Macitentan Dosage

Medically reviewed by Drugs.com. Last updated on Oct 30, 2023.

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

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for macitentan. 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: Do not administer this drug to a pregnant female because it may cause fetal harm. Females of reproductive potential must exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Pregnancy must be prevented during treatment and for one month after stopping treatment by using acceptable methods of contraception. For all female patients, this drug is available only through a restricted program called the OPSUMIT(R) 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).

Monitoring:

• Metabolic: Monitor for signs of fluid retention after initiation of therapy.
• Pregnancy: 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.
• Counsel men regarding potential effects on fertility.

Further information

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

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