150 mg injection, in pre-filled pen 
secukinumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cosentyx is and what it is used for 
2. What you need to know before you use Cosentyx 
3. How to use Cosentyx 
4. Possible side effects 
5. How to store Cosentyx 6. Contents of the pack 
and other ingredients 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 drug works by neutralizing the activity of a protein called IL-17A, which is found in elevated levels in diseases such as psoriasis, psoriatic arthritis, and axial spondyloarthritis.

Cosentyx is used to treat the following inflammatory diseases:

  • plaque psoriasis
  • psoriatic arthritis
  • axial spondylarthritis including ankylosing spondylitis (radiographic axial spondylarthritis) and non-radiographic axial spondylarthritis.

Plaque psoriasis

Cosentyx is used to treat a skin condition called plaque psoriasis, which causes inflammation of the skin. Cosentyx reduces inflammation and other symptoms of the disease. Cosentyx is used in adults, adolescents, and children (6 years and older) with moderate to severe plaque psoriasis.

The advantage of using Cosentyx in plaque psoriasis is that it improves skin healing and reduces symptoms such as dandruff, itching, and pain.

Psoriatic arthritis

Cosentyx is used to treat a condition called psoriatic arthritis. This is an inflammatory disease of the joints, which is often accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If these do not have enough effect, you will receive Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve your physical functions and delay the harmful effects on cartilage and bone in the affected joints.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or in combination with another medicine called methotrexate.

The advantage of using Cosentyx in psoriatic arthritis is that it reduces the signs and symptoms of the disease, delays the damage to cartilage and bones in the joints, and increases your ability to perform normal daily activities.

Axial spondylarthritis including ankylosing spondylitis (radiographic axial spondylitis) and non-radiographic axial spondylarthritis

Cosentyx is used to treat diseases called “ankylosing spondylitis” and “non-radiographic axial spondylitis”. These are inflammatory diseases that mainly affect the spine and cause inflammation in the vertebrae. If you have ankylosing spondylitis or non-radiographic axial spondylarthritis, you will first be given other medicines. If these do not have enough effect, you will receive Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation and improve your physical functions.

Cosentyx is used in adults with ankylosing spondylitis and active non-radiographic axial spondylitis.

The benefit of using Cosentyx in ankylosing spondylitis and non-radiographic axial spondylitis is that it reduces the signs and symptoms of the disease and improves your physical functions.

2. What you need to know before using Cosentyx

Do not use Cosentyx:

  • if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor before using Cosentyx if you think you may be allergic.
  • if you have an active infection that your doctor considers important.

Warnings and cautions

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

  • if you have an ongoing infection
  • if you have prolonged or repeated infection s
  • if you have tuberculosis
  • if you have ever had an allergic reaction to latex
  • if you have an inflammatory disease that affects the gastrointestinal tract and is called Crohn’s disease
  • if you have an inflammation of the colon called ulcerative colitis
  • if you have recently been vaccinated or if you are going to be vaccinated during treatment with Cosentyx
  • if you are receiving any other treatment for psoriasis, such as another immunosuppressive drug or ultraviolet (UV) light therapy.

Inflammatory bowel disease ( Crohn’s disease or ulcerative colitis )

Stop using Cosentyx and tell your doctor immediately or seek medical attention immediately if you experience stomach cramps and pain, diarrhea, weight loss, blood in the stool, or other signs of bowel problems.

Pay attention to your infection and allergic reactions

Cosentyx can cause serious side effects, including infections and allergic reactions. You must be aware of these conditions when taking Cosentyx.

Stop using Cosentyx immediately and talk to your doctor or seek medical attention if you notice any signs of a possible serious infection or allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and young people

Cosentyx is not recommended for children under 6 years of age with plaque psoriasis as it has not been studied in this age group.

Cosentyx is not recommended for use in children and adolescents (under 18 years of age) in other uses as it has not been studied in this age group.

Other medicines and Cosentyx

Tell your doctor or pharmacist:

  • if you are taking, have recently taken, or might take any other medicines.
  • if you have recently had or are about to be vaccinated. You should not be given certain types of vaccine (live vaccine) while using Cosentyx.

Pregnancy, breastfeeding, and fertility

  • The use of Cosentyx should preferably be avoided during pregnancy. The effect of this drug in pregnant women is not known. If you are a woman of childbearing potential, you should avoid getting pregnant. You must use effective contraception during treatment with Cosentyx and for at least 20 weeks after the last Cosentyx- dose one. Talk to your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
  • Talk to your doctor if you are breast-feeding or planning to breast-feed. You and your doctor should decide whether to breast-feed or use Cosentyx. You should not do both. After using Cosentyx, you should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines

Cosentyx is unlikely to affect your ability to drive or use machines.

3. How to use Cosentyx

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.

Cosentyx is given as an injection under the skin (a so-called subcutaneous injection ). You and your doctor will decide if you should inject Cosentyx yourself.

You mustn’t try to inject yourself unless you have been instructed to do so by a doctor, nurse, or pharmacist. A caregiver can also inject Cosentyx after appropriate training.

For detailed instructions on how to inject Cosentyx, see the “Cosentyx SensoReady Pen 150 mg Instructions for Use” at the end of this leaflet.

How much Cosentyx is given and how long the treatment lasts

Your doctor will decide how much Cosentyx you need and for how long.

Plaque psoriasis

Adults

  • The recommended dose is 300 mg as a subcutaneous injection.
  • Each 300 mg dose is given as two injections of 150 mg.

After the first dose, you will receive additional weekly injections in weeks 1, 2, 3, and 4. You will then receive monthly injections. On each occasion, you will receive 300 mg, given as two injections of 150 mg.

Children 6 years and older

  • The recommended dose given by subcutaneous injection is based on body weight as follows:
    • Weight below 25 kg: 75 mg with powder for solution for injection.
    • Weight 25 kg or higher but less than 50 kg: 75 mg with powder for solution for injection.
    • Weight 50 kg or higher: 150 mg with the powder for solution for injection, the pre-filled syringe, or the pre-filled pen. Your doctor may increase the dose by one to 300 mg with the powder for solution for injection, the pre-filled syringe, or the pre-filled pen.
  • Each 75 mg dose is given as a 75 mg injection. Each 150 mg dose is given as a 150 mg injection. Each dose of 300 mg is given as two injections of 150 mg.

After the first dose, you will receive additional weekly injections in weeks 1, 2, 3, and 4. You will then receive monthly injections.

Psoriatic arthritis

For patients with psoriatic arthritis who also have moderate to severe plaque psoriasis or who have not responded adequately to treatment with so-called TNFα inhibitors:

  • The recommended dose is 300 mg as a subcutaneous injection.
  • Each 300 mg dose is given as two injections of 150 mg.

After the first dose, you will receive additional weekly injections in weeks 1, 2, 3, and 4. You will then receive monthly injections. On each occasion, you will receive 300 mg given as two injections of 150 mg.

For other patients with psoriatic arthritis:

  • The recommended dose is 150 mg as a subcutaneous injection.

After the first dose, you will receive additional weekly injections in weeks 1, 2, 3, and 4. You will then receive monthly injections.

Depending on how you respond to treatment, your doctor may increase the dose to 300 mg.

Ankylosing spondylitis (Radiographic axial spondylarthritis)

  • The recommended dose is 150 mg as a subcutaneous injection.

After the first dose, you will receive additional weekly injections in weeks 1, 2, 3, and 4. You will then receive monthly injections.

Depending on how you respond to treatment, your doctor may increase the dose to 300 mg. Dose of 300 mg is given as two injections of 150 mg.

Non-radiographic axial spondylarthritis

  • The recommended dose is 150 mg as a subcutaneous injection.

After the first dose, you will receive additional weekly injections in weeks 1, 2, 3, and 4. You will then receive monthly injections.

Cosentyx is intended for long-term treatment. Your doctor will regularly check your condition to make sure that the treatment is having the desired effect.

If you use more Cosentyx than you should

If you have been given more Cosentyx than you should or if a dose has been given earlier than prescribed by your doctor, tell your doctor.

If you forget to use Cosentyx

If you forget to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then contact your doctor to discuss when to inject the following dose.

If you stop using Cosentyx

It is not dangerous to stop using Cosentyx, but if you stop, your symptoms of psoriasis, psoriatic arthritis, or axial spondyloarthritis may return.

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

4. Possible side effects

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

Serious side effects are

Stop using Cosentyx immediately and tell your doctor or seek medical attention if you get any of the following side effects.

Possible serious infection – signs can be:

  • fever, flu-like symptoms, night sweats
  • fatigue or shortness of breath, a cough that does not go away
  • hot, red, and painful skin, or painful rash with blisters
  • burning when you urinate.

Severe allergic reaction – signs may be:

  • difficulty breathing or swallowing
  • low blood pressure, which can cause dizziness or intoxication
  • swelling of the face, lips, tongue, or throat
  • severely itchy skin with red rashes or lumps.

Your doctor will decide if and when you can resume treatment.

Other side effects are

Most of the following side effects are mild to moderate. If any of these side effects gets serious, talk to 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 nasal congestion ( nasopharyngitis, rhinitis ).

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

  • cold sores ( oral herpes )
  • diarrhea
  • Suva ( rhinorrhea )
  • foot fungus ( tinea pedis )
  • headache
  • nausea
  • fatigue.

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

  • cod (fungal infection)
  • signs of low levels of white blood cells, such as fever, sore throat, or cold sores due to infection ( neutropenia )
  • outer ear infection (external otitis )
  • excretion from the eye with itching, redness, and swelling ( conjunctivitis )
  • itchy rash ( urticaria )
  • lower respiratory tract infections
  • abdominal cramps and pain, diarrhea, weight loss, or blood in the stool (signs of intestinal problems).

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

  • severe allergic reaction with shock ( anaphylactic reaction ).
  • reddening and scaly skin over a large area of ​​the body, which can itch or hurt (exfoliative dermatitis ).

No known frequency (cannot be calculated from the available data):

  • fungal infection of the skin and mucous membranes (including esophagus, esophageal candidiasis ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

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 which is stated on the outer carton or pen after “EXP”.
  • if the liquid contains clearly visible particles, is cloudy or clearly brown.

Keep the pen sealed in its carton. Sensitive to light. Store in a refrigerator at 2 ° C-8 ° C. Do not freeze. Do not shake.

Cosentyx can, if necessary, be stored at room temperature at a maximum of 30 ° C at one time for up to 4 days.

This medicine is for single use only.

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

6. Contents of the packaging and other information

Content declaration

  • The active substance is secukinumab. Each pen contains 150 mg of secukinumab.
  • The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and water for injections.

What the medicine looks like and the contents of the pack

Cosentyx solution for injection is a clear liquid. The color can vary from uncolored to pale yellow. Cosentyx 150 mg solution for injection in a pre-filled pen is available in packs containing 1 or 2 pre-filled pens and in a multipack containing 6 (3 packs of 2) pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Sandoz GmbH

Biochemiestrasse 10

6336 Long-distance fighting

Austria

Contact the representative of the marketing authorization holder to find out more about this medicine: Show larger

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma Pharmaceutical Products, Satel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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