Iloprost

What is Iloprost?

• Iloprost (Ventavis) is a prostacyclin mimetic, used to treat certain kinds of pulmonary arterial hypertension.

Iloprost Structure

Iloprost 2D structure

Iloprost ball-and-stick animation

What are the uses of this medicine?

• Iloprost (Ventavis) is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs.
• Ventavis may improve your ability to exercise and your symptoms for a short time by lowering your blood pressure and opening up the blood vessels in your lungs.

How does this medicine work?

• Iloprost is a synthetic analog of prostacyclin PGI2.
• Iloprost dilates systemic and pulmonary arterial vascular beds.
• It also affects platelet aggregation but the relevance of this effect to the treatment of pulmonary hypertension is unknown.
• The two diastereoisomers of iloprost differ in their potency in dilating blood vessels, with the 4S isomer substantially more potent than the 4R isomer.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• medicines used to treat high blood pressure or heart problems
• medicines that lessen blood clotting (for example warfarin, Coumadin, Jantoven)

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

Recommended dosage:

• Patients should receive 6 to 9 doses (inhalations) per day (minimum of 2 hours between doses during waking hours) as follows:
• Starting dose: 2.5 mcg.
• Uptitrate to 5 mcg if 2.5 mcg is well tolerated.
• Maintenance dose: 5 mcg.

Administration:

• Iloprost comes as a solution to inhale by mouth.
• It is usually inhaled six to nine times a day during waking hours.
• Take Ventavis exactly as your doctor tells you to take it.
• Your doctor may change your dose if needed.
• You should not take Ventavis more than every 2 hours.
• The benefits of Ventavis may not last 2 hours, so you may adjust the times that you use it to cover planned activities.
• Do not drink Ventavis.
• Do not let Ventavis solution come into contact with your skin or eyes.
• If it does, rinse your skin or eyes with water right away.
• Do not allow other people to be exposed to Ventavis while you are breathing it, especially babies.
• If you take too much Ventavis, you may have a headache, red face, dizziness, nausea, vomiting and diarrhea.
• If this happens stop taking Ventavis.
• If your symptoms do not go away, call your doctor or get emergency help right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL

This medicine is available in fallowing brand namesː

• Ventavis

What side effects can this medication cause?

The most common side effects of this medicine may include:

• vasodilation (flushing), cough increased, headache, trismus, insomnia, nausea, hypotension, vomiting, alkaline phosphatase increased, flu syndrome, back pain, tongue pain, palpitations, syncope, GGT increased, muscle cramps, hemoptysis, and pneumonia.

• Ventavis may cause side effects, including feeling dizzy, lightheaded and faint.

What special precautions should I follow?

• Hypotension leading to syncope has been observed. Monitor vital signs while initiating Ventavis. Ventavis should not be administered in patients with systolic blood pressure below 85 mmHg.
• Signs of pulmonary edema occur when inhaled Ventavis is administered in patients with pulmonary hypertension, stop treatment immediately, as this may be a sign of pulmonary venous hypertension.
• Ventavis inhalation can induce bronchospasm. Bronchospasm may be more severe or frequent in patients with a history of hyperreactive airways. Ventavis has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections.
• Advise patients that they may have a fall in blood pressure with Ventavis, so they may become dizzy or even faint. They should stand up slowly when they get out of a chair or bed. If fainting gets worse, patients should consult their physicians about dose adjustment.
• Advise patients that Ventavis should be inhaled at intervals of not less than 2 hours and that the acute benefits of Ventavis may not last 2 hours. Thus, patients may want to adjust times of administration to cover planned activities.
• Do not drive a car or operate any tools or machines if dizziness or fainting from low blood pressure is a problem for you.
• You may have trouble breathing after taking Ventavis because it may cause the muscles around your airway to tighten (bronchospasm). Get emergency help right away if you have trouble breathing.
• It is not known if Ventavis passes into your breast milk. You and your doctor should decide if you will take Ventavis or breast feed.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dizziness, headache, flushing, nausea, jaw pain or back pain.
• Hypotension, vomiting, and diarrhea are possible.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• A specific antidote is not known.
• Interruption of the inhalation session, monitoring, and symptomatic measures are recommended.

Can this medicine be used in pregnancy?

• Limited published data from case series and case reports with Ventavis in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• It is not known if Ventavis can harm your unborn baby. Ventavis should only be used during pregnancy if the benefit to you is worth the possible risk to your baby.

Can this medicine be used in children?

• Safety and efficacy in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: iloprost
• Inactive ingredients: ethanol, hydrochloric acid for pH adjustment, sodium chloride, tromethamine, and water for injection.

Who manufactures and distributes this medicine?

Manufactured for:

• Actelion Pharmaceuticals US, Inc.
• a Janssen Pharmaceutical Company,
• Titusville, NJ, USA
• Made in Germany

What should I know about storage and disposal of this medication?

• Store Ventavis between 68°F to 77°F (20°C to 25°C).
• Safely throw away Ventavis that is out of date or no longer needed.

• Dailymed label info on Iloprost
• FDA Iloprost

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