Cosentyx 150 mg. 1 ml. 2 injections

What is Cosentyx and what is it used for?
Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body.
Cosentyx belongs to a group of medicines called interleukin (IL) inhibitors. The drug works by neutralizing the activity of a protein called IL-17A whose levels are elevated in some diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Cosentyx is used to treat the following inflammatory diseases:
• Plaque psoriasis;
• Psoriatic arthritis;
• Ankylosing spondylitis.
Plaque psoriasis
Cosentyx is used to treat a skin condition called "plaque psoriasis", which is an inflammation affecting the skin. Cosentyx reduces inflammation and other symptoms of the disease. Cosentyx is used in adults with moderate to severe plaque psoriasis.
Using Cosentyx in plaque psoriasis will help you improve skin cleansing and reduce symptoms like skin peeling, itching and pain.
Psoriatic arthritis
Cosentyx is used to treat a disease called "psoriatic arthritis". This is an inflammatory joint disease, often combined with psoriasis. If you have active psoriatic arthritis, you will initially be given other medicines. If you do not respond well enough to the use of these medicines, Cosentyx will be given to reduce the signs and symptoms of active psoriatic arthritis, to improve physical function and to slow the damage to the cartilage and bone of the affected joints.
Cosentyx is used in adults with active psoriatic arthritis and can be given alone or with another medicine called methotrexate.
Applying Cosentyx to psoriatic arthritis will favorably affect the signs and symptoms of the disease, slow down damage to the cartilage and bone of affected joints, and improve your ability to perform your normal daily activities.
Ankylosing spondylitis
Cosentyx is used to treat a disease called "ankylosing spondylitis". This is an inflammatory disease primarily affecting the spine, where inflammation of the joints of the spine is observed. If you have ankylosing spondyditis, you will initially be given other medicines. If you do not respond well enough to the use of these medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation and improve physical function.
Cosentyx is used in adults with active ankylosing spondylitis.
The administration of Cosentyx to ankylosing spondylitis will favorably affect the signs and symptoms of the disease and will improve your physical function.
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). If you think you may be allergic, talk to your doctor before using Cosentyx.
If you have an active infection that is important to your doctor.
Warnings and precautions
Tell your doctor or pharmacist before using Cosentyx:
• if you currently have an infection;
• if you have chronic infection or recurrent infections;
• if you have tuberculosis;
• if you have Crohn's disease;
• if you have recently been immunized or you are being immunized during treatment with Cosentyx.
• if you are receiving another treatment for psoriasis such as other immunosuppressants or ultraviolet (UV) light therapy.
Beware of infections and allergic reactions
Cosentyx has the potential to cause serious side effects, including infections and allergic reactions. You should be alert to the appearance of certain signs of these conditions while you are using Cosentyx.
Stop using Cosentyx and tell your doctor or seek immediate medical attention if you notice any signs that you may experience a serious infection or allergic reaction. Such signs are listed under "Serious Adverse Reactions" in section 4.
Children and adolescents
Cosentyx is not recommended in children and adolescents (below 18 years of age) because 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 been or are about to be vaccinated. You should not be given certain types of vaccines (live vaccines) during the use of Cosentyx.
Pregnancy, breastfeeding and fertility
• It is preferable to avoid using Cosentyx during pregnancy. The effects of this medicine on the pregnant woman are not known. If you are a woman of childbearing potential, it is recommended that you avoid pregnancy and use adequate methods of contraception while using Cosentyx for at least 20 weeks after taking the last dose of Cosentyx. Talk to your doctor if you are pregnant, think you may be pregnant or planning a pregnancy.
• Talk to your doctor if you are breast-feeding or planning to breast-feed. Together with your doctor, you will decide whether to breastfeed or use Cosentyx. You do not have to do both. After using Cosentyx, you should not breast-feed for at least 20 weeks after the last dose.
Driving and using machines
Cosentyx has no or negligible influence on the ability to drive and use machines.
3. How to use Cosentyx?
Cosentyx is given by injection under the skin (known as a subcutaneous injection) by a healthcare professional. Make sure you have discussed with your doctor, when you will be given injections and when the follow-up visits are scheduled.
For detailed information on how to prepare and inject Cosentyx, see the "Instructions for Using Cosentyx Powder for Injection" at the end of this leaflet.
How much Cosentyx should be given and for how long?
Your doctor will decide how much Cosentyx you need and how long.
Plaque psoriasis
• The recommended dose is 300 mg given by subcutaneous injection.
• Each 300 mg dose is given as two 150 mg injections.
After the first dose, you will be given injections every week of weeks 1, 2 and 3. From week 4, injections will be given to you monthly. Each time you will receive a 300 mg dose given as two 150 mg injections.
Psoriatic arthritis
For psoriatic arthritis in patients who have moderate to severe plaque psoriasis or patients who have not responded well to drugs called tumor necrosis factor (TNF) inhibitors:
• The recommended dose is 300 mg given by subcutaneous injection.
• Each 300 mg dose is given as two 150 mg injections.
After the first dose, you will be given injections every week of weeks 1, 2 and 3. From week 4, injections will be given to you monthly. Each time you will receive a 300 mg dose given as two 150 mg injections.
In other patients with psoriatic arthritis:
• The recommended dose is 150 mg given by subcutaneous injection.
After the first dose, you will be given injections every week of weeks 1, 2 and 3. From week 4, injections will be given to you monthly.
Ankylosing spondylitis
• The recommended dose is 150 mg given by subcutaneous injection.
After the first dose, you will be given injections every week of weeks 1, 2 and 3. From week 4, injections will be given to you monthly.
Treatment with Cosentyx is prolonged. Your doctor will check your condition regularly to ensure that the treatment has the desired effect.
If you use more Cosentyx than you should
If you have received more than the necessary dose of Cosentyx or if your dose has been administered earlier than your doctor has told you, tell your doctor.
If you forget to use Cosentyx
If you miss the injection of one injection of Cosentyx, talk to your doctor.
If you stop using Cosentyx
It is not dangerous to stop using Cosentyx. Although, if you stop, the symptoms of psoriasis, psoriatic arthritis or ankylosing spondylitis may recur.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop using Cosentyx and tell your doctor or seek medical attention immediately if you get any of the side effects listed below:
Possible serious infection - signs may include:
• fever, flu-like symptoms, night sweats;
• feeling tired or short of breath, a cough that does not go away;
• hot, reddened and painful skin or a painful skin rash with blisters;
• burning sensation during urination.
Serious allergic reaction - signs may include:
• difficulty in breathing or swallowing;
• low blood pressure, which may cause dizziness or dizziness;
• swelling of the face, lips or throat;
• severe itching of the skin, with a red rash or raised roughness.
Your doctor will decide whether and when you can resume treatment.
Other Adverse Reactions
Most of the side effects listed below are mild to moderate. If any of these side effects gets serious, tell your doctor, pharmacist or nurse.
Very common (may affect more than 1 in 10 people):
• upper respiratory tract infections with symptoms such as a flushed throat or nasal congestion (nasopharyngitis, rhinitis).
Common (may affect up to 1 in 10 people):
• herpes simplex (herpes simplex);
• diarrhea;
• runny nose (rhinorrhoea).
Uncommon (may affect up to 1 in 100 people):
• fungal infection in the mouth (oral candidiasis);
• signs of decreased white blood cell count, such as fever, red throat or mouth ulcers due to infection (neutropenia);
• Athlete's pitch (tinea pedis);
• infection of the outer ear (otitis externa);
• drainage of the eye with itching, redness and edema (conjunctivitis);
• itchy rash (urticaria).
Rare (may affect up to 1 in 1,000 people):
• severe allergic shock reaction (anaphylactic reaction).
Not known (frequency can not be estimated from the available data):
• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How do you store Cosentyx?
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton or vial after EXP.
Before reconstitution: Store the vial in the refrigerator between 2 ° C and 8 ° C.
After reconstitution: The solution may be used immediately or stored at 2 ° C to 8 ° C for 24 hours. Do not freeze. The solution should be administered within one hour of removal from the refrigerator (2 ° C to 8 ° C).
This medicine is for single use only. Ask your pharmacist where to dispose of the product you do not need.
6. Package Contents and Additional Information
What does Cosentyx contain?
- The active substance is secuquinumab. Each Cosentyx powder for solution for injection contains 150 mg of secukinumab. After reconstitution, 1 ml of solution contains 150 mg of secukinumab.
- The other ingredients are sucrose, L-histidine, L-histidine hydrochloride monohydrate and polysorbate 80.
What Cosentyx looks like and contents of the pack
Cosentyx powder for solution for injection is a white solid powder in a glass vial. Do not use if the lyophilised powder does not completely dissolve or if the liquid contains easily visible particles if it is cloudy or visibly brown. Cosentyx is supplied in packs containing one vial.

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