Patient Medication Information: uses, side effects, how to take - Treprostinil Injection (DR Reddy's Laboratories)
SERIOUS WARNINGS AND PRECAUTIONS
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What is Treprostinil Injection used for?
Treprostinil Injection 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.
How does Treprostinil Injection work?:
Treprostinil Injection 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.
What are the ingredient in Treprostinil Injection?
Medicinal Ingredient: Treprostinil
Non-medicinal ingredients: Hydrochloric acid, metacresol (0.3%), sodium chloride, sodium citrate, sodium hydroxide, and water for injection.
Treprostinil Injection comes in the following dosage forms:
Treprostinil Injection is supplied in 20 mL multi-use vials at concentrations of 1 mg / mL, 2.5 mg / mL, 5 mg / mL, and 10 mg / mL of treprostinil. Treprostinil Injection 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.
Do not use Treprostinil Injection if:
Treprostinil Injection should not be used in patients with known hypersensitivity (allergy) to the active ingredient, any of its non- medicinal ingredients, or to similar compounds.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Treprostinil Injection. 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 Treprostinil Injection, 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.
The following may interact with Treprostinil Injection:
The lowering of blood pressure and inhibition of platelet aggregation caused by Treprostinil Injection may be increased by drugs that alter blood pressure (diuretics, antihypertensive agents, vasodilators) or inhibit platelet aggregation (anticoagulants).
How to take Treprostinil Injection:
Therapy with Treprostinil Injection may be used for prolonged periods, and your ability to use Treprostinil Injection and care for a pump and needles should be carefully considered. Your health professional will decide whether Treprostinil Injection 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 Treprostinil Injection dose.
Treprostinil Injection 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 Treprostinil Injection 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 Treprostinil Injection therapy, your doctor will adjust your infusion rate to establish a dose at which PAH symptoms are improved, while minimizing Treprostinil Injection side effects.
ABOUT THIS MEDICATION
PROPER USE OF THIS MEDICATION
Overdose: If you think that you received too much Treprostinil Injection 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.
What are possible side effects from using Treprostinil
Injection?
These are not all the possible side effects you may feel when taking Treprostinil Injection. 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 Treprostinil Injection 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 Treprostinil Injection, 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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| 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 |
Reporting Side Effects
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
Treprostinil Injection should be stored at room temperature and should not be frozen or kept under hot conditions. Treprostinil Injection vials should be looked at to make sure the vial contents are clear and the vial is not damaged.
A single vial of Treprostinil Injection 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 Treprostinil Injection can be administered up to 72 hours at 37 °C.
Diluted Treprostinil Injection 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.
If you want more information about Treprostinil Injection:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-
If you think you, or a person you are caring for, have taken too much Treprostinil Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
HOW TO STORE IT
MORE INFORMATION
- database.html; the manufacturer’s website: http://www.drreddys.com, or by calling Dr. Reddy’s Laboratories Canada Inc. at 1-855-845-1739
Manufactured By:
Dr. Reddy’s Laboratories Ltd.
Bachupally – 500 090 India
Imported and Distributed By:
Dr. Reddy’s Laboratories Canada Inc.
Mississauga ON L4W 4Y1 Canada