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?