Macipah 10

✔️ Uses | Macipah 10

Macipah is indicated for the long-term management of pulmonary arterial hypertension (PAH) in adult patients classified as WHO Functional Class II–III.
Clinical efficacy has been demonstrated in patients with:

• Idiopathic or heritable PAH
• PAH associated with connective tissue diseases
• PAH related to congenital heart disease

✔️ Dosage and Administration | Macipah 10

Recommended dose: 10 mg once daily, taken orally

Doses above 10 mg daily have not been studied in PAH patients and are not recommended

• Tablets should be swallowed whole with water
• May be taken with or without food
• Should be taken at the same time each day

Elderly: Limited clinical data are available for patients over 75 years; use with caution

Pediatric population: Safety and efficacy have not been established in patients under 18 years

• If a dose is missed, it should be taken as soon as remembered. The next dose should be taken at the usual scheduled time. Do not take two doses together.
• Single doses up to 600 mg have been administered to healthy volunteers. Reported symptoms included headache, nausea, and vomiting. In the event of overdose, supportive treatment should be provided. Due to high protein binding, dialysis is unlikely to be effective.

✔️ Pregnancy & Lactation

Macitentan therapy should only be initiated after pregnancy has been ruled out in women of childbearing potential. Pregnancy should be avoided during treatment and for one month after discontinuation. Monthly pregnancy testing is recommended during therapy.

It is not known whether macitentan is excreted in human breast milk. Use during breastfeeding is contraindicated.

✔️ Male Fertility

Testicular tubular atrophy was observed in animal studies. Although the relevance to humans is unknown, impairment of spermatogenesis cannot be excluded.

✔️ Strong CYP3A4 Inducers

Medicines such as rifampicin significantly reduce Macipah exposure and may compromise efficacy. Concomitant use should be avoided.

✔️ Strong CYP3A4 Inhibitors

Agents such as ketoconazole may approximately double Macipah exposure. Several HIV medications (e.g., ritonavir) are strong CYP3A4 inhibitors. Avoid combined use; alternative PAH therapies should be considered when such inhibitors are required.

✔️ Macipah is contraindicated in patients with:

• Known hypersensitivity to macitentan or any component of the formulation
• Pregnancy
• Breastfeeding
• Severe hepatic impairment

✔️ Precautions and Warnings

• The benefit–risk profile of Macipah has not been established in patients with WHO Functional Class I PAH
• Hepatic impairment: Elevated liver enzymes have been associated with endothelin receptor antagonists. Macipah should not be initiated in patients with severe liver disease or aminotransferase levels exceeding 3 times the upper limit of normal. Liver function tests should be performed prior to treatment
• Hemoglobin levels: Decreases in hemoglobin may occur, typically stabilizing within 4–12 weeks. Initiation is not recommended in patients with severe anemia
• Pulmonary veno-occlusive disease: If pulmonary edema develops, this diagnosis should be considered
• CYP3A4 interactions: Avoid use with strong CYP3A4 inducers; use caution with strong or moderate CYP3A4 inhibitors
• Dual CYP3A4 and CYP2C9 inhibitors: Caution is advised when co-administered with agents such as fluconazole or amiodarone
• Renal impairment: No dose adjustment is required; however, clinical data in severe renal impairment or dialysis patients are limited—use with caution

✔️ Side Effects

• Nasopharyngitis
• Headache
• Anemia

✔️ Storage:

• Store below 30°C
• Protect from light and moisture
• Keep out of reach of children