treprostinil
Trepulmix · ATC code B01AC21
Brand names: Trepulmix, Remodulin, Treposa, Treprostinil Betapharm, Treprostinil Orpha-Devel, Treprostinil Tillomed, Trisuva, Treprostinil Beta, Treprostinil Ferrer, Treprostinil Reddy, Tresuvi, Genprostin, Trepiva, Trepoks, Trepulor
- Key facts
- Active substance
- treprostinil
- Drug class
- Antithrombotic
- ATC code
- B01AC21
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Trepulmix 1 mg/ml solution for infusion / Trepulmix 2.5 mg/ml solution for infusion / Trepulmix 5 mg/ml solution for infusion
- Marketing authorisation holder
- SciPharm Sàrl
- Information as of
- 2026-10-28
Key facts
Treprostinil (Trepulmix) is a prostacyclin analogue given by continuous subcutaneous infusion. It is used for chronic thromboembolic pulmonary hypertension (CTEPH).
What it is used for
- Adults with WHO Functional Class III or IV and inoperable CTEPH, or persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity.
Dosing
- Initial infusion rate 1.25 ng/kg/min; if poorly tolerated, 0.625 ng/kg/min.
- Increase under medical supervision by up to 1.25 ng/kg/min per week for the first four weeks, then up to 2.5 ng/kg/min per week, to an individually tolerated maintenance dose.
- Hepatic impairment: initial dose 0.625 ng/kg/min with cautious increases; severe hepatic impairment is contraindicated.
- Given undiluted by continuous subcutaneous infusion via an ambulatory pump; avoid abrupt withdrawal (rebound symptoms).
Contraindications
- Hypersensitivity to the active substance or any of the excipients; pulmonary veno-occlusive disease.
- Severe decompensated left heart failure; severe coronary heart disease or unstable angina; myocardial infarction within the last six months; severe arrhythmias.
- Severe hepatic impairment (Child-Pugh Class C).
- Active gastrointestinal ulcer, intracranial haemorrhage or other bleeding; cerebrovascular events within the last three months.
- Co-administration with other prostanoids.
Important warnings
- Potent vasodilator: not recommended with systolic arterial pressure less than 85 mmHg; monitor blood pressure and heart rate with any dose change.
- If pulmonary oedema develops, consider pulmonary veno-occlusive disease and stop treatment.
- Increased bleeding risk through inhibition of platelet aggregation.
- Patients must be trained to manage the catheter and infusion device.
Side effects
- Very common: headache, vasodilatation, diarrhoea, nausea, jaw pain, and infusion site pain, reaction, bleeding or haematoma.
- Common: dizziness, hypotension, rash, myalgia, arthralgia, pain in extremities, infusion site abscess or infection, oedema, flushing.
Interactions
- Diuretics, antihypertensives or other vasodilators increase the risk of hypotension.
- Platelet aggregation inhibitors, NSAIDs and anticoagulants increase the risk of bleeding.
- CYP2C8 inhibitors (e.g. gemfibrozil) double exposure; consider dose adjustment when CYP2C8 inhibitors or inducers are added or stopped.
Pregnancy and breastfeeding
- Use in pregnancy only if the benefit to the mother justifies the risk to the foetus; contraception is recommended.
- Breastfeeding women should discontinue 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.
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)
- TrepulmixSciPharm Sàrl · EMEA/H/C/005207
Source: European Medicines Agency (EMA), product information
Austria
- RemodulinFerrer Internacional, S.A. · 1 register entry
- TreposaAmomed Pharma Gmbh · 1 register entry
- Treprostinil BetapharmBetapharm Arzneimittel Gmbh · 1 register entry
- Treprostinil Orpha-DevelOrpha-Devel Handels Und Vertriebs Gmbh · 1 register entry
- Treprostinil TillomedTillomed Pharma Gmbh · 1 register entry
- TrisuvaAop Orphan Pharmaceuticals Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- RemodulinFerrer Internacional, S.A. · 1 register entry
- Treprostinil BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Treprostinil BetapharmBetapharm Arzneimittel Gmbh · 1 register entry
- Treprostinil FerrerFerrer Internacional, S.A. · 1 register entry
- Treprostinil ReddyReddy Holding Gmbh · 1 register entry
- Treprostinil TillomedTillomed Pharma Gmbh · 2 register entries
- TresuviOrpha-Devel Handels Und Vertriebs Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- GenprostinGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
- TrepivaPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- TrepoksCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- TrepulorVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Remodulin, Tresuvi
- Bulgaria
- Тресуви
- Croatia
- Remodulin, Treprostinil Tillomed, Tresuvi
- Cyprus
- Remodulin
- Czechia
- Remodulin, Treprostinil Tillomed, Tresuvi
- Denmark
- Remodulin, Treprostinil Tillomed, Tresuvi
- Estonia
- Remodulin, Tresuvi
- Finland
- Remodulin, Treposa, Treprostinil Tillomed
- France
- Remodulin, Treposuvi, Treprostinil Reddy Pharma, Treprostinil Tillomed
- Greece
- Remodulin, Treprostinil Tillomed, Tresuvi
- Hungary
- Remodulin, Treprostinil Zentiva, Tresuvi
- Iceland
- Remodulin, Trepulmix
- Ireland
- Treposuvi, Treprostinil Tillomed
- Italy
- Remodulin, Treprostinil Dr. Reddy’s, Treprostinil Tillomed, Tresuvi
- Latvia
- Remodulin, Treposuvi
- Liechtenstein
- Trepulmix
- Lithuania
- Remodulin, Treprostinil Tillomed, Tresuvi
- Luxembourg
- Remodulin
- Malta
- Tresuvi
- Netherlands
- Remodulin, Treposuvi, Treprostinil Tillomed
- Norway
- Remodulin, Treprostinil Tillomed, Trepulmix, Tresuvi
- Poland
- Remodulin, Treprostinil Reddy, Treprostinil Tillomed, Tresuvi
- Portugal
- Remodulin, Treprostinilo Tillomed, Tresuvi
- Romania
- Tresuvi
- Slovakia
- Remodulin, Treprostinil Tillomed, Tresuvi
- Slovenia
- Remodulin, Treprostinil Amomed, Treprostinil Tillomed
- Spain
- Treprostinilo Dr. Reddys, Treprostinilo Ferrer, Treprostinilo Zentiva, Tresuvi
- Sweden
- Remodulin, Treprostinil Tillomed, Tresuvi
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Related calculators
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Trepulmix – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/trepulmix-epar-product-information_en.pdf
- 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
- 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
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC B01AC.
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.