Ventavis is an synthetic prostacyclin. It works by opening blood vessels in the lungs.

Ventavis is a prescription medicine used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH). PAH is a condition in which blood pressure is too high in the blood vessels between the heart and the lungs.

Ventavis can temporarily improve your symptoms and may improve your ability to exercise.

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

Before using Ventavis, tell your doctor if you have liver or kidney disease, heart disease, low blood pressure, asthma or COPD, or a chest cold with cough.

Ventavis inhalation is usually given 6 to 9 times per day. Your doses should not be spaced less than 2 hours apart, even if you feel like the effects of the medicine have worn off in less than 2 hours.

Ventavis should be used only with the I-neb ADD System, or the Prodose AAD System. Do not use Ventavis with any other type of nebulizers. You will be shown how to use your nebulizer at home.

Ventavis may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Use Ventavis exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not swallow Ventavis inhalation solution. It is to be used only with a nebulizer device.

Ventavis is an inhaled medicine that should be used only with the I-neb ADD System. Do not use Ventavis with any other type of nebulizers.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Ventavis is usually given 6 to 9 times per day. Follow your doctor's dosing instructions very carefully.

Your doses should not be spaced less than 2 hours apart, even if you feel like the effects of the medicine have worn off in less than 2 hours.

Each ampule (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 2.5 mcg inhaled orally once; if tolerated, increase to 5 mcg and maintain this dose
Maintenance dose: 2.5 or 5 mcg inhaled orally 6 to 9 times per day, no more than once every 2 hours while awake, based on individual need and tolerability
Maximum dose: 45 mcg/day (5 mcg/dose 9 times per day)

Comment: Avoid initiation of therapy in patients with systolic blood pressure below 85 mmHg.

Use: For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (New York Heart Association [NYHA] Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%)

To make sure Ventavis is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• low blood pressure;

• asthma; or

• chronic obstructive pulmonary disease (COPD).

Do not start or stop taking this medicine during pregnancy without your doctor's advice. Having PAH during pregnancy may cause complications in the mother such as heart failure, stroke, or death. Having PAH during pregnancy can also cause complications in the baby such as premature birth, low birthweight, miscarriage, or stillbirth. The benefit of treating PAH may outweigh any risks to the mother or baby.

You should not breastfeed while using Ventavis.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, headache, nausea, vomiting, diarrhea, or redness in your face.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid allowing anyone else to breathe in this medication while you are inhaling your dose, especially a baby.

Avoid getting this medication in your eyes or on your skin. If this does happen, rinse with water.

Get emergency medical help if you have signs of an allergic reaction to Ventavis:: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• pounding heartbeats or fluttering in your chest;

• pain or tightness in your jaw;

• unusual bleeding (nosebleeds, bleeding gums);

• pneumonia - fever, chills, cough with mucus, chest pain, feeling short of breath; or

• fluid build-up in or around the lungs - pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats.

Common Ventavis side effects include:

• pneumonia, increased cough, coughing up blood;

• pounding heartbeats;

• low blood pressure, feeling light-headed;

• flu symptoms;

• flushing (warmth, redness, or tingly feeling);

• headache;

• abnormal liver function tests;

• nausea, vomiting;

• muscle cramps, back pain;

• tongue pain, jaw tightness or pain, trouble chewing or speaking; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• blood pressure medication;

• a blood thinner such as warfarin (Coumadin, Jantoven); or

• medication used to prevent blood clots, such as clopidogrel, rivaroxaban, Plavix, Xarelto, and others.

This list is not complete. Other drugs may interact with iloprost, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.