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How do patients enroll in the PS-Ambrisentan REMS?
Upon receipt of a completed Patient Enrollment Form, a REMS Coordinating Center Associate will ensure that the prescriber submitting the Patient Enrollment Form is enrolled in the REMS. Upon confirmation of an enrolled prescriber, the associate will enter the information into the REMS system completing the patient’s enrollment and linking the enrolled patient with the enrolled prescriber. An enrolled prescriber may also enroll female patients through the REMS website or mobile app. Both the prescriber and patient (or parent/guardian for minors) must sign the form.
How do prescribers enroll in the PS-Ambrisentan REMS?
To become certified, a prescriber must complete and submit the Prescriber Enrollment and Agreement Form. The form may be completed and submitted online via the REMS website, through the REMS mobile app, or by printing and faxing a completed form to the REMS Coordinating Center.
What are the PS-Ambrisentan REMS requirements for prescribers?
Health Care 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 faxing a completed Prescriber Enrollment Form to the REMS Coordinating Center at 1-888-870-1819. Enrollment may also be completed online at www.PSAmbrisentanREMS.com or on the prescriber mobile app.
For all females:
- I will determine the reproductive potential status of all female patients using the definitions provided in the Prescriber Guide and document and submit the results to the REMS using the Patient Enrollment Form.
- I will counsel all female patients that ambrisentan is only available through a restricted distribution program called the PS-Ambrisentan REMS.
- I will enroll all female patients by completing and submitting the Patient Enrollment Form.
For females of reproductive potential:
- I will counsel Females of Reproductive Potential about 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.
- I will assess the pregnancy status of Females of Reproductive Potential by ordering and reviewing a pregnancy test before treatment initiation, before writing each prescription, and for one month after treatment discontinuation.
- I will counsel Females of Reproductive Potential if they are not complying with the required testing or if they are not using appropriate contraception.
For pre-pubertal females:
- I will counsel each Pre-Pubertal Female patient and her parent/guardian about the risk of embryo-fetal toxicity using the Guide for Female Patients.
- I will regularly assess the reproductive status of each Pre-Pubertal Female during their treatment with ambrisentan.
- I will assess the reproductive status for Pre-Pubertal Females who are 8 years of age and older and will document and submit findings to the REMS at least annually using the Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form.
At all times
- I will report a change or misclassification in reproductive status to the REMS using the Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form within 10 business days of becoming aware of the change in reproductive status.
- I will report pregnancies to the REMS.
How do I find a pharmacy to fill an ambrisentan prescription for patients?
Pharmacies that dispense ambrisentan must be enrolled in the PS-Ambrisentan REMS. Both community and specialty pharmacies participate in the PS-Ambrisentan REMS. Your patient should decide what type of pharmacy is best for her. You may need to help your patients find a pharmacy enrolled in the PS-Ambrisentan REMS. For a list of enrolled pharmacies, visit PSAmbrisentanREMS.com
or call the REMS Coordinating Center at 1-888-301-0333. Your patient may also contact her insurance carrier for assistance in determining what pharmacies and ambrisentan products are supported by her current insurance plan.
Do prescribers need to enroll in the PS-Ambrisentan REMS if already enrolled in the Letairis REMS?
Yes. You must be enrolled in the PS-Ambrisentan REMS, even if already enrolled in the Letairis REMS.
Do healthcare providers who prescribe ambrisentan have to enroll in the PS-Ambrisentan REMS?
Healthcare providers who prescribe ambrisentan must be specially certified. To become certified, a prescriber must read the Prescriber Guide and the Prescribing Information, enroll in the PS-Ambrisentan REMS, and agree to follow the PS-Ambrisentan REMS prescriber requirements. Prescribers must enroll in the PS-Ambrisentan REMS and comply with the PS-Ambrisentan REMS requirements to prescribe ambrisentan, even if previously enrolled in the Letairis REMS.
What if a patient gets pregnant during treatment with ambrisentan or within one month of discontinuation of treatment?
Prescribers must notify the REMS Coordinating Center at (888) 301-0333 of any pregnancies that occur during treatment with ambrisentan or within one month of discontinuation of treatment.
Does the PS-Ambrisentan REMS have a mobile app?
Yes, there is a REMS mobile app for prescribers. Many activities including entering a patient's monthly pregnancy test, entering a patient's reproductive potential status, patient enrollment and more can be completed on the mobile app.