IMPORTANT SAFETY INFORMATION AND INDICATION
TRYVIO may cause serious side effects, including:
Serious birth defects.
- TRYVIO may cause serious birth defects if taken during pregnancy.
- People who can become pregnant must not be pregnant when they start taking TRYVIO or become pregnant during treatment with TRYVIO or for 1 month after stopping treatment with TRYVIO.
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People who can become pregnant should have a negative pregnancy test before starting treatment with TRYVIO, each month during treatment with TRYVIO, and 1 month after stopping TRYVIO.
- People who can become pregnant are people who:
- have entered puberty, even if they have not started their menstrual period, and
- have a uterus, and
- have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
- People who cannot become pregnant are people who:
- have not yet entered puberty, or
- do not have a uterus, or
- have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
- are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
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People who can become pregnant should use acceptable birth control before starting treatment with TRYVIO, during treatment with TRYVIO, and for 1 month after stopping TRYVIO because the medicine may still be in your body.
- If you have had a tubal sterilization, have a progesterone implant, or have an intrauterine device (IUD), these methods can be used alone, and no other form of birth control is needed.
- Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with TRYVIO.
- If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
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Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
- Tell your healthcare provider right away if you miss a menstrual period or you think you might be pregnant.
People can only receive TRYVIO through a restricted program called the TRYVIO REMS. If you are a person who can become pregnant, your healthcare provider will talk to you about pregnancy testing recommendations and the need to use acceptable birth control, the benefits and risks of TRYVIO, and the need to report suspected pregnancy right away to your healthcare provider.
TRYVIO is only available through certified pharmacies that participate in the TRYVIO REMS program. Your healthcare provider can give you information about how to find a certified pharmacy. For more information, go to www.TRYVIOREMS.com or call 1-866-429-8964.
Who should not take TRYVIO?
Do not take TRYVIO if you are:
- pregnant or currently trying to become pregnant.
- allergic to aprocitentan or any of the ingredients in TRYVIO.
Before taking TRYVIO, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have heart failure
- have anemia
- have kidney problems or get dialysis
- are pregnant or plan to become pregnant during treatment with TRYVIO. TRYVIO can cause serious birth defects.
- are breastfeeding or plan to breastfeed. It is not known if TRYVIO passes into your breastmilk. Do not breastfeed if you take TRYVIO. Talk to your healthcare provider about the best way to feed your baby if you take TRYVIO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
What are the possible side effects of TRYVIO? TRYVIO may cause serious side effects, including:
- Serious birth defects.
- Liver problems. TRYVIO may cause liver problems. Your healthcare provider should do blood tests to check your liver before starting treatment and as needed during treatment with TRYVIO. Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with TRYVIO:
- nausea or vomiting
- yellowing of your skin or whites of your eyes
- pain in the upper right stomach
- dark urine
- tiredness
- fever
- loss of appetite
- itching
- Fluid retention. Fluid retention and swelling are common during treatment with TRYVIO and can be serious. Tell your healthcare provider right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your healthcare provider may treat you with other medicines (diuretics) if you develop fluid retention or swelling.
- Low red blood cell levels (anemia). Anemia is common during treatment with TRYVIO and can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment with TRYVIO.
- Decreased sperm count. TRYVIO may cause decreased sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you.
Your healthcare provider may stop treatment with TRYVIO if you develop certain side effects. Tell your
healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the Medication Guide for TRYVIO and discuss it with your healthcare provider.
What is TRYVIO?
TRYVIO is a prescription medicine used to treat high blood pressure (hypertension) in adults who are taking other high blood pressure medicines and whose blood pressure is not well controlled. It is not known if TRYVIO is safe and effective in children.