Brand Name : Tryvio
Salt/Generic Name : Aprocitentan (receptor antagonist)
Manufacturer : Idorsia Pharmaceuticals (in US; Idorsia/Actelion group)
Formulation & Strength : Oral film-coated tablets, 12.5 mg once daily
Indication : Adjunct treatment for resistant hypertension in adults not adequately controlled with ≥3 antihypertensives (including a diuretic)
Drug Class : Dual endothelin receptor antagonist
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Generic Name: Aprocitentan
Brand Name: Tryvio
Drug Class: Dual Endothelin Receptor Antagonist (ERA), blocking both ETA and ETB receptors
Used once daily (12.5 mg) as an add-on treatment for adults with resistant hypertension—those whose blood pressure remains uncontrolled despite being on three or more antihypertensive medications, including a diuretic
Dose: 12.5 mg orally once daily, with or without food
Missed Dose: Skip and resume next scheduled dose; do not double up
Restricted Access: Only available via the TRYVIO REMS program due to embryo-fetal toxicity risks.
Boxed Warning: Can cause serious birth defects—contraindicated in pregnancy; women of reproductive potential need monthly pregnancy tests and must use contraception during treatment and for 1 month after stopping
Hepatotoxicity: Requires regular liver function tests (LFTs) and bilirubin monitoring
Fluid Retention/Edema: Monitor for signs of swelling or heart failure; diuretics may be needed .
Anemia and Hemoglobin Reduction: Monitor CBC before and during therapy .
Sperm Count: May cause reduced sperm count—patients concerned with fertility should discuss this with their doctor
Edema/fluid retention (~9%–≥2%)
Anemia (~4%)
Additional effects: mild itching, appetite loss
Serious symptoms warrant monitoring of swelling, breathlessness, and liver or anemia symptoms
In the Phase 3 PRECISION trial, added 12.5 mg Tryvio lowered systolic BP by approximately 15 mm Hg when used alongside standard therapy for 4 weeks .
Administration Tip: Swallow tablets whole; can take with or without food.
Monitoring: Blood pressure, liver enzymes, hemoglobin, signs of fluid retention.
No dose adjustment required in mild-to-moderate renal impairment (eGFR ≥ 15 mL/min), but avoid in severe renal failure
Tryvio (aprocitentan) is a first-in-class oral endothelin receptor antagonist for treatment-resistant hypertension. It’s effective in lowering blood pressure, but due to serious risks like birth defects, liver damage, fluid retention, and anemia, it requires strict monitoring and enrollment in the REMS program
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