Tryvio

Pronunciation: try-vee-oh
Generic name: aprocitentan
Dosage form: oral tablet
Drug class: Miscellaneous cardiovascular agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 25, 2024.

What is Tryvio?

Tryvio (aprocitentan) is a once-daily, dual oral ERA (endothelin receptor antagonist) that may be used to treat high blood pressure that is not adequately controlled by other high blood pressure medications (antihypertensives). It is used in combination with other antihypertensives and reportedly has a low potential for drug interactions.

Tryvio works by preventing the binding of endothelin (ET)-1 to ETA and ETB. Endothelin-1 is an amino acid peptide that is produced by several different cells and tissues, such as endothelial and vascular smooth muscle cells, macrophages, and the renal medulla. It is associated with several effects, such as vasoconstriction (the narrowing of blood vessels), fibrosis (thickening and scarring of tissue), and inflammation. By preventing the binding of ET-1, Tryvio lowers blood pressure.

Tryvio was FDA-approved on 19 March 2024 and is the first oral anti-hypertensive therapy with a new mechanism of action to be approved in almost 40 years.

Warnings

Tryvio comes with a Boxed Warning for embryo-fetal toxicity because it can cause major birth defects. It must not be taken during pregnancy and acceptable forms of contraception should be used before initiation of treatment, during treatment, and for one month after stopping treatment. Pregnancy must be excluded before treatment initiation.

ERAs, such as Tryvio, can cause liver toxicity and liver failure. Your healthcare provider will monitor your liver function and total bilirubin regularly during treatment and before you start treatment.

May cause fluid retention that requires treatment.

May decrease hemoglobin levels and sperm counts.

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.

It is not known if Tryvio is safe and effective in children.

Before taking

Do not take Tryvio if you are:

• pregnant or currently trying to become pregnant
• allergic to aprocitentan or any of the inactive 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
• are breastfeeding or plan to breastfeed
• wish to protect your fertility
• plan to have unprotected sex.

Pregnancy

Tryvio can 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 or for 1 month after stopping treatment.

People who can become pregnant should have a negative pregnancy test before starting treatment with Tryvio, each month during treatment, 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
• are infertile for other medical reasons and this infertility is permanent and cannot be reversed.

People who can become pregnant should use acceptable birth control before starting treatment with Tryvio, during treatment, 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. Also, see the prescribing information for a list of acceptable birth control options.

Tell your healthcare provider right away if you miss a menstrual period or you think you might be pregnant.

Breastfeeding

It is not known if Tryvio passes into your breastmilk. Do not breastfeed during treatment. Talk to your healthcare provider about the best way to feed your baby if you take Tryvio.

Fertility

Tryvio may decrease sperm counts in males and affect their ability to father a child. Tell your healthcare provider if being able to have children is important to you.

Unprotected sex

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.

How should I take Tryvio?

Take Tryvio exactly how your healthcare provider tells you to take it and do not stop taking it unless your healthcare provider tells you to.

• Take the tablets once a day. Try to take them at around the same time each day.
• Swallow the tablets whole.
• Take with or without food.

The recommended dosage of Tryvio is 12.5 mg orally once daily.

What happens if I miss a dose?

If you miss a dose of Tryvio, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses on the same day to make up for a missed dose.

What happens if I overdose?

If you take too much Tryvio, contact your healthcare provider or Poison Control Center at 1-800-222-1222 or www.poison.org, or go to the nearest hospital emergency room right away.

What are the side effects of Tryvio?

Tryvio may cause serious side effects, including:

• Serious birth defects. See warnings above
• Liver problems. 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 and swelling. Although these are common during treatment with Tryvio, they 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). Although common during treatment with Tryvio, anemia can be serious. Your healthcare provider will do blood tests to check your red blood cells before starting and as needed during treatment.

The most common side effects of Tryvio affecting at least 2% of people are edema, fluid retention, or anemia.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Your healthcare provider may stop treatment if you develop certain side effects. These are not all the possible side effects of TRYVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

What other drugs will affect Tryvio?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Drug interaction studies have not yet detected any clinically significant differences in the pharmacokinetics of the following drugs with Tryvio: midazolam or rosuvastatin.

See the product information for a full list of interactions.

Storage

Store Tryvio tablets at room temperature, between 68°F to 77°F (20°C and 25°C).

Keep it in the original container, and tightly close the bottle cap after opening. Do not throw away the desiccant packet in the bottle. Protect from light and moisture.

Keep out of the reach of children.

Tryvio ingredients

Active ingredient: aprocitentan

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Film coating: hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, polyvinyl alcohol, silica colloidal hydrated, talc, titanium dioxide, and triethyl citrate.

Manufacturer

Idorsia Pharmaceuticals US Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer