Consumer Drug Information

treprostinil

Generic Name: treprostinil injection (tre PROS ti nil)
Brand names: Remodulin, Tyvaso, Tyvaso Starter Kit, Tyvaso Refill Kit

What is treprostinil injection?

Treprostinil dilates (or widens) the arteries and decrease the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Treprostinil may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about treprostinil injection?

Before using this medication, tell your doctor if you have low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.

You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup infusion pump and infusion sets available so as not to interrupt your treatment if one infusion pump stops working.

Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using treprostinil injection?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication:

liver disease;
kidney disease; or
bleeding or blood clotting disorder.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is treprostinil injection given?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Treprostinil is given as an continuous (around-the-clock) injection using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how to use an infusion pump and inject your medicine. Do not give yourself an injection if you do not understand these instructions. Call your doctor, nurse, or pharmacist for help with injection instructions.

Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.

You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Store unopened vials (bottles) of treprostinil at room temperature away from moisture and heat. After the medicine has been placed into a syringe or pump, it should be given within 72 hours. If the medicine has been diluted (mixed with a liquid), you must use the medicine within 48 hours after mixing. Call your doctor if your symptoms do not improve or if they get worse.

What happens if I miss a dose?

Call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include warmth and redness or tingling under your skin, headache, feeling light-headed, fainting, nausea, vomiting, diarrhea, or seizure (convulsions).

What should I avoid while using treprostinil injection?

Do not stop using treprostinil without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Treprostinil injection side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
swelling in your hands or feet; or
feeling like you might pass out.

Less serious side effects may include:

pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;
dizziness;
mild skin rash;
headache or jaw pain;
flushing (warmth, redness or tingling); or
diarrhea or nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Treprostinil Dosing Information

Usual Adult Dose for Pulmonary Hypertension:

Infusion:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). Although doses of up to 100 nanograms/kg/minute have been reported, there is little experience with doses greater than 40 nanograms/kg/minute.

Inhalation:
Use only with the Tyvaso Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso delivers approximately 6 mcg of treprostinil
Initial dosage: 3 breaths [18 mcg] per treatment session. If 3 breaths are not tolerated, reduce to 1 or 2 breaths. Administer in 4 separate treatment sessions each day approximately four hours apart, during waking hours.
Maintenance dose: Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated. Titrate to target maintenance dosage of 9 breaths or 54 mcg per treatment session as tolerated.

Usual Pediatric Dose for Pulmonary Hypertension:

Inhalation:
Less than 16 years: Safety and efficacy have not been established.
16 to 18 years:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). There is little experience with doses greater than 40 nanograms/kg/minute.

What other drugs will affect treprostinil injection?

Before using treprostinil, tell your doctor if you are using any of the following drugs:

blood pressure medication;
bosentan (Tracleer);
a blood thinner such as warfarin (Coumadin).
a diuretic (water pill); or
medication to treat congestive heart failure, such as hydralazine (Apresoline, BiDil), nesiritide (Natrecor), nitroglycerin, or nitroprusside (Nitropress).

This list is not complete and there may be other drugs that can interact with treprostinil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about treprostinil injection.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.