Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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PS-Ambrisentan
Shared System REMS
REMS last update: 03/28/2019

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
ambrisentan (Info at Drugs@FDA) ANDA 210058 ZYDUS PHARMS 03/28/2019
ambrisentan (Info at Drugs@FDA) ANDA 210715 CIPLA 04/26/2019

What is the purpose of the REMS?

The goal of the PS-Ambrisentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated with ambrisentan by:
  1. Ensuring prescribers are educated on the following:
    • the risk of embryo-fetal toxicity
  2. Ensuring prescribers are educated on and adhere to the following:
    • counseling patients about the risk and the need for monthly monitoring
    • enrolling patients in the PS-Ambrisentan REMS Program
    • monitoring patients at baseline and monthly
  3. Ensuring that pharmacies are educated on the following:
    • the risk of embryo-fetal toxicity
  4. Ensuring that pharmacies are educated on and adhere to the following:
    • confirming that the appropriate patient monitoring and counseling has occurred before dispensing ambrisentan
  5. Ensuring that patients are informed about:
    • the risk of embryo-fetal toxicity
    • appropriate baseline and monthly patient monitoring
    • appropriate contraception

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 application holder(s) REMS Website or the approved REMS materials for more information.

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

Females of reproductive potential who are prescribed ambrisentan

Before treatment initiation
  • Review the Guide for Female Patients.
  • Get a pregnancy test.
  • Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Receive counseling from the prescriber on the risk of embryo-fetal toxicity and the need to use highly reliable contraception during treatment and for one month following treatment discontinuation, and emergency contraception using the Guide for Female Patients.
During treatment;before dispensing
  • Receive counseling from the REMS Program or the healthcare provider whodispenses ambrisentan on the risk of embryo-fetal toxicity, the need to use highly reliable contraception during treatment and for one month following treatment discontinuation, emergency contraception, to get monthly pregnancy tests, and to report a pregnancy immediately.
  • Get a pregnancy test.
  • Adhere to the safe use condition: Communicate with the REMS Program to confirm completion of pregnancy testing.
During treatment and after treatment discontinuation for one month
  • Adhere to the safe use condition: Use highly reliable contraception as described in the Guide for Female Patients.
After treatment discontinuation;one month
  • Get a pregnancy test.

Pre-pubertal females who are prescribed ambrisentan:

Before treatment initiation
  • Review the Guide for Female Patients.
  • Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Receive counseling from the prescriber on the risk of embryo-fetal toxicity using the Guide for Female Patients.
At all times
  • If over the age of 8: Be monitored for a change in reproductive status.
  • Inform the prescriber if there is a change in your reproductive status.

Post-menopausal females or females with other medical reasons for permanent,irreversible infertility who are prescribed ambrisentan:

Before treatment initiation
  • Review the Guide for Female Patients.
  • Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
At all times
  • Inform the prescriber if there is a change in your reproductive status.

Outpatient pharmacies and healthcare providers that dispense ambrisentan must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative review the Pharmacy Guide.
  • Have the authorized representative enroll in the REMS Program by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in dispensing ambrisentan on the REMS Program requirements using the Pharmacy Guide.
  • Establish processes and procedures to verify if the female of reproductive potential is counseled and the authorization number is valid.
Before dispensing
  • Obtain authorization to dispense each prescription from the REMS Program to verify female patients are enrolled, the reproductive status has not changed, the prescriber is certified, and pregnancy test is completed for females of reproductive potential or the prescriber authorizes the refill through the processes and procedures established as a requirement of the REMS Program.
  • For patients who provide the authorization number: Verify the authorization number is valid through the processes and procedures established as a requirement of the REMS Program.
  • For females of reproductive potential: Verify that the patient is counseled through the processes and procedures established as a requirement of the REMS Program.
  • For females of reproductive potential: Dispense no more than a 30 days’ supply.
At all times
  • Report pregnancies to the REMS Program.
  • Report a change or misclassification in reproductive status to the REMS Program.
  • Not distribute, transfer, loan, or sell ambrisentan, except to certified dispensers.
  • For pharmacies authorized to receive bulk shipments: Maintain and submit records of daily product dispensing data.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits carried out by the manufacturers or a third party acting on behalf of the manufacturers to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense ambrisentan must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative review the Pharmacy Guide.
  • Have the authorized representative enroll in the REMS Program by completing Inpatient Pharmacy Enrollment Form and submitting it to the REMS Program.
  • Train all relevant staff involved in dispensing ambrisentan on the REMS Program requirements using the Pharmacy Guide.
  • Establish processes and procedures to verify the female patient is enrolled or will be enrolled in the REMS Program prior to discharge, her reproductive status, and the female patient is under the supervision and care of a certified prescriber.
  • For females of reproductive potential: Establish processes and procedures to verify pregnancy testing is complete, the patient is counseled on the risk of embryo-fetal toxicity, the need to use highly reliable contraception during pregnancy tests, and to inform the prescriber of a pregnancy immediately.
Before dispensing
  • Verify the female patient is under the supervision and care of a certified prescriber, her reproductive status, she is enrolled or will be enrolled in the REMS Program prior to discharge through the processes and procedures established as a requirement of the REMS Program.
  • For females of reproductive potential: Verify the pregnancy testing is complete, the patient is counseled on the risk of embryo-fetal toxicity, the need to use highly reliable contraception during treatment and for one month after stopping treatment, to get monthly pregnancy tests, and to inform the prescriber of a pregnancy immediately through the processes and procedures established as a requirement of the REMS Program.
At discharge
  • Dispense no more than a 15 days’ supply.
At all times
  • Report pregnancies to the REMS Program.
  • Report a change or misclassification in reproductive status to the REMS Program.
  • Not distribute, transfer, loan, or sell ambrisentan, except to certified dispensers.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits carried out by the manufacturers or a third party acting on behalf of the manufacturers to ensure that all processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute ambrisentan must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies and to identify pharmacies that are not authorized to receive bulk shipments.
  • For certified pharmacies that are not authorized to receive bulk shipments: establish processes and procedures to verify if the patient is male or a valid authorization number is provided with the order, and to ship no more than a 30 days’ supply per patient per prescription.
  • Train all relevant staff involved in distribution on the REMS Program requirements.
At all times
  • Distribute only to certified pharmacies.
  • For certified pharmacies that are not authorized to receive bulk shipments:Distribute only after verifying the patient is male or a valid authorization number is provided with the order through the processes and procedures established as a requirement of the REMS Program
  • For certified pharmacies that are not authorized to receive bulk shipments: ship no more than a 30 days’ supply per patient per prescription through the processes and procedures established as a requirement of the REMS Program.
  • Maintain and submit daily records of drug distribution for all ambrisentan shipments.
  • Comply with audits carried out by the manufacturers, or a third party acting on behalf of the manufacturers to ensure that all processes and procedures are in place and are being followed.

Healthcare Providers who prescribe ambrisentan must:

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the following: Prescriber Guide.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation (firstdose)
  • For all females: Assess the patient’s reproductive status using the definitions in the Prescriber Guide. Document and submit the results to the REMS Program using the Patient Enrollment Form.
  • For all females: Counsel the patient that the drug is only available through a restricted distribution program.
  • For females of reproductive potential: Counsel the patie on the risk of embryo-fetal toxicity, the need to use highly reliable contraception during treatment and for one month following treatment discontinuation, and emergency contraception using the Guide for Female Patients.
  • For females of reproductive potential: Assess the patient’s pregnancy status by ordering and reviewing her pregnancy test result.
  • For pre-pubertal females: Counsel the patient on the risk of embryo-fetal toxicity using the Guide for Female Patients
  • Enroll all female patients by completing the Patient Enrollment and submitting it to the REMS Program.
During treatment;before each prescription
  • For females of reproductive potential: Counsel the patient if she is not complying with the required testing or if she is not using appropriate contraception.
  • For females of reproductive potential: Assess the patient’s pregnancy status by ordering and reviewing her pregnancy test result.
During treatment; at least annually
  • For pre-pubertal females at least age 8 or older: Document reproductive status and submit to the REMS Program using Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form.
After treatment discontinuation; for one month
  • For females of reproductive potential: Assess the patient’s pregnancy status by ordering and reviewing her pregnancy test result.
At all times
  • For pre-pubertal females: Assess the patient’s reproductive status.
  • Report pregnancies to the REMS Program
At all times, within 10 business days
  • Report a change or misclassification in reproductive status to the REMS Program using the Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form.

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.

Material Name Material Name Link
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 REMS Website Screenshots.pdf
Prescriber Enrollment and Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Prescriber Enrollment and Agreement Form.pdf
Change in Reproductive Status and Pre-Pubertal Annual Verification Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Change in Reproductive Status and Pre-Pubertal Annual Verification Form.pdf
Guide for Female Patients (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Guide for Female Patients.pdf
Inpatient Pharmacy Enrollment and Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Inpateint Pharmacy Enrollment and Agreement Form.pdf
Outpatient Pharmacy Enrollment and Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Outpateint Pharmacy Enrollment and Agreement Form.pdf
Patient Enrollment and Consent Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Patient Enrollment and Consent Form.pdf
Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Pharmacy Guide.pdf
Prescriber Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 Prescriber Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 REMS Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS-Ambrisentan 2019 03 28 REMS Full.pdf

What updates have been made to the REMS?

Date Summary of change
03/28/2019 Approval of REMS

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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