General FAQs

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What does PS mean?

PS stands for "Parallel System", which means that there are two REMS for the same drug that run side by side. These two parallel REMS are the PS-Ambrisentan REMS for some generic formulations of ambrisentan and the Letairis REMS for the brand of ambrisentan called Letairis.

What type of information is collected by the PS-Ambrisentan REMS and who will see it?

The REMS collects personal information when you enroll in the REMS, when you use REMS services, and when you visit PSAmbrisentanREMS.com. Once you are enrolled with the REMS, you are not anonymous to us.

As a female patient, we collect health-related information from you and your doctor (or a designated agent) to complete requirements to comply with the REMS.

The REMS uses your identifiable personal information to fulfill your requests for products and services, and to contact you on REMS-related matters. Before information is reported to the companies that sponsor the PS-Ambrisentan REMS (i.e., the manufacturers) or the FDA, your personal identifying information is removed. We use aggregated (non-personally identifiable) information to help us understand trends, website performance and patient needs.

Please see the Privacy Policy for complete details.

Why aren’t I receiving emails from the PS-Ambrisentan REMS?

Because email clients differ, and spam filters sometimes filter legitimate email, the REMS suggests you add the REMS domain to your Safe Senders list in your email client. This will minimize the chance that you will miss an email from the PS-Ambrisentan REMS. Follow the instructions for adding a domain to your Safe Sender list for your email client.

How do I download the PS-Ambrisentan REMS app on my mobile device?

For an Android, the app is available on Google Play. For Apple iOS the app is available in the Apple App Store. You can find the app by searching for "PS-Ambrisentan REMS".

What if I need help using the website?

Call the REMS Coordinating Center for help at 1-888-301-0333.

What browser types and versions does the PS-Ambrisentan REMS website support?

We support the latest and previous releases of all major browsers on a rolling basis. Each time a new version is released, we begin supporting that version and typically stop supporting the third most recent version. Major browsers include Edge, Chrome, Firefox, and Safari.

How does the PS-Ambrisentan REMS website use cookies?

Cookies are used to display the correct alerts and notifications that assist you in complying with the REMS requirements.

We never store your unencrypted sensitive information in a cookie and you can find more information about how we use cookies in our Privacy Policy.

What do I do if I can't view a document on the website?

If you are attempting to open a document, but nothing appears you may have a pop-up blocker installed on your PC or, in the case of a PDF file, you may not have the Adobe Reader software installed. To rectify this, you can disable the feature in your browser for pop-up blockers. To install Adobe Reader, you can visit the Adobe site here.

How do I report a problem with the PS-Ambrisentan REMS website?

You may report website problems to the REMS Coordinating Center by calling 1-888-301-0333.

How do I obtain a username and password for the PS-Ambrisentan REMS website?

PPhysicians and other appropriately licensed healthcare professionals who prescribe ambrisentan (prescribers) must be specially certified in the PS-Ambrisentan REMS. To become certified, a prescriber must first read the Prescribing Information (PI) and the Prescriber Guide. The prescriber must then enroll in the PS-Ambrisentan REMS. The enrollment process will create a username and password.

Pharmacies, practitioners, and health care settings that dispense ambrisentan (dispensers) must be specially certified. To become certified, an authorized representative of the pharmacy must read the Pharmacy Guide. The authorized representative must then enroll the pharmacy in the PS-Ambrisentan REMS. When a pharmacist enrolls, they create their own credentials. These credentials are for them, when they login they need to specify the store's NPI number. A pharmacist can be related to more than one pharmacy.

Female patients taking ambrisentan must be enrolled in the PS-Ambrisentan REMS. Your doctor will enroll you. However, to save time at the doctor's office, you can start the enrollments process using the Pre-Enroll tool found on the Patient page and the Patient App. The enrollment process will create a username and password.

Male patients taking ambrisentan are not enrolled in the PS-Ambrisentan REMS, and therefore do not need a username and password.

What if I do not receive the verification email after I created my account?

If you haven’t received your verification email, first check your spam and/or junk email folder. If the mail is not present, please call the REMS Coordinating Center at 1-888-301-0333.

What do I do if I forgot my password?

On the login screen, select “Forgot your password?” and follow the instructions.

What do I do if I forgot my username?

If you are a healthcare provider, your username is your individual NPI number. If you are a patient your username was selected by you at the time of enrollment. If you can’t remember your username, you can call the REMS Coordinating Center at 1-888-301-0333 for assistance.

What do I do if my user account is locked?

If you are locked out of your user account, call the REMS Coordinating Center at 1-888-301-0333

How do I change my username and/or password?

Your username cannot be changed. You may however change your password in the Preferences section of the website. Use the Preferences sub menu under the top far right menu item labeled Username.

What is two-factor authentication (2FA)?

Two-factor authentication can be set in your Preferences and allows for improved security over an account and login.

Two-factor authentication adds a second level of authentication to an account log-in. In addition to something you know, such as your user name and password, a user is required to supply something they have. With 2FA disabled, the user is required to provide their username and password. With 2FA enabled, the user is required to additionally enter a unique code that is provided through an SMS text, an email, or an authenticator app. 2FA is configured to use email by default. This can be changed via Preferences after account creation. The second factors available in the PS-Ambrisentan REMS are:

We recommend the Authenticator App.

Prescriber FAQs

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.

Pharmacy FAQs

How does a patient enroll in the PS-Ambrisentan REMS?

Only female patients are required to enroll in the REMS. To enroll a female, the prescriber must complete a Patient Enrollment and Consent Form. The form may be completed and submitted online via the REMS website, through the REMS mobile apps, or by printing and faxing a completed form to the REMS Coordinating Center.

How does a pharmacy enroll in the PS-Ambrisentan REMS?

In order to dispense ambrisentan, the pharmacy must be enrolled. Pharmacies must complete an enrollment form specific to its pharmacy type (outpatient or inpatient). Additional information can be found in the Pharmacy Guide.

What are the PS-Ambrisentan REMS requirements for pharmacies?

The REMS requirements for pharmacies depend on the pharmacy type. For specific information on pharmacy requirements, please refer to the Pharmacy Guide.

What are the pharmacy types for which a pharmacy can be classified?

Outpatient Pharmacy

Pharmacies that dispense ambrisentan for outpatient use must be specially certified to enroll as one of the following pharmacy types. Each of these pharmacy types has specific requirements that must be followed to fill and dispense an ambrisentan prescription:
  • A retail pharmacy that agrees to order ambrisentan on a per patient per prescription basis (Just-in-Time (JIT) pharmacy). These pharmacies are the filling pharmacy.
  • A central fill pharmacy. Central fill pharmacies are the filling pharmacy.
  • A specialty pharmacy. Specialty pharmacies are the filling pharmacy.

Inpatient Pharmacy

An inpatient pharmacy is a pharmacy that dispenses prescriptions in an inpatient setting such as hospital, nursing home, hospice, asylum/mental facility, assisted living, prison, or rehabilitation. Inpatient pharmacies are a filling pharmacy.

How does a pharmacy validate or obtain a REMS Dispense Authorization (RDA)?

Outpatient Pharmacies

The validity of an RDA presented by the patient can be confirmed on the REMS website or by contacting the REMS Coordinating Center and providing the RDA number and the patient's date of birth from the RDA as well as the pharmacy's NPI number.

If the patient does not provide an RDA, the pharmacy must obtain an RDA from the PS-Ambrisentan REMS website (www.PSAmbrisentanREMS.com) or the REMS Coordinating Center by providing the patient's REMS ID or name, the patient's date of birth and the pharmacy's NPI number.

If an RDA cannot be validated or obtained for the patient, the pharmacy must instruct the patient to call the REMS Coordinating Center to provide the missing information. When a REMS Coordinating Center associate is contacted by the patient, the associate will determine what is preventing the issuance of an RDA.

Once an RDA is validated or obtained, the pharmacy staff must record the NDC number and days supply of the dispensed drug. This can be done through the REMS Coordinating Center or the PS-Ambrisentan REMS website. To record this information in the website, the pharmacy staff will first enter the pharmacy's NPI Number, the RDA number, and the patient's date of birth followed by the NDC number and days supply.

If monthly counseling has not been completed for the patient when the RDA is issued, the RDA will contain counseling guidelines and a message indicating that the pharmacist may:
  1. Counsel the patient using the counseling guidelines on the RDA
  2. Call the REMS Coordinating Center to receive counseling guidelines and then counsel the patient
  3. Instruct the patient to call the REMS Coordinating Center to receive counseling

Inpatient Pharmacies

An RDA is not required for inpatient pharmacies. Enrolled inpatient pharmacies attest that:
  1. Processes and procedures are in place to ensure the PS-Ambrisentan REMS requirements are met for female patients.
  2. Ambrisentan is dispensed to female patients under the supervision and care of a certified prescriber.
  3. Ambrisentan will be dispensed to a female patient after verifying the female patient's reproductive status, and that she is enrolled in the REMS or will be enrolled prior to discharge .
  4. For females of reproductive potential: Verify that 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.
  5. No more than a 15-day temporary supply of ambrisentan will be dispensed upon discharge of a female patient.

Does a pharmacy 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.

Can a chain pharmacy create an account to enroll and manage multiple pharmacies?

This functionality is not supported at this time; however, a chain pharmacy corporation may provide to the REMS a list of its originating pharmacies that will be supported by its central fill pharmacies. The REMS will add these pharmacies to the “Find a Pharmacy” list of available pharmacies that are able to fill an ambrisentan prescription.

Patient FAQs

What is ambrisentan?

Ambrisentan is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs. Ambrisentan can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
It is not known if ambrisentan is safe and effective in children

What are the serious risks of ambrisentan?

Ambrisentan can cause serious birth defects if taken during pregnancy. Females must not be pregnant when they start taking ambrisentan or become pregnant while taking ambrisentan, or for one month after stopping ambrisentan.

What is the PS-Ambrisentan Risk Evaluation and Mitigation Strategy (REMS)?

Because of the risk of serious birth defects, the FDA has required a special program called a Risk Evaluation and Mitigation Strategy (REMS) for ambrisentan. The purpose of the REMS is to make sure the benefits of ambrisentan outweigh the risks. All females must enroll in the PS-Ambrisentan REMS to receive ambrisentan, even if you have been previously enrolled in the Letairis REMS. Specific requirements apply to females who can get pregnant.

Is this REMS mandatory?

Yes, the PS-Ambrisentan REMS is mandatory for female patients.

What are the PS-Ambrisentan REMS requirements for female patients?

Females Who Cannot Get Pregnant:

You are considered a female who cannot get pregnant if you have not yet entered puberty, or you do not have a uterus, or you have gone through menopause, or you are infertile for any other medical reason and this infertility is permanent and cannot be reversed.

Before starting ambrisentan, you must:

  • Review the Guide for Female Patients.
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with your prescriber.
  • Receive counselling from your prescriber on the risk of serious birth defects (Pre-pubertal females only)
At all times, you must:
  • Inform your doctor if there is a change in your ability to become pregnant
  • If you have not yet entered puberty and are over the age of 8: Be monitored regularly to see if your ability to become pregnant changes and tell your prescriber if your ability to become pregnant changes

If you are the parent or caregiver of a female child who started taking ambrisentan before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Females Who Can Get Pregnant:

You are considered to be a female who can get pregnant if you have entered puberty, have a uterus, and have not gone through Menopause.

Before starting ambrisentan, you must:
  • Review the Guide for Female Patients.
  • Get a pregnancy test. Your doctor orders the pregnancy tests for you.
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with your prescriber.
  • Receive counseling from your prescriber on the risk of serious birth defects, the need to use highly reliable birth control during treatment and for one month after stopping treatment, and emergency birth control.
Before each prescription while taking ambrisentan, you must:
  • Receive counseling from the REMS Coordinating Center or the healthcare provider who dispenses ambrisentan on the risk of serious birth defects, the need to use highly reliable birth control during treatment and for one month after stopping treatment, emergency birth control, to get monthly pregnancy tests, and to report a pregnancy immediately.
  • Get a pregnancy test. Your doctor orders the pregnancy tests for you. The REMS Coordinating Center will contact you to ask if you have taken this test before ambrisentan is refilled. Be sure you get your monthly pregnancy test as ordered by your doctor. If you do not get your pregnancy test every month, you may not receive your ambrisentan on time.

Do not have unprotected sex. Use appropriate birth control during your ambrisentan treatment and for 1 month after stopping your ambrisentan treatment because the medicine may still be in your body.

Talk to your doctor or pharmacist right away if you have unprotected sex, if you think your birth control has failed, or if you think you may be pregnant. Your doctor may tell you to use emergency birth control. Do not wait until your next appointment to tell your doctor if you miss your menstrual period or if you think you may be pregnant.

How do I enroll in the PS-Ambrisentan REMS?

If you are a female patient, you must be enrolled in the PS-Ambrisentan REMS to receive ambrisentan, even if you have been previously enrolled in the Letairis REMS. Follow these steps with your doctor:

  1. Read and understand the Guide for Female Patients, which can be found on the PS-Ambrisentan REMS website, PSAmbrisentanREMS.com.
  2. Talk with your doctor to ensure the benefits outweigh the risks of ambrisentan
  3. Ask questions. Make sure you understand what you need to do to enroll and take part in the REMS. Make sure you know how to receive and take ambrisentan
  4. You and your doctor will fill out the Patient Enrollment and Consent Form. The form may be completed and submitted online via the REMS website, through the REMS mobile apps, or by printing and faxing a completed form to the REMS Coordinating Center at 1-888-870-1819.
  5. You will select your preferred method of contact during enrollment (text, email, push notification to a mobile app, or phone call).

Can I be pre-enrolled in the PS-Ambrisentan REMS?

  1. Your doctor must complete the enrollment, but you can start the enrollment with the Patient Pre-Enrollment process on either the REMS website (www.PSAmbrisentanREMS.com) or the patient mobile app.
  2. You will enter information such as your name, address, phone number, date of birth, and email address. When you are done, you will receive a "Patient Pre-Enrollment Confirmation Number." Give this number to your doctor to complete your enrollment.

Do patients 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 male patients taking ambrisentan need to enroll?

No, males are not required to enroll in the PS-Ambrisentan REMS.

What are birth control options for female patients taking ambrisentan?

Talk to your doctor if you have questions about your birth control options. Tell your doctor if you want to change your birth control method. Information about birth control options can be found in the Guide for Female Patients.

How will I receive my ambrisentan?

Your prescription must be filled by a pharmacy enrolled in the PS-Ambrisentan REMS. Both community and specialty pharmacies participate in the PS-Ambrisentan REMS. You should decide what type of pharmacy is best for you.

You and your doctor can find a list of pharmacies enrolled in the REMS on the REMS website, www.PSAmbrisentanREMS.com. You may also contact your insurance carrier for help in knowing which pharmacies and ambrisentan products are supported by your current insurance plan.

How you receive your prescription will depend on which pharmacy you choose. Some pharmacies may mail your prescription to you while others may give you your prescription at your local pharmacy.

If you are a female who can get pregnant, each month you will be contacted by your preferred method of contact to confirm that you have taken a monthly pregnancy test before refilling your prescription. It is important that you are able to be contacted in order to avoid delays in your refills. Once the monthly pregnancy test has been confirmed, you will receive a REMS Dispense Authorization (RDA) through your preferred method.

You will need an RDA to get your prescription filled. Show this RDA to the pharmacist. If you do not have an RDA, the pharmacist may call the REMS Coordinating Center or check the PS-Ambrisentan REMS website to confirm if an RDA has been given. If an RDA has not been given, the pharmacist will ask you to contact the REMS Coordinating Center to confirm that you have had your monthly pregnancy test.

What is an RDA?

An RDA is a REMS Dispense Authorization and is necessary for the pharmacy to obtain in order to fill a prescription for ambrisentan for a female patient. An RDA is generated once it is confirmed that the prescriber and patient are enrolled, and for a female of reproductive potential, a pregnancy test has been completed. See question 11 for more information.

What should a patient do if she gets pregnant while taking ambrisentan?

Talk to your doctor or pharmacist right away if you have unprotected sex, if you think your birth control has failed, or if you think you may be pregnant. Your doctor may tell you to use emergency birth control. Do not wait until your next appointment to tell your doctor if you miss your menstrual period or if you think you may be pregnant.

If a patient is unable to get pregnant, does she still need to enroll?

All female patients taking ambrisentan are required to enroll in the PS-Ambrisentan REMS. When completing the enrollment form, your doctor will determine your reproductive status. Pre-pubertal females will be educated using the Guide for Female Patients, which can be found on the REMS website. Female patients that cannot become pregnant will be regularly evaluated for any change in reproductive status. Any change will be documented by your doctor's completion of the Ambrisentan Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form.

Where can the medication guide be found for this product?

The medication guide can be found on the PS-Ambrisentan REMS website (PSAmbrisentanREMS.com). A medication guide will also be included with each prescription of ambrisentan.

Where can patients fill ambrisentan prescriptions?

Your prescription must be filled by a pharmacy enrolled in the PS-Ambrisentan REMS. A list of enrolled pharmacies can be found by visiting the REMS website (PSAmbrisentanREMS.com). If additional assistance is required, please contact the REMS Coordinating Center at 1-888-301-0333.

What does it mean to transfer doctors?

Transferring to another doctor means your current doctor will no longer be able to see any of your information in the PS-Ambrisentan REMS and the REMS will no longer provide information about you to your current doctor. To continue ambrisentan treatment, you will need to find another doctor enrolled in the REMS. You can choose to transfer back to this doctor at any time.

If I transfer doctors, will my previous doctor still be able to see my information in the PS-Ambrisentan REMS system?

Once you complete the transfer request below, your current doctor will no longer be able to see any of your information in the REMS. Your current doctor may still have access to his or her own copies of your medical information.

Will a transfer cause an interruption in my treatment?

This depends on when you received your last prescription and how quickly you can begin treatment with a new doctor. You should talk to your doctor to ensure that an interruption in treatment does not occur.

How does a transfer work?

You may initiate a transfer via the REMS website, through the REMS mobile app or by contacting the REMS Coordinating Center. When you are done, you will receive a Transfer Doctor Confirmation Number via the method from which you initiated the transfer. You will need to provide this Confirmation Number to your new doctor. The doctor will use this Confirmation Number to register you under their care in the PS-Ambrisentan REMS. Once this is complete, your treatment will continue with the new doctor.
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