Remodulin: Uses, Side Effects and Dosage

What REMODULIN is used for:

REMODULIN is used in adolescents (16 years of age or older) and adults for the long-term treatment of pulmonary arterial hypertension (PAH; high blood pressure in the lungs). These patients have not responded well to standard treatment in the past.

How REMODULIN works:

REMODULIN belongs to a group of medicines called vasodilators. It works by helping the blood vessels in your body to relax. This widens the blood vessels and improves blood flow throughout your body, including your lungs. This helps to reduce blood pressure in the lungs and improve your heart function and ability to exercise.

The ingredients in REMODULIN are:

Medicinal ingredient: Treprostinil sodium

Non-medicinal ingredients: hydrochloric acid, metacresol (preservative), sodium chloride, sodium citrate, sodium hydroxide, and water for injection.

REMODULIN comes in the following dosage form:

Solution for infusion; 1 mg/mL, 2.5 mg/mL, 5 mg/mL and 10 mg/mL of treprostinil (as treprostinil sodium)

Do not use REMODULIN if:

• you are allergic to:

  • treprostinil sodium or any of the other ingredients in REMODULIN.
  • any other medication with a similar structure to REMODULIN.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take REMODULIN. Talk about any health conditions or problems you may have, including if you:

• are currently taking any medications.
• have liver problems.
• have kidney problems.
• have bleeding problems as REMODULIN may increase your risk of bleeding.
• have pulmonary veno-occlusive disease (a rare and serious type of high blood pressure in the lungs). This condition is caused by a buildup of abnormal fibrous tissue in the small blood vessels of the lungs.
• are 65 years of age or older.
• are pregnant, think you might be pregnant or planning on becoming pregnant.
• are breast-feeding or planning to breast-feed.

Other warnings you should know about:

REMODULIN will be prescribed to you and you will be monitored by a healthcare professional experienced in the treatment of PAH while taking REMODULIN.

Sepsis and septic shock (infection of the blood): If you need long-term intravenous infusions of REMODULIN, your healthcare professional will surgically insert a catheter in you. It is a long, flexible tube inserted into a vein. This route of administration carries a risk of blood infections and sepsis, which can lead to death. Tell your healthcare professional right away if you experience any of the following symptoms during treatment:

• fever/chills
• confusion
• rapid heart rate
• shortness of breath
• gradual low blood pressure
• clammy skin

Pregnancy and breast-feeding:

• It is not known if REMODULIN will harm your unborn baby. You and your healthcare professional will decide whether the potential benefits of taking REMODULIN outweigh the potential risks to your unborn child. If you discover that you are pregnant during treatment, tell your healthcare professional right away.
• It is not known if REMODULIN passes into breast milk. You and your healthcare professional will decide whether you should take REMODULIN or breast-feed. You should not do both. Ask your healthcare professional about the best ways to feed your baby during your treatment.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with REMODULIN:

• medicines that affect blood pressure (e.g., medicines used to treat high blood pressure, including diuretics, also known as “water pills”, or other vasodilators).
• medicines used to prevent blood clotting (also known as “blood thinners”).
• medicines that affect a certain liver enzyme called CYP2C8 (e.g., gemfibrozil, used to treat high blood cholesterol; rifampin, used to treat tuberculosis).

How to take REMODULIN:

• REMODULIN is used for long-term treatment, possibly for years. REMODULIN is given using a specialized pump that delivers the medication as a continuous infusion. Your healthcare professional will carefully assess your ability to self-administer REMODULIN and care for the pump and needles. They will decide whether REMODULIN will be given to you subcutaneously (under the skin) or intravenously (in a vein). They will also teach you how to prepare your dose of REMODULIN and how to use the pump.

• If you are taking REMODULIN intravenously (in a vein):

  • a catheter will be surgically placed so that you can receive REMODULIN through a continuous infusion pump system.
  • It must be diluted with 0.9% Sodium Chloride Injection or Sterile Water for Injection before administration. Your healthcare professional will tell you how to dilute REMODULIN.
  • During use, a single reservoir (syringe) of diluted REMODULIN can be administered with an infusion pump for up to 48 hours at 40°C. This applies to REMODULIN diluted to concentrations as low as 0.004 mg/mL in 0.9% Sodium Chloride Injection or Sterile Water for Injection.

• If you are taking REMODULIN subcutaneously (under the skin):

  • A catheter will be given to you to self-insert so that you can receive undiluted REMODULIN through a continuous infusion pump system.
  • During use, a single reservoir (syringe) of undiluted REMODULIN can be administered with an infusion pump for up to 72 hours at 37°C.
• Take REMODULIN exactly as your healthcare professional has told you.
• Inspect the liquid in the vial before each dose. Make sure it is clear and free of leaks and particles. If it is hazy, shows particles or leaks, it should be discarded.
• Do not suddenly stop your treatment or change your dose as it may worsen your condition. Talk with your healthcare professional first. They will decrease your dose of REMODULIN gradually to avoid side effects.

Usual dose:

Your healthcare professional will decide the best dose for you depending on your condition and how well you react to REMODULIN.

If there are signs that your condition is returning or worsening, or you have unwanted side effects, tell your healthcare professional right away. They may adjust your dose.

Overdose:

Symptoms of an overdose with REMODULIN include:

• flushing
• headache
• low blood pressure (e.g., dizziness, fainting)
• nausea or vomiting
• diarrhea

If you think you, or a person you are caring for, have taken too much REMODULIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If your REMODULIN infusion is interrupted or if you miss a dose, ask your healthcare professional right away for advice. Follow their instructions carefully. You should have a second infusion pump and extra infusion sets to avoid potential interruptions in your treatment.

Possible side effects from using REMODULIN:

These are not all the possible side effects you may have when taking REMODULIN. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with REMODULIN may include:

• headache
• nausea or vomiting
• jaw pain
• lack of energy
• swelling
• flushing
• diarrhea
• dizziness
• pain, tingling or numbing sensation in the hands, arms, legs or feet
• joint or bone pain
• skin rash
• itchy skin
• muscle pain or spasms
• sweating

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store REMODULIN vials at room temperature (15° to 30°C).
• A single vial of REMODULIN should be used for no more than 30 days after the initial puncture of the rubber stopper.
• Diluted REMODULIN solution (for intravenous use) can be stored up to 4 hours at room temperature or 24 hours in the refrigerator.
• Keep out of reach and sight of children.

If you want more information about REMODULIN:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling Unither Biotech at 1-866-206-4441.

Date of Authorization: 2026-04-21

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