Important Safety Information
Full Prescribing Information
Patient Package Insert
Instructions For Use
If you are a person living with pulmonary arterial hypertension (PAH), or a caregiver, these are terms that you may hear when discussing the disease with your healthcare professional.
6-minute walk distance (6MWD): a measurement of how far someone can walk in 6 minutes. Doctors use the 6MWD to evaluate a patient’s ability to exercise. By repeating the test at each patient visit, doctors can monitor changes in that individual’s ability to exercise over time
Ampule: a sealed, lightweight clear plastic vial (containing a 1 day supply of Tyvaso)
Anticoagulant: a drug that keeps the blood from clotting; also referred to as a "blood thinner." Commonly used blood thinners include low-dose aspirin or warfarin (Coumadin®)
Arterial: relating to arteries, the tube-like vessels that carry blood from the heart to the rest of the body
Chronic obstructive lung (or "pulmonary") disease: lung disease that makes it difficult to breathe. The disease commonly takes 2 forms—chronic bronchitis, which causes long-term swelling and a large amount of mucus in the lungs' main airways; or emphysema, a disease that destroys the lungs' air sacs
Endothelin receptor antagonists (ETRAs): a class of medication used in PAH to help dilate (open) the arteries. ETRAs are available in oral (pill) form
Median: a value in an ordered set of values below and above which there is an equal number of values or which is the average of the two middle values if there is no middle number. For example, 6 is the median in the following ordered set of numbers—2, 4, 6, 8, 10—because it is exactly midway between 2 and 10
NYHA Functional Classification System: a scale developed by the New York Heart Association (NYHA) and used by doctors to measure the severity of PAH and determine the type of treatment each patient needs
Phosphodiesterase-5 (PDE-5) inhibitors: a class of medication that helps to relax smooth muscle in the arteries and that may increase blood flow to the lungs of patients with PAH. PDE-5 inhibitors are available in oral (pill) and intravenous (injected into a vein) formulations
Placebo: an inactive substance used alongside a real medicine in certain types of clinical studies to compare and assess the side effects and effectiveness of the study medication
Prostacyclin: a naturally occurring substance that helps to keep blood vessels dilated (open) and working properly. Levels may be low in patients with PAH
Prostanoids: the first class of medicines approved to treat PAH. These medications help replace some of the activity of prostacyclin that is missing in patients with PAH. They are available in 2 forms—one that is infused (in a vein or under the skin) and one that is inhalable (breathed into the lungs)
Pulmonary: relating to the lungs
Pulmonary arterial hypertension (PAH): hypertension (high blood pressure) in the arteries of the lungs. In PAH, hypertension occurs in the arteries that lead from the heart to the lungs (the pulmonary arteries). PAH is different from general hypertension, which involves high blood pressure in the arteries found throughout the body
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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