SUMMARY CMI

VENTAVIS^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using VENTAVIS?

VENTAVIS contains the active ingredient iloprost (as trometamol). VENTAVIS is used to treat:

• moderate or severe stages of pulmonary hypertension, caused by some defect of the vessel walls, connective tissue disease or other medications
• moderate and severe cases of secondary pulmonary hypertension that may have been caused by blood clots in the lungs, where surgery is not possible

For more information, see Section 1. Why am I using VENTAVIS? in the full CMI.

2. What should I know before I use VENTAVIS?

Do not use VENTAVIS if you have certain conditions affecting the heart, if you are at an increased risk of bleeding, have or had a stroke recently or if you have ever had an allergic reaction to VENTAVIS or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use VENTAVIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VENTAVIS and affect how it works. The most common medications that affect how VENTAVIS works are medicines for the heart or to lower blood pressure and medicines that thin the blood.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use VENTAVIS?

• VENTAVIS is taken as inhalation therapy using a special device (a nebuliser).
• The usual dose per inhalation and frequency depends on your individual condition and will be worked out by your doctor.

More instructions can be found in Section 4. How do I use VENTAVIS? in the full CMI.

5. What should I know while using VENTAVIS?

For more information, see Section 5. What should I know while using VENTAVIS? in the full CMI.

6. Are there any side effects?

Common side effects: nose bleeds, headache, flushing, chest pain, cough, nausea, jaw pain, leg swelling, fast or irregular heartbeat, signs of low blood pressure, e.g. dizziness, pain when swallowing, mouth and tongue irritation, diarrhoea, vomiting, rash and back pain.

Serious side effects: signs of allergic reaction, e.g. shortness of breath, wheezing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

VENTAVIS^® (VEN·ta·vis)

Active ingredient: iloprost (as trometamol)

Consumer Medicine Information (CMI)

This leaflet provides important information about using VENTAVIS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using VENTAVIS.

Where to find information in this leaflet:

1. Why am I using VENTAVIS?
2. What should I know before I use VENTAVIS?
3. What if I am taking other medicines?
4. How do I use VENTAVIS?
5. What should I know while using VENTAVIS?
6. Are there any side effects?
7. Product details

1. Why am I using VENTAVIS?

VENTAVIS contains the active ingredient iloprost (as trometamol). VENTAVIS is a synthetic prostacyclin analogue. It works by widening blood vessels, allowing more blood to reach the lungs and receive oxygen. This widening results in a decreased work load on the heart, which in turn allows the heart to function more effectively, leading to an improved supply of oxygen to the body and reduced strain on the heart.

VENTAVIS is used to treat:

• Moderate or severe stages of pulmonary hypertension, caused by some defect of the vessel walls, connective tissue disease or other medications
• Moderate and severe cases of secondary pulmonary hypertension that may have been caused by blood clots in the lungs, where surgery is not possible

Pulmonary hypertension is a condition where blood pressure is too high in the vessels which transport blood from the heart to the lungs.

2. What should I know before I use VENTAVIS?

Warnings

Do not use VENTAVIS if:

• you are allergic to iloprost, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• you have increased risk of bleeding (for example active stomach ulcers, injuries, haemorrhaging or other bleeding)
• you have severe coronary heart disease or unstable angina (chest pain), heart attack within the last six months
• you have heart failure, severe irregular heart rate, suspected fluid build-up in the lungs
• you have had a stroke or other interruption of blood supply to the brain within the last 3 months
• you have pulmonary hypertension due to the blockage of the veins
• you have congenital or acquired valvular defects with heart function which are not related to your disease

Check with your doctor if you:

• have any other medical conditions, such as:
  - heart failure
  - low blood pressure
  - lung infections or other lung disease including Chronic Obstructive Pulmonary Disease (COPD) and severe asthma
  - liver function problems, or problems with your kidneys that require dialysis
• take any medicines for any other condition

Pulmonary hypertension

• If you have a history of fainting in association with pulmonary hypertension; you should avoid any unusual straining, for example during exercise.
• If fainting occurs when you get out of bed, it may be helpful to take the first dose of the day while you are still in bed; if fainting gets worse, tell your doctor.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

If you suffer from pulmonary hypertension, avoid getting pregnant as pregnancy may lead to a worsening of your condition and may even endanger your life.

If there is the possibility that you may become pregnant, use reliable contraception from the time you start treatment and during treatment.

Tell your doctor straight away if you are pregnant, or think you might be pregnant.

The medicine should only be used during pregnancy if your doctor decides that the potential benefit outweighs the potential risk to the foetus.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not breastfeed if you are taking this medicine. It is not known whether the medicine passes into human milk.

Children under 18 years of age

VENTAVIS is not recommended for use in children under 18 years of age.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with VENTAVIS and affect how it works. These include:

• Medicines used to treat high blood pressure or heart disease
• Medicines which inhibit blood clotting or platelet aggregation. This includes:
  - Aspirin^® or acetylsalicylic acid
  - Warfarin
  - Heparin
  - Clopidogrel
  - NSAIDs, e.g. ibuprofen (Nurofen^®), diclofenac (Voltaren^®)

These medicines may be affected by VENTAVIS or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect VENTAVIS.

4. How do I use VENTAVIS?

Using VENTAVIS with a nebuliser

• VENTAVIS is taken as inhalation therapy using a special device (a nebuliser).
• During nebulisation sessions a facial mask must not be used. Only a mouthpiece should be used.
• VENTAVIS solution should not come in contact with your skin or eyes.
• Oral ingestion of VENTAVIS solution should be avoided.
• To minimise accidental exposure, it is recommended to use VENTAVIS with nebulisers with a filter or inhalation-triggered systems, and to keep the room well ventilated.
• Your doctor will advise you on the appropriate nebuliser to be used. Any additional instructions from the manufacturer of the nebulising device should also be followed carefully.

How much to use

• The usual dose per inhalation that is right for you depends on your individual condition and will be worked out by your doctor
• In patients with liver problems, severe kidney problems and require dialysis, your doctor may consider different initial doses and dosing intervals depending on how you tolerate the treatment.
• At the beginning of each inhalation session, a new ampoule of VENTAVIS should be used. Break the ampoule and transfer the contents of one ampoule of VENTAVIS completely into the nebuliser immediately before use.
• VENTAVIS solution that is not used in one inhalation session must be discarded.
• Follow the instructions provided and use VENTAVIS until your doctor tells you to stop.

When to use VENTAVIS

• You may have 6 – 9 inhalation sessions per day depending on your individual condition.
  This is because the effects of VENTAVIS will only last 1-2 hours.
• The duration of one inhalation session is about 4 to 10 minutes.

If you forget to use VENTAVIS

VENTAVIS should be used regularly at the same times each day.

If you miss your dose at the usual time, contact your doctor for instructions on what to do.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much VENTAVIS

If you think that you have used too much VENTAVIS, you may need urgent medical attention.

Too much VENTAVIS may lead to dizziness, headache, flushing (reddening of the face), nausea (feeling sick), jaw pain or back pain. You may also experience an increase or decrease in blood pressure, slow heartbeat, fast heartbeat, vomiting, diarrhoea or limb pain.

You should immediately:

• phone the Poisons Information Centre
  (Australia: 13 11 26 or New Zealand: 0800 POISON or 0800 764 766), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using VENTAVIS?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using VENTAVIS.
• If the effect of VENTAVIS seems too strong or too weak, talk to your doctor or pharmacist.
• Follow the instructions provided and use VENTAVIS until your doctor tells you to stop.

Call your doctor straight away if you:

• Become pregnant while taking this medicine.

Things you should not do

• Do not stop using this medicine suddenly. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.
• Do not take VENTAVIS to treat any other complaints unless your doctor tells you to.
• Do not give VENTAVIS to anyone else, even if they have the same condition as you.
• Do not stop taking your medicine or lower the dosage without checking with your doctor.
  If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how VENTAVIS affects you.

Do not drive or operate any tools or machines if you sense low blood pressure or dizziness occurring; the ability to properly drive or operate machines might be seriously affected.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight where the temperature stays below 30°C.

Do NOT store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

If the packaging is damaged, return it to your pharmacist for disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What VENTAVIS contains

Do not take this medicine if you are allergic to any of these ingredients.

What VENTAVIS looks like

VENTAVIS comes as a (liquid) solution in a 3-mL glass ampoule and is administered as an aerosol by using a special inhalation device.

Each VENTAVIS ampoule contains 2 mL of solution for one inhalation session. A pack of VENTAVIS contains 6 or 30 ampoules (Aust R 97219).

Not all pack sizes may be marketed.

Who distributes VENTAVIS

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Bayer New Zealand Limited
PO Box 2825
Shortland Street
Auckland 1140
New Zealand

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.

^® Registered Trademark of Bayer AG, Germany

^© Bayer Australia Ltd All rights reserved.

This leaflet was prepared in June 2024.

Published by MIMS September 2024

1 Name of Medicine

Iloprost.

2 Qualitative and Quantitative Composition

Ventavis 10 microgram/mL nebuliser solution. One ampoule with 2 mL nebuliser solution contains 26.8 microgram iloprost trometamol equivalent to 20 microgram iloprost. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nebuliser solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of patients with primary pulmonary hypertension or secondary pulmonary hypertension due to connective tissue disease or drug induced, in moderate or severe stages of the disease. In addition, treatment of moderate or severe secondary pulmonary hypertension due to chronic pulmonary thromboembolism, where surgery is not possible.

4.2 Dose and Method of Administration

The solution is administered with a suitable inhalation device (nebuliser) as recommended in instruction for use and handling). Previous therapy should be adjusted to individual needs (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). In order for the correct dose of iloprost to be delivered to the patient a suitable nebuliser must be used. The HaloLite nebuliser described in the Clinical trials section is not currently available in Australia. Clinical data on the use of other similar nebulisers with Ventavis is not available.
Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided.

Recommended dose.

Adults.

Patients with hepatic impairment.

Patients with renal impairment.

Paediatric patients/ children and adolescents (below 18 years of age).

Duration of treatment.

Long-term treatment.

Instructions for use/ handling.

Use with nebulisers.

4.3 Contraindications

Hypersensitivity to iloprost or to any of the excipients.
Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
Severe coronary heart disease or unstable angina, myocardial infarction within the last six months, decompensated cardiac failure if not under close medical supervision, severe arrhythmias, suspected pulmonary congestion, cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
Pulmonary hypertension due to venous occlusive disease.
Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Risk of syncope.

Hypotension.

Bronchospasm.

Pulmonary venous hypertension.

Use in hepatic and renal impairment.

Use in the elderly.

Paediatric use.

Other.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Iloprost may increase the antihypertensive effect of vasodilating and antihypertensive agents. Caution is recommended in case of coadministration of Ventavis with vasodilating or antihypertensive agents as dose adjustment might be required.
Because iloprost inhibits platelet function, its use with anticoagulants (such as heparin, coumarin type anticoagulants), or other inhibitors of platelet aggregation (such as acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, nonselective phosphodiesterase inhibitors [e.g. theophylline, pentoxifylline, dipyridamole], selective phosphodiesterase 3 [PDE3] inhibitors [e.g. milrinone, cilostazol, anagrelide] and nitrovasodilators) may enhance iloprost mediated platelet inhibition, thereby increasing the risk of bleeding (see Section 4.8 Adverse Effects (Undesirable Effects)). If bleeding occurs, iloprost administration should be stopped. Careful monitoring of the patients taking anticoagulants or inhibitors of platelet aggregation according to common medical practice is recommended.
Oral premedication with acetylsalicylic acid up to 300 mg/day over a period of 8 days had no impact on the pharmacokinetics of iloprost. The results of human studies show that iloprost infusions do not affect the pharmacokinetics of multiple oral doses of digoxin in patients and iloprost has no impact on the pharmacokinetics of coadministered t-PA. In an animal study, it was found that iloprost may result in a reduction in t-PA steady-state plasma concentration.
In animal experiments, the vasodilatory effect of iloprost is attenuated when the animals are pretreated with glucocorticoids, while the inhibitory effect on platelet aggregation remains unaffected. The significance of this finding for use of Ventavis in man is not yet known.
Although, clinical studies have not been conducted, in vitro studies investigating the inhibitory potential of iloprost on the activity of cytochrome P450 enzymes revealed that no relevant inhibition of drug metabolism via these enzymes by iloprost is expected.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Care should be exercised during initiation of therapy until any effects on the individual have been determined. In patients experiencing hypotensive symptoms such as dizziness, ability to drive or operate machines may be seriously affected.

4.8 Adverse Effects (Undesirable Effects)

In addition to local effects resulting from administration of iloprost by inhalation such as increased cough, adverse reactions with iloprost are related to the pharmacological properties of prostaglandins. The most frequently observed adverse reactions (≥ 20%) in clinical trials include vasodilatation, headache and cough. The most serious adverse reactions were hypotension, bleeding events and bronchospasm.
The adverse drug reactions (ADRs) reported below are based on clinical trial data involving 131 patients taking the medication. The frequencies of ADRs are defined as: very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000. See Table 1.
As expected in patients with pulmonary hypertension, syncopes were common, and did not differ significantly between the treatment groups in frequency (see Section 4.4 Special Warnings and Precautions for Use).
In clinical trials peripheral oedema was reported in 12.2% of patients on iloprost and 16.2% of patients on placebo. Peripheral oedema is a very common symptom of the disease itself, but it may also be related to the therapy.

Postmarketing adverse events.

Adverse reactions in healthy volunteers.

Reporting suspected adverse effects.

4.9 Overdose

Cases of overdose were reported. Frequently observed symptoms following overdose are dizziness, headache, flushing, nausea, jaw pain or back pain. Hypotension, an increase of blood pressure, bradycardia or tachycardia, vomiting, diarrhoea and limb pain might also be possible.

Therapy.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Phase II study (A00794).

Phase III study (A02997).

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Characteristics in patients.

Renal dysfunction.

Hepatic dysfunction.

Age and gender.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Trometamol, ethanol 96%, sodium chloride, hydrochloric acid and water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Container type: Ampoules of 3 mL, colourless, glass type I, containing 2 mL nebuliser solution. Each ampoule contains 20 microgram iloprost.
Pack sizes: Pack containing 6 or 30 ampoules.
Some strengths, pack sizes and/or pack types may not be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes