Treprostinil (Remodulin)

Pronunciation: trep-ROSS-tin-ill.

Generic name
treprostinil (as treprostinil sodium)
Drug class
Prostacyclin (PGI2) analogue / vasodilator
Form
Solution for infusion, 1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL, delivered via a small portable infusion pump
Route
Continuous subcutaneous or intravenous infusion
Legal status
Prescription-only medicine, administered only under specialist supervision, in every market confirmed this session (United States, United Kingdom, European Union, Canada); previously authorised but not currently marketed in Australia; always check your own country and product label.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Remodulin (historical, TGA-registered 2004) (5) · Full directory

What treprostinil (as treprostinil sodium) is and how it works

Treprostinil is a man-made version of prostacyclin, a substance the body makes naturally to widen blood vessels. Given as a continuous infusion, it widens the blood vessels in the lungs and reduces the workload on the heart in pulmonary arterial hypertension (PAH), a serious condition of high blood pressure in the arteries of the lungs. (1) (2) (4)

Treprostinil by continuous infusion (Remodulin) is delivered day and night through a small pump, either just under the skin (subcutaneous) or into a vein through a permanent catheter (intravenous). Two safety facts are especially important: first, this medicine should never be stopped suddenly or have its dose sharply reduced without your care team's direction, since real, serious worsening of PAH symptoms -- and, in a small number of cases, death -- has been reported in association with abrupt discontinuation, even though a direct cause-and-effect 'rebound' mechanism has not been established by every regulator that has reviewed the evidence. Second, if you receive treprostinil into a vein through a permanent catheter, there is a real risk of serious, potentially fatal bloodstream infection, which is why subcutaneous (under-the-skin) delivery is preferred whenever it can be tolerated.

Mechanism of action: how treprostinil (as treprostinil sodium) works

Treprostinil is a synthetic tricyclic benzidine analogue of prostacyclin (PGI2), acting as a direct vasodilator of the pulmonary and systemic arterial vascular beds and an inhibitor of platelet aggregation. (4)

What treprostinil (as treprostinil sodium) is used for

Pulmonary arterial hypertension (PAH)

Used for the long-term treatment of pulmonary arterial hypertension (WHO Group 1) to reduce exercise-related symptoms, in patients with NYHA Class II-IV symptoms (US) or NYHA Class III (UK, France) who have not responded adequately to conventional therapy, and in patients transitioning from another infused prostacyclin (epoprostenol) to reduce the risk of clinical deterioration during the switch. (1) (2) (4)

Before taking treprostinil (as treprostinil sodium)

Do not take / not appropriate for

  • Do not receive treprostinil if you have a known hypersensitivity to the drug, its excipients, or structurally related compounds. (all countries) (4)

Tell your clinician about

  • If you have liver problems, since treprostinil clearance can be reduced by up to 80% in hepatic impairment, requiring a lower starting dose and slower increases.
  • If you have low blood pressure, since treprostinil can cause or worsen low blood pressure (hypotension).
  • If you take blood thinners or have a bleeding disorder, since treprostinil reduces platelet clumping and can increase bleeding risk.
  • If you have kidney problems, since dosing may need to be more conservative.
  • If you develop signs of fluid in the lungs (worsening shortness of breath) while on treatment, since this can indicate an underlying condition (pulmonary veno-occlusive disease) that needs urgent evaluation.
  • Your ability and your caregiver's ability to manage a continuous infusion pump and catheter care, since treatment is often needed for prolonged periods, possibly years.
(1) (2) (4)

How to take treprostinil (as treprostinil sodium)

  • Treprostinil for PAH is given as a continuous infusion, 24 hours a day, using a small portable pump -- it is not a medicine you take as an occasional dose.
  • Subcutaneous (under-the-skin) delivery is the preferred route because it carries a lower infection risk than intravenous delivery; the intravenous route is generally reserved for when subcutaneous delivery cannot be tolerated because of site pain or reaction.
  • Always have a backup infusion pump and supplies immediately available, since any interruption in delivery needs to be addressed quickly.
  • NEVER stop or sharply reduce your infusion on your own, even briefly -- always follow your care team's specific instructions, and if an accidental interruption happens, contact your care team promptly about restarting.
  • Use careful, sterile (aseptic) technique when preparing and handling your infusion system to reduce infection risk, as trained by your care team.
(1) (4)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

A missed or interrupted infusion is a medical concern, not a routine missed dose -- contact your care team promptly if your infusion is interrupted for any reason, rather than waiting or restarting on your own without guidance.

Overdose

Seek urgent medical attention if an overdose is suspected. Symptoms may include flushing, headache, nausea, vomiting, diarrhoea, or low blood pressure (dizziness, fainting). Do not wait for symptoms to worsen before contacting your care team or emergency services. (2)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Infusion site pain (very common, especially with subcutaneous delivery -- reported in the majority of patients).

What to notice: Infusion site pain (very common, especially with subcutaneous delivery -- reported in the majority of patients).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (4)

Infusion site reaction (redness, swelling, itching).

What to notice: Infusion site reaction (redness, swelling, itching).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (4)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (4)

Diarrhea.

What to notice: Diarrhea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (4)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (4)

Jaw pain.

What to notice: Jaw pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (4)

Flushing/vasodilation.

What to notice: Flushing/vasodilation.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Swelling (edema).

What to notice: Swelling (edema).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (4)

Low blood pressure (hypotension).

What to notice: Low blood pressure (hypotension).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Serious warnings

Never stop or sharply reduce your infusion suddenly — high caution

Symptoms: Worsening shortness of breath, chest pain, dizziness, or fainting, especially in the hours after an infusion is stopped or interrupted.

Action: Contact your care team immediately if your infusion is interrupted for any reason -- do not wait, and never stop your infusion or reduce your dose on your own. Real, serious worsening of PAH symptoms, and in a small number of clinical-trial cases death within 24 hours of abrupt discontinuation, has been reported, although Health Canada's own review of the evidence specifically states that a direct causal relationship between abrupt discontinuation and a 'rebound' rise in pulmonary artery pressure has not been established -- the UK regulator, by contrast, describes this specifically as a risk of rebound pulmonary arterial hypertension. Both the real seriousness of this risk and this genuine difference in how regulators describe the underlying mechanism are worth knowing. (1) (2) (4)

Catheter-related bloodstream infection (intravenous delivery) — high caution

Symptoms: Fever, chills, redness or pus around the catheter site, or feeling generally very unwell.

Action: Seek urgent medical attention -- bloodstream infections associated with a permanent intravenous catheter can be serious and, rarely, fatal. This is why subcutaneous (under-the-skin) delivery is preferred whenever it can be tolerated; if you have an intravenous catheter, follow your care team's sterile technique instructions carefully and report any signs of infection immediately. (1) (2) (4)

Low blood pressure (hypotension) — moderate caution

Symptoms: Dizziness, light-headedness, or fainting.

Action: Tell your care team if you feel unusually dizzy or faint -- your dose may need adjustment. This medicine is not recommended for patients with a systolic blood pressure below 85 mmHg per the UK label reviewed. (1) (2)

Increased bleeding risk — moderate caution

Symptoms: Unusual bruising, prolonged bleeding from cuts, or blood in stool or urine.

Action: Tell your care team promptly about any unusual bleeding, especially if you also take blood-thinning medicines. Treprostinil reduces platelet clumping and can increase bleeding risk. (1)

New or worsening fluid in the lungs (possible pulmonary veno-occlusive disease) — important safety information

Symptoms: New or worsening shortness of breath after starting or increasing treprostinil.

Action: Seek prompt medical attention -- this can indicate an underlying lung-vessel condition (pulmonary veno-occlusive disease) that needs urgent evaluation. (4)

Interactions

  • Blood thinners (anticoagulants) and other medicines that increase bleeding risk: tell your care team about all medicines you take, since combined use may increase bleeding risk. (1)
  • Other blood-pressure-lowering medicines: may increase the risk of low blood pressure when combined with treprostinil. (2)
  • Medicines that affect the CYP2C8 liver enzyme (e.g. gemfibrozil, rifampin): can significantly increase or decrease treprostinil levels; your care team may need to adjust your dose. (4)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Data on use during pregnancy are very limited. Discuss the risks and benefits with your care team if you are pregnant or planning pregnancy. (1) (2) (3) (4) (5) (6)

Breastfeeding

It is not known whether treprostinil passes into breast milk. Your care team will help you weigh the importance of the medicine to you against any potential risk to a nursing infant. (1) (2) (3) (4) (5) (6)

Children

Safety and effectiveness in patients under 16 have not been established; not an authorised paediatric indication per the Canadian monograph reviewed. (1) (2) (3) (4) (5) (6)

Elderly

Clinical studies did not include enough patients aged 65 and over to determine whether they respond differently; dose selection should be cautious, reflecting the greater frequency of reduced liver, kidney, or heart function in this age group. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Patients with mild to moderate hepatic impairment require a lower starting dose and more conservative up-titration, with close monitoring; treprostinil has not been studied in severe hepatic impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

No formal studies have been done in kidney impairment; doses should be increased more conservatively. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline blood pressure and assessment for conditions that increase bleeding or infection risk.
  • Assessment of your (or your caregiver's) ability to manage a continuous infusion pump and catheter care for a prolonged period, possibly years.
  • Liver function assessment, since dosing depends on hepatic status.

During treatment

  • Regular monitoring for infusion-site problems, signs of infection (especially with intravenous delivery), and blood pressure.
  • Prompt reporting of any interruption in infusion delivery to your care team.
  • Never adjust your own dose or stop treatment without your care team's specific instruction.
(1) (4)

Storage

Store as directed by your pharmacy/care team; inspect the solution for clarity, particulate matter, discoloration, or leakage before use, and do not use if any of these are present.

Professional information

Clinician-facing context only, sourced from the current US DailyMed prescribing information, UK EMC SmPC, France's ANSM database, and Health Canada's product monograph reviewed for this dossier; verify against the current full label for the specific product before prescribing.

United States, Canada

Indication: PAH, NYHA Class II-IV (US) / III-IV (Canada)

Dose summary: Initial subcutaneous or intravenous infusion rate 1.25 ng/kg/min, reduced to 0.625 ng/kg/min if not tolerated; increased in increments of 1.25 ng/kg/min/week for the first 4 weeks, then up to 2.5 ng/kg/min/week thereafter based on response.

Renal context: No formal renal-impairment studies; increase doses more conservatively. (4)

United Kingdom, European Union

Indication: Idiopathic/heritable PAH, NYHA Class III

Dose summary: Individualised continuous SC (preferred) or IV infusion, titrated by specialist based on symptoms and tolerability.

Renal context: Sources reviewed for this dossier did not detail UK/EU-specific renal dosing guidance beyond the hepatic-impairment caution. (2)

Mechanism of action

Hepatic guidance

Reduce initial dose to 0.625 ng/kg/min ideal body weight in mild-to-moderate hepatic insufficiency, with more conservative up-titration and close monitoring; not studied in severe hepatic dysfunction.

Overdose note

Manage supportively based on presenting symptoms (flushing, headache, nausea, vomiting, diarrhoea, hypotension); no specific antidote described in the sources reviewed for this dossier. (4)

Frequently asked questions

Is treprostinil (Remodulin) available in the US, UK, EU, Canada, Australia, and New Zealand?

The continuous-infusion formulation is confirmed authorised via direct regulator sources in the United States, United Kingdom, European Union (France), and Canada. Australia originally registered treprostinil/Remodulin in 2004, but two independent government-adjacent sources directly checked in 2026 confirm no current trade products exist there -- it is classified 'Previously authorised, not currently marketed'. New Zealand is disclosed as unable to verify after a direct, repeated Medsafe search found no treprostinil-specific data sheet. (1) (2) (3) (4) (5) (6)

What happens if my treprostinil infusion is stopped suddenly?

This is a real safety concern. Stopping suddenly or sharply reducing the dose has been associated with serious worsening of PAH symptoms, and in a small number of clinical-trial cases, death within 24 hours, although the exact cause-and-effect mechanism is described differently by different regulators -- the UK describes it as a risk of 'rebound' pulmonary arterial hypertension, while Health Canada's review states that a direct causal relationship with rebound hypertension specifically has not been established, even though the real risk of symptom worsening is documented. Either way, never stop or reduce your infusion on your own -- contact your care team immediately if an interruption happens. (1) (2) (4)

Why is subcutaneous delivery preferred over intravenous delivery?

Intravenous treprostinil requires a permanent (indwelling) catheter into a vein, which carries a real risk of serious, potentially fatal bloodstream infection. Subcutaneous (under-the-skin) delivery avoids this specific infection risk, which is why it is the preferred route whenever it can be tolerated -- intravenous delivery is generally reserved for patients who cannot tolerate subcutaneous infusion because of site pain or reaction. (1) (2) (4)

Is this the same as the oral or inhaled treprostinil products?

No. This content covers the continuous subcutaneous/intravenous infusion formulation (Remodulin). Separate oral (Orenitram) and inhaled (Tyvaso) treprostinil formulations exist in some markets with different risk profiles -- neither involves an indwelling catheter, so the catheter-related infection risk described here does not apply to those formulations. (1)

What is the mechanism of action of treprostinil (as treprostinil sodium)?

Treprostinil is a synthetic tricyclic benzidine analogue of prostacyclin (PGI2), acting as a direct vasodilator of the pulmonary and systemic arterial vascular beds and an inhibitor of platelet aggregation. (4)

What is the generic name of Treprostinil (Remodulin)?

The generic name is treprostinil (as treprostinil sodium). (1) (4)

What class of drug is treprostinil (as treprostinil sodium)?

Treprostinil (Remodulin) is classed as: Prostacyclin (PGI2) analogue / vasodilator. (1) (4)

References

  1. REMODULIN (treprostinil) injection, solution -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved prescribing information · United States · dated 2025-01-01 · accessed 2026-07-31 · source 1
  2. Treprostinil 1 mg/ml Solution For Infusion -- SmPCelectronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · dated 2025-01-01 · accessed 2026-07-31 · source 2
  3. REMODULIN (treprostinil) -- medicine extractBase de Donnees Publique des Medicaments (ANSM / French Ministry of Health) -- official French medicines database · European Union (France) · dated 2005-02-28 · accessed 2026-07-31 · source 3
  4. REMODULIN (treprostinil) Injection Solution -- Product Monograph, Control Number 302563Health Canada -- Product Monograph (United Therapeutics Corp.) · Canada · dated 2026-04-21 · accessed 2026-07-31 · source 4
  5. Treprostinil -- Healthdirect medicine listing; TGA ARTG search resultsHealthdirect Australia (government-funded health information service) and Therapeutic Goods Administration (TGA) search results · Australia · accessed 2026-07-31 · source 5
  6. Direct Medsafe site and database search for treprostinilMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient treprostinil (as treprostinil sodium) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Tyvaso DPI48 ug, 32 ug, 16 ug, 80 ug, 64 ug · united therapeutics corporation
  • Orenitram5 mg, .125 mg, 1 mg, 2.5 mg, .25 mg · united therapeutics corporation
  • Remodulin100 mg/20mL, 8 mg/20mL, 50 mg/20mL, 20 mg/20mL, 200 mg/20mL · united therapeutics corporation
  • Yutrepia26.5 ug, 53 ug, 79.5 ug, 106 ug · liquidia technologies, inc.
  • TYVASO1.74 mg/2.9mL · united therapeutics corporation

United Kingdom

  • Treprostinil (various manufacturers, incl. Tillomed) (2)MHRA licensed confirmed · 1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL · not independently re-confirmed this session

Canada

  • REMODULIN

Australia

  • Remodulin (historical, TGA-registered 2004) (5)no current trade products confirmed 2026 · historical: 1/2.5/5/10 mg/mL · not applicable -- no current trade product
View brands in additional countries.

European Union

Remodulin (3)