Aprocitentan Dosage

Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.

Usual Adult Dose for Hypertension

12.5 mg orally once a day with or without food

Comments:

• Verify negative pregnancy status in patients of childbearing potential before initiating treatment; pregnancy should be excluded with negative pregnancy tests monthly during treatment and 1 month after the last dose.
• No controlled trials have shown a reduction of risk of fatal and nonfatal cardiovascular events (primarily stokes and myocardial infarctions) with this drug.

Use: In combination with other antihypertensive drugs, for the treatment of hypertension in patients whose blood pressure is not adequately controlled on other drugs

Renal Dose Adjustments

Mild to severe renal dysfunction (estimated GFR [eGFR] 15 mL/min or more): No adjustment recommended
ESRD (eGFR less than 15 mL/min): Not recommended

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate and severe liver impairment (Child-Pugh B and C): Not recommended

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNING:

• EMBRYOFETAL TOXICITY: This drug can cause major birth defects if used during pregnancy. A negative pregnancy test should be obtained from patients of childbearing potential before initiating this drug and patients should be advised to take monthly pregnancy tests during treatment and 1 month after the last dose. Patients of childbearing potential should use acceptable methods of contraception before the start of treatment, during treatment, and for 1 month after the last dose. Due to the risk of birth defects, this drug is only available through a restricted program called the Tryvio REMS.

CONTRAINDICATIONS:

• Pregnancy
• Hypersensitivity to the active component or any of the ingredients.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Not recommended

Other Comments

Administration advice:

• Swallow tablets whole.
• If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses on the same day.

Storage requirements:

• Store in the original package at 20C to 25C (68F to 77F); excursions permitted from 15C to 30C (59F to 86F).
• Protect from light and moisture.
• Do not discard desiccant.

General:

• Control of high blood pressure should be part of comprehensive cardiovascular risk management, like lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Patients may require more than one drug to achieve blood pressure goals.
• High-risk patients, independent of hypertension, such as those with diabetes or hyperlipidemia, may benefit more from aggressive blood pressure reduction, as the relative risk reduction from blood pressure reduction is similar across different populations.
• For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Monitoring:

• Cardiovascular: For signs/symptoms of worsening heart failure
• General: For signs/symptoms of weight gain
• Hematologic: Hemoglobin (before starting and periodically during therapy)
• Hepatic: Serum aminotransferase levels and total bilirubin (before starting and periodically during therapy and as clinically indicated)
• Metabolic: For signs/symptoms of fluid retention

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Patients of childbearing potential:
• Avoid pregnancy; use acceptable methods of contraception before therapy, during therapy, and for 1 month after the last dose.
• Have pregnancy tests before starting this drug, monthly during therapy, and 1 month after the last dose.
• Inform your health care provider if pregnancy is suspected and seek additional contraceptive advice from a gynecologist or similar expert as needed.
• Use emergency contraception in the event of unprotected sex or contraceptive failure as discussed with your health care provider.
• Prepubertal females and/or their guardian(s) should report any changes in their reproductive status immediately to their prescriber.
• Do not breastfeed during therapy.
• If unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching occurs, notify your health care provider.
• Inform your health care provider if unusual weight increase or swelling of the ankles or legs occurs.

See also:

Further information

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

Medical Disclaimer