FABHALTA 200 mg Hard Capsule

Зміст інструкції

1. FABHALTA 200 mg hard capsules
   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. How to store FABHALTA
   6. Package contents and other information

FABHALTA 200 mg hard capsules

iptacopan

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is FABHALTA and what is it used for

FABHALTA contains the active ingredient iptacopan, which belongs to a group of medicines
called complement inhibitors.
FABHALTA is used:

• alone in adults to treat paroxysmal nocturnal haemoglobinuria (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 who have anaemia (low levels of red blood cells) due to the destruction of their red blood cells.
• in adults to treat patients with a disease called C3 glomerulopathy (C3G)
• in association with a renin-angiotensin system (RAS) inhibitor, or
• alone if a RAS inhibitor does not work adequately or cannot be used

The active ingredient of FABHALTA, iptacopan, targets a protein called Factor B,
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 destruction and
breakdown of red blood cells, which can lead to anaemia, fatigue, difficulty with daily
activities, pain, stomach pain (abdomen), dark urine, shortness of breath, 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 anaemia.
In patients with C3G, the complement system is overactive, leading to the deposition of C3 in the
glomeruli (a part of the kidneys) which causes inflammation and fibrosis (scarring and thickening of the
tissues). As a result, patients with C3G often have high levels of protein in their
urine (proteinuria) and a progressive decline in kidney function over time. By binding to the
Factor B protein, iptacopan can reduce the deposition of C3 in the kidney. This drug has been shown to
reduce protein levels in the urine and the decline in kidney function.

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 meningitidisand Streptococcus pneumoniae, unless your doctor decides that urgent treatment with FABHALTA is necessary.
• if you have an infection caused by a type of bacteria called encapsulated bacteria, including Neisseriameningitidis, Streptococcus pneumoniaeor Haemophilus influenzaetype B, before starting treatment with FABHALTA.

Warnings and precautions
Serious infection caused by encapsulated bacteria
FABHALTA may increase the risk of infection caused by encapsulated bacteria, including Neisseria

meningitidis(bacteria that cause meningococcal disease, including serious infections of the
membranes surrounding the brain and the blood) and Streptococcus pneumoniae(bacteria that cause
pneumococcal diseases, including infections of the lungs, ears, and blood).
Talk to your doctor before starting FABHALTA to make sure you receive the vaccination against

Neisseria meningitidisand Streptococcus pneumoniae. You may also receive the vaccination against

Haemophilus influenzaetype B if it is available in your country. Even if you have received these vaccinations
in the past, you may still need to be revaccinated before starting FABHALTA.
These vaccinations must be given 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 for up to 2 weeks after vaccination to reduce the risk of
infection.
You should be aware that vaccination reduces the risk of serious infections but may not
prevent all serious infections. You should be carefully monitored by your doctor for symptoms of
infection.
Tell your doctor immediately if you experience any of the following symptoms of serious 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 shortness of breath/rapid breathing
• fever with a high heart rate
• headache with feeling unwell (nausea) or vomiting
• headache with a stiff neck or back
• confusion
• muscle 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 are no
available data 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 medicines you get without a prescription. In particular:
Tell your doctor or pharmacist if you are taking certain medicines because they may prevent
FABHALTA from working properly:

• some medicines used to treat bacterial infections - such as rifampicin

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. You should
also tell your doctor if you become pregnant during treatment with FABHALTA. The doctor
will discuss with you the potential risks of taking FABHALTA during pregnancy or
breastfeeding.
The doctor will decide whether you should take FABHALTA during pregnancy only after a careful
assessment of the benefit-risk ratio.
It is not known whether iptacopan, the active ingredient of FABHALTA, passes into human milk and may have effects
on breastfed newborns/infants.
The doctor will decide whether you should stop breastfeeding or stop treatment with
FABHALTA, considering the benefit of breastfeeding for your baby and the benefit of treatment for you.

Driving and using machines
This medicine does not or negligibly alters the ability to drive and use machines.

3. How to take FABHALTA

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
Do not exceed the prescribed 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 every day at the same time will help you remember when to take the medicine.
It is important that you take FABHALTA according to your doctor's instructions. For patients with EPN,
this is important to reduce the risk of red blood cell degradation due to EPN.

FABHALTA with food
FABHALTA can be taken with or without food.

Switching from other medicines for EPN to FABHALTA
If you are switching from any other medicine for EPN, ask your doctor when to start
taking FABHALTA.

How long to take FABHALTA
EPN is a permanent condition and you are expected to need to use FABHALTA for a
long period. Your doctor will regularly monitor your condition to check that the treatment
is having the desired effect.
If you have questions about the duration of treatment with FABHALTA, ask your doctor.

If you take more FABHALTA than you should
If you have accidentally taken too many capsules or if someone else has accidentally taken your
medicine, contact 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 the next dose is due), then take the next dose at the usual time. If you
have EPN and miss several doses in a row, contact your doctor who may decide to monitor you
for any signs of red blood cell destruction (see the paragraph “If you stop taking FABHALTA” below).

If you stop taking FABHALTA
Stopping treatment with FABHALTA may worsen your condition. Do not stop
taking FABHALTA without first talking to your doctor.
If you have EPN and your doctor decides to stop treatment with this medicine, you will
be carefully monitored for at least 2 weeks after stopping treatment for any
signs of red blood cell destruction. Your doctor may prescribe you a different medicine for
EPN or restart treatment with FABHALTA.
Symptoms or problems that may occur due to red blood cell destruction include:

• low levels of hemoglobin in the blood, detectable by blood tests
• fatigue
• blood in the urine
• stomach (abdominal) pain
• shortness of breath
• difficulty swallowing
• erectile dysfunction (impotence)
• blood clots (thrombosis)

If you experience any of these effects 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 a serious infection. If you experience any of the symptoms of
a serious infection listed in the section “Serious infection caused by encapsulated bacteria” in section 2
of this leaflet, you should inform your doctor immediately.

Side effects for EPN
Very common(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

• persistent cough or irritation of the airways (bronchitis)
• low levels of platelets (which help the blood to clot) in the blood (thrombocytopenia), which may cause you to bleed or bruise more easily
• dizziness
• stomach (abdominal) pain
• nausea
• joint pain (arthralgia)
• urinary tract infection

Uncommon(may affect up to 1 in 100 people)

• lung infection, which can 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 get 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 Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 package after “Scad.” and on the
blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FABHALTA contains

• The active substance is iptacopan.
• The other ingredients 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)

Description of the appearance of FABHALTA and package contents
Pale yellow, opaque hard capsules, with “LNP200” on the body and “NVR” on the cap,
containing white to almost white powder, up to pale lilac-pink. The capsule size is approximately
21 - 22 mm.
FABHALTA is supplied in PVC/PE/PVDC blisters with an aluminum foil support.
FABHALTA is available in

• packs containing 28 or 56 hard capsules and in
• multipacks comprising 3 blisters, each containing 56 capsules.

Not all pack sizes may be marketed.

Marketing authorization 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
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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