Iloprost (Inhalation)

Iloprost (Inhalation) is used to treat the symptoms of pulmonary arterial hypertension (PAH). PAH is high blood pressure in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When this high blood pressure occurs, the blood vessels in the lungs become tighter and have smaller openings. As a result, the right ventricle has to work harder to pump enough blood through the lungs. Iloprost is a synthetic (man-made) type of hormone called prostacyclin. Prostacyclin is normally made in the lungs and helps keep the blood vessels relaxed. People with PAH do not produce enough prostacyclin in their lungs. Iloprost will help the blood vessels relax, which increases blood flow to the lungs and decreases the workload on the heart.

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

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly.

This medicine may cause your blood pressure to drop. 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, difficulty, 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how iloprost inhalation affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown any specific problems in the elderly that would limit the usefulness of iloprost inhalation. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require careful monitoring and dose adjustments for those taking iloprost inhalation.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are also taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical problems may affect how this medicine is used. Be sure to tell your doctor if you have any other medical issues, especially:

• Severe asthma, or a history of it
• History of bleeding problems
• History of breathing problems
• History of chronic obstructive pulmonary disease (COPD)
• Acute lung infections
• Pulmonary edema (fluid in the lungs)—Use with caution. May worsen these conditions.

• 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 stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Ventavis

Available Dosage Forms:

• Solution

Therapeutic Class: Vasodilator

Pharmacologic Class: Prostaglandin

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.