Pricing
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All price changes →Indications & Uses
Macipah is indicated for:
Pharmacology
Endothelin (ET)-1 and its receptors (ETA and ETB) cause a number of harmful effects, including vasoconstriction, fibrosis, proliferation, hypertrophy and inflammation. In diseases such as PAH, the local ET system is upregulated, and this plays a part in vascular hypertrophy and organ damage.
Macitentan is an endothelin receptor antagonist. It blocks the binding of ET-1 to both ETA and ETB receptors. In human pulmonary arterial smooth muscle cells, macitentan shows high affinity and stays on the ET receptors for a long time.
One of the metabolites of macitentan is also active at the ET receptors. In vitro, it is estimated to be about 20% as potent as the parent drug. The clinical impact of dual endothelin blockage is unknown.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Macitentan is 10 mg once daily, taken by mouth. Doses higher than 10 mg once daily have not been studied in patients with PAH, so they are not recommended. Swallow the tablet whole with water. You can take it with or without food, but try to take it at about the same time every day.
If a dose is missed, the patient should take it as soon as possible and then take the next dose at the usual time. Two doses should not be taken together to make up for the missed one.
Elderly: There is limited clinical data with Macitentan in patients over 75 years of age, so it should be used with caution in this group.
Pediatric population: The safety of Macitentan in children and adolescents below 18 years has not yet been established.
Side Effects
With Macitentan, the side effects people report most often are nasopharyngitis (14%), headache (13.6%) and anemia (13.2%).
Cautions & Contraindications
Warnings & Precautions
The benefit/risk balance of Macitentan has not been established in patients with WHO class I functional status of pulmonary arterial hypertension. Hepatic impairment: Raised liver aminotransferases (AST, ALT) have been linked with PAH and with endothelin receptor antagonists (ERAs). Macitentan should not be initiated in patients with severe hepatic impairment or with elevated aminotransferases (>3 × ULN). A liver enzyme test should be done before initiation of Macitentan. Hemoglobin concentration: Lower hemoglobin concentrations have been seen with endothelin receptor antagonists (ERAs), Macitentan included. The Macitentan-related decreases were not progressive, though, and they stabilised after the first 4 to 12 weeks of treatment. Initiation of Macitentan is not recommended in patients with severe anemia. Pulmonary veno-occlusive disease: If signs of pulmonary oedema appear when Macitentan is given to patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered. Concomitant use with strong CYP3A4 inducers: Strong CYP3A4 inducers can reduce the efficacy of Macitentan. The combination of Macitentan with strong CYP3A4 inducers (e.g., rifampicin, St. John's wort, carbamazepine and phenytoin) should be avoided. Concomitant use with strong CYP3A4 inhibitors: Take caution when Macitentan is given together with strong or moderate CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir and saquinavir). Concomitant use with moderate dual CYP3A4 and CYP2C9 inhibitors: Take caution when Macitentan is given together with moderate dual inhibitors of CYP3A4 and CYP2C9 (e.g., fluconazole and amiodarone). Caution should also be exercised when Macitentan is given together with both a moderate CYP3A4 inhibitor (e.g., ciprofloxacin, cyclosporine, dilitiazem, erythromycin, verapamil) and a moderate CYP2C9 inhibitor. Renal impairment: Based on PK data, no dose adjustment is needed in patients with renal impairment. There is no clinical data on the use of Macitentan in PAH patients with severe renal impairment or in patients undergoing dialysis. Caution is recommended in this population.
Contraindications
Macitentan must not be given to anyone who is hypersensitive to the active ingredient. It is also contraindicated in pregnancy and breastfeeding, and in patients with severe hepatic impairment.
Pregnancy & Breastfeeding
Doctors should start Macitentan in a woman who could become pregnant only after they have confirmed that she is not pregnant. She should also avoid becoming pregnant for 1 month after she stops taking Macitentan. A pregnancy test every month during treatment is recommended, so that a pregnancy can be picked up early.
It is not known whether Macitentan passes into human milk. Macitentan is contraindicated during breastfeeding.
Male fertility
Testicular tubular atrophy was seen in male animals treated with Macitentan. Whether this matters for humans is unknown, but sperm production (spermatogenesis) could get worse.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Healthy volunteers have taken Macitentan as a single dose of up to 600 mg. They had headache, nausea and vomiting. If an overdose happens, give standard supportive measures as needed. Macitentan binds strongly to proteins in the blood, so dialysis is unlikely to be effective.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Macitentan below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Macipah 10 mg
What is Macipah 10 mg Tablet?
Macipah 10 mg Tablet is a medicine that contains Macitentan. It is made by Unimed Unihealth Pharmaceuticals Ltd. It belongs to the Anti-hypertensive group of medicines.
What is Macipah used for?
Macipah is used for: Hypertension.
What are the side effects of Macipah?
With Macitentan, the side effects people report most often are nasopharyngitis (14%), headache (13.6%) and anemia (13.2%).
Can I take Macipah during pregnancy or while breastfeeding?
Doctors should start Macitentan in a woman who could become pregnant only after they have confirmed that she is not pregnant. She should also avoid becoming pregnant for 1 month after she stops taking Macitentan. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Macipah?
Healthy volunteers have taken Macitentan as a single dose of up to 600 mg. They had headache, nausea and vomiting. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Macipah?
Store Macitentan below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Macipah?
Some medicines can interact with Macitentan, for example: Ritonavir, Ketoconazole, Rifampicin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Macipah is already among the lowest-priced brands of Macitentan at this strength.
Do I need a prescription for Macipah?
Macipah is a prescription (Rx) medicine. Take it as your doctor advises.