What does PS mean?
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.
Why aren’t I receiving emails from the PS-Ambrisentan REMS?
How do I download the PS-Ambrisentan REMS app on my mobile device?
What if I need help using the website?
What browser types and versions does the PS-Ambrisentan REMS website support?
What do I do if I can't view a document on the website?
How do I report a problem with the PS-Ambrisentan REMS website?
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?
What do I do if I forgot my password?
What do I do if I forgot my username?
What do I do if my user account is locked?
How do I change my username and/or password?
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:
How do patients enroll in the PS-Ambrisentan REMS?
How do prescribers enroll in the PS-Ambrisentan REMS?
What are the PS-Ambrisentan REMS requirements for prescribers?
Health Care Providers who prescribe ambrisentan must:
To become certified to prescribe
For all females:
For females of reproductive potential:
For pre-pubertal females:
At all times
How do I find a pharmacy to fill an ambrisentan prescription for patients?
Do prescribers need to enroll in the PS-Ambrisentan REMS if already enrolled in the Letairis REMS?
Do healthcare providers who prescribe ambrisentan have to enroll in the PS-Ambrisentan REMS?
What if a patient gets pregnant during treatment with ambrisentan or within one month of discontinuation of treatment?
Does the PS-Ambrisentan REMS have a mobile app?
How does a patient enroll in the PS-Ambrisentan REMS?
How does a pharmacy enroll in the PS-Ambrisentan REMS?
What are the PS-Ambrisentan REMS requirements for pharmacies?
What are the pharmacy types for which a pharmacy can be classified?
Outpatient PharmacyPharmacies 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:
Inpatient PharmacyAn 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)?
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:
Inpatient PharmaciesAn RDA is not required for inpatient pharmacies. Enrolled inpatient pharmacies attest that:
Does a pharmacy need to enroll in the PS-Ambrisentan REMS if already enrolled in the Letairis REMS?
Can a chain pharmacy create an account to enroll and manage multiple pharmacies?
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?
What is the PS-Ambrisentan Risk Evaluation and Mitigation Strategy (REMS)?
Is this REMS mandatory?
What are the PS-Ambrisentan REMS requirements for female patients?
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:
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:
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:
Can I be pre-enrolled in the PS-Ambrisentan REMS?
Do patients need to enroll in the PS-Ambrisentan REMS if already enrolled in the Letairis REMS?
Do male patients taking ambrisentan need to enroll?
What are birth control options for female patients taking ambrisentan?
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?
What should a patient do if she gets pregnant while taking ambrisentan?
If a patient is unable to get pregnant, does she still need to enroll?
Where can the medication guide be found for this product?
Where can patients fill ambrisentan prescriptions?
What does it mean to transfer doctors?
If I transfer doctors, will my previous doctor still be able to see my information in the PS-Ambrisentan REMS system?
Will a transfer cause an interruption in my treatment?
How does a transfer work?