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

Watch and Learn

Watch and Learn

Watch and Learn

How to Use Tyvaso

The thought of adding another therapy to your current treatment routine may feel overwhelming at first. However, Tyvaso^® can improve exercise capacity for some patients with pulmonary arterial hypertension (PAH) who are already on bosentan (an endothelin receptor antagonist (ETRA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). Resources are available to help track and plan your 4 daily treatments and to help you achieve treatment success in managing your PAH.

Using the Tyvaso Inhalation System

• You will use only 1 plastic ampule of Tyvaso a day
• Each treatment session should take about 2 to 3 minutes
• You take between 3 to 9 breaths of Tyvaso per treatment session, depending on how much medication your doctor prescribes
• You inhale Tyvaso through your mouth in 4 treatment sessions each day

Remember:

• Your Tyvaso Inhalation System is programmed to deliver 3 breaths in a row. The 3 breaths are referred to as a "cycle." If, for example, your doctor prescribes 9 breaths of Tyvaso, you will take 3 cycles of 3 breaths each
• You’ll need about 5 minutes each day to prepare the system for all 4 of your treatment sessions. Sessions should take place during waking hours about 4 hours apart and can be adjusted for planned activities. For example, you may take Tyvaso before breakfast, lunch, dinner, and at bedtime
• You can keep track of your treatment sessions with the convenient Tyvaso Treatment Tracker (Also available in Spanish)
• The Tyvaso Inhalation System must be turned off and on between cycles to deliver additional breaths of Tyvaso, as needed
• If you miss a scheduled treatment session, take Tyvaso as soon as you remember

You should take Tyvaso only with the Tyvaso Inhalation System and exactly as your doctor has prescribed.

• The Instructions for Use Manual (Also available in Spanish) is included in the initial shipment from your Specialty Pharmacy Service (SPS) provider and may also be downloaded here. It’s part of the comprehensive Tyvaso Inhalation System Starter Kit that you’ll receive along with a Tyvaso Patient Tool Kit. The tool kit also includes a Tyvaso Treatment Tracker (Also available in Spanish), to help you keep track of your treatment sessions.

IMPORTANT

• Do not start treatment with Tyvaso until you have been shown how to use the Tyvaso Inhalation System. Make sure you understand all of the directions
• Tyvaso is for use only with the Tyvaso Inhalation System

Always ask your doctor or Specialty Pharmacy Service provider to go over anything you are unsure of.

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).

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