II. Indications

  1. Hypertension
    1. Fourth-line agent in Refractory Hypertension not controlled on 3 other agents
    2. Requires REMS program (due to Teratogenicity)

III. Contraindications

  1. Pregnancy
  2. Stage 5 Chronic Kidney Disease (eGFR <15 ml/min) or Hemodialysis
  3. Advanced Congestive Heart Failure
  4. Liver Disease

IV. Mechanism

  1. Aprocitentan is a Endothelin Receptor Antagonist
  2. Endothelin is a vasonstrictor and Aldosterone mediator
  3. Endothelin Receptor Antagonists inhibit endothelin activity, resulting in vasodilation

V. Medications

  1. Aprocitentan (Tryvio) 12.5 mg tablets

VI. Dosing

  1. Take 12.5 mg orally once daily with or without food

VII. Adverse Effects

  1. Peripheral Edema
  2. Decreased male fertility
    1. Aprocitentan may decrease Sperm Count
  3. Liver Function Test Abnormalities

VIII. Safety

  1. Pregnancy Category X
    1. Must be enrolled in REMS program to prescribe Aprocitentan
    2. Women of childbearing age with a Uterus
      1. Contraception 1 month before, during and 1 month after
      2. Obtain monthly Pregnancy Test while taking Aprocitentan
  2. Monitoring
    1. Liver Function Tests (baseline and periodically)
      1. Serum Aminotransferase levels (AST, ALT)
      2. Serum Total Bilirubin

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