Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Your doctor will also give you a Patient Alert Card, which contains important safety information you need to be aware of before and during your treatment with Simponi.

What is in this leaflet

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

Rheumatoid arthritis

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:

• Reduce the signs and symptoms of your disease.
• Slow down the damage to your bones and joints.
• Improve your physical function.

Psoriatic arthritis

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:

• Reduce the signs and symptoms of your disease.
• Slow down the damage to your bones and joints.
• Improve your physical function.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

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:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.

Ulcerative colitis

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

Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children. If your child has polyarticular juvenile idiopathic arthritis your child will first be given other medicines. If your child does not respond well enough to these medicines, your child will be given Simponi in combination with methotrexate to treat the disease.

Warnings and precautions

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.

• You may get infections more easily while using Simponi.
• Infections may progress more rapidly and may be more severe. In addition, some previous infections may reappear.
  Tuberculosis (TB)
  Tell your doctor straight away if symptoms of TB appear during or after your treatment. Symptoms of TB include persistent cough, weight loss, tiredness, fever or night sweats.
  • Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB. Your doctor will test you to see if you have TB. Your doctor will record these tests on your Patient Alert Card.
  • It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had or has TB.
  • If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi.
  Hepatitis B virus (HBV)
  • Tell your doctor if you are a carrier or if you have or have had HBV before you are given Simponi.
  • Tell your doctor if you think you might be at risk of contracting HBV
  • Your doctor should test you for HBV
  • Treatment with TNF blockers such as Simponi may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases.
  Invasive fungal infections
  If you have lived in or travelled to an area where infections caused by specific type of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis), are common, tell your doctor straight away. Ask your doctor if you don’t know if these fungal infections are common in the area in which you have lived or travelled.

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.

• If you use Simponi or other TNF blockers, your risk for developing lymphoma or another cancer may increase.
• Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
• There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death.
• On rare occasions, a specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF-blockers. Most of these patients were adolescent or young adult males. This type of cancer has usually resulted in death. Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or are heavy smokers may be at increased risk for cancer with Simponi treatment. If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
• Some patients treated with golimumab have developed certain kinds of skin cancer. If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your doctor.

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.

• New and worsening congestive heart failure has been reported with TNF blockers, including Simponi. Some of these patients died.
• If you have mild heart failure and you are being treated with Simponi, you must be closely monitored by your doctor.

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

• Talk to your doctor if you are going to have any operations or dental procedures.
• Tell your surgeon or dentist performing the procedure that you are having treatment with Simponi by showing them your Patient Alert Card.

Autoimmune disease

Tell your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent rash, fever, joint pain and tiredness.

• On rare occasions, people treated with TNF blockers have developed lupus.

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.

• You should not receive certain (live) vaccines while using Simponi.
• Certain vaccinations may cause infections. If you received Simponi while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Simponi use so they can decide when your baby should receive any 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.

• Some of these reactions may be serious or, rarely, life-threatening.
• Some of these reactions occurred after the first administration of Simponi.

Children and adolescents

Simponi is not recommended for children weighing less than 40 kg with polyarticular juvenile idiopathic arthritis or in children and adolescents younger than 18 years for any other condition.

Other medicines and Simponi

• Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
• You should not take Simponi with medicines containing the active substance anakinra or abatacept. These medicines are used for the treatment of rheumatic diseases.
• Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.
• You should not receive certain (live) vaccines while using Simponi.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.

Pregnancy and breast-feeding

Talk to your doctor before using Simponi if:

• You are pregnant or are planning to become pregnant while using Simponi. The effects of this medicine in pregnant women are not known. The use of Simponi in pregnant women is not recommended. If you are being treated with Simponi, you must avoid becoming pregnant by using adequate contraception during your treatment and for at least 6 months after the last Simponi injection.
• Before starting breast-feeding, your last treatment with Simponi must be at least 6 months ago. You must stop breast-feeding if you are to be given Simponi.
• If you received Simponi during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your Simponi use before the baby receives any vaccine (for more information see section on vaccination).

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.

Driving and using machines

Simponi may have a minor influence on your ability to drive and use tools or machines. Dizziness may occur after you take Simponi. If this happens, do not drive or use any tools or machines.

Simponi contains latex and sorbitol

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

Simponi contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How much Simponi is given

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:

• The recommended dose is 50 mg (the content of 1 pre-filled syringe) given once a month, on the same date each month.
• Talk to your doctor before taking your fourth dose. Your doctor will determine if you should continue Simponi treatment.
  • If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of 2 pre-filled syringes) given once a month, on the same date each month.

Polyarticular juvenile idiopathic arthritis:

• The recommended dose is 50 mg given once a month, on the same date each month.
• Talk to your child’s doctor before your child takes their fourth dose. Your child’s doctor will determine if they should continue Simponi treatment.

Ulcerative colitis

• The table below shows how you will usually use this medicine.

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

• In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled syringe) 4 weeks after your last treatment, then every 4 weeks thereafter.
• In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after your last treatment, then every 4 weeks thereafter.

How Simponi is given

• Simponi is given by injection under the skin (subcutaneously).
• At the start, your doctor or nurse may inject Simponi. However, you and your doctor may decide that you may inject Simponi yourself. In this case you will get training on how to inject Simponi yourself.

Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for administration” at the end of this leaflet.

If you use more Simponi than you should

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

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 less than 2 weeks late, inject the forgotten dose as soon as you remember and stay on your original schedule.
• If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose.

If you are not sure what to do, talk to your doctor or pharmacist.

If you stop using Simponi

If you are considering stopping Simponi, talk to your doctor or pharmacist first.

The following additional side effects have been observed with Simponi:

Very common side effects (may affect more than 1 in 10 people):

• Upper respiratory tract infections, sore throat or hoarseness, runny nose

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

• Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
• Feeling dizzy
• Headache
• Feeling numb or having a tingling feeling
• Superficial fungal infections
• Abscess
• Bacterial infections (such as cellulitis)
• Low red blood cell counts
• Positive blood lupus test
• Allergic reactions
• Indigestion
• Stomach pain
• Feeling sick (nausea)
• Flu
• Bronchitis
• Sinus infection
• Cold sores
• High blood pressure
• Fever
• Asthma, shortness of breath, wheezing
• Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause fever
• Pain and ulcers in the mouth
• Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)
• Hair loss
• Rash and itching of the skin
• Difficulty sleeping
• Depression
• Feeling weak
• Bone fractures
• Chest discomfort

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

• Kidney infection
• Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
• Skin blisters
• Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
• Low platelet count
• Low white blood cell counts
• Combined low platelet, red, and white blood cell count
• Thyroid disorders
• Increase in blood sugar levels
• Increase in blood cholesterol levels
• Balance disorders
• Vision disturbances
• Sensation of heart beating irregularly
• Narrowing of the blood vessels in the heart
• Blood clots
• Flushing
• Constipation
• Chronic inflammatory condition of the lungs
• Acid reflux
• Gall stones
• Liver disorders
• Breast disorders
• Menstrual disorders

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

• Failure of the bone marrow to produce blood cells
• Infection of the joints or the tissue around them
• Impaired healing
• Inflammation of blood vessels in internal organs
• Leukaemia
• Melanoma (a type of skin cancer)
• Merkel cell carcinoma (a type of skin cancer)
• Scaly, peeling skin
• Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• Pain and discoloration in the fingers or toes
• Taste disturbances
• Bladder disorders
• Kidney disorders
• Inflammation of the blood vessels in your skin which results in rash

Side effects of which the frequency is not known:

• A rare blood cancer affecting mostly young people (hepatosplenic T-cell lymphoma)

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

What Simponi contains

The active substance is golimumab. One 0.5 mL pre-filled syringe contains 50 mg of golimumab.

The other ingredients are sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.

What Simponi looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

1. Preparing for use of the pre-filled syringe

Hold the pre-filled syringe by the body of the pre-filled syringe

• Do not hold by the plunger head, plunger, needle guard wings, or needle cover.
• Do not pull back on the plunger at any time.
• Do not shake the pre-filled syringe at any time.
• Do not remove the needle cover from the pre-filled syringe until instructed to do so.
• Do not touch the needle guard activation clips (as indicated by asterisks * in figure 1) to prevent prematurely covering the needle with the needle guard.

Check the number of pre-filled syringes

Check the pre-filled syringes to make sure

• the number of pre-filled syringes and strength is correct
  • If your dose is 50 mg, you will get one 50 mg pre-filled syringe
  • If your dose is 100 mg, you will get two 50 mg pre-filled syringes and you will need to give yourself two injections. Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
  • If your dose is 200 mg, you will get four 50 mg pre-filled syringes and you will need to give yourself four injections. Choose different sites for these injections and give the injections one right after the other.

Check expiry date (see figure 2)

• Check the expiration date (as indicated by “EXP”) on the label by looking through the viewing window located within the body of the pre-filled syringe.
• If you cannot see the expiration date through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the expiration date to the viewing window.
• You can also check the expiration date printed on the carton.

Do not use the pre-filled syringe if the expiration date has passed. The 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

• To ensure proper injection, allow the pre-filled syringe to sit at room temperature outside the box for 30 minutes, out of the reach of children.

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

• Hold the pre-filled syringe by its body with the covered needle pointing downward.
• Look at the liquid through the viewing window of the pre-filled syringe and make sure that it is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow. The solution can be used if it contains a few small translucent or white particles of protein.
• If you cannot see the liquid through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the liquid to the viewing window (see figure 2).

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.

2. Choosing and preparing the injection site (see figure 3)

• You usually inject the medicine into the front of the middle thighs.
• You can also use the lower stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
• Do not inject into areas where the skin is tender, bruised, red, scaly, hard or has scars or stretch marks.
• If multiple injections are required for a single administration, the injections should be administered at different sites on the body.

Injection site selection for caregivers (see figure 4)

• If a caregiver is giving you the injection, they can also use the outer area of the upper arms.
• Again, all sites mentioned can be used regardless of your body type or size.

Preparing injection site

• Wash your hands thoroughly with soap and warm water.
• Wipe the injection site with an alcohol swab.
• Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Do not touch this area again before giving the injection.

3. Injecting the medicine

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 (see figure 5)

• When you are ready to inject, hold the body of the pre-filled syringe with one hand.
• Pull the needle cover straight off and throw it away after your injection. Do not touch the plunger while you do this.
• You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both normal and do not need to be removed.
• Inject the dose promptly after removing 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

• Hold the body of the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the area of skin that you previously cleaned. Hold firmly.

Do not pull back on the plunger at any time.

Inject the medicine

• Place the needle at approximately a 45-degree angle to the pinched skin. In a single and swift motion, insert the needle through the skin as far as it will go (see figure 6).

• Inject all of the medicine by pushing in the plunger until the plunger head is completely between the needle guard wings (see figure 7).

• When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see figure 8).

• Slowly take your thumb off the plunger head to allow the empty pre-filled syringe to move up until the entire needle is covered by the needle guard, as shown by the figure 9:

4. After the injection

Use a cotton ball or gauze

• There may be a small amount of blood or liquid at the injection site. This is normal.
• You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
• You may cover the injection site with a small adhesive bandage, if necessary.

Do not rub your skin.

Throw the pre-filled syringe away (see figure 10)

• Place your pre-filled syringe in a sharps container straight away. Make sure you dispose of the bin as instructed by your doctor or nurse.

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.