Signs and Symptoms of PAH*

Symptoms of pulmonary arterial hypertension (PAH)* are caused by a lack of oxygen due to narrowed blood vessels in the lungs and increased stress on the heart. PAH* symptoms may not be obvious at first, but over time they can become more limiting.

  Symptoms of PAH* may include†:  
  Breathlessness or shortness of breath (dyspnea), the most common symptom  
  Feeling tired all the time  
  Dizziness, especially when climbing stairs or when standing up  
  Fainting (syncope)  
  Swollen ankles and legs (edema)  
  Chest pain, especially during physical activity (angina)  

Patients not using any pulmonary arterial hypertension* treatments may experience increased breathlessness, so that even walking short distances may become difficult.3

Understanding Functional Class

Once a diagnosis has been made, your healthcare provider may determine your Functional Class. The Functional Class system categorizes the severity of your disease according to your symptoms. Functional Class describes how symptoms of PAH*, such as shortness of breath, chest pain, or lightheadedness, limit physical activity.5 Placing patients into Functional Classes helps your healthcare team make decisions about your treatment.

  Symptoms and classification5  
  The New York Heart Association (NYHA) functional classification system is an important method your doctor may use to measure the severity of your symptoms to decide what type of treatment is right for you.  
  Class I No limitations in usual physical activity and very mild symptoms.  
  Class II Normal activity causes some shortness of breath, tiredness, chest pain, or lightheadedness.  
  Class III Even mild activity causes shortness of breath, tiredness, chest pain, or lightheadedness, and is significantly limited because of these symptoms.  
  Class IV Shortness of breath, tiredness, chest pain, and lightheadedness, even at rest.  

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†Ventavis does not improve all of the symptoms of PAH*.

*Patient Indication and Important Safety Information

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*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 more information about Ventavis, please call 1-866-ACTELION (1-866-228-3546).