Patient

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.