Important Safety Information
Full Prescribing Information
Patient Package Insert
Instructions For Use
Pulmonary arterial hypertension (PAH) is high blood pressure in the arteries of the lungs (the pulmonary arteries). These arteries carry blood from the heart to the lungs, where it picks up oxygen before being pumped to the rest of your body.
Over time, the arteries in the lungs become narrow. This narrowing increases the pressure within the arteries and decreases blood flow from the heart to the lungs. The increased pressure can also cause further injury to the arteries. The heart must then pump harder, causing the walls on the right side of the heart to thicken and weaken.
In the early stages of pulmonary arterial hypertension (PAH), the most common symptoms are shortness of breath and feeling tired or weak. As PAH worsens, symptoms become more severe and interfere with daily activities.
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. People living with PAH may make too little prostacyclin. Tyvaso is an inhalable prostanoid and acts similarly to the natural prostacyclin that is in the body, helping to keep the pulmonary arteries open and working properly.
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.
Tyvaso must be prescribed by your doctor, and can be taken only by using the Tyvaso Inhalation System.
Back to TopProstanoid therapy is an established treatment option for pulmonary arterial hypertension (PAH). It mimics the action of prostacyclin, a substance naturally produced by the body to help keep blood vessels open and working properly.
The Tyvaso® Inhalation System is a portable, handheld device that delivers Tyvaso directly to your lungs. The system consists of the following items:
You need a prescription from your doctor to receive both Tyvaso and the Tyvaso Inhalation System.
Because Tyvaso® is an inhalable (or breathed in) medication, your doctor or Specialty Pharmacy Service (SPS) provider will train you to use the Tyvaso Inhalation System once you have been prescribed Tyvaso. Tyvaso is an add-on to oral therapy and requires training prior to use.
Tyvaso® and the Tyvaso Inhalation System are available only through the following Specialty Pharmacy Service providers:
You need a prescription from your doctor to receive both Tyvaso and the Tyvaso Inhalation System.
Before you begin therapy with Tyvaso®, you’ll receive a Tyvaso Inhalation System Starter Kit from your Specialty Pharmacy Service (SPS) provider. It includes:
Each month, you’ll receive a refill kit from your SPS provider that includes:
The Instructions for Use Manual (Also available in Spanish) will tell you all you need to know to properly assemble, use, care for, and troubleshoot your Tyvaso® Inhalation System.
Here are some key things to remember:
Tyvaso® and the Tyvaso Inhalation System are available only through the following Specialty Pharmacy Service (SPS) providers:
Your SPS provider will replace your device automatically every 2 years. Should your device need replacing before then, please contact your SPS provider.
Each month, your Specialty Pharmacy Service provider will send you a 28-day supply of Tyvaso®, along with a kit containing a new set of accessories for your Tyvaso Inhalation System.
Don't hesitate to contact your SPS provider if you have any questions about taking Tyvaso, operating the Tyvaso Inhalation System, or if you need more medication.
You’ll continue receiving your monthly supply of Tyvaso for as long as your doctor continues to prescribe the treatment.
Tyvaso® is supplied in plastic ampules packaged in a light-protective foil pouch. Each pouch contains 4 ampules, and each ampule provides a full day’s supply of Tyvaso. Once a pouch is opened, the ampules inside must be used within 7 days. Unopened ampules should be stored in the foil pouch, protected from light. Tyvaso does not need to be refrigerated.
The most common side effects seen with Tyvaso® are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. Tyvaso may cause other side effects as well. Tell your doctor about any side effect that bothers you or does not go away, so that you can get help managing the problem.
See Important Safety Information, Patient Package Insert and Full Prescribing Information for more information about Tyvaso.
Tyvaso® is the ONLY inhalable prostanoid treatment approved as an add-on therapy to be used in addition to oral medications such as bosentan (an endothelin receptor antagonist (ETRA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor).
Since Tyvaso may interact with certain medications, tell your doctor if you’re taking any of the following:
Be sure to make a list of all the medicines, vitamins, and herbal supplements you take routinely or even occasionally. Update the list as needed, keep it with you, and show it to your doctor or Specialty Pharmacy Service provider.
To learn more about Tyvaso®, simply:
Living PAH was created to help you cope with the day-to-day challenges presented by pulmonary arterial hypertension (PAH). It is designed to help you learn more about PAH and your treatment options, while offering emotional support and a chance to talk with others who have been down a similar path.
Living PAH:
Learn more about Living PAH at www.livingpah.com.
You can learn more about pulmonary arterial hypertension (PAH) through the Pulmonary Hypertension Association (PHA) and the National Heart Lung and Blood Institute (NHLBI).
The PHA is a leading community-based organization for patients with PAH. Its mission is to find ways to prevent and cure PAH, while providing hope and practical services to the community of people who have PAH or have a loved one with this disorder. To learn more, visit www.PHAssociation.org.
The NHLBI is part of the National Institutes of Health (NIH), the agency responsible for conducting a majority of all federally funded medical research. The NHLBI website has easy-to-understand information about many diseases affecting the heart and lungs. Visit www.nhlbi.nih.gov, and search for PAH.
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%).
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:
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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