User Guide for TRYVIO models including: 2024, 12, 09, 12 Rems Patient, 12, Rems Patient, Patient
REMS Patient Guide
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What is TRYVIOTM?
TRYVIOTM (aprocitentan) is a prescription medicine for the treatment of high blood pressure, to lower blood pressure in patients who are not adequately controlled on other drugs. TRYVIOTM is for use in combination with other blood pressure lowering medications.
What are the serious risks of TRYVIOTM?
· TRYVIOTM can cause serious birth defects if taken during pregnancy, including when taken before you know you are pregnant or during the first trimester.
· You cannot take TRYVIOTM if you are pregnant. · You must not become pregnant while taking TRYVIOTM, or · Within one month after stopping TRYVIOTM. · Your doctor will tell you about serious birth defects (embryo-fetal toxicity) associated with taking TRYVIOTM while pregnant.
What is the TRYVIOTM 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 TRYVIOTM. The purpose of the REMS is to make sure the benefits of TRYVIOTM outweigh the risks. The TRYVIOTM REMS provides patients and healthcare providers with information and requirements to manage the risk of birth defects associated with taking TRYVIOTM.
Before you begin treatment with TRYVIOTM
Read this guide. Ask your healthcare provider any questions you have about TRYVIOTM, its benefits and risks, and the TRYVIOTM REMS requirements. Receiving counseling about the risk of serious birth defects.
Your healthcare provider has determined that you can become pregnant using the definitions that apply to the TRYVIO REMS shown below:
Patients Who Can Become Pregnant: · Patients with a uterus who have entered puberty and all patients with a uterus that have not passed through Menopause (as defined below). · For the purpose of the TRYVIOTM REMS, puberty includes those patients with a uterus who have undergone noticeable bodily changes
(continued breast budding and pubic hair growth) and have not yet had a menstrual period. · For the purpose of the TRYVIOTM REMS, patients who have undergone tubal sterilization are classified as patients who can become pregnant. Patients Who Cannot Become Pregnant: · Patients with a uterus who have not yet undergone noticeable bodily changes and are not considered to be of reproductive potential · Patients with a uterus who have passed through Menopause (as defined below) · Patients with other medical reasons for permanent, irreversible infertility · Patients without a uterus (including patients who were born male) Definition of Menopause: · Menopause is defined as 12 months without menstruation (not induced by a medical condition or medical therapy) or post-surgical from
removal of ovaries.
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Reference ID: 5492449
REMS Patient Guide
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If you are a patient who can become pregnant, you should:
Have a negative pregnancy test immediately before starting TRYVIOTM. Have a negative pregnancy test each month while taking TRYVIOTM and for one month after discontinuing treatment. Use acceptable birth control at all times while taking TRYVIOTM and for one month after stopping TRYVIOTM using one of the four options
in the chart below.
Report possible pregnancy immediately.
Option 1
One method from this list:
· Standard intrauterine device (Copper T 380A IUD)
· Intrauterine system (LNG-20 IUS: progesterone IUS)
· Progesterone implant · Tubal sterilization
Option 2
One method from this list:
· Estrogen and progesterone oral contraceptives ("the pill")
· Estrogen and progesterone transdermal patch
· Vaginal ring · Progesterone injection
PLUS One method from this list:
· Male condom · Diaphragm with spermicide · Cervical cap with spermicide
Option 3
One method from this list:
· Diaphragm with spermicide · Cervical cap with spermicide PLUS One method from this list:
· Male condom
Option 4
One method from this list:
· Partner's vasectomy
PLUS One method from this list:
· Male condom · Diaphragm with spermicide · Cervical cap with spermicide · Estrogen and progesterone
oral contraceptives ("the pill") · Estrogen and progesterone transdermal patch · Vaginal ring · Progesterone injection
Talk to your healthcare provider right away if:
· You have a positive pregnancy test. · You think your birth control has failed. Your healthcare provider may discuss medical options with you, such as emergency contraception. · You missed your period. · You think you are pregnant.
How will I receive TRYVIOTM?
TRYVIOTM is only available at certified pharmacies. You must receive TRYVIOTM through a certified pharmacy and will receive a Risk of Birth Defects with TRYVIOTM with your prescription.
For support while taking TRYVIOTM:
Online: www.TRYVIOREMS.com
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Reference ID: 5492449
Phone: 1-866-429-8964
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