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Ventavis
(ven TAY vis)
(iloprost) Inhalation Solution

Read the Patient Information that comes with Ventavis before you start using it and each time you get a refill. There may be new information. The leaflet does not take the place of talking with your doctor about your medical condition or your 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.

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

What should I tell my doctor before taking 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. Your doctor may need to give you a lower dose of Ventavis.
• are pregnant, or plan to become pregnant. It is not known if Ventavis can harm your unborn baby. Ventavis should only be used during pregnancy if the benefit to you is worth the possible risk to your baby.
• are breast-feeding. It is not known if Ventavis passes into your breast milk. You and your doctor should decide if you will take Ventavis or breast feed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Ventavis and other medicines may affect each other causing side effects.

Ventavis may affect the way other medicines work, and other medicines may affect how Ventavis works.

Especially tell your doctor if you take:

• medicines used to treat high blood pressure or heart problems
• medicines that lessen blood clotting (warfarin, Coumadin, Jantoven)

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Ventavis?

See the end of this leaflet for detailed instructions for using Ventavis.

• Take Ventavis exactly as your doctor tells you to take it. Your doctor may change your dose if needed.
• You should not take Ventavis more than every 2 hours. The benefits of Ventavis may not last 2 hours, so you may adjust the times that you use it to cover planned activities.
• Do not drink Ventavis.
• Do not let Ventavis solution come into contact with your skin or eyes. If it does, rinse your skin or eyes with water right away.
• Do not allow other people to be exposed to Ventavis while you are breathing it, especially babies and pregnant women.
• If you take too much Ventavis, you may have a headache, red face, dizziness, nausea, vomiting and diarrhea. If this happens stop taking Ventavis. If your symptoms do not go away, call your doctor or get emergency help right away.

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 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.

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
• 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.

How should I store Ventavis?

• Store Ventavis between 68°F to 77°F (20°C to 25°C).
• Safely throw away Ventavis that is out of date or no longer needed.

Keep Ventavis and all medicines out of the reach of children.

General Information about Ventavis

Medicines are sometimes prescribed for conditions that are not listed in the patient leaflet. Do not use Ventavis for a condition for which it was not prescribed. Do not give Ventavis to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about Ventavis. If you would like more information about Ventavis talk with your doctor. You can ask your doctor or pharmacist for information about Ventavis that is written for health professionals. For more information go to www. VENTAVIS.com or call 1-866-ACTELION (1-866-228-3546).

What are the ingredients in Ventavis?

Active ingredient: iloprost

Inactive ingredients: tromethamine, ethanol, sodium chloride, hydrochloric acid or pH adjustment, and water for injection.

Ventavis is a clear, colorless solution.

Patient Instructions for Using Ventavis

To take Ventavis, you will need to use either the Prodose Adaptive Aerosol Delivery (AAD) System or the I-neb Adaptive Aerosol Delivery (AAD) System. These systems are used to give you the right dose of Ventavis. You should not use other systems to take Ventavis as other systems may not give you the amount of Ventavis you need.

Do not use Ventavis until your doctor has showed you how to use one of these systems the right way. Make sure you understand all the instructions or ask questions until you do.

I-neb AAD System

Prodose AAD System

If you are using the Prodose System, your doctor will give you 2 dosing discs for it.

Prodose AAD System Dosing Discs

The Prodose dosing discs are white with a red band (2.5 mcg) or purple band (5 mcg) across each disc.

These dosing discs will control the amount of Ventavis you use. Do not change the dosing disc in your Prodose System without talking to your doctor. Always use all of the contents of 2 ampules (10 microgram per 1 mL only) when using your Prodose System.

Ventavis Ampule

If you use less than the 2 mL of liquid with the Prodose System it may not give you enough medicine.

If you are using the I-neb System, you will receive two medicine chambers (one with a red latch and one with a purple latch) and two color-matching dosing discs to use with the 10 micrograms per 1 mL of Ventavis.

I-neb System Medication Chamber

You should use the red dosing disc with the red latched medicine chamber (gives you a 2.5 microgram dose). You should use the purple dosing disc with the purple-latched medicine chamber (gives you a 5 microgram dose). Always use all of the contents of only 1 ampule when using the I-neb System.

If you are using the I-neb System and usually have long treatment times, your doctor may ask you to switch to a third medicine chamber (one with a gold latch). The medicine chamber with the gold latch and matching dosing disc are only for use with the 20 micrograms per 1 mL ampule of Ventavis. You should use the gold dosing disc with the gold latched medicine chamber (gives you a 5 microgram dose.).

Do not change the medicine chamber and dosing disc in your I-neb System without talking to your doctor.

Do not put any medicines other than Ventavis in your Prodose System or I-neb System.

To Use Ventavis:

Open the small glass bottle (ampule) of Ventavis by using either an ampule breaker or a rubber pad. Use either the ampule breaker or the rubber pad. You do not need to use both methods to open a Ventavis ampule.

When using an ampule breaker:

Step 1.Line up the blue dot on the Ventavis ampule with the dot on the ampule breaker, if available, and then insert the top of the ampule into the

Step 2.Gently break open the neck of the ampule by pushing away from the dot on the Ventavis ampule to snap off the ampule lid.

Step 3. Carefully throw away the top of the ampule into a safe container.

When using a rubber pad:

Step 1. Hold the ampule with the blue dot facing away from your body.

Step 2. Wrap the rubber pad around the ampule to protect yourself from getting cut.

Step 3. Use your thumbs to break open the neck of the ampule by snapping the top toward you.

Step 4. Using the small tube (pipette ) that comes with Ventavis, draw-up the entire amount of one ampule of Ventavis and empty it into the center of the Prodose System or the I-neb System medicine chamber. The amount of Ventavis you receive will be controlled by either the dosing disc or the medicine chamber.

I-neb System

Prodose System

Step 5. Throw away in a safe container the:

• top of the ampule (the ampule lid)
• open ampule

Keep both the ampule and the pipette out of the reach of children.

Step 6. To breathe in your dose of Ventavis, follow the instructions that come with your Prodose System or I-neb System. Each treatment session with Ventavis lasts about 4 to 10 minutes. Call your doctor if you usually have longer treatment times as your dose may need to be changed.

The Prodose System or I-neb System allows you to stop your treatment for up to ten minutes with no effect on the final dose you get. If your treatment is stopped for more than ten minutes, the Prodose System or I-neb System will reset itself. If that happens, throw away the solution in the chamber and wait at least two hours before taking your next dose. If you take a second dose right away you could get too much medicine.

Step 7. Throw away any Ventavis that is left in the medicine chamber after each treatment. Do not use the rest of the Ventavis because it will not give you the right dose.

Step 8. Clean your system after each treatment. Follow the instructions that come with your system.

Step 9. Make sure you have access to a back-up Prodose System or I-neb System to use for Ventavis treatments. This is important if your original system does not work for some reason.

Last reviewed on RxList: 5/10/2012
This monograph has been modified to include the generic and brand name in many instances.