1. Why am I using FABHALTA?

FABHALTA contains the active ingredient iptacopan. FABHALTA is used to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

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

2. What should I know before I use FABHALTA?

• Do not use if you have ever had an allergic reaction to iptacopan or any of the ingredients listed at the end of the CMI.
• Talk to your doctor about your vaccination history. You may need to receive some vaccinations unless your doctor decides that urgent treatment with FABHALTA is needed.
• If you have a serious bacterial infection prior to starting treatment, do not take FABHALTA and tell your doctor.

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 FABHALTA? in the full CMI.

3. What if I am taking other medicines?

FABHALTA is not expected to interact with other medicines.

4. How do I use FABHALTA?

• The recommended dose is 200 mg twice daily, once in the morning and once in the evening.
• Swallow the FABHALTA capsule with a glass of water. FABHALTA can be taken with or without food.

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

5. What should I know while taking FABHALTA?

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

6. Are there any side effects?

Common and very common side effects include headache, dizziness, diarrhoea, joint and stomach pain, feeling sick, and common colds.

Inform your doctor if you experience a persistent cough or irritation of the airways, sudden bleeding or bruising which may be caused by fewer platelets in the blood, and symptoms of serious infections.

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.

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FABHALTA®

Active ingredient: iptacopan

Consumer Medicine Information (CMI)

This leaflet provides important information about using FABHALTA. 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 FABHALTA.

Where to find information in this leaflet:

1. Why am I using FABHALTA?

FABHALTA contains the active ingredient iptacopan. FABHALTA is designed to target the Factor B protein which is part of the body’s defence system called the ‘complement system’. FABHALTA prevents your body’s immune system from breaking down red blood cells.

FABHALTA is used to treat adult patients with a blood disorder called paroxysmal nocturnal hemoglobinuria (PNH).

In patients with PNH, the complement system is overactive and attacks the red blood cells which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, pain in the stomach (abdomen), dark urine, shortness of breath, difficulty swallowing, erectile dysfunction, and blood clots. By attaching to the Factor B protein, FABHALTA blocks the complement system from attacking the red blood cells and so controls the symptoms of the disease. This medicine has been shown to increase the number of red blood cells (reduce anaemia) and control PNH.

If you have any questions about how FABHALTA works or why this medicine has been prescribed for you, ask your doctor, pharmacist or healthcare provider.

2. What should I know before I take FABHALTA?

Warnings

Do not use FABHALTA if:

• you are not vaccinated against Neisseria meningitidis, Streptococcus pneumoniae unless your doctor decides that urgent treatment with FABHALTA is needed.
• you have or recently have had a serious infection caused by encapsulated bacteria. These are severe infections affecting the upper respiratory tract - your nose, throat, lungs, or the linings of the brain and can spread throughout the blood and body. Symptoms include persistent fever, persistent cough or coughing up blood or pus, difficulty in breathing, severe headache or neck stiffness.
• you are allergic to iptacopan, or any of the ingredients listed at the end of this leaflet. If you think you may be allergic, ask your doctor for advice.
• you are currently using another complement inhibitor medicine to treat PNH, unless advised by your doctor.

If any of these apply to you, do not take FABHALTA and tell your doctor.

Serious infection caused by encapsulated bacteria

• FABHALTA may increase your risk of infections caused by encapsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae.
• Talk to your doctor before you start FABHALTA to be sure that you are vaccinated against Neisseria meningitidis and Streptococcus pneumoniae. You may also receive vaccination against Haemophilus influenzae type B. Even if you have had these vaccinations in the past, you might still need a booster before starting this medicine.
• These vaccinations should be given at least 2 weeks before starting FABHALTA. If this is not possible, you will be vaccinated as soon as possible after you start FABHALTA and your doctor will prescribe antibiotics for you to use until 2 weeks after you have been vaccinated to reduce the risk of infection. Vaccination reduces the risk of serious infections but may not prevent all serious infections. You should be closely monitored by your doctor for symptoms of infection.

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. You should also tell your doctor if you become pregnant during the treatment with FABHALTA.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Your doctor will discuss with you the potential risks of taking FABHALTA during pregnancy or breast-feeding.

Children and adolescents

Do not give FABHALTA to children or adolescents below 18 years of age. No data are available on the safety and effectiveness of FABHALTA in this age group.

Older people (65 years of age or above)

You can use FABHALTA if you are aged 65 years or over at the same dose as for other adults. Check with your doctor if you are not sure.

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.

FABHALTA is not expected to interact with other medicines.

4. How do I take FABHALTA?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not take more than the prescribed dose.

At least 2 weeks before you start treatment with this medicine, your doctor will review your medical records and may give you one or more vaccinations against certain bacterial infections (see section 2). If you cannot be vaccinated at least 2 weeks before you start treatment with FABHALTA, your doctor will prescribe antibiotics for you to use until 2 weeks after you have been vaccinated, to reduce the risk of infection.

How much to take

• The usual dose is 200 mg twice daily. Swallow the FABHALTA capsule with a glass of water.

When to take FABHALTA

• Take FABHALTA once in the morning and once in the evening. Taking your medicine at the same time each day will help you to remember when to take your medicine.
• FABHALTA can be taken with or without food.
• If you have questions about how long you will need to take FABHALTA, talk to your doctor. PNH is a life-long condition and so it is expected that you will use this medicine for a long time.

Switching from other PNH medicines to FABHALTA

• If you are switching from a medicine called eculizumab, you should start taking FABHALTA no later than one week after the last dose of eculizumab.
• If you are switching from a medicine called ravulizumab, you should start taking FABHALTA no later than 6 weeks after the last dose of ravulizumab.
• If you are switching from any other PNH medicine, ask your doctor when to start taking FABHALTA.

If you forget to take FABHALTA

If you miss your dose at the usual time, take one dose of FABHALTA as soon as you remember (even if it is soon before the next scheduled dose), then take the next dose at the usual time.

If you use too much FABHALTA

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

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), 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 taking FABHALTA?

Things you should do

• Keep all doctor's appointments, as your doctor needs to regularly monitor your condition.
• Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. PNH is a lifelong condition, and it is expected that you will need to use FABHALTA for a long time.
• If your doctor decides to stop your treatment with this medicine, your doctor will monitor you closely for at least 2 weeks after stopping treatment for any signs of the breakdown of red blood cells (haemolysis) due to PNH. Your doctor may prescribe a different PNH medicine or have you restart FABHALTA treatment.

Call your doctor straight away if you experience any of these symptoms of a decrease in haemoglobin level in your blood:

• tiredness
• blood in the urine
• pain in the stomach (abdomen)
• shortness of breath
• blood clots (thrombosis)
• trouble swallowing
• erectile dysfunction (impotence).

Remind any doctor, dentist or pharmacist you visit that you are using FABHALTA.

Things you should not do

• Do not stop taking FABHALTA without talking to your doctor first. PNH is a lifelong condition, and it is expected that you will need to use FABHALTA for a long time.

Driving or using machines

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

This medicine has no or negligible influence on the ability to drive and use machines.

Drinking alcohol

Tell your doctor if you drink alcohol.

There are no known interactions between FABHALTA and alcohol.

Looking after your medicine

• Store below 30°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, 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.

Do not use this medicine after the expiry date stated on the packaging.

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 FABHALTA contains

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

What FABHALTA looks like

FABHALTA is supplied as hard capsules containing 200 mg iptacopan (as iptacopan hydrochloride monohydrate). The hard capsules are pale yellow, opaque hard capsules, imprinted with “LNP200” on the body and “NVR” on the cap, containing white or almost white to pale purplish-pink powder (AUST R 410830).

FABHALTA is supplied in PVC/PE/PVDC blisters in packs containing 56 hard capsules.

Who distributes FABHALTA

FABHALTA is supplied in Australia by:

Novartis Pharmaceuticals Australia Pty Limited

(ABN 18 004 244 160)

54 Waterloo Road

Macquarie Park NSW 2113

Telephone 1 800 671 203

Website: www.novartis.com.au

This leaflet was prepared in August 2024.

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