Iloprost

What is iloprost used for?

Iloprost is a prescription medicine that is used to treat high blood pressure in the lungs.

Description

VENTAVIS® (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing iloprost formulated for inhalation via the I-neb® AAD® (Adaptive Aerosol Delivery) System. VENTAVIS is supplied in 1 mL single-use glass ampules containing either 10 mcg/mL or 20 mcg/mL.

For the 10 mcg/mL solution, one mL of the solution contains 0.01 mg iloprost and also contains 0.81 mg ethanol, approximately 0.51 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection, 9.0 mg sodium chloride, and 0.121 mg tromethamine.

For the 20 mcg/mL solution, one mL of the solution contains 0.02 mg iloprost and also contains 1.62 mg ethanol, approximately 0.76 mg hydrochloric acid (for pH adjustment to 8.4) in water for injection, 9.0 mg sodium chloride, and 0.242 mg tromethamine.

The solution contains no preservatives.

The chemical name for iloprost is (E)-(3aS, 4R, 5R, 6aS)-hexahydro-5-hydroxy-4-[(E)-(3S,4RS)-3-hydroxy-4-methyl-1-octen-6-ynyl]-Δ2(1H),Δ-pentalenevaleric acid. Iloprost consists of a mixture of the 4R and 4S diastereoisomers at a ratio of approximately 53:47. Iloprost is an oily substance, which is soluble in methanol, ethanol, ethyl acetate, acetone, and pH 7 buffer, sparingly soluble in buffer pH 9, and very slightly soluble in distilled water, buffer pH 3, and buffer pH 5. The molecular formula of iloprost is C22H32O4. Its relative molecular weight is 360.49. The structural formula is shown below:

Mechanism of Action

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.

Before taking iloprost, tell your doctor:

• If you are allergic to iloprost; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have low blood pressure.
• If you are breast-feeding. Do not breast-feed while you take iloprost.

This is not a list of all drugs or health problems that interact with iloprost.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take iloprost with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take iloprost?

• Tell all of your health care providers that you take iloprost. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how iloprost affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check blood pressure and heart rate as the doctor has told you.
• Always have a backup system close by in case you need to use it.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using iloprost while you are pregnant.

How is iloprost best taken?

Use iloprost as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For breathing into the lungs only using the I-neb® AAD® system.
• Do not swallow iloprost.
• Do not mix other drugs in nebulizer.
• After you take a dose, throw away any drug that is left in the chamber so it is ready for the next dose. Clean as you have been told by your doctor.
• If iloprost gets in the eyes or on the skin, rinse with water.
• Do not expose others to iloprost while you are breathing it, especially babies and pregnant women.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is less than 2 hours until your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of iloprost that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Any unexplained bruising or bleeding.
• Trouble breathing that is new or worse.
• Coughing up blood.
• A heartbeat that does not feel normal.
• Trouble opening your mouth.

What are some other side effects of iloprost?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Back pain.
• Mouth pain.
• Cough.
• Headache.
• Jaw tightness.
• Flushing.
• Muscle cramps.
• Upset stomach or throwing up.
• Trouble sleeping.
• Flu-like signs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out iloprost?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.