Approved Risk Evaluation and Mitigation Strategies (REMS)

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Tracleer (bosentan)
NDA #21290
REMS last update: 12/04/2015

View the Tracleer Prescribing Information and Medication Guide at DailyMed.
View Tracleer's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the product-specific REMS website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Tracleer must

To become certified to prescribe
  • Be able to determine whether a female is of reproductive potential as defined in the Prescriber and Pharmacy Guide for the Tracleer REMS program.
  • Review the drug’s prescribing information.
  • Review the following educational materials: Prescriber and Pharmacy Guide for the Tracleer REMS program and Medication Guide.
  • Enroll in the REMS by completing the Prescriber Enrollment and Agreement and submitting it to the REMS program.
Before the first prescription
  • Counsel the patient that drug is only available through a restricted distribution program.
  • Provide the patient the Guide for Patients and Medication Guide.
  • Assess the patient’s pretreatment liver function by ordering and reviewing a liver function test.
  • For a Female of Reproductive Potential (FRP): counsel the patient on the risk of teratogenicity, the need to use reliable contraception during treatment and for one month following treatment discontinuation, and her medical options in the event of unprotected sexual intercourse or known or suspected contraception failure.
  • For a FRP: counsel the patient to immediately contact her prescriber if the patient misses her period or suspects a pregnancy.
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
  • For a Pre-Pubertal Female of Non-Reproductive Potential (FNRP): counsel the patient and/or patient guardian on the risk of teratogenicity.
  • For a FNRP: counsel the patient and/or patient guardian to immediately contact their prescriber if the patient begins to menstruate.
  • Enroll the patient by completing and submitting the Patient Enrollment and Consent Form to the REMS program.
Before each prescription after the first prescription
  • For a patient not complying with required testing: counsel the patient on program requirements.
Monthly during treatment
  • Assess the patient’s liver function by ordering and reviewing a liver function test.
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
At least annually during treatment
  • For a FNRP at least 8 or older: assess the patient’s change in reproductive status. Document and submit the results using the Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form.
One month after treatment discontinuation
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
At all times
  • For a female: within 10 business days of becoming aware of a change, report any changes or misclassification in reproductive status to the REMS program using the Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form.
  • Report any adverse event, including hepatoxicity, or any pregnancy.

Females of Reproductive Potential (FRP) Patients who are prescribed Tracleer

Before the first prescription
  • Review the education materials for patients: Guide for Patients and Medication Guide.
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
  • Get a pregnancy test and liver function test.
  • Receive counseling from the prescriber on the requirements of the REMS program and risk of serious birth defects.
During treatment
  • For females who can get pregnant: Use contraception as described in the Guide for Patients.
Monthly during treatment
  • Get a pregnancy test.
  • Receive counseling from the pharmacy on the need to use reliable contraception during treatment and for one month after stopping treatment.
One month after discontinuing
  • Get a pregnancy test and liver function test.
At all times
  • Immediately, inform the prescriber if the patient misses her period or suspects a pregnancy.

Pre-pubertal Females of Non-Reproductive Potential (FRNP) Patients and/or Patient Guardian who are prescribed Tracleer

Before the first prescription
  • Review the education materials for patient: Guide for Patients and Medication Guide.
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
  • Get a liver function test.
  • Receive counseling from the prescriber on the risk of teratogenicity.
Monthly during treatment
  • Get a liver function test.
At least annually during treatment
  • If 8 years or older, get evaluated for a change in reproductive status.
At all times
  • Inform the prescriber if the patient begins to menstruate.

Post-Menopausal Pre-pubertal Females of Non-Reproductive Potential (FNRP) Patients and Female Patients with other medical reason for permanent, irreversible infertility who are prescribed Tracleer

Before the first prescription
  • Review the education materials for patient: Guide for Patients and Medication Guide.
  • Enroll in the REMS by completing the Patient Enrollment Form and Consent Form with the prescriber.
  • Get a liver function test.
Monthly
  • Get a liver function test.

Male Patients who are prescribed Tracleer

Before the first prescription
  • Review the education materials for patient: Guide for Patients and Medication Guide.
  • Enroll in the REMS by completing the Patient Enrollment Form and Consent Form with the prescriber.
  • Get a liver function test.
Monthly
  • Get a liver function test.

Outpatient pharmacies that dispense Tracleer must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the outpatient pharmacy.
  • Train all relevant staff involved in dispensing on the REMS program procedures and REMS materials.
  • Establish processes and procedures to verify that patient and prescriber enrollment forms are only received from the REMS program, prescriber is enrolled, and patient is enrolled.
Before dispensing
  • Counsel the patient on the risk of hepatoxicity and the need for monthly liver testing.
  • Provide the patient with a Medication Guide.
  • Verify that the liver function testing was completed by asking the patient or their prescriber.
  • For a female of reproductive potential (FRP): counsel the patient on the risk of serious birth defects and the need to use reliable contraception during treatment and for one month after stopping treatment.
  • For a FRP: counsel the patient on the need to complete a monthly pregnancy test and to inform her prescriber immediately if she suspects a pregnancy.
  • For a FRP: verify that the pregnancy test was completed by asking the patient. If the patient is unable to confirm, then ask the prescriber. If both the patient and prescriber are unable to confirm, then ask the prescriber to authorize a refill and remind the prescriber of obligation to order and review a monthly pregnancy test.
  • Obtain authorization to dispense by contacting the REMS coordinating center.
  • Dispense no more than a thirty days’ supply.
At all times
  • Report any adverse events, including hepatotoxicity, and any reports of pregnancy to the Manufacturer.
  • Do not distribute, transfer, loan, or sell product, except to certified dispensers.
  • Maintain records of dispensing data for all enrolled patients.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense Tracleer must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the inpatient pharmacy.
  • Train all relevant staff involved in dispensing on REMS program requirements and REMS materials.
  • Establish processes and procedures to verify the patient is under the supervision and care of a healthcare provider who is enrolled and a patient is enrolled or will be enrolled prior to discharge.
  • Have the authorized representative enroll in the REMS by completing the Inpatient Pharmacy Enrollment Form.
Before dispensing
  • Obtain authorization to dispense by contacting the REMS Program Coordinating Center.
Upon discharge
  • Dispense no more than a fifteen days’ supply.
At all times
  • Report any adverse events, including hepatotoxicity, and any reports of pregnancy to the Manufacturer.
  • Do not distribute, transfer, loan, or sell product, except to certified dispensers.
  • Maintain records of compliance with REMS requirements.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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