Product Distribution

What are TYVASO and TYVASO DPI?

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat:

• Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and effective in children under 18 years of age.
• Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), which is high blood pressure in the lungs due to inflammation and sometimes scarring in the lungs. TYVASO or TYVASO DPI can improve the ability to exercise.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical conditions, including if you:

• Have low blood pressure
• Have or have had bleeding problems
• Have asthma or chronic obstructive pulmonary disease (COPD)
•  Are pregnant or plan to become pregnant. It is not known if either product will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if either product passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Either product and other medicines may affect each other.

Especially tell your healthcare provider if you take:

• Medicines used to treat high blood pressure or heart disease
• Medicines that decrease blood clotting (anticoagulants)
• Water pills (diuretics)
• Gemfibrozil (Lopid^®) or rifampin (Rimactane^®, Rifadin^®, Rifamate^®, Rifater^®)

What are the possible side effects of TYVASO or TYVASO DPI?

Both products can cause serious side effects, including:

• Low blood pressure (symptomatic hypotension).If you have low blood pressure, either product may lower your blood pressure more.
• Bleeding problems. Either product may increase the risk of bleeding, especially in people who take blood thinners (anticoagulants).

The most common side effects of both products are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, diarrhea, and shortness of breath. Like other inhaled prostaglandins, you may have trouble breathing after taking TYVASO or TYVASO DPI because it may cause the muscles around your airway to tighten (bronchospasm). These are not all the possible side effects. Call your doctor for medical advice about side effects or if you have trouble breathing.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO or TYVASO DPI, talk with your healthcare provider. Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO^® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.tyvaso.com or call 1-877-UNITHER (1-877-864-8437).