Tyvaso

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

What is Tyvaso inhalation?

Tyvaso (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.

Tyvaso is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise and can help prevent your condition from getting worse.

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

Important information

Before using Tyvaso, tell your doctor if you have a breathing disorder such as asthma or COPD (chronic obstructive pulmonary disease), an infection in your lungs (including pneumonia), low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

Slideshow: Flashback: FDA Drug Approvals 2013

Tyvaso inhalation should be used only with the inhalation system. The inhalation system comes with patient instructions for safe and effective use. Do not use the medication 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.

Before taking this medicine

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

To make sure Tyvaso 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. Tyvaso is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Tyvaso inhalation?

Use Tyvaso exactly as it was prescribed for you. 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.

Tyvaso 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 Tyvaso in the inhalation system.

Wash your hands before preparing your 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 Tyvaso 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 Tyvaso 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 Tyvaso regularly to get the most benefit. You should not reduce your dose or stop using this medicine 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 Tyvaso inhalation.

Store the 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 Tyvaso 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 Tyvaso inhalation?

Do not swallow Tyvaso 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.

Tyvaso side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tyvaso: 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 Tyvaso 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)

What other drugs will affect Tyvaso?

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 Tyvaso inhalation.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Tyvaso 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 1996-2014 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-03-13, 3:21:59 PM.

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