treprostinil

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

What is treprostinil inhalation?

Treprostinil dilates (widens) the arteries and decreases 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). This medicine improves your ability to exercise and can help prevent your condition from getting worse.

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

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

You should not use treprostinil if you are allergic to it.

To make sure treprostinil inhalation is safe for you, tell your doctor if you have:

  • asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;

  • an infection in your lungs, including pneumonia;

  • kidney disease;

  • liver disease;

  • low blood pressure;

  • a bleeding or blood clotting disorder;

  • if you take a blood thinner (warfarin, Coumadin, Jantoven); or

  • if you take medicine to treat high blood pressure (hypertension).

FDA pregnancy category B. Treprostinil is not expected to harm 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. Tell your doctor if you are breast-feeding a baby.

How should I use treprostinil inhalation?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine should be used only with a Tyvaso inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use this medicine at home if you do not fully understand how to use the inhalation system and properly clean it daily. Ask your doctor or pharmacist if you have any questions.

Treprostinil inhalation is usually given 4 times per day at evenly spaced intervals during waking hours. Each time you use the medicine, you will inhale up to 9 breaths of the medication. Follow your doctor's instructions.

Do not mix other inhalation medicines with treprostinil in the Tyvaso inhalation system.

Wash your hands before preparing your treprostinil doses in the inhalation system.

Before your first dose of each day, twist off the top of one ampule and empty the contents into the medicine cup of the inhalation system. One ampule of treprostinil inhalation contains enough medicine for all 4 of a day's doses.

To keep the medicine in the cup from spilling, store the inhalation system upright and tightly capped with the plugs when not in use.

At the end of the day after your last dose, empty and rinse out the medicine cup, even if there is still some medicine left in it.

The effects of treprostinil inhalation will lessen over time between doses. Talk with your doctor if you need to time your dosing around any planned activities.

Do not use more than 9 breaths per treatment session, 4 times per day.

Use treprostinil regularly to get the most benefit. You should not reduce your dose or stop using treprostinil suddenly. Stopping suddenly may make your condition worse. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup inhalation system available so as not to interrupt your treatment if one system stops working.

Call your doctor if your symptoms do not improve, or if they get worse while using treprostinil inhalation.

Store treprostinil ampules in their foil pouch at room temperature away from moisture, heat, and light. Once you have opened a foil pouch, the ampules in it should be used within 7 days.

Any treprostinil placed into the medicine cup of the inhalation system must be used within 24 hours. Throw away any unused medicine at the end of the day after your last dose.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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 or tingling, vomiting, or fainting.

What should I avoid while using treprostinil inhalation?

Do not swallow treprostinil inhalation. The medication should be inhaled using only the Tyvaso inhalation system.

Rinse with water if this medication gets in your eyes.

If this medication gets on your skin, wash the area with soap and water.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Treprostinil inhalation side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • easy bruising or bleeding (nosebleeds, bleeding gums), or any bleeding that will not stop;

  • unexpected vaginal bleeding;

  • coughing up blood or vomit that looks like coffee grounds; or

  • blood in your urine or stools, black or tarry stools.

Common side effects may include:

  • cough, sore throat;

  • pain or irritation in your throat after use;

  • dizziness;

  • nausea, diarrhea;

  • headache; or

  • flushing (warmth, redness or tingling).

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.

See also: Side effects (in more detail)

Treprostinil dosing information

Usual Adult Dose for Pulmonary Hypertension:

Oral formulation:
Initial dose: 0.25 mg orally every 12 hours with food
Recommended titration: 0.25 or 0.5 mg 2 times daily every 3 to 4 days (if 0.25 mg 2 times daily increments are not tolerated consider titrating slower)
-The total daily dose can be divided and given every 8 hours with food, titrating by increments of 0.125 mg 3 times daily.
Mean dose: 3.5 mg orally every 12 hours with food.
Maximum dose: Determined by tolerability. The maximum dose studied was 21 mg orally every 12 hours with food.

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 (R) Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso (R) 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:

Oral formulation: Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

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 inhalation?

Other drugs may interact with treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about treprostinil inhalation.
  • 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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-03-13, 3:21:59 PM.

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