What is Ventavis?

Ventavis is a prescription medicine for adults with certain kinds of severe pulmonary arterial hypertension (PAH). It is used to improve exercise ability and symptoms for a short time. PAH is a condition where blood pressure is too high in the blood vessels between the heart and the lungs such as the pulmonary arteries. Ventavis lowers blood pressure within the pulmonary arteries by opening up the blood vessels in the lungs.

Ventavis has not been studied in children under the age of 18.

What are The Risks?

Ventavis can cause serious side effects such as:

• Dizziness, lightheadedness, and fainting (syncope) because it lowers your blood pressure. These are also common symptoms of PAH. To reduce your chances of fainting, stand up slowly when you get out of chairs or bed. Use Ventavis before increased physical exertion. Tell your doctor if fainting gets worse with Ventavis. Your doctor may need to adjust your dose or change your 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.

• Other side effects. The most common side effects with Ventavis include reddening of the face caused by dilation of blood vessels (flushing), increased cough, low blood pressure (hypotension), headaches, nausea, spasm of the jaw muscles that causes trouble opening your mouth, and fainting (syncope).

What Should I Tell My Health Care Professional?

Before you start using Ventavis, tell your health care provider if you:

• have liver or kidney problems. Your doctor may need to give you a lower dose of Ventavis.

• are pregnant, or planning to become pregnant. It is not known if Ventavis can harm your unborn baby.

• are breast-feeding. It is not known if Ventavis passes into your milk.

Are There Any Interactions With Drugs or Foods?

Tell your doctor about all the medicines you are taking including prescription and nonprescription medicines, vitamins, and herbal supplements. Ventavis and certain other medicines may affect each other in the way they work in your body. Be sure to tell your doctor if you take:

• medicines used to treat high blood pressure or heart disease

• medicines that decrease blood clotting

How Do I Take Ventavis?

• Ventavis is used with the Prodose AAD system. Read the instructions that come with Ventavis. Do not use Ventavis until your doctor has trained you on how to use the Prodose AAD system.

• Take Ventavis exactly as prescribed by your doctor. Ventavis is usually used 6 to 9 times a day during waking hours. Your doctor will tell you how to space your doses. You should take Ventavis when you wake up and also before any physical activity, but not more frequently than every 2 hours. Do not change your dose without talking to your doctor.

• Ventavis is breathed (inhaled) into your lungs with the help of a Prodose AAD device. One treatment session will usually last about 4 to 10 minutes.

• Do not drink Ventavis.

• Do not let Ventavis solution come into contact with your skin or eyes. If it does, rinse the skin or your eyes right away with water.

• If you take too much Ventavis, you may get a severe headache, chest pain, reddening of the face, jaw pain, dizziness, nausea, vomiting and diarrhea. If this happens stop taking Ventavis. If symptoms persist, call your doctor.

• Do not allow other people to be exposed to Ventavis while you are breathing it, especially babies and pregnant women.

Ventavis FDA Approved 2004
Patient Information Sheet Revised 04/2005

Date created: June 7, 2005