Morgantown, WV 26505. 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.

Patient Agreement and Signature

To become enrolled in the Bosentan REMS, a patient and/or parent/legal guardian is indicating that:

FEMALES OF REPRODUCTIVE POTENTIAL

Before treatment, I must:

• Review the Guide for Patients.
• Get a liver test and a pregnancy test.
• Enroll in the Bosentan REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the Bosentan REMS.
• Receive counseling from the prescriber on the risk of liver problems, the signs and symptoms of liver problems, the need to contact the prescriber if I have any signs or symptoms of liver problems, the need to complete liver testing, the risk of serious birth defects, the need to use reliable contraception during treatment and for one month following treatment discontinuation, the need to complete pregnancy testing, the need to contact the prescriber if I suspect I am pregnant, and emergency contraception using the Guide for Patients.

During treatment, before each prescription, I must:

• Get a liver test and a pregnancy test.
• Adhere to the safe use condition: Communicate with the Bosentan REMS or pharmacy to confirm completion of pregnancy testing and liver testing.
• Receive counseling from the prescriber or pharmacy on the risks of liver problems and serious birth defects associated with bosentan treatment

During treatment and after treatment discontinuation for one month, I must:

• Adhere to the safe use condition: Use reliable contraception as described in the Guide for Patients.

After treatment discontinuation for one month, I must:

• Get a pregnancy test.

At all times, I must:

• Inform the prescriber if I have any signs or symptoms of liver problems as described in the Guide for Patients.
• Inform the prescriber immediately if I suspect I may be pregnant

PRE-PUBERTAL FEMALES

Before treatment, I must:

• Review the Guide for Patients.
• Get a liver test.
• Enroll in the Bosentan REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the Bosentan REMS.
• Receive counseling from the prescriber on the risk of liver problems, the signs and symptoms of liver problems, the need to contact the prescriber if I have any signs or symptoms of liver problems, the need to complete liver testing, the risk of serious birth defects, and the need to contact the prescriber when I begin to menstruate using the Guide for Patients.

During treatment, before each prescription, I must:

• Get a liver test.
• Adhere to the safe use condition: Communicate with the Bosentan REMS or pharmacy to confirm completion of liver testing.
• Receive counseling from the prescriber or pharmacy on the risks of liver problems and serious birth defects associated with bosentan treatment.

At all times, I must:

• If over the age of 8: Be monitored for a change in reproductive status.
• Inform the prescriber if I have any signs or symptoms of liver problems as described in the Guide for Patients.
• Inform the prescriber if I have a change in reproductive status.

POST-MENOPAUSAL FEMALES OR FEMALES WITH OTHER MEDICAL REASONS FOR PERMANENT, IRREVERSIBLE INFERTILITY

Before treatment, I must:

• Review the Guide for Patients.
• Get a liver test.
• Enroll in the Bosentan REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the Bosentan REMS.
• Receive counseling from the prescriber on the risk of liver problems, the signs and symptoms of liver problems, the need to contact the prescriber if I have any signs or symptoms of liver problems, and the need to complete liver testing using the Guide for Patients.

During treatment, before each prescription, I must:

• Get a liver test.
• Adhere to the safe use condition: Communicate with the Bosentan REMS or pharmacy to confirm completion of liver testing.
• Receive counseling from the prescriber or pharmacy on the risk of liver problems associated with bosentan treatment.

At all times, I must:

• Inform the prescriber if I have any signs or symptoms of liver problems as described in the Guide for Patients.
• Inform the prescriber if I have a change in reproductive status.

MALES

Before treatment, I must:

• Review the Guide for Patients.
• Get a liver test.
• Enroll in the Bosentan REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the Bosentan REMS.
• Receive counseling from the prescriber on the risk of liver problems, the signs and symptoms of liver problems, the need to contact the prescriber if I have any signs or symptoms of liver problems, and the need to complete liver testing using the Guide for Patients.

During treatment, before each prescription, I must:

• Get a liver test.
• Adhere to the safe use condition: Communicate with the Bosentan REMS or pharmacy to confirm completion of liver testing.
• Receive counseling from the prescriber or pharmacy on the risk of liver problems associated with bosentan treatment.

At all times, I must:

• Inform the prescriber if I have any signs or symptoms of liver problems as described in the Guide for Patients

Patient Information (All fields required unless otherwise indicated)

First Name: MI (optional): Last Name: Gender:  Female  Male
Date of Birth (MM/DD/YYYY): Email (optional):
Primary Phone #: Alternate Phone # (optional):
Address: City:
State: Zip Code:
Parent/Legal Guardian (optional): Relationship (optional):

By signing below, you attest that you understand the requirements of the Bosentan REMS as indicated on this form and in the Guide for Patients, and you will follow the requirements of the Bosentan REMS

Patient Reproductive Classification and Acknowledgement of Counseling (To

be completed by the prescriber)

For this patient, have you reviewed their current liver tests?

• Yes
• No

If your patient is FEMALE, select the correct female patient category (please see definitions of these terms in the Prescriber Guide):

• Female of Reproductive Potential
• Female of Non-Reproductive Potential

If this patient is a female of reproductive potential, has a negative pregnancy test been completed prior to prescribing bosentan?

• Yes
• No

Please specify:

• Pre-pubertal Female
• Post-menopausal Female
• Female with other medical reasons for permanent, irreversible infertility

For this patient, have you provided counseling on the risks associated with bosentan treatment and the Bosentan REMS requirements?

• Yes
• No

Prescriber Information (All fields required unless otherwise indicated)

First Name: MI (optional): Last Name:
NPI#:
Address: City:
State: Zip Code:
Phone: Ext (optional): Fax:

Prescriber Signature

By signing below, you attest that the patient indicated on this form meets the reproductive potential classification as defined in the Prescriber Guide, and that you agree to follow the requirements of the Bosentan REMS

• Prescriber Signature:
• Date:

References

• Bosentan REMS

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