Patient Leaflet Updated 04-Aug-2023 | Merck Sharp & Dohme (UK) Limited
Simponi 50 mg solution for injection in pre-filled syringe
Simponi® 50 mg solution for injection in pre-filled syringe
golimumab
Your doctor will also give you a Patient Reminder Card, which contains important safety information you need to be aware of before and during your treatment with Simponi.
1. What Simponi is and what it is used for
2. What you need to know before you use Simponi
3. How to use Simponi
4. Possible side effects
5. How to store Simponi
6. Contents of the pack and other information
Simponi contains the active substance called golimumab.
Simponi belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the treatment of the following inflammatory diseases:
In children 2 years of age and older, Simponi is used for the treatment of polyarticular juvenile idiopathic arthritis.
Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha’ (TNF-α). This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Simponi which you will take in combination with another medicine called methotrexate to:
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Simponi to:
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Simponi to:
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Simponi to treat your disease.
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children. If you have polyarticular juvenile idiopathic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Simponi in combination with methotrexate to treat the disease.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Simponi.
Talk to your doctor, pharmacist or nurse before using Simponi.
Infections
Tell your doctor straight away if you already have or get any symptoms of infection, during or after your treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.
Cancer and lymphoma
Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.
Heart failure
Tell your doctor straight away if you get new or worsening symptoms of heart failure. Symptoms of heart failure include shortness of breath or swelling of your feet.
Nervous system disease
Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body. Your doctor will decide if you should receive Simponi.
Operations or dental procedures
Autoimmune disease
Tell your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent rash, fever, joint pain and tiredness.
Blood disease
In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Vaccinations
Talk to your doctor if you have had, or are due to have a vaccine.
Talk to your child’s doctor regarding vaccinations for your child. If possible, your child should be up to date with all vaccinations before using Simponi.
Therapeutic infectious agents
Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Allergic reactions
Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Simponi is not recommended for children less than 2 years of age with polyarticular juvenile idiopathic arthritis because it has not been studied in this group.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Talk to your doctor before using Simponi if:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Simponi has minor influence on your ability to drive and use tools or machines. Dizziness may however occur after you take Simponi. If this happens, do not drive or use any tools or machines.
Latex sensitivity
A part of the pre-filled syringe, the needle cover, contains latex. Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex.
Sorbitol intolerance
This medicine contains 20.5 mg sorbitol (E420) in each pre-filled syringe.
Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Polyarticular juvenile idiopathic arthritis:
Ulcerative colitis
Initial treatment
A starting dose of 200 mg (the contents of 4 pre-filled syringes) followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.
Maintenance treatment
Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for Use” at the end of this leaflet.
If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away. Always take the outer carton and this leaflet with you, even if it is empty.
If you forget to use Simponi on your planned date, inject the forgotten dose as soon as you remember.
Do not use a double dose to make up for a forgotten dose.
When to inject your next dose:
If you are not sure what to do, talk to your doctor or pharmacist.
If you are considering stopping Simponi, talk to your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects and may require treatment. The risk of certain side effects is greater with the 100 mg dose compared with the 50 mg dose. Side effects may appear up to several months after the last injection.
Tell your doctor straight away if you notice any of the following serious side effects of Simponi which include:
Tell your doctor straight away if you notice any of the above symptoms.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Side effects of which the frequency is not known:
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
The active substance is golimumab. One 0.5 mL pre-filled syringe contains 50 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and water for injections. For more information on sorbitol (E420), see Section 2.
Simponi is supplied as solution for injection in a single-use pre-filled syringe Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.
The solution is clear to slightly opalescent (having a pearl-like shine), colourless to light yellow and may contain a few small translucent or white particles of protein. Do not use Simponi if the solution is discoloured, cloudy or you can see foreign particles in it.
For any information about this medicine, please contact:
For information in large print, tape, CD or Braille, telephone 0800 7318450
This leaflet was last revised in 06/2023.
If you would like to self inject Simponi, you must be trained by a healthcare professional to prepare an injection and give it to yourself. If you have not been trained, please contact your doctor, nurse or pharmacist to schedule a training session.
In these instructions:
1. Preparing for use of the pre-filled syringe
2. Choosing and preparing the injection site
3. Injecting the medicine
4. After the injection
The components of the pre-filled syringe include: a needle and needle cover at one end and a plunger with a plunger head, needle guard activation clips and needle guard wings at the other. The Body of the plunger has a viewing window through which the expiration date, which is printed on the label underneath, can be viewed.
Hold the pre-filled syringe by the body of the pre-filled syringe
Check the number of pre-filled syringes
Check the pre-filled syringes to make sure
Check expiry date
Do not use the pre-filled syringe if the expiration date has passed. The printed expiration date refers to the last day of the month. Please contact your doctor or pharmacist for assistance.
Wait 30 minutes to allow pre-filled syringe to reach room temperature
Do not warm the pre-filled syringe in any other way (for example, do not warm it in a microwave or in hot water).
Do not remove the pre-filled syringe’s needle cover while allowing it to reach room temperature.
Get the rest of your equipment ready
While you are waiting you can get the rest of your equipment ready, including an alcohol swab, a cotton ball or gauze and a sharps container.
Check the liquid in the pre-filled syringe
Do not use the pre-filled syringe if the liquid is the wrong colour, cloudy, or contains larger particles. If this happens, talk to your doctor or pharmacist.
Injection site selection for caregivers
Preparing injection site
Do not touch this area again before giving the injection.
The needle cover should not be removed until you are ready to inject the medicine. The medicine should be injected within 5 minutes after the needle cover has been removed.
Do not touch the plunger during needle cover removal.
Remove the needle cover
Do not touch the needle or allow it to touch any surface.
Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacist.
Position the pre-filled syringe to inject
Do not pull back on the plunger at any time.
Inject the medicine
Use a cotton ball or gauze
Do not rub your skin.
Throw the pre-filled syringe away
Do not attempt to recap the needle.
Do not ever re-use a pre-filled syringe, for your safety and health and for the safety of others.
If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.
PIL.SIM.50.PFS.23.GB.8398.II-002.NO RCN
120 Moorgate, London, EC2M 6UR, UK
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