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Full Prescribing
Information

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

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

  • Have low blood pressure
  • Have bleeding problems
  • Are pregnant or plan to become pregnant. It is not known if TYVASO will harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if TYVASO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with TYVASO.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TYVASO 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?

 

TYVASO can cause serious side effects, including:

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

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. These are not all the possible side effects of TYVASO. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at

www.fda.gov/MedWatch
or call 1-800-FDA-1088.

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

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