Pronunciation:

EYE-loe-prost

Brand Names:

• Ventavis

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Vasodilator

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Iloprost inhalation is used to treat the symptoms of pulmonary arterial hypertension (PAH). This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When high blood pressure is present, the blood vessels in the lungs are tighter and have smaller openings. This means the right ventricle must work harder to pump enough blood through the lungs. Iloprost is a synthetic (man-made) type of hormone called prostacyclin. Prostacyclin is produced in the lungs and keeps the blood vessels relaxed. People with PAH do not make enough prostacyclin in the lungs. Iloprost will cause the blood vessels to relax, which increases the supply of blood to the lungs and reduces the workload of the heart.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of iloprost inhalation in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iloprost inhalation in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving iloprost inhalation.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abrocitinib
• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Certoparin
• Choline Salicylate
• Citalopram
• Clonixin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sertraline
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tinzaparin
• Tolfenamic Acid
• Tolmetin
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vortioxetine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, severe, history of or
• Bleeding problems, history of or
• Breathing problems, history of or
• Chronic obstructive pulmonary disease (COPD), history of or
• Lung infections, acute or
• Pulmonary edema (fluid in the lungs)—Use with caution. May make these conditions worse.

• Hypotension (low blood pressure)—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor to benefit your condition as much as possible. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Iloprost inhalation solution is breathed in (inhaled) through the mouth and into the lungs. It should be used when you wake up and before any physical activity, but not more than once every 2 hours.

The iloprost inhalation solution (Ventavis®) is used with a nebulizer that is connected to an air compressor. The nebulizer will create a mist that is breathed into the lungs using a mouthpiece. Ventavis® solution should only be used with the I-neb® AAD® System. The solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Do not mix the iloprost solution with other medicines in the nebulizer.

To avoid missing a dose, always keep an extra nebulizer on hand in case there are problems with the machine.

Do not drink this medicine and do not allow the solution to come in contact with your skin or eyes. If it does, rinse it off with water right away.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (solution):
  • For pulmonary arterial hypertension:
    • Adults—At first, 2.5 micrograms (mcg) given 6 to 9 times per day while awake. Do not use more than once every 2 hours. Your doctor may adjust your dose if needed. However, the dose is usually not more than 45 mcg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

This medicine may cause your blood pressure to go down. Your doctor will check your blood pressure before you start the medicine and may check it during your regular office visits. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away.

Dizziness, lightheadedness, or fainting may occur after you use this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or lightheaded.

Check with your doctor right away if you have chest pain, difficult, fast, or noisy breathing, sometimes with wheezing, blue lips and fingernails, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, shortness of breath, or swelling in the legs and ankles. These may be signs of pulmonary edema (fluid in the lungs).

Tell your doctor if you are pregnant or plan to become pregnant before using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Black, tarry stools

chest pain

cough

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

extreme fatigue

fast, pounding, or irregular heartbeat or pulse

fever

hives, itching, or rash

irregular breathing

noisy breathing

pinpoint red spots on the skin

swelling of the eyelids, face, lips, fingers, feet, or lower legs

tightness in the chest

troubled breathing or swallowing

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

chills

cough increased

coughing or spitting up blood

difficulty opening the mouth

feeling of warmth

headache

lockjaw

nausea

redness of the face, neck, arms, and occasionally, upper chest

sweating

trouble sleeping

Less common

Change in taste

mouth irritation

tongue irritation or pain

Incidence not known

Nosebleeds

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.