Details for: REMODULIN
Company: UNITED THERAPEUTICS CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02246552 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 1 MG / ML | SOLUTION | INTRAVENOUS |
| 02246552 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 1 MG / ML | SOLUTION | SUBCUTANEOUS |
| 02246553 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 2.5 MG / ML | SOLUTION | SUBCUTANEOUS |
| 02246553 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 2.5 MG / ML | SOLUTION | INTRAVENOUS |
| 02246554 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 5 MG / ML | SOLUTION | INTRAVENOUS |
| 02246554 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 5 MG / ML | SOLUTION | SUBCUTANEOUS |
| 02246555 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 10 MG / ML | SOLUTION | INTRAVENOUS |
| 02246555 | REMODULIN | TREPROSTINIL (TREPROSTINIL SODIUM) | 10 MG / ML | SOLUTION | SUBCUTANEOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Remodulin is approved for the long-term, subcutaneous (under the skin) or intravenous (directly into a vein) treatment of pulmonary arterial hypertension (PAH) in NYHA Class III and IV patients who did not respond adequately to conventional therapy.
What it does
Remodulin causes widening of blood vessels in the lungs and body, and prevents platelets in the blood from sticking together. The effects of these actions may include improvement in some measures of heart function and ability to exercise.
When it should not be used
Remodulin should not be used in patients with known hypersensitivity (allergy) to the active ingredient, any of its non-medicinal ingredients, or to similar compounds.
What the medicinal ingredient is
Treprostinil
What the non-medicinal ingredients are
Hydrochloric acid, metacresol (0.3%), sodium chloride, sodium citrate, sodium hydroxide, and water for injection.
What dosage form it comes in
Remodulin is supplied in 20 mL multi-use vials at concentrations of 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, and 10.0 mg/mL of treprostinil. Remodulin can be used undiluted for subcutaneous use, but must be diluted for intravenous infusion with 0.9% Sodium Chloride Injection or Sterile Water for Injection at concentrations as low as 0.004 mg/mL prior to administration.
Warnings and precautions
- Long term intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs), and sepsis (blood infection, fever, headache, fatigue), which may be fatal.
- Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of pulmonary hypertension symptoms, and should be avoided.
- Remodulin is approved for subcutaneous (undiluted) or intravenous (diluted) use only.
- In order to reduce the risk of infection, sterile technique must be used in the preparation and administration of Remodulin
- Remodulin should be used only by doctors experienced in the diagnosis and treatment of pulmonary hypertension. Remodulin therapy must be started by a health professional with equipment for emergency care and monitoring.
- Remodulin dosage should be increased cautiously in patients with liver or kidney problems.
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:
- You have liver or kidney dysfunction.
- You are a pregnant or nursing female.
- You are younger than 16, or older than 65 years of age.
- You have any allergies to Remodulin, including treprostinil sodium, hydrochloric acid, metacresol, sodium chloride, sodium citrate, sodium hydroxide or components of the container.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The lowering of blood pressure and inhibition of platelet aggregation caused by Remodulin may be increased by drugs that alter blood pressure (diuretics, antihypertensive agents, vasodilators) or inhibit platelet aggregation (anticoagulants).
Proper use of this medication
How to take Remodulin:
Therapy with Remodulin may be used for prolonged periods, and your ability to use Remodulin and care for a pump and needles should be carefully considered. Your health professional will decide whether Remodulin will be given to you subcutaneously or intravenously, and will teach you how to use the pump. They will determine your correct starting dose, and will instruct you when to change your Remodulin dose.
Remodulin is given subcutaneously (under the skin) by continuous infusion, through a self-inserted catheter (tube), using an infusion pump designed for subcutaneous drug delivery.
Diluted Remodulin is given intravenously (into the vein) by continuous infusion, through a surgically-placed catheter, using an infusion pump designed for intravenous drug delivery.
Usual Dose
Once you begin Remodulin therapy, your doctor will adjust your infusion rate to establish a dose at which PAH symptoms are improved, while minimizing Remodulin side effects.
Overdose
If you think that you received too much REMODULIN due to:
- Accidental bolus
- Errors in pump program rate of administration
- Or any other reason
Missed Dose
Patients must have a second infusion pump and infusion sets available, to avoid potential interruptions of the infusion.
Side effects and what to do about them
What are possible side effects from using Remodulin?
These are not all the possible side effects you may feel when taking Remodulin. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
The most common side effects reported with Remodulin given subcutaneously are infusion site pain and reaction (redness or rash). Other side effects include headache, diarrhea, nausea, rash, jaw pain, vasodilatation, dizziness, edema and hypotension (low blood pressure, fainting), and these are generally considered to be related to the effects of Remodulin, whether given subcutaneously or intravenously. Events potentially related to intravenous delivery include line infections (redness, tenderness, swelling, or pus at infusion site), sepsis (blood infection, fever, headache, fatigue), arm swelling, parathesias (numbness), hematoma (bruising) and pain. You should contact your health professional about treatment for any side effects you may experience.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Infusion site pain | ✔ | ||
| Infusion site reaction Redness/rash | ✔ | ||
| Widening of the blood vessels | ✔ | ||
| Dizziness, swelling | ✔ | ||
| Uncommon | |||
| Low blood pressure, fainting | ✔ | ||
| IV Line Infection (redness, tenderness, swelling, or pus at infusion site) | ✔ | ||
| Sepsis (blood infection, fever, headache, fatigue) | ✔ | ||
| Increased bleeding | ✔ | ||
How to store
Remodulin should be stored at room temperature and should not be frozen or kept under hot conditions. Remodulin vials should be looked at to make sure the vial contents are clear and the vial is not damaged.
A single vial of Remodulin should be used for no more than 30 days after the initial puncture of the rubber stopper.
During use, a single reservoir (syringe) of undiluted Remodulin can be administered up to 72 hours at 3°C.
Diluted Remodulin solution (for intravenous use) can be administered up to 48 hours at 40°C when diluted to concentrations as low as 0.004 mg/mL in 0.9% Sodium Chloride Injection or Sterile Water for Injection.
Inspect the liquid as often as possible to make sure it is clear and free of leaks and particles. If it is hazy, shows particles or leaks, it should be discarded.
Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON K1A 0K9
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
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 this Patient Medication Information by visiting the Health Canada website (hc-sc.gc.ca/index-eng.php); the manufacturer’s website: http://www.northernther.com, or by calling Unither Biotech.at: 1-866-206-4441
This leaflet was prepared by United Therapeutics Corporation.
Last revised: June 13, 2017