Iloprost

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

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;
• pounding heartbeats or fluttering in your chest;
• coughing up blood;
• unusual bleeding (nosebleeds, bleeding gums);
• fever, chills, cough with yellow or green mucus;
• chest tightness, stabbing chest pain, wheezing, feeling short of breath; or
• anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Less serious side effects may include:

• flushing (warmth, redness, or tingly feeling);
• increased cough;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• muscle cramps, back pain;
• sleep problems (insomnia);
• tongue pain, jaw tightness or pain, trouble chewing or speaking; or
• altered sense of taste.

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.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Iloprost inhalation is usually given 6 to 9 times per day. Follow the directions on your prescription label.

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.

Your doctor may occasionally change your dose or daily dosing schedule to make sure you get the best results.

Iloprost is an inhaled medicine that should be used only with the I-neb ADD System, or the Prodose AAD System. Do not use iloprost inhalation with any other type of nebulizers.

You will be shown how to use your nebulizer at home. Your nebulizer system comes with patient instructions for safe and effective use, and for cleaning and care. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Each single-use ampule (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after emptying the entire contents into your nebulizer.

Store at room temperature away from moisture and heat.

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

In clinical trials of Ventavis, no case of overdose was reported. Signs and symptoms to be anticipated are extensions of the dose-limiting pharmacological effects, including hypotension, headache, flushing, nausea, vomiting, and diarrhea. A specific antidote is not known. Interruption of the inhalation session, monitoring, and symptomatic measures are recommended.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that lower your blood pressure
• medications to treat heart problems
• vasodilators such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), clonidine (Catapres), hydralazine (Bidil, Hydra-Zide), or minoxidil
• antiplatelets (a type of blood thinner)  such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)
• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)

This is not a complete list of iloprost drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with iloprost including the following:

Risk of Fainting. Iloprost can cause dizziness, lightheadedness, or fainting. Your doctor should monitor your blood pressure and heart rate while taking iloprost. To help avoid this, get up slowly if you are lying down or in bed. Tell your doctor if you experience any of these symptoms while taking iloprost. Do not drive a car or operate any tools or machines if dizziness or fainting from low blood pressure is a problem for you.

High pressure in the pulmonary veins: If you develop any of the following signs and symptoms, stop use and tell your doctor immediately. 

• shortness of breath or difficulty breathing that worsens when lying down
• wheezing or gasping for breath
• coughing up pink, frothy mucus
• chest pain

Bronchospasm. Iloprost can cause the muscles around your airway to tighten and make it difficult to breathe. Seek emergency help if you have trouble breathing.

Do not take iloprost if you are allergic to iloprost or to any of its ingredients.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if iloprost crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using iloprost.

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

Iloprost 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.

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

This medication 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 the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

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.

Avoid allowing anyone else to breathe in this medication while you are inhaling your dose, especially children or pregnant women.

• Pharmacologic actions (e.g., direct vasodilation of pulmonary and systemic arterial vascular beds, inhibition of platelet aggregation) similar to those of epoprostenol.1 3 5 8 10 11 12 13

• Longer half-life and duration of pulmonary vasodilatory effect than epoprostenol; unlike epoprostenol, is stable in solution at neutral pH and at room temperature; therefore, can be administered by repeated oral inhalation rather than continuous IV infusion.1 4 5 8 10 11 12 13

• Oral inhalation results in alveolar drug deposition and possibly greater selectivity for pulmonary vasculature.5 8 10 11 12 13 16

• 4S isomer substantially more potent than 4R isomer.1

• Importance of providing patient a copy of the manufacturer’s patient information and a copy of the user guide for the I-neb AAD system.1 2 3 6

• Importance of patients receiving adequate training in the proper administration of iloprost (including dosing frequency), manipulation of ampuls of the drug, and operation and maintenance of the nebulizer.1 2 6

• Importance of advising patients to use iloprost only as prescribed with the I-neb AAD system, in accordance with the manufacturer’s instructions.1 2

• Importance of not changing the microprocessor disc or drug chamber in the nebulizer without consulting clinician.1 2

• Importance of not mixing iloprost with other drugs and of not administering other drugs via the I-neb AAD system.1 2

• Importance of having immediate access to a back-up I-neb AAD system in order to avoid potential interruptions in drug therapy secondary to equipment malfunction.1

• Advise patients that the interval between inhalation sessions should be ≥2 hours and that the duration of acute benefits may be <2 hours.1

• Advise patients that they may experience dizziness, lightheadedness, or fainting due to decreased BP; caution them to rise slowly after sitting or lying down.1 2 3

• Advise patients to avoid driving or operating machinery if they experience dizziness or fainting and to consult their clinician about dosage adjustment if fainting persists or worsens.1 2 3

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and dietary and herbal supplements, as well as any concomitant illnesses (e.g., liver or kidney disease).1 2

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

(EYE loe prost)

• Iloprost Tromethamine
• Prostacyclin PGI2

• Prostacyclin
• Prostaglandin
• Vasodilator

Pulmonary arterial hypertension: Treatment of pulmonary arterial hypertension (World Health Organization [WHO] group I) in patients with New York Heart Association (NYHA) class III or IV symptoms to improve exercise tolerance, symptoms, and diminish clinical deterioration.

Refer to adult dosing.

Child-Pugh class B or C: Consider increasing dosing interval (eg, every 3-4 hours) based on response at the end of the dose interval.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience back pain, mouth pain, cough, headache, jaw tightness, flushing, muscle cramps, nausea, vomiting, insomnia, or flu-like symptoms. Have patient report immediately to prescriber severe dizziness, passing out, bruising, bleeding, angina, tachycardia, difficulty breathing, coughing up blood, urinary retention, change in amount of urine passed, abnormal heartbeat, shortness of breath, excessive weight gain, swelling in arms or legs, or difficulty opening mouth (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.