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Important Safety Information Full Prescribing Information Patient Package Insert Instructions For Use

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Safety & Side Effects

What Should I Tell my Healthcare Provider Before Taking Tyvaso?

Before taking Tyvaso^®, tell your doctor about all of your medical conditions, including if you:

• Have lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
• Have a lung infection
• Have liver problems or kidney problems
• Have low blood pressure
• Are pregnant or plan to become pregnant. It is not known if Tyvaso will harm your unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso
• Are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking Tyvaso

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tyvaso and other medicines may affect each other.

Especially tell your doctor if you take any of these medicines:

• Medicines that decrease blood clotting
• Water pills (diuretics)
• Medicines used to treat high blood pressure or heart disease
• Gemfibrozil (Lopid^®), which is used to lower high blood cholesterol
• Rifampin (Rimactane^®, Rifadin^®, Rifamate^®, Rifater^®), an antibiotic used to treat infections

Know the medicines you take. Keep a list of them and show it to your doctor and specialty pharmacist when you get a new medicine.

It is not known if Tyvaso is safe or effective in people under 18 years of age.

What Are the Possible Side Effects of Tyvaso?

The most common side effects of Tyvaso include:

• Coughing
• Headache
• Nausea
• Reddening of your face and neck (flushing)
• Throat irritation and pain
• Fainting or loss of consciousness

Tyvaso can cause serious side effects, including:

• Tyvaso may increase the risk of bleeding in people who take blood thinners (anticoagulants)
• If you have low blood pressure, Tyvaso may lower your blood pressure further

Ask your doctor if you are not sure if this applies to you.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tyvaso. For more information, ask your doctor or specialty pharmacist.

Call your doctor for medical advice about side effects.

Indication

Tyvaso 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 exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities.

Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

Important Safety Information for Tyvaso

• Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System
• The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age
• If you have low blood pressure, Tyvaso may cause symptomatic hypotension (low blood pressure)
• Because Tyvaso reduces the ability of your blood to clot (coagulate), it may increase your risk for bleeding if you are taking blood thinners (anticoagulants), such as warfarin or heparin
• The use of Tyvaso with diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase your risk for hypotension (low blood pressure)

Other medical conditions and medicines may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking, including:

• If you are taking gemfibrozil (for high cholesterol) or rifampin (for infection), your Tyvaso dosage may need adjustment
• If you have liver or kidney problems, your ability to tolerate Tyvaso may be affected
• If you are pregnant, breast-feeding, or planning to become pregnant, talk with your healthcare provider about whether you should take Tyvaso

The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your doctor about any side effects that bother you or do not go away. Your doctor may be able to help you manage the side effects.

For more information about Tyvaso, please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use Manual. Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).

Tyvaso FAQs|Important Safety Information|Full Prescribing Information|Patient Package Insert|Instructions for Use Manual

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