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macitentan

Opsumit · ATC code C02KX04

Also known as: Masitentan · Brand names: Opsumit, Macepulan, Macicon, Macitentan Devatis, Macitentan Ratiopharm, Macitentan Sandoz, Macitentan Stada, Macitentan Viatris, Macitentan Zentiva, Opsaren, Brespa, Fulmorex, Macitrin, Masilva, Masipah …

Key facts
Active substance
macitentan
ATC code
C02KX04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Opsumit 10 mg film-coated tablets · Opsumit 2.5 mg dispersible tablets
Marketing authorisation holder
84
Information as of
2026-10-28

Key facts

Macitentan is an endothelin receptor antagonist for the long-term treatment of pulmonary arterial hypertension (PAH) in adults and children (Opsumit).

What it is used for

  • Opsumit 10 mg film-coated tablets: long-term treatment of PAH of WHO Functional Class II to III in adults and in patients under 18 years weighing at least 40 kg, as monotherapy or in combination.
  • Opsumit 2.5 mg dispersible tablets: long-term treatment of PAH of WHO Functional Class II to III in children aged 2 years to less than 18 years.

Dosing

  • Opsumit 10 mg film-coated tablets (adults and children from 40 kg): 10 mg once daily, at about the same time every day; swallow whole with water.
  • Opsumit 2.5 mg dispersible tablets (children from 2 years): by bodyweight 5 mg (≥10 and <20 kg), 7.5 mg (≥20 and <40 kg) or 10 mg (≥40 kg) once daily, dispersed in water.
  • A missed dose should be taken as soon as possible; do not take two doses at once.
  • No dose adjustment in the elderly or in hepatic or renal impairment; do not start in severe hepatic impairment or aminotransferases >3 × ULN; not recommended in dialysis.

Contraindications

  • Hypersensitivity to the active substance, soya (film-coated tablets) or any excipient.
  • Pregnancy; women of childbearing potential not using reliable contraception; breastfeeding.
  • Severe hepatic impairment; baseline AST and/or ALT >3 × ULN.

Important warnings

  • Liver function: liver tests before starting and monthly ALT and AST monitoring recommended; discontinue for sustained unexplained elevations, bilirubin >2 × ULN or symptoms of liver injury.
  • Decreases in haemoglobin and anaemia, some requiring transfusion; measure haemoglobin before starting; not recommended in severe anaemia.
  • If pulmonary oedema occurs, consider pulmonary veno-occlusive disease.
  • Exclude pregnancy before starting, monthly pregnancy tests; avoid pregnancy for 1 month after stopping.
  • Avoid combination with strong CYP3A4 inducers.

Side effects

  • Most common in the SERAPHIN study: nasopharyngitis (14%), headache (13.6%) and anaemia (13.2%).
  • Very common: bronchitis, haemoglobin decrease; common: pharyngitis, influenza, urinary tract infection, leukopenia, thrombocytopenia, hypotension, flushing, nasal congestion, aminotransferase elevations.
  • Uncommon: hypersensitivity reactions (e.g. angioedema, pruritus, rash).

Interactions

  • Strong CYP3A4 inducers (e.g. rifampicin, St. John's wort, carbamazepine, phenytoin) may reduce efficacy and should be avoided.
  • Caution with strong CYP3A4 inhibitors (e.g. ketoconazole, voriconazole, clarithromycin, ritonavir) and with moderate dual CYP3A4 and CYP2C9 inhibitors.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy and in women of childbearing potential not using reliable contraception.
  • Contraindicated during breastfeeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • MacepulanG.L. Pharma Gmbh · 1 register entry
  • MaciconGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Macitentan DevatisDevatis Gmbh · 1 register entry
  • Macitentan RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
  • Macitentan SandozSandoz Gmbh · 1 register entry
  • Macitentan StadaStadapharm Gmbh · 1 register entry
  • Macitentan ViatrisViatris Limited · 1 register entry
  • Macitentan ZentivaZentiva, K.S. · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Macitentan1 A Pharma Gmbh, Pharmascience International Ltd, Generinobel Gmbh, Ratiopharm Gmbh, Glenmark Arzneimittel Gmbh, Devatis Gmbh, Viatris Germany Gmbh, Zentiva Pharma Gmbh, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Abdi Farma Gmbh, Aliud Pharma Gmbh · 12 register entries
  • OpsarenRenata Pharmaceuticals (Ireland) Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • BrespaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • FulmorexFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MacitrinABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MasilvaDEVA HOLDİNG A.Ş. · 1 register entry
  • MasipahNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MasiteraHUMANİS SAĞLIK A.Ş. · 1 register entry
  • OpsentanDEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • OpsumitJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • PhealeraPHEALX İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • PulhipBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 27 more European countries
Belgium
Macitentan Ab, Macitentan Eg, Macitentan Sandoz, Macitentan Teva
Bulgaria
Мацитентан Зентива, Мацитентан Тева
Croatia
Jesoxade, Macitentan Teva, Macitentan Viatris
Cyprus
Macitentan Sandoz
Czechia
Jesoxade, Macitentan Olpha, Macitentan Teva, Macitentan Vivanta
Denmark
Macitentan "sandoz", Macitentan Devatis, Macitentan Glenmark, Macitentan Newbury, Macitentan Stada, Macitentan Teva, Macitentan Viatris, Macitentan Vivanta, Macitentan Zentiva, Opsaren
Estonia
Macitentan Norameda, Macitentan Olpha
Finland
Macitentan Devatis, Macitentan Glenmark, Macitentan Sandoz, Macitentan Stada, Macitentan Viatris, Macitentan Vivanta, Macitentan Zentiva, Opsaren
France
Macitentan Olpha, Opsaren
Greece
Macitentan Bioars, Macitentan Pharmapath, Macitentan Sandoz, Macitentan Win Medica, Maleci, Pulmart, Sozation
Hungary
Cidevia, Macepulan, Macitentan Onkogen, Macitentan Pharmapath, Macitentan Pharmascience, Macitentan Sandoz, Macitentan Stada, Macitentan Teva, Macitentan Zentiva
Iceland
Macitentan Accord, Macitentan Accordpharma, Macitentan Adalvo, Macitentan Coripharma, Macitentan Glenmark, Macitentan Newbury, Macitentan Norameda, Macitentan Pharmascience, Macitentan Stada, Macitentan Teva, Macitentan Viatris, Opsumit, Pulmart
Ireland
Macitentan Abdi, Macitentan Clonmel, Macitentan Msn, Macitentan Rowex, Macitentan Teva, Opsaren
Italy
Macitentan Abdi, Macitentan Aurobindo, Macitentan Eg, Macitentan Glenmark, Macitentan Medac, Macitentan Olpha, Macitentan Reig Jofre, Macitentan Sandoz, Macitentan Tecnigen, Macitentan Teva, Macitentan Viatris, Macitentan Vivanta, Macitentan Zentiva
Latvia
Macitentan Norameda, Macitentan Olpha
Liechtenstein
Macitentan Accord, Macitentan Accordpharma, Opsumit
Lithuania
Macitentan Norameda, Macitentan Olpha
Luxembourg
Macitentan Ab, Macitentan Eg
Malta
Cidevia, Macitentan Clonmel, Macitentan Heumann, Macitentan Pharmascience, Macitentan Sandoz, Macitentan Torrent, Opsaren
Netherlands
Macitentan Aurobindo, Macitentan Cf, Macitentan Devatis, Macitentan Glenmark, Macitentan Sandoz, Macitentan Stada Arzneimittel Ag, Macitentan Teva, Macitentan Viatris, Macitentan Vivanta
Norway
Macitentan Accord, Macitentan Accordpharma, Macitentan Devatis, Macitentan Glenmark, Macitentan Newbury, Macitentan Sandoz, Macitentan Stada, Macitentan Teva, Macitentan Viatris, Macitentan Vivanta, Macitentan Zentiva, Opsaren, Opsumit
Poland
Jesoxade, Macitentan Olpha, Macitentan Onkogen, Macitentan Sandoz, Macitentan Stada, Macitentan Teva, Macitentan Tzf, Macitentan Zentiva
Portugal
Macitentan Onkogen, Macitentano
Romania
Jesoxade, Macitentan Stada, Macitentan Teva, Macitentan Viatris, Macitentan Zentiva
Slovakia
Macitentan Olpha, Macitentan Stada, Macitentan Teva, Macitentan Viatris, Macitentan Zentiva
Spain
Macitentan Dr. Reddys, Macitentan Olpha, Macitentan Sandoz, Macitentan Skm, Macitentan Viatris, Macitentán Glenmark, Macitentán Reig Jofre, Macitentán Stada, Macitentán Tarbis, Macitentán Tecnigen, Macitentán Teva, Macitentán Vivanta, Macitentán Zentiva
Sweden
Macitentan Amarox, Macitentan Bioglan, Macitentan Devatis, Macitentan Glenmark, Macitentan Newbury, Macitentan Olpha, Macitentan Sandoz, Macitentan Stada, Macitentan Teva, Macitentan Viatris, Macitentan Vivanta, Macitentan Zentiva, Opsaren, Sozation

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. European Medicines Agency. Opsumit – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/opsumit-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.