Iloprost (Inhalation Route)

This is the 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 the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Iloprost works by blocking a hormone (a naturally occurring substance), that is found in the blood and lungs in large quantities of the people with pulmonary arterial hypertension. Iloprost helps by increasing the supply of blood to the lungs and reducing the workload of the heart.

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

This product is available in the following dosage forms:

• Solution

Before Using

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.

Pediatric

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

Geriatric

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

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Desvenlafaxine


• Duloxetine


• Milnacipran


• Venlafaxine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 or


• Chronic obstructive pulmonary disease (COPD) or


• Lung infection or


• Pulmonary edema (fluid in the lungs)a€”Use with caution. May make these conditions worse.

• Kidney disease or


• Liver diseasea€”Use with caution. Effects may be increased because of the slower removal of this medicine from the body .

• Low blood pressurea€”Iloprost therapy should not be started in patients with low blood pressure .

Proper Use

Iloprost should be taken when you wake up and also before any physical activity, but not more than every 2 hours. Do not change your dose without talking to your doctor .

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Iloprost is breathed (inhaled) into your lungs with either I-nebA® ADDA® System or ProdoseA® AADA® System . Carefully follow your doctor`s instructions for using the medicine and operating and cleaning the equipment. Do not put other medicines into this equipment.

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

To avoid missing a dose or any possible problems with the drug delivery device you are using, you should have a back-up with eitherI-nebA® ADDA® System or ProdoseA® AADA® System .

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:
    
    
    
    • Adultsa€”2.5 micrograms (mcg) for the first dose; if well tolerated, dosing may be increased to 5 mcg and maintained at that dose, taken 6 to 9 times per day (not more than every 2 hours) during waking hours.
    
    
    • Childrena€”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

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

It is very important that your doctor check your blood pressure regularly while you are taking this medicine. 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.

Patients may have a drop in blood pressure, and may become dizzy, lightheaded, or faint. 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 not alert. You should stand up slowly when you get out of a chair or bed.

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. Your doctor may adjust the doses of all the medicines you are taking or monitor you carefully for side effects.

Side Effects

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

• Chest pain


• Decreased urine output


• Difficult or labored breathing


• Dilated neck veins


• Extreme fatigue


• Fainting


• Fast, pounding, or irregular heartbeat or pulse


• Irregular breathing


• Kidney failure


• Shortness of breath


• Swelling of face, fingers, feet, or lower legs


• Tightness in the chest


• Tingling of hands or feet


• Troubled breathing


• Unusual weight gain or loss


• Weight gain


• Wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision


• Confusion


• Diarrhea


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


• Feeling of warmth


• Headache


• Nausea


• Redness of the face, neck, arms and occasionally, upper chest


• Sweating


• Unusual tiredness or weakness


• Vomiting

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

• Abnormal lab test


• Back pain


• Chills


• Cough increased


• Coughing or spitting up blood


• Difficulty opening the mouth


• Feeling of warmth


• Fever


• General feeling of discomfort or illness


• Joint pain


• Lockjaw


• Loss of appetite


• Muscle aches and pains


• Muscle cramps


• Muscle spasms, especially of the neck and back


• Runny nose


• Shivering


• Sore throat


• Trouble sleeping


• Sleeplessness


• Unable to sleep

Less common

• Sneezing


• Tongue pain

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.