Pronunciation:

EYE-loe-prost

Brand Names:

• Ventavis

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Vasodilator

Pharmacologic—

Prostaglandin

Uses of This Medicine:

Iloprost is used to treat the symptoms of pulmonary arterial hypertension. 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.

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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of iloprost in children with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of iloprost in the elderly with use in other age groups, elderly patients may be more sensitive to the effects of this medicine.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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—

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.

• Citalopram
• Clovoxamine
• Desvenlafaxine
• Duloxetine
• Escitalopram
• Femoxetine
• Flesinoxan
• Fluoxetine
• Fluvoxamine
• Nefazodone
• Paroxetine
• Sertraline
• Venlafaxine
• Zimeldine

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 or
• Chronic obstructive pulmonary disease or
• Lung infection—Caution, iloprost has not been studied in patients these conditions

• Kidney disease or
• Liver disease—May increase the amount of iloprost in your blood

• Low blood pressure—Iloprost therapy should not be started in patients with low blood pressure

Proper Use of This Medicine:

The importance of proper administration techniques including dosing frequency, ampule dispensing, Prodose AAD System operation, and equipment cleaning.

The importance of proper dosing intervals of not less than 2 hours apart

The importance of a back-up Prodose AAD System, to avoid potential interruptions in drug delivery due to equipment malfunctions.

Discarding any remaining solution in the medication chamber after each inhalation session

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 (solutions):
  • For pulmonary arterial hypertension:
    • Adults—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 (no more that every 2 hours) during waking hours.
    • 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:

Regular visits: If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits.

Patients may have a drop in blood pressure, and may become dizzy 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.

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:

Frequency unknown

Chest pain

decreased urine output

difficult or labored breathing

dilated neck veins

extreme fatigue

fainting

fast, pounding, or irregular heartbeat or pulse

irregular breathing

irregular heartbeat

kidney failure

palpitations

shortness of breath

swelling of face, fingers, feet, or lower legs

tightness in chest

troubled breathing

tingling of hands or feet

unusual weight gain or loss

weight gain

wheezing

Symptoms of overdose

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

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

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

chills

cough increased

coughing or spitting up blood

diarrhea

difficulty opening the mouth

feeling of warmth

fever

general feeling of discomfort or illness

headache

joint pain

lockjaw

loss of appetite

muscle aches and pains

muscle cramps

muscle spasms, especially of neck and back

nausea

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

runny nose

shivering

sore throat

sweating

trouble sleeping

sleeplessness

unable to sleep

unusual tiredness or weakness

vomiting

Less common

Sneezing

tongue pain

troubled breathing

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