Simponi 100 mg solution for injection in pre-filled pen

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 Reminder 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.

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 Reminder 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 Reminder 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.

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 100 mg is not recommended for children and adolescents (younger than 18 years).

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, 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 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.

Simponi contains latex and sorbitol

Latex sensitivity

A part of the pre-filled pen, 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 41 mg sorbitol (E420) in each pre-filled pen.

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 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 1 pre-filled pen) given once a month, on the same date each month.

Ulcerative colitis

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

Initial treatment

A starting dose of 200 mg (the contents of 2 pre-filled pens) followed by 100 mg (the contents of 1 pre-filled pen) 2 weeks later.

Maintenance treatment

• In patients weighing less than 80 kg, 50 mg (the 50 mg pre-filled pen or pre-filled syringe must be used to administer this dose) 4 weeks after your last treatment, then every 4 weeks thereafter. Your doctor may decide to prescribe 100 mg (the contents of 1 pre-filled pen), depending on how well Simponi works for you.
• In patients weighing 80 kg or more, 100 mg (the contents of 1 pre-filled pen) 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 Use” 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
• Low white 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
• Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
• 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
• 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
• Inflamed eye (conjunctivitis)
• Eye allergy
• 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
• Severely decreased number of white 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)
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
• Scaly, peeling skin
• Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• Pain and discolouration 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)
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)

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 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.

What Simponi contains

The active substance is golimumab. One 1 mL pre-filled pen contains 100 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.

What Simponi looks like and contents of the pack

Simponi is supplied as solution for injection in a single-use pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens. 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 pen

• Do not shake the pre-filled pen at any time.
• Do not remove the cap from the pre-filled pen until immediately before the injection.

Check the number of pre-filled pens

Check the pre-filled pens to make sure

• the number of pre-filled pens and strength is correct
  • If your dose is 100 mg, you will get one 100 mg pre-filled pen
  • If your dose is 200 mg, you will get two 100 mg pre-filled pens and you will need to give yourself two injections. Choose different sites for these injections and give the injections one right after the other.

Check expiry date

• Check the expiration date printed or written on the carton.
• Check the expiration date (as indicated as “EXP”) on the pre-filled pen.
• Do not use the pre-filled pen 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.

Check security seal

• Check the security seal around the cap of the pre-filled pen.
• Do not use the pre-filled pen if the seal is broken. Please contact your doctor or pharmacist.

Wait 30 minutes to allow pre-filled pen to reach room temperature

• To ensure proper injection, allow the pre-filled pen to sit at room temperature outside the box for 30 minutes out of the reach of children.
• Do not warm the pre-filled pen in any other way (for example, do not warm it in a microwave or in hot water).
• Do not remove the pre-filled pen’s cap 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 pen

• Look through the viewing window to make sure that the liquid in the pre-filled pen 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.
• You will also notice an air bubble, which is normal.
• Do not use the pre-filled pen 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

• You usually inject the medicine into the front of the middle thighs.
• You can also use the 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 if you are not administering the injection yourself

• 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 cap should not be removed until you are ready to inject the medicine.
• The medicine should be injected within 5 minutes after the cap has been removed.

Remove the cap

• When you are ready to inject, twist the cap slightly to break the security seal.
• Pull the cap off and throw it away after your injection.
• Do not put the cap back on because it may damage the needle inside the pre-filled pen.
• Do not use the pre-filled pen if it is dropped without the cap in place. If this happens please contact your doctor or pharmacist.

Push the pre-filled pen firmly against the skin

• Hold the pre-filled pen comfortably in your hand. DO NOT press the button at this time.
• You will choose from 2 injection methods. Injecting without pinching the skin is recommended. However, if you prefer, you may pinch the skin to create a firmer surface for your injection.
• Push the open end of the pre-filled pen firmly against the skin at a 90-degree angle until the Safety Sleeve slides fully into the Clear Cover.

• Position the open end of the pre-filled pen straight onto your skin (90 degrees)
• Push pre-filled pen firmly against your skin so that the safety sleeve slides up into the clear cover

Press button to inject

• Continue to push the pre-filled pen firmly against your skin and press the raised part of the button with your fingers or thumb. You will not be able to press in the button unless the pre-filled pen is pushed firmly against your skin and the Safety Sleeve slides into the Clear Cover.
• Once the button is pressed, it will remain pressed in so you do not need to keep pressure on it.

• You will hear a loud ‘click’ sound – don’t be alarmed. The first ‘click’ means that the needle has been inserted and the injection has started. You may or may not feel a needle prick at this time.

Do not lift the pre-filled pen away from your skin. If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.

Continue to hold until the second ‘click’

• Continue to hold the pre-filled pen down firmly against your skin until you hear a second ‘click’. This usually takes about 3-6 seconds, but it may take up to 15 seconds for you to hear the second ‘click’ sound.
• The second ‘click’ means that the injection is finished and the needle has gone back into the pre-filled pen. If you have hearing problem, count 15 seconds from the time you first press the button and then lift the pre-filled pen from the injection site.
• Lift the pre-filled pen from the injection site.

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 for 10 seconds.
• You may cover the injection site with a small adhesive bandage, if necessary.
• Do not rub your skin.

Check the window – a yellow indicator confirms proper administration

• The yellow indicator is connected to the plunger of the pre-filled pen. If the yellow indicator is not shown in the window, the plunger has not advanced adequately, and the injection has not occurred.
• The yellow indicator will fill about half of the viewing window. This is normal.
• Talk to your doctor or pharmacist if the yellow indicator is not visible in the window or if you suspect that you may not have received a complete dose. Do not administer a second dose without speaking to your doctor.

Throw the pre-filled pen away

• Place your pen in a sharps container straight away. Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.

If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.