Cosentyx

Italy

Brand name Cosentyx

Form powder for solution for injection

Active substance / Dosage

SECUKINUMAB

Prescription type Restricted prescription – dispensable on hospital or specialist prescription

ATC code

L04AC10

Registration number 043873

Manufacturer NOVARTIS EUROPHARM LIMITED

Cosentyx powder for solution for injection

Table of Contents

Package leaflet: Information for the user
Cosentyx 75 mg solution for injection in pre-filled syringe
1. What Cosentyx is and what it is used for
2. What you should know before using (or before your child uses) Cosentyx
3. How to use Cosentyx
Cosentyx 75 mg pre-filled syringe at the end of this leaflet.
4. Possible side effects
5. How to store Cosentyx
6. Package contents and other information
Instructions for the use of Cosentyx 75 mg pre-filled syringe
Package leaflet: Information for the user
Cosentyx 150 mg solution for injection in pre-filled syringe
1. What Cosentyx is and what it is used for
2. What you should know before using Cosentyx
3. How to use Cosentyx
Cosentyx 150 mg pre-filled syringe" at the end of this leaflet.
4. Possible side effects
5. How to store Cosentyx
6. Package contents and other information
Instructions for the use of Cosentyx 150 mg pre-filled syringe
Package leaflet: Information for the user
Cosentyx 150 mg solution for injection in pre-filled pen
1. What Cosentyx is and what it is used for
2. What you need to know before using Cosentyx
3. How to use Cosentyx
4. Possible side effects
5. How to store Cosentyx
6. Package contents and other information
Instructions for use of Cosentyx 150 mg SensoReady pen
1. Important safety checks before injection:
3. Cleaning the injection site
4. Removing the cap
5. Position of the pen
6. Start the injection
7. Completing the injection
8. Check that the green indicator fills the window
9. Disposal of the Cosentyx SensoReady pen
Patient Information Leaflet: Information for the user
Cosentyx 300 mg solution for injection in pre-filled syringe
1. What Cosentyx is and what it is used for
2. What you need to know before using Cosentyx
3. How to use Cosentyx
Cosentyx 300 mg pre-filled syringe" at the end of this leaflet.
4. Possible side effects
5. How to store Cosentyx
6. Contents of the pack and other information
Instructions for use Cosentyx 300 mg pre-filled syringe
Package leaflet: information for the user
Cosentyx 300 mg solution for injection in a pre-filled pen
1. What Cosentyx is and what it is used for
2. What you should know before using Cosentyx
3. How to use Cosentyx
4. Possible side effects
5. How to store Cosentyx
6. Package contents and other information
Instructions for the use of the Cosentyx 300 mg UnoReady pen
1. Important safety checks before injection:
3. Cleaning the injection site
4. Removing the cap
5. Pen Position
6. Start the injection
7. Completing the injection
8. Check that the green indicator fills the window
9. Disposal of the used Cosentyx 300 mg UnoReady pen
Package leaflet: Information for the user
Cosentyx 150 mg powder for injectable solution
1. What Cosentyx is and what it is used for
2. What you need to know before using Cosentyx
3. How to use Cosentyx
4. Possible side effects
5. How to store Cosentyx
6. Package contents and other information
Instructions for Use of Cosentyx Powder for Injectable Solution

Package leaflet: Information for the user

Cosentyx 75 mg solution for injection in pre-filled syringe

secukinumab
Please read all of this leaflet carefully before you (or your child) use this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you (or your child) only. Do not pass it on to others, even if their symptoms seem identical to yours (or your child’s), as it may be harmful.
If you (or your child) experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Cosentyx is and what it is used for
What you need to know before using (or your child uses) Cosentyx
How to use Cosentyx
Possible side effects
How to store Cosentyx
Contents of the pack and other information

1. What Cosentyx is and what it is used for

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody that belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralizing the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis, and axial spondyloarthritis.
Cosentyx is indicated for the treatment of the following inflammatory diseases:

Pediatric plaque psoriasis
Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Pediatric plaque psoriasis
Cosentyx is used to treat a skin condition called "plaque psoriasis" that causes skin inflammation. Cosentyx reduces inflammation and other symptoms of the disease. Cosentyx is used in adolescents and children (from 6 years of age) with moderate to severe plaque psoriasis.
The use of Cosentyx in plaque psoriasis will provide benefit to you (or your child), resulting in improvement of skin symptoms and reduction of signs such as skin thickening, itching, and pain.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis
Cosentyx is used in patients (aged 6 years and older) to treat conditions falling within the categories of juvenile idiopathic arthritis known as "enthesitis-related arthritis" and "juvenile psoriatic arthritis." These conditions are inflammatory diseases affecting the joints and the sites where tendons attach to bone.
The use of Cosentyx in enthesitis-related arthritis and juvenile psoriatic arthritis will provide you (or your child) with benefits by reducing symptoms and improving physical function (or your child's physical function).

2. What you should know before using (or before your child uses) Cosentyx

Do not use Cosentyx:

if you (or your child) are allergic to secukinumab or to any of the other ingredients of this medicine (listed in section 6). If you (or your child) think you may be allergic, ask your doctor for advice before using Cosentyx.
if you (or your child) have an active infection considered significant by your doctor (for example, active tuberculosis).

Warnings and precautions
Talk to your doctor, nurse, or pharmacist before using Cosentyx:

if you (or your child) currently have an infection.
if you (or your child) have long-term (chronic) or recurring infections.
if you (or your child) have ever had an allergic reaction to latex.
if you (or your child) have an inflammatory bowel disease called Crohn's disease.
if you (or your child) have inflammation of the large intestine called ulcerative colitis.
if you (or your child) have recently been vaccinated or are scheduled to be vaccinated during treatment with Cosentyx.
if you (or your child) are receiving any other type of treatment for psoriasis, such as another immunosuppressant or ultraviolet (UV) light phototherapy.

Tuberculosis
Talk to your doctor if you (or your child) currently have or have previously had tuberculosis. Also, inform your doctor if you (or your child) have recently been in close contact with someone who has tuberculosis. Your doctor will assess your condition (or your child's) and may perform a test before you (or your child) start using Cosentyx. If your doctor believes you (or your child) are at risk of tuberculosis, they may prescribe medication for its treatment. If symptoms of tuberculosis develop during treatment with Cosentyx (such as persistent cough, weight loss, lethargy, or low-grade fever), inform your doctor immediately.
Hepatitis B
Talk to your doctor if you (or your child) currently have or have previously had a hepatitis B infection. This medicine may cause reactivation of the infection. Before and during treatment with secukinumab, your doctor may monitor you (or your child) for signs of infection. Inform your doctor if you notice any of the following symptoms: worsening fatigue, yellowing of the skin or whites of the eyes, dark urine, loss of appetite, nausea and/or pain in the upper right part of the abdomen.
Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
You (or your child) should stop using Cosentyx and inform your doctor or seek immediate medical help if you (or your child) experience abdominal cramps and pain, diarrhoea, weight loss, blood in the stool, or any other signs of intestinal problems.
Be alert to infections and allergic reactions
Cosentyx may potentially cause serious side effects, including infections and allergic reactions. You should be vigilant for signs of these conditions while you (or your child) are being treated with Cosentyx.
You (or your child) should stop using Cosentyx and inform your doctor or seek immediate medical help if you observe any signs suggestive of a serious infection or allergic reaction. These signs are listed in section 4 under "Serious side effects".
Children and adolescents
Cosentyx is not recommended for the treatment of children under 6 years of age with plaque psoriasis, as it has not been studied in this age group.
Cosentyx is not recommended for children under 6 years of age with juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis).
Cosentyx is not recommended for the treatment of children and adolescents (under 18 years of age) in other indications, as it has not been studied in this age group.
Other medicines and Cosentyx
Inform your doctor or pharmacist:

if you (or your child) are taking, have recently taken, or might take any other medicines.
if you (or your child) have recently been vaccinated or are scheduled to be vaccinated. You (or your child) should not receive certain types of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breastfeeding and fertility

It is preferable to avoid using Cosentyx during pregnancy. The effects of the medicine in pregnant women are unknown. If you (or your child) are of childbearing age, you (or your child) will be advised to avoid pregnancy and to use an effective method of contraception during treatment with Cosentyx and for at least 20 weeks after the last dose of Cosentyx. Inform your doctor if you (or your child) are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Inform your doctor if you (or your child) are breastfeeding or plan to breastfeed. You (or your child) and your doctor will need to decide whether to breastfeed or use Cosentyx. You (or your child) cannot do both. After using Cosentyx, you (or your child) must not breastfeed for at least 20 weeks after the last dose.

Driving and using machines
It is unlikely that Cosentyx will affect your ability to drive or use machinery.

3. How to use Cosentyx

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
Cosentyx is administered by injection under the skin (subcutaneous injection). You and your
doctor must decide whether, after appropriate training, you should self-inject Cosentyx or if the injection
should be given by a person assisting you.
It is important not to attempt to perform the injection yourself until you have been taught how to do so by your doctor, nurse, or pharmacist.
For detailed instructions on how to reconstitute and inject Cosentyx, see “Instructions for use of

Cosentyx 75 mg pre-filled syringe at the end of this leaflet.

Instructions for use can also be found via the QR code and website below:
‘QR code to be included’
www.cosentyx.eu
How much Cosentyx is given and for how long
Your doctor will decide how much Cosentyx you (or your child) need and for how long.
Pediatric plaque psoriasis (children aged 6 years and older)

The recommended dose is based on body weight as follows:
o Body weight below 25 kg: 75 mg as subcutaneous injection.
o Body weight 25 kg or above and below 50 kg: 75 mg as subcutaneous injection.
o Body weight 50 kg or above: 150 mg as subcutaneous injection.
Your doctor may increase the dose to 300 mg.
Each 75 mg dose is administered as a single 75 mg injection. Other pharmaceutical forms/dosages may be available for administering 150 mg and 300 mg doses.

After the first dose, additional weekly injections will be given at weeks 1, 2, 3 and 4, followed by monthly injections.
Juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis)

The recommended dose is based on body weight as follows:
o Weight below 50 kg: 75 mg as subcutaneous injection.
o Weight 50 kg or above: 150 mg as subcutaneous injection.
Each 75 mg dose is administered as a single 75 mg injection. Other pharmaceutical forms/dosages may be available for administering the 150 mg dose.

After the first dose, additional weekly injections will be given at weeks 1, 2, 3 and 4, followed by monthly injections.
Cosentyx is used for long-term treatment. Your doctor will regularly monitor your condition (or your child’s) to ensure the treatment is having the desired effect.
If you use more Cosentyx than you should
If you (or your child) have received more Cosentyx than prescribed or the dose was administered earlier than scheduled, inform your doctor.
If you forget to use Cosentyx
If you (or your child) have forgotten to inject a dose of Cosentyx, administer it as soon as you remember. Then inform your doctor to discuss when the next dose should be given.
If you (or your child) stop treatment with Cosentyx
It is not dangerous to stop using Cosentyx. However, if you (or your child) discontinue treatment, psoriasis symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will get them.
Serious side effects
Stop using Cosentyx and contact your doctor or seek immediate medical help if you (or your child) experience any of the following side effects:
Possible serious infections – signs may include:

fever, flu-like symptoms, night sweats
feeling tired or short of breath, persistent cough
skin that is warm, red and painful, or a painful rash with blisters
burning sensation when urinating.

Severe allergic reaction – signs may include:

difficulty breathing or swallowing
low blood pressure which may cause dizziness or lightheadedness
swelling of the face, lips, tongue or throat
severe skin itching, with redness or raised hives.
Your doctor will decide whether and when you (or your child) can restart treatment.

Other side effects
Most of the following side effects are mild or moderate. If any of these side effects become severe, inform your doctor, pharmacist or nurse.
Very common (may affect more than 1 in 10 people):

upper respiratory tract infections with symptoms such as sore throat and runny nose (nasopharyngitis, rhinitis)

Common (may affect up to 1 in 10 people):

cold sores (oral herpes)
diarrhoea
runny nose (rhinorrhoea)
headache
nausea
fatigue
itchy, red and dry skin (eczema)

Uncommon (may affect up to 1 in 100 people):

oral thrush (oral candidiasis)
signs of low white blood cell levels, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
outer ear infection (otitis externa)
eye discharge with itching, redness and swelling (conjunctivitis)
itchy skin rash (urticaria)
lower respiratory tract infections
cramps and abdominal pain, diarrhoea, weight loss or blood in the stool (signs of intestinal problems)
small itchy blisters on the palms of the hands, soles of the feet and edges of fingers and toes (dyshidrotic eczema)
athlete’s foot (tinea pedis)

Rare (may affect up to 1 in 1,000 people):

severe allergic reaction with shock (anaphylactic reaction)
redness and peeling of the skin over a large area of the body, possibly with itching or pain (exfoliative dermatitis)
inflammation of small blood vessels, which may cause a rash with red or purple spots (vasculitis)
swelling of the neck, face, mouth or throat which may cause difficulty swallowing or breathing (angioedema)

Not known (frequency cannot be estimated from the available data):

fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
painful swelling and skin ulceration (pyoderma gangrenosum)

Reporting of side effects
If you (or your child) experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 Cosentyx

Keep this medicine out of the sight and reach of children.
Do not use this medicine:

after the expiry date stated on the carton after “Exp.” or on the syringe label after “EXP”.
if the solution contains visible particles, is cloudy, or is clearly brown.

Store the sealed syringe in the carton to protect the medicine from light. Store in a refrigerator
between 2°C and 8°C. Do not freeze. Do not shake.
If necessary, Cosentyx may be kept outside the refrigerator for a single period not exceeding 4 days at room temperature, not above 30°C.
This medicine is for single use only.
Do not dispose of medicines via wastewater. 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 Cosentyx contains

The active substance is secukinumab. Each pre-filled syringe contains 75 mg of secukinumab.
The other components are trehalose dihydrate, histidine, monohydrochloride monohydrate histidine, methionine, polysorbate 80 and water for injections.

Description of the appearance of Cosentyx and contents of the pack
Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to
slightly yellow.
Cosentyx 75 mg solution for injection in pre-filled syringe is available in single packs
containing 1 pre-filled syringe and in multiple packs containing 3 (3 packs of 1) pre-filled
syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 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 European Medicines Agency website: https://www.ema.europa.eu .

Instructions for the use of Cosentyx 75 mg pre-filled syringe

Read these instructions COMPLETELY before administering the injection. It is important not to attempt to administer the medicine yourself or have someone administer it until you have received proper training from your doctor, nurse, or pharmacist. The package contains one single-dose plastic blister pack with a sealed pre-filled syringe of Cosentyx 75 mg.

Appearance of the Cosentyx 75 mg pre-filled syringe
Plunger
Grip

Technical diagram of a syringe with labels indicating the needle cap

Syringe safety device
Wings of the
Viewing window,
safety device
plunger tip
and syringe
needle cap
label and expiry date

After injecting the medicine, the syringe needle safety device is activated. This is designed to help protect healthcare providers, patients who self-administer the injection, physicians, prescribers, and caregivers from accidental needle-stick injuries.

Diagram showing a wipe cloth labeled WIPE, a mass of organic material, and a separate biological waste container, separated by plus signs

What you need for the injection:

Alcohol swab
Cotton ball or gauze
Sharps disposal container

Important safety information
Warning: Keep the syringe out of sight and reach of children.

The syringe needle cap may contain natural rubber (latex), which should not be handled by individuals sensitive to this substance.
Do not open the sealed outer packaging until it is time to use the medicine.
Do not use this medicine if the seal on the outer box or the blister seal is damaged, as use may not be safe.
Do not use if the syringe has fallen on a hard surface or if it has been dropped after removing the needle cap.
Never leave the syringe unattended where others could tamper with it.
Do not shake the syringe.
Be careful not to touch the safety wings of the syringe before use. Touching them may cause the syringe safety mechanism to activate prematurely.
Do not remove the protective needle cap until you are ready to inject.
The syringe cannot be reused. Dispose of the syringe immediately after use in a sharps disposal container.

Storage of the Cosentyx 75 mg pre-filled syringe

Store this medicine sealed in its original carton to protect it from light. Store in the refrigerator at 2°C to 8°C. DO NOT FREEZE.
Before preparing the syringe for injection, remember to remove it from the refrigerator and allow it to reach room temperature (15–30 minutes).
Do not use the syringe after the expiry date printed on the carton after “Exp.” or on the syringe label after “EXP.” If expired, return the entire package to the pharmacy.

Injection site

Schematic drawing of a male torso with dark areas highlighted on the upper outer arms

The injection site is the area of the body where the syringe will be used.

The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area within 5 centimeters around the navel.
Choose a different site each time you give an injection.
Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

Schematic drawing of the human body viewed from the back, with gray areas highlighted on the upper outer part of both arms

If the injection is administered by someone assisting you, the upper outer arms may also be used.

Preparing the Cosentyx 75 mg pre-filled syringe for use

Remove the syringe package from the refrigerator and leave it closed for approximately 15–30 minutes so it can reach room temperature.
Wash your hands thoroughly with soap and water when you are ready to use the syringe.
Clean the injection site with an alcohol swab.
Remove the syringe from the carton and take it out of the blister pack by holding the protective body.
Inspect the syringe. The liquid should be clear. Its color may range from colorless to slightly yellow. Small air bubbles may be visible, which is normal. DO NOT USE if the liquid contains visible particles, is cloudy, or is clearly brown. DO NOT USE if the syringe is damaged. In all these cases, return the entire package to the pharmacy.

How to use the Cosentyx 75 mg pre-filled syringe

Hands holding a syringe and a vial to prepare medication

Carefully remove the protective needle cap from the syringe by holding the syringe body. Discard the protective needle cap. A small drop of liquid may appear at the needle tip. This is normal.

Technical drawing showing a hand inserting a medical device into the skin at a 45-degree angle indicated by a diagram

Gently pinch the skin at the injection site and insert the needle as shown. Push the needle in deeply at an angle of approximately 45 degrees to ensure the full dose is administered.

Technical drawing showing two hands holding a syringe for injection

Hold the syringe as shown. Press the plunger slowly and all the way down until the plunger tip is between the safety wings of the syringe. Continue to hold the plunger down while keeping the syringe in place for 5 seconds. Keep the plunger fully depressed while carefully withdrawing the needle from the injection site.

A hand holds a pre-filled syringe and pulls the plunger back

Slowly release the plunger to allow the syringe safety device to automatically cover the exposed needle. Mild bleeding at the injection site may occur. If so, press a cotton ball or gauze pad over the injection site and hold for 10 seconds. Do not rub the injection site. If needed, a small plaster may be placed over the injection site.

Disposal instructions

A hand inserts a syringe with needle into the skin

Dispose of the used syringe by placing it in a designated sharps disposal container (a puncture-resistant, closable container). For your safety and the safety of others, used needles and syringes must never be reused.

Package leaflet: Information for the user

Cosentyx 150 mg solution for injection in pre-filled syringe

secukinumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of this leaflet:

What Cosentyx is and what it is used for
What you need to know before using Cosentyx
How to use Cosentyx
Possible side effects
How to store Cosentyx
Contents of the pack and other information

1. What Cosentyx is and what it is used for

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody that belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralizing the activity of a protein called IL-17A, which is present at increased levels in conditions such as psoriasis, hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis.
Cosentyx is indicated for the treatment of the following inflammatory diseases:

Plaque psoriasis
Hidradenitis suppurativa
Psoriatic arthritis
Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis
Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Plaque psoriasis
Cosentyx is used to treat a skin condition called "plaque psoriasis" which causes skin inflammation. Cosentyx reduces inflammation and other symptoms of the disease. Cosentyx is used in adults, adolescents, and children (from 6 years of age) with moderate to severe plaque psoriasis.
The use of Cosentyx in plaque psoriasis will benefit you by improving skin manifestations and reducing symptoms such as skin thickening, itching, and pain.

Hidradenitis suppurativa
Cosentyx is used to treat a condition called hidradenitis suppurativa, sometimes also known as inverse acne or Verneuil's disease. This condition is a chronic and painful inflammatory skin disease. Symptoms may include painful lumps (nodules) and abscesses (boils) that may drain pus. It commonly affects specific areas of the skin, such as the under-breast area, armpits, inner thighs, groin, and buttocks. Scarring may also develop in the affected areas.
Cosentyx can reduce the number of nodules and abscesses you have, as well as the pain often associated with this disease. If you have hidradenitis suppurativa, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Cosentyx.
Cosentyx is used in adults with hidradenitis suppurativa and may be used alone or in combination with antibiotics.

Psoriatic arthritis
Cosentyx is used to treat a condition called "psoriatic arthritis". This condition is an inflammatory joint disease, often accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If you do not respond adequately to these medicines, Cosentyx will be given to reduce the signs and symptoms of active psoriatic arthritis, improve physical function, and slow down damage to cartilage and bone in the joints affected by the disease.
Cosentyx is used in adults with active psoriatic arthritis and may be used alone or in combination with another medicine called methotrexate.
The use of Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down damage to cartilage and bone in the affected joints, and improving your ability to perform normal daily activities.

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis
Cosentyx is used to treat conditions called "ankylosing spondylitis" and "non-radiographic axial spondyloarthritis". These conditions are inflammatory diseases that primarily affect the spine, causing inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If you do not respond adequately to these medicines, Cosentyx will be given to reduce the signs and symptoms of the disease, reduce inflammation, and improve your physical function.
Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial spondyloarthritis.
The use of Cosentyx in ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit you by reducing the signs and symptoms of the disease and improving your physical function.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis
Cosentyx is used in patients (aged 6 years and older) to treat conditions falling under the categories of juvenile idiopathic arthritis called "enthesitis-related arthritis" and "juvenile psoriatic arthritis". These conditions are inflammatory diseases affecting the joints and the sites where tendons attach to bone.
The use of Cosentyx in enthesitis-related arthritis and juvenile psoriatic arthritis will provide benefit to you (or your child) by reducing symptoms and improving physical function (or your child's physical function).

2. What you should know before using Cosentyx

Do not use Cosentyx:

if you are allergic to secukinumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Cosentyx.
if you have an active infection that your doctor considers significant (for example, active tuberculosis).

Warnings and precautions
Talk to your doctor, nurse, or pharmacist before using Cosentyx:

if you currently have an infection.
if you have long-term (chronic) or recurring infections.
if you have ever had an allergic reaction to latex.
if you have an inflammatory bowel disease called Crohn's disease.
if you have inflammation of the large intestine called ulcerative colitis.
if you have recently been vaccinated or are scheduled to be vaccinated during treatment with Cosentyx.
if you are receiving any other type of treatment for psoriasis, such as another immunosuppressant or ultraviolet (UV) light phototherapy.

Tuberculosis
Talk to your doctor if you currently have or have previously had tuberculosis. Also inform your doctor if you have recently been in close contact with someone who has tuberculosis. Your doctor will assess your condition and may perform a test before you start using Cosentyx. If your doctor believes you are at risk of tuberculosis, they may prescribe medication for its treatment. If symptoms of tuberculosis develop during treatment with Cosentyx (such as persistent cough, weight loss, lethargy, or low-grade fever), inform your doctor immediately.

Hepatitis B
Talk to your doctor if you have or have previously had hepatitis B infection. This medicine may cause reactivation of the infection. Before and during treatment with secukinumab, your doctor may monitor for signs of infection. Inform your doctor if you experience any of the following symptoms: worsening fatigue, yellowing of the skin or whites of the eyes, dark urine, loss of appetite, nausea and/or pain in the upper right part of the abdomen.

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Stop using Cosentyx and inform your doctor or seek immediate medical help if you experience abdominal cramps and pain, diarrhea, weight loss, blood in the stool, or any other signs of intestinal problems.

Be aware of infections and allergic reactions
Cosentyx may potentially cause serious side effects, including infections and allergic reactions. You should be alert for signs of these conditions while undergoing treatment with Cosentyx. Stop using Cosentyx and inform your doctor or seek immediate medical help if you notice any signs suggesting a serious infection or allergic reaction. These signs are listed in section 4 under “Serious side effects”.

Children and adolescents
Cosentyx is not recommended for the treatment of children under 6 years of age with plaque psoriasis, as it has not been studied in this age group.
Cosentyx is not recommended for children under 6 years of age with juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis).
Cosentyx is not recommended for the treatment of children and adolescents (under 18 years of age) in other indications, as it has not been studied in this age group.

Other medicines and Cosentyx
Inform your doctor or pharmacist:

if you are taking, have recently taken, or might take any other medicines.
if you have recently been vaccinated or are scheduled to be vaccinated. Certain types of vaccines (live vaccines) must not be administered while you are using Cosentyx.

Pregnancy, breastfeeding, and fertility

It is advisable to avoid using Cosentyx during pregnancy. The effects of the medicine in pregnant women are unknown. If you are of childbearing age, you will be advised to avoid pregnancy and to use an effective method of contraception during treatment with Cosentyx and for at least 20 weeks after the last dose. Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Inform your doctor if you are breastfeeding or intend to breastfeed. You and your doctor will need to decide whether to breastfeed or use Cosentyx. You cannot do both. After using Cosentyx, you must not breastfeed for at least 20 weeks after the last dose.

Driving and using machines
It is unlikely that Cosentyx will affect your ability to drive or use machinery.