About Ventavis

Patients should always talk with their healthcare team first if there are any questions about their individual treatment.

*What is Ventavis?

Ventavis is a prescription medicine used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. Ventavis may improve your ability to exercise and your symptoms for a short time by lowering your blood pressure and opening up the blood vessels in your lungs.

• In the key clinical study, Ventavis showed clinical improvement as defined by 3 specific measurements: ability to exercise as measured by the 6-minute walk test, symptoms (NYHA Functional Class), and decrease in the worsening of PAH symptoms.
• Ventavis is a medication you breathe in through a special device called the I-neb Adaptive Aerosol Delivery (AAD) System.

The study showing Ventavis is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors (65%) or connective tissue diseases (23%).

Ventavis has not been studied in children younger than 18 years old.

What is the most important information I should know about Ventavis?

Ventavis may not be right for you. Before taking Ventavis, tell your doctor about all of your medical conditions, including if you have liver or kidney problems; are pregnant, or plan to become pregnant; or are breast-feeding. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines used to treat high blood pressure or heart problems or medicines that lessen blood clotting (warfarin, Coumadin, Jantoven). Ventavis and other medicines may affect each other, causing side effects.

What are the possible side effects of Ventavis?

• Ventavis may cause side effects, including feeling dizzy, lightheaded, and faint. If you have any of these side effects, you should stand up slowly when you get out of chairs or bed. Tell your doctor if your fainting gets worse during treatment with Ventavis. Your doctor may need to change your dose or treatment.
• Do not drive a car or operate any tools or machines if dizziness or fainting from low blood pressure is a problem for you.
• You may have trouble breathing after taking Ventavis, because it may cause the muscles around your airway to tighten (bronchospasm). Get emergency help right away if you have trouble breathing.
• The most common side effects of Ventavis include red face (flushing), increased cough, low blood pressure, headaches, nausea, spasm of your jaw muscles that makes it hard to open your mouth, and fainting.

Talk to 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 Ventavis. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information for Ventavis.

*What is Tracleer?

Tracleer is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs, (WHO Group I). Tracleer can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.

• In two different studies, Tracleer improved 6-minute walk distance by 35 and 76 meters. These studies focused on patients with WHO Functional Class III-IV.¹
• Clinical worsening was defined as any one of the following: a need to go to the hospital for PAH, stopping treatment because of worsening of PAH, a need for intravenous (IV) treatment (epoprostenol), or death.^2,3

Studies showing Tracleer is effective included mainly patients with NYHA Functional Class II-IV PAH. In these patients, PAH was caused by: unidentified or hereditary factors (60%); connective tissue disease (21%); being born with a hole in the heart between the left and right sides (18%).

In patients with WHO Functional Class II symptoms, Tracleer slowed the worsening of PAH, however, did not show meaningful improvement in walk distance. If you are a patient with WHO Functional Class II symptoms, your healthcare provider will consider whether the potential benefits of Tracleer outweigh the risk of liver damage, which may prevent future use of Tracleer as your disease progresses.

Tracleer is only:

• prescribed by healthcare providers who are enrolled in T.A.P.
• available to people who understand and agree to enroll in T.A.P.

It is not known if Tracleer is safe and works in children below 12 years of age.

Please see full Prescribing Information and Medication Guide for Tracleer.

References: 1. TRACLEER^® (bosentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc., February 2011. 2. Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002;346(12):896-903. 3. Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelin receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet. 2001;358:1119-1123.