FABHALTA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

FABHALTA®200mg hard capsules

iptacopan

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is FABHALTA and what is it used for
2. What you need to know before you take FABHALTA
3. How to take FABHALTA
4. Possible side effects
5. Storage of FABHALTA
6. Contents of the pack and other information

1. What is FABHALTA and what is it used for

FABHALTA contains the active substance iptacopan, which belongs to a group of medicines called complement inhibitors.

FABHALTA is used:

• on its own in adults to treat paroxysmal nocturnal hemoglobinuria (PNH), a disease in which the immune system (the body's natural defense system) attacks and damages red blood cells. FABHALTA is used in adults with anemia (low red blood cell levels) due to the breakdown of red blood cells.
• in adults to treat patients with a disease called complement 3 glomerulopathy (C3G)

• in combination with a renin-angiotensin system inhibitor (RASI), or
• alone, if a RASI does not work well or cannot be used.

The active substance of FABHALTA, iptacopan, targets a protein called Factor B, which is involved in a part of the body's immune system called the "complement system".

In patients with PNH, the complement system is overactive, causing the breakdown and destruction of red blood cells, which can lead to anemia, fatigue, difficulty performing daily tasks, pain, stomach pain (abdomen), dark urine, difficulty breathing, difficulty swallowing, impotence, and blood clots. By binding to and blocking the Factor B protein, iptacopan can prevent the complement system from attacking red blood cells. This medicine has been shown to increase the number of red blood cells and, therefore, may improve the symptoms of anemia.

In patients with C3G, the complement system is overactive, leading to the deposition of C3 in the glomerulus (a part of the kidneys), causing inflammation and fibrosis (scarring and thickening of tissue). As a result, patients with C3G often have high levels of protein in the urine (proteinuria) and progressive kidney function deterioration over time. By binding to the Factor B protein, iptacopan can reduce the deposition of C3 in the kidney. This medicine has been shown to reduce protein levels in the urine and kidney function deterioration.

2. What you need to know before you take FABHALTA

Do not take FABHALTA

• if you are allergic to iptacopan or any of the other ingredients of this medicine (listed in section 6).
• if you have not been vaccinated against Neisseria meningitidis and Streptococcus pneumoniae, unless your doctor decides that you need urgent treatment with FABHALTA.
• if you have an infection caused by a type of bacteria called encapsulated bacteria, such as Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B, before starting treatment with FABHALTA.

Warnings and precautions

Severe infection caused by encapsulated bacteria

FABHALTA may increase the risk of infection caused by encapsulated bacteria, including Neisseria meningitidis (the bacteria that causes meningococcal disease, including severe infection of the brain and blood) and Streptococcus pneumoniae (the bacteria that causes pneumococcal disease, which includes infection of the lungs, ears, and blood).

Talk to your doctor before starting FABHALTA to make sure you receive the vaccine against Neisseria meningitidis and Streptococcus pneumoniae. You may also receive the vaccine against Haemophilus influenzae type B if it is available in your country. Even if you have received these vaccines in the past, you may need to be revaccinated before starting FABHALTA.

These vaccines must be administered at least 2 weeks before starting FABHALTA. If this is not possible, you will be vaccinated as soon as possible after starting FABHALTA, and your doctor will prescribe antibiotics for you to use until 2 weeks after being vaccinated to reduce the risk of infection.

You should be aware that vaccination reduces the risk of severe infections, but it may not prevent all severe infections. Your doctor will closely monitor you for symptoms of infection.

Immediately inform your doctor if you experience any of the following symptoms of severe infection during treatment with FABHALTA:

• fever with or without chills or shivering
• headache and fever
• fever and rash
• fever with chest pain and cough
• fever with difficulty breathing/rapid breathing
• fever with rapid heart rate
• headache with feeling unwell (nausea) or vomiting
• headache with stiffness in the neck or back
• confusion
• body aches with flu-like symptoms
• sweaty skin
• eyes sensitive to light

Children and adolescents

Do not give FABHALTA to children or adolescents under 18 years of age. There is no data available on the safety and efficacy of FABHALTA in this age group.

Other medicines and FABHALTA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular:

Tell your doctor or pharmacist if you are using certain medicines that may prevent FABHALTA from working properly:

• certain medicines used to treat bacterial infections, such as rifampicin

Tell your doctor or pharmacist if you are using any of the following medicines, as FABHALTA may prevent them from working properly:

• certain medicines used to treat epilepsy, such as carbamazepine
• certain medicines used to prevent organ rejection after organ transplantation, such as cyclosporine, sirolimus, tacrolimus
• certain medicines used to treat migraines, such as ergotamine
• certain medicines used to treat chronic pain, such as fentanyl
• certain medicines used to control involuntary movements or sounds, such as pimozide
• certain medicines used to treat abnormal heart rhythm, such as quinidine
• certain medicines used to treat type 2 diabetes, such as repaglinide
• certain medicines used to treat hepatitis C infection, such as dasabuvir
• certain medicines used to treat cancer, such as paclitaxel

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should also tell your doctor if you become pregnant while taking FABHALTA. Your doctor will discuss with you the potential risks of taking FABHALTA during pregnancy or breastfeeding.

Your doctor will decide whether you should take FABHALTA during pregnancy only after carefully weighing the benefits and risks.

It is not known whether iptacopan, the active substance of FABHALTA, passes into breast milk and may affect the newborn or breastfed child.

Your doctor will decide whether you should stop breastfeeding or stop FABHALTA treatment, taking into account the benefit of breastfeeding for your baby and the benefit of treatment for you.

Driving and using machines

This medicine has a negligible influence on the ability to drive and use machines.

3. How to take FABHALTA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Do not exceed the recommended dose.

The recommended dose is 200 mg (one capsule) to be taken orally twice a day (once in the morning and once in the evening). Swallow the FABHALTA capsule with a glass of water.

Taking FABHALTA at the same time every day will help you remember when to take your medicine.

It is important that you take FABHALTA as instructed by your doctor. For patients with PNH, this is important to reduce the risk of red blood cell destruction due to PNH.

Using FABHALTA with food

FABHALTA can be taken with or without food.

Switching from other medicines for PNH to FABHALTA

If you are switching from any other medicine for PNH, ask your doctor when you should start taking FABHALTA.

How long to take FABHALTA

PNH is a lifelong condition, and you are expected to use FABHALTA for a long time. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you have any questions about how long you will need to take FABHALTA, talk to your doctor.

If you take more FABHALTA than you should

If you accidentally take too many capsules or if someone else accidentally takes your medicine, talk to your doctor immediately.

If you forget to take FABHALTA

If you forget one or more doses, take a dose of FABHALTA as soon as you remember (even if it is just before your next scheduled dose), then take your next dose at the usual time. If you have PNH and forget to take several doses in a row, contact your doctor, who may decide to monitor you for signs of red blood cell breakdown (see section "If you stop taking FABHALTA" below).

If you stop taking FABHALTA

Stopping your treatment with FABHALTA may worsen your condition. Do not stop taking FABHALTA without first talking to your doctor.

If you have PNH and your doctor decides to stop your treatment with this medicine, you will be closely monitored for at least 2 weeks after stopping treatment to detect any signs of red blood cell destruction. Your doctor may prescribe a different medicine for PNH or restart your treatment with FABHALTA.

The symptoms or problems that may occur due to red blood cell destruction include:

• low hemoglobin levels in the blood, according to blood tests
• fatigue
• blood in the urine
• stomach pain (abdomen)
• difficulty breathing
• difficulty swallowing
• erectile dysfunction (impotence)
• blood clots (thrombosis)

If you experience any of these symptoms after stopping treatment, contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

The most serious side effect is severe infection. If you experience any of the symptoms of severe infection listed in section 2 of this leaflet "Severe infection caused by encapsulated bacteria", you must immediately inform your doctor.

Side effects for PNH

Very common(may affect more than 1 in 10 people)

• infections of the nose and throat (upper respiratory tract infection)
• headache
• diarrhea

Common(may affect up to 1 in 10 people)

• persistent cough or irritation of the respiratory tract (bronchitis)
• low platelet count (which helps blood clotting) in the blood (thrombocytopenia), which may cause you to bleed or bruise more easily
• dizziness
• stomach pain (abdomen)
• feeling unwell (nausea)
• joint pain (arthralgia)
• urinary tract infection

Uncommon(may affect up to 1 in 100 people)

• lung infection, which may cause chest pain, cough, and fever
• itchy rash (urticaria)

Side effects for C3G

Very common(may affect more than 1 in 10 people)

• infections of the nose and throat (upper respiratory tract infection)

Common(may affect up to 1 in 10 people)

• pneumococcal infection, including lung infection (pneumonia) and blood infection (sepsis)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of FABHALTA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and additional information

Composition of FABHALTA

• The active substance is iptacopan.
• The other excipients are:

• Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172)
• Printing ink: black iron oxide (E172), concentrated ammonia solution (E527), potassium hydroxide (E525), propylene glycol (E1520), shellac (E904)

Appearance and pack contents of the product

Pale yellow opaque hard capsules, with "LNP200" on the body and "NVR" on the cap, containing white or almost white to pale reddish-violet powder. The capsule size is approximately 21 to 22 mm.

FABHALTA is supplied in PVC/PE/PVDC blisters with an aluminum foil backing.

FABHALTA is available in

• packs containing 28 or 56 hard capsules and in
• multipacks consisting of 3 packs of 56 hard capsules each.

Not all pack sizes may be marketed.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharmaceutical Manufacturing LLC

Verovškova Ulica 57

1000 Ljubljana

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Farmacéutica S.A.

Gran Via De Les Corts Catalanes 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

Further information about this medicinal product can be obtained from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of informationDetailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu