Treprostinil (tre-PROS-ti-nil)

Treats pulmonary arterial hypertension (PAH) and pulmonary hypertension with interstitial lung disease (PH-ILD) to improve exercise ability.

Brand Name(s):

Tyvaso, Tyvaso DPI, Tyvaso DPI Institutional Kit, Tyvaso DPI Titration Kit

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder, Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use only in your lungs. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away with water. Do not take this medicine by mouth.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Tyvaso® Oral Inhalation Solution should only be inhaled using the Tyvaso® Inhalation system, a special lung drug delivery device, for 2 to 3 minutes.
• Do not change your doses or stop using your medicine without asking your doctor first.
• Tyvaso DPI™ Inhalation powder should only be inhaled using the Tyvaso DPI™ Inhaler.
• Tyvaso DPI™ Inhaler:
  • Remove the mouthpiece cover and look at the mouthpiece to make sure it is clean.
  • Hold the inhaler away from your mouth, breathe out fully. Keep your head level, put the mouthpiece fully into your mouth and close your lips around it. Tilt the inhaler slightly downward to prevent your tongue from blocking the powder.
  • Breathe in through your mouth quickly and deeply as you can until you have taken a full deep breath. Hold your breath for as long as you can. Then breathe out and continue to breathe normally.
  • Hold your breath for as long as you can. Then breathe out and continue to breathe normally. Put the mouthpiece cover back after each inhalation and lift up the mouthpiece in an upright position to open the inhaler.
  • Do not rinse the inhaler. Always keep it dry.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze. Use the ampules within 7 days after the foil pack has been opened.
• Store the Tyvaso DPI™ unopened blister strips in the refrigerator. You may also store at room temperature for 5 weeks.
• Store the Tyvaso DPI™ opened blister strips in the refrigerator. You may remove the medicine from the refrigerator and store at room temperature for 3 days. Do not return it in the refrigerator.
• Store theTyvaso DPI™ Inhaler at room temperature. You may also store it in the refrigerator but should allow the medicine at room temperature for 10 minutes before use. Throw away used inhaler after 7 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how treprostinil works. Tell your doctor if you are using gemfibrozil or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, low blood pressure, bleeding problems, or breathing problems (including COPD, asthma).
• This medicine may cause the following problems:
  • Low blood pressure
  • Increased risk of bleeding
• This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Standing up slowly from a sitting or lying position can help.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Cough, sore throat, trouble breathing
• Lightheadedness, dizziness, fainting
• Unusual bleeding or bruising
• Warmth or redness in your face, neck, arms, or upper chest

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088