When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to treprostinil.

How to Use This Medicine:
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. Do not take this medicine orally.
• The drug should only be inhaled using Tyvaso® Inhalation system, a special lung drug delivery device.
• Do not change your doses or stop using your medicine without asking your doctor.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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.

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 any of the following:
  
  • Gemfibrozil, rifampin
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic or water pill

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, lung disease or breathing problems (such as asthma, COPD, or lung infection).
• This medicine may cause the following problems:
  
  • Low blood pressure
  • High risk of bleeding
• This medicine may make you dizzy, drowsy, or lightheaded. You should stand up slowly when you get out of a chair or bed. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. You may also check your blood pressure regularly at home.
• 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 or sore throat
• Lightheadedness, dizziness, or fainting
• Trouble with breathing
• 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 or 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