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Macitentan Dosage

Applies to the following strength(s): 10 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pulmonary Hypertension

10 mg orally once a day

Uses: For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

If hepatic dysfunction develops during treatment:
-Discontinue treatment if sustained, unexplained, clinically relevant aminotransferase elevations occur or if elevations are accompanied by an increase in bilirubin greater than 2 times the upper limit of normal, or by clinical symptoms of liver injury.
-Treatment may be reinitiated in patients who have not experienced clinical symptoms of liver injury once hepatic enzyme levels return to within normal range. Specialist advice should be sought.

Precautions

US BOXED WARNINGS:
PREGNANCY:
-Contraindicated in pregnancy
-May cause fetal harm
-Females of reproductive potential must have pregnancy ruled out prior to initiating therapy and must use acceptable forms of birth control and undergo a pregnancy test every month for the duration of therapy and for one month following discontinuation of therapy.
-Macitentan is only available to female patients (regardless of reproductive potential) through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy (REMS).
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for macitentan. The REMS consists of a medication guide, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/REMS

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:
-Macitentan may be taken with or without food.
-Tablets should be swallowed whole (not split, crushed, or chewed).

General:
Monitoring: Females of reproductive potential are required to have pregnancy ruled out prior to initiating therapy and to use acceptable forms of birth control and undergo a pregnancy test every month for the duration of therapy and for one month following discontinuation of therapy.

Patient advice:
-Female patients are required to sign an enrolment form.
-Female patients of reproductive potential are required to comply with the pregnancy testing and contraception requirements.
-Patients should promptly receive any medical tests recommended by the healthcare provider.

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