(ven TAY vis)
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
- 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
- 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
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 mus cles around
your airway to tighten (bronchos pas m). Get emergency help right away if you have trouble
Other important side effects of Ventavis include:
- red face (flushing)
- increased cough
- low blood pressure
- spasm of your jaw muscles that makes it hard to open your mouth
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
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-
How should I s tore 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 for 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 the I-neb Adaptive Aerosol Delivery (AAD) System. This
system is 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 this system the right way. Make
sure you understand all the instructions or ask questions until you do.
I-neb AAD System
With 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
Do not change the medicine chamber and dosing disc in your I-neb System without talking to
Do not put any medicines other than Ventavis in your 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
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 ampule breaker.
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 I-neb System medicine chamber. The amount of
Ventavis you receive will be controlled by either the dosing disc or the medicine chamber.
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 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 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 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 I-neb System to use for Ventavis treatments. This is
important if your original system does not work for some reason.