Collective name for radiographic axial SpA (ankylosing spondylitis / Bechterew disease) and non-radiographic axial SpA. Axial spondyloarthritis is an inflammatory disease where the joints of the spine and elsewhere in the body are stiff and painful. Patients may benefit from this medicine because it lessens the symptoms of your disease and improves bodily function.
Psoriatic arthritis is a disease of inflammation of the joints, usually accompanying the skin disease psoriasis. In psoriatic arthritis, this medicine may be used as monotherapy or together with the medicine methotrexate. Patients may benefit from this medicine because it lessens the symptoms of your disease and improves bodily function.
Plaque psoriasis (psoriasis vulgaris) is an inflammation of the skin. Cosentyx decreases the inflammation and other symptoms of the disease (redness. scales, itch, pain). Consentyx is used in adults, young people up to age 18 and children (6 years and older) who have moderate to serious plaque psoriasis. Patients may benefit from this medicine because it lessens the inflammation of the skin and symptoms such as scales, itches and pain.
Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody. Monoclonal antibodies are proteins which recognise one particular type of protein in the body and bind to it.
Cosentyx belongs to the group of medicines called interleukine inhibitors (IL-inhibitors).
In axial SpA, psoriatic arthritis and plaque psoriasis, there is an increase in IL-17A in the body. This excess of IL-17A gives off signals by binding to what is called a receptor. This stimulates the body to set an inflammatory reaction in motion.
Cosentyx binds to excess IL-17A. This stops or lessens the inflammatory reaction.
Cosentyx is a biological. Biologicals usually have complex protein structures and represent new developments in biomedical research.
Cosentyx works in a different way from other biologicals, which target the proteins TNFα or IL-12/23. This means that this medicine may help when other biologicals have stopped working.
Use this questionnaire as a check list prior to subcutaneous administration of this medicine - in some cases you should be extra careful or refrain from using this medicine. If the answer to any of the questions is ‘yes’, please contact your doctor / specialist nurse.
NB: Please also do this if you are not sure about any of these questions or if you have any other questions.
Questions:
There is more information in the insert or the patient leaflet (“When you should not use this medicine or be extra careful in using it”).
When you should not use this medicine
When you should be extra careful with this medicine
Contact your doctor, nurse of pharmacist before taking this medicine if:
Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
Stop using this medicine and tell your doctor immediately or seek immediate medical assistance if you notice stomach cramps and stomach ache, weight loss, blood in your stools or other signs of bowel problems.
Be alert to infections and allergic reactions
Cosentyx may cause serious side-effects, such as infections and allergic reactions. When using this medicine, you should be alert to symptoms of these disorders.
Stop using this medicine and contact your doctor immediately or seek immediate medical assistance if you experience symptoms of a (serious) infection or an allergic reaction. These symptoms are listed in the Chapter ‘Side-effects’ in this booklet and in paragraph 4 ‘Serious side-effects’ of the package insert.
Children and young people up to age 18
This medicine is not recommended for children with plaque psoriasis who are younger than 6 years of age, because it has not been studied in this age group.
This medicine is not recommended for children and young people up to 18 years of age in case of other indications, as this has not been studied in this age group.
Other medicines and Cosentyx
Tell your doctor or pharmacist:
Pregnancy and breastfeeding
It is recommended that you do not use this medicine during pregnancy. The effects of this medicine in pregnant women are not known. If you are a woman who could become pregnant, you are advised to ensure that you do not become pregnant. Use reliable contraception during the period when you use this medicine and for at least 20 weeks after taking the last dose of this medicine. If you are pregnant, think you may be pregnant or would like to become pregnant, please contact your doctor.
Contact your doctor if you are breastfeeding or planning to breastfeed. You can decide together with your doctor whether to start breastfeeding or whether to start this medicine. You cannot breastfeed while taking this medicine. After using this medicine, you may not breastfeed for at least 20 weeks after the last dose.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive or to operate machinery.
Always use this medicine exactly as your doctor has instructed. Contact your doctor, nurse or pharmacist if you are unsure how to use this medicine.
This medicine is administered by an injection underneath the skin (this is called subcutaneous injection). You should decide in consultation with your doctor whether you wish to inject this medicine yourself.
It is important that you don’t try to inject yourself before having practised doing so with your doctor, nurse or pharmacist. Someone else may administer this medicine to you if he or she has received appropriate training.
Comprehensive instructions about injecting this medicine are found in the Chapter ‘Self-injection with the SensoReady® pen’ in this booklet and in the Chapter ‘Instructions for the use of the Cosentyx SensoReady® pen’ in the package insert.
You may receive this medicine in a pre-filled syringe, rather than a pre-filled pen. When a pre-filled pen is prescribed, this may be interpreted as a pre-filled syringe.
How much Consentyx is given and for how long?
Your doctor will decide how much Cosentyx you need and for how long. This depends on the condition for which you are prescribed this medicine.
After the first dose (Week 0) you will first receive weekly injections in Weeks 1, 2, 3 and 4, and then monthly injections.
This medicine is for long-term treatment. Your doctor will assess your condition on a regular basis to check whether the treatment is having the desired effect.
Axial SpA
The recommend dose for patients with axial SpA is 150 mg via subcutaneous injection. In case of inadequate response for patients with active ankylosing spondylitis, this may be increased to 300 mg. This does not require another period of weekly starting-up doses.
Psoriatic arthritis
The recommended dose is 300 mg via subcutaneous injection for patients with psoriatic arthritis who also have moderate to serious plaque psoriasis or for patients for whom TNFα-inhibitors are insufficiently effective.
For other patients with psoriatic arthritis the recommended dose is 150 mg via subcutaneous injection . In case of inadequate response the dose may be increased to 300 mg.
You will receive a dose of 300 mg or 150 mg at every time point. Each dose of 300 mg is administered in two injections of 150 mg.
Plaque psoriasis
The recommended dose for patients with plaque psoriasis is 300 mg via subcutaneous injection. Each dose of 300 mg is administered in two injections of 150 mg.
Have you used too much of this medicine?
If you have received more of this medicine than you should, or if the dose was administered earlier than the doctor had instructed, please tell your doctor.
Have you forgotten to take this medicine?
If you have forgotten to inject a dose of this medicine, then take the dose as soon as you remember. Then discuss with your doctor when you should take the next dose.
If you stop using this medicine
It is not dangerous to stop using this medicine. When you stop, your symptoms may return.
Do you have any other questions about how to use this medicine?
Then contact your doctor, pharmacist or nurse.
Cosentyx dosing schedule
Below you will find the dosing schedule for this medicine. If your doctor has prescribed to you a dose of 150 mg, you will get one injection on each occasion and the pink schedule applies to you. If your doctor has prescribed to you a dose of 300 mg, you will get two injections on each occasion and the purple schedule applies to you.
If your dose has been increased from 150 mg to 300 mg, you do not need to carry out the starting-up dosing again.
Cosentyx dosage schedule
Before injecting you must read these instructions FULLY.
These instructions are intended to help you administer an injection correctly using the Cosentyx SensoReady pen.
It is important that you don’t try to inject yourself before having practised doing so with your doctor, nurse or pharmacist.
Do not remove the cap before you are ready to administer the injection.
Save the box containing your pen in the fridge, between 2°C and 8°C, out of the reach of children. Remember to take the pen out of the fridge before preparing to inject, to allow it to come to room temperature (15 - 30 minutes).
What you need for your injection
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✔ Included in the box:: |
✘ Not included in the box: |
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Would you like to see the full injection instructions? Watch the injection instructions video.
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The fluid should be clear. The colour may vary from colourless to slightly yellow.
Contact your pharmacist if your pen fails these safety checks.
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Select your injection site:
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for carers or health practitioners only: If a carer or health practitioner administers the injection, they may do so on the outside of your upper arm. |
Cleaning the injection site:
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Removing the cap:
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How do you hold the pen? Hold the pen perpendicularly (at 90°) on the cleaned injection site.
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Read this before injecting
During the injection you will hear 2 loud clicks.
The 1st click means that the injection has started. A few seconds later, the 2nd click indicates that the injection is nearly complete.
Hold the pen firmly against your skin until you see a green indicator filling the window and no longer moving.
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Starting your injection:
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Completing your injection:
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Check that the green indicator has completely filled up the window:
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Disposing of your Cosentyx SensoReady pen:
For the Cosentyx 300 mg dose: repeat the injection steps for a second dose of 150 mg. |
Do not use this medicine:
Store the pen sealed in its box to protect against light. Store in the fridge (2°C – 8°C). Do not store in the freezer. Do not shake.
If necessary, you may store Cosentyx outside the fridge at room temperature below 30°C for a single period of at most 4 days.
This medicine is exclusively designed to be used once only. Ask your pharmacist how to dispose of medication you no longer use.
Keep out of the sight and reach of children.
When travelling by aeroplane
Attention: one week (or longer) before your departure
Attention: just before your departure
Like any medicine, this medicine may have side-effects, although not everyone will get them. The most complete and up-to-date information is contained in the package insert.
Serious side-effects
Stop using this medicine and contact your doctor without delay or seek medical assistance if you notice any of the following side-effects. Your doctor will decide whether and when you can restart treatment.
Potentially serious infection – possible symptoms:
Serious allergic reaction – possible symptoms:
Other side-effects
Most of the following side-effects are light to moderate. If any of these side-effects become serious, tell your doctor, pharmacist or nurse.
Some side-effects are very common (occurring in more than 1 in 10 people):
Some side-effects are common (occurring in up to 1 in 10 people):
Some side-effects are uncommon (occurring in at most 1 in 100 people):
Some side-effects are rare (occurring in at most 1 in 1000 people):
Side-effect with unknown frequency:
Reporting side-effects
If you are suffering from side-effects, contact your doctor, nurse or pharmacist. This also applies to possible side-effects not listed in the package insert. You may also report side-effects directly to the Nederlands Bijwerkingen Centrum Lareb, on www.lareb.nl. By reporting side-effects, you can help us collect more information about the safety of this medicine.
For the most up-to-date information about side-effects we refer you to the package insert.
How often should I administer this medicine?
After the first dose (Week 0) you will receive one injection per week in Weeks 1, 2, 3 and 4, and then monthly injections.
Axial SpA
At each time point you will receive a dose of 150 mg administered in a single injection or a dose of 300 mg administered in two injections of 150 mg each. Check which dose you have been prescribed.
Plaque psoriasis
At each time point you will receive a dose of 300 mg administered in two injections of 150 mg each.
How long does treatment with the medicine last?
Your doctor will decide how much Cosentyx you need and for how long. This medicine is for long-term treatment. Your doctor will assess your condition on a regular basis to check whether the treatment is having the desired effect.
How long can I store this medicine?
Do not use this medicine after the use-by-date. This is printed on the outer packaging or on the pen label after ‘EXP’.
What should I do if the fluid in the pre-filled pen is cloudy?
Do not use this medicine if the fluid contains clearly visible particles, is cloudy or unmistakably brown in colour.
What should I do if I inject this medicine sooner than the date listed in my dosing schedule?
If you have received more of this medicine than you should, or if the dose was administered earlier than the doctor had instructed, please tell your doctor.
What should I do if I have forgotten to inject this medicine?
If you have forgotten to inject a dose of this medicine, then take the dose as soon as you remember. Then discuss with your doctor when you should take the next dose.
What should I do with the pre-filled pen after I have injected this medicine?
What should I do if I see a little bit of blood at the injection site?
There could be a little bit of blood at the injection site. Press a piece of gauze or a tissue onto the site and hold for 10 seconds. Do not rub the injection site. You may cover the injection site with a plaster if necessary.
Can I use other medicines in addition to Cosentyx?
Tell your doctor or pharmacist:
What should I do if I want to stop using this medicine?
Discuss with your doctor, nurse or pharmacist before stopping this medicine.
It is not dangerous to stop using this medicine. However, if you stop, your symptoms may return.
Do you have any other questions about how to use this medicine?
Then contact your doctor, pharmacist or nurse.
Antibodies
An antibody is a protein used by the immune system to identify and neutralise foreign objects in the body (such as bacteria and viruses).
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease causing the joints to become swollen, stiff and painful. Psoriatic arthritis mostly occurs in patients who also have the skin condition of psoriasis.
Autoimmune disease
Autoimmune diseases are diseases where an immune response is mounted against substances and tissues that are normally present in the body. This is called autoimmunity. Autoimmune diseases are treated with drugs which suppress or change the immune system.
Immune system
The immune system is the body’s defence systems and plays an important role in axial SpA, psoriatic arthritis and plaque psoriasis. The immune system is not functioning properly which can lead to joint inflammation, joint damage and/or skin conditions.
Interleukine-17A (IL-17A)
Interleukine-17A is a protein of the immune system which is present in greater numbers in the body in people with axial SpA, psoriatic arthritis and plaque psoriasis.
Psoriasis
Psoriasis is an autoimmune disease mainly affecting the skin, but which can also affect the nails, joints and other organs. Plaque psoriasis is the most common, ‘usual’ form of psoriasis, identifiable by clearly demarcated red scaly patches.
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