Macitentan — Membership Pricing

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What Macitentan is approved for (FDA label)

Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1 ). 1.1 Pulmonary Arterial Hypertension Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years.

Source: Read the full FDA label on DailyMed. Label effective date: June 11, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Macitentan (FDA label)

WARNING: EMBRYO-FETAL TOXICITY Macitentan tablets are contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindications ( 4.1), Warnings and Precautions ( 5.1 )], Use in Specific Populations (8.1 )]. Therefore, for females of reproductive potential, exclude pregnancy before the start of treatment with macitentan tablets. Advise use of effective contraception before the initiation of treatment, during treatment, and for one month after stopping treatment with macitentan tablets [see Dosage and Administration ( 2.2 ), Use in Specific Populations (8.3)]. When pregnancy is detected, discontinue macitentan tablets as soon as possible [see Warnings and Precautions ( 5.1 )]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Based on animal data, macitentan tablets may cause fetal harm if used during pregnancy (4.1, 5.1 , 8.1 ) . Females of reproductive potential: exclude pregnancy before start of treatment. Prevent pregnancy prior to initiation of treatment, during treatment and for one month after treatment by using effective methods of contraception ( 2.2, 8.3). When pregnancy is detected, discontinue macitentan tablets as soon as possible ( 5.1 ).

Source: FDA prescribing information (DailyMed). Set ID: 226049ba-9c76-0798-6725-ee027a041820. SPL document ID: 17fd8988-391a-db5d-c01f-8163ab7de3cc. Label effective date: June 11, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Macitentan (FDA label)

Tablets: 10 mg, white to off-white, round, biconvex film-coated tablet. Engraved “APO” on one side, “M” over “10” on the other side. Tablet: 10 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 226049ba-9c76-0798-6725-ee027a041820. SPL document ID: 17fd8988-391a-db5d-c01f-8163ab7de3cc. Label effective date: June 11, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Macitentan (FDA label)

Clinically significant adverse reactions that appear in other sections of the labeling include: Embryo-fetal Toxicity [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Fluid Retention [see Warnings and Precautions ( 5.3 )] Decrease in Hemoglobin [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (more frequent than placebo by ≥3%) are anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection ( 6.1 ).

Source: FDA prescribing information (DailyMed). Set ID: 226049ba-9c76-0798-6725-ee027a041820. SPL document ID: 17fd8988-391a-db5d-c01f-8163ab7de3cc. Label effective date: June 11, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Macitentan (FDA label)

Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Pregnancy Macitentan tablets may cause fetal harm when administered to a pregnant woman. Macitentan tablets are contraindicated in females who are pregnant. Macitentan was consistently shown to have teratogenic effects when administered to animals. If macitentan tablets are used during pregnancy, advise the patient of the potential risk to a fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . 4.2 Hypersensitivity Macitentan tablets are contraindicated in patients with a history of a hypersensitivity reaction to macitentan or any component of the product [see Adverse Reactions ( 6.2 )].

Source: FDA prescribing information (DailyMed). Set ID: 226049ba-9c76-0798-6725-ee027a041820. SPL document ID: 17fd8988-391a-db5d-c01f-8163ab7de3cc. Label effective date: June 11, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Macitentan (FDA label)

ERAs cause hepatotoxicity and liver failure. Obtain baseline liver enzymes and monitor as clinically indicated ( 5.2 ). Fluid retention may require intervention ( 5.3 ). Decreases in hemoglobin ( 5.4 ). Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment ( 5.5 ). Decreases in sperm count have been observed in patients taking ERAs ( 5.6 ). 5.1 Embryo-fetal Toxicity Based on data from animal reproduction studies, macitentan tablets may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. The available human data for ERAs do not establish the presence or absence of major birth defects related to the use of macitentan tablets. Advise patients who can become pregnant of the potential risk to a fetus. Obtain a pregnancy test prior to initiation of therapy with macitentan tablets.

Source: FDA prescribing information (DailyMed). Set ID: 226049ba-9c76-0798-6725-ee027a041820. SPL document ID: 17fd8988-391a-db5d-c01f-8163ab7de3cc. Label effective date: June 11, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Macitentan (FDA label)

Strong CYP3A4 inducers (rifampin) reduce exposure to macitentan: avoid co-administration with macitentan tablets ( 7.1 , 12.3 ). Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with macitentan tablets ( 7.2 , 12.3 ). Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with macitentan tablets ( 7.3 , 12 .3 ). 7.1 Strong CYP3A4 Inducers Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure. Concomitant use of macitentan tablets with strong CYP3A4 inducers should be avoided [see Clinical Pharmacology ( 12.3 ) ] . 7.2 Strong CYP3A4 Inhibitors Concomitant use of strong CYP3A4 inhibitors like ketoconazole approximately double macitentan exposure.

Source: FDA prescribing information (DailyMed). Set ID: 226049ba-9c76-0798-6725-ee027a041820. SPL document ID: 17fd8988-391a-db5d-c01f-8163ab7de3cc. Label effective date: June 11, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.