Prospecto: information for the user

Cimzia 200 mg injectable solution in cartridge for dose dispenser

certolizumab pegol

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they do not appear in this prospect. See section 4.

1. What is Cimzia and for what it is used

2. What you need to know before starting to use Cimzia

3. How to use Cimzia

4. Possible adverse effects

5. Storage of Cimzia

6. Contents of the package and additional information

Your doctor will also give you a “Patient Information Leaflet”, which contains important safety information that you should know before you are administered Cimzia and during the treatment with this medicine. Carry this “Patient Information Leaflet” with you.

Cimzia contains the active ingredient certolizumab pegol, a human antibody fragment. Antibodies are proteins that specifically recognize and bind to other proteins. Cimzia binds to a specific protein called tumor necrosis factor α (TNFα). In this way, this TNFα is blocked by Cimzia, which reduces inflammation in diseases such as rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and psoriasis. Medications that bind to TNFα are also called TNF inhibitors.

Cimzia is used in adults for the treatment of the following inflammatory diseases:

• Rheumatoid arthritis,
• Axial spondyloarthritis(including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• Psoriatic arthritis
• Plaque psoriasis.

Rheumatoid Arthritis

Cimzia is used to treat rheumatoid arthritis. Rheumatoid arthritis is an inflammatory disease of the joints. If you have active moderate to severe rheumatoid arthritis, you may first receive other medications, usually methotrexate. If you do not respond well to these medications, you will be given Cimzia in combination with methotrexate to treat your rheumatoid arthritis. If your doctor determines that methotrexate is inappropriate, Cimzia may be administered alone.

Cimzia in combination with methotrexate may also be used to treat active, severe, and progressive rheumatoid arthritis without previously using methotrexate or other medication treatments.

Cimzia will be administered in combination with methotrexate, and is used to:

• Reduce the signs and symptoms of your disease,
• Decrease the damage to the cartilage and bone of the joints caused by the disease,
• Improve your physical function and development of daily tasks.

Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis.

Cimzia is used for the treatment of ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis (sometimes referred to as non-radiographic axial spondyloarthritis). These diseases are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medications. If you do not respond well to these medications, you will be given Cimzia to:

• Reduce the signs and symptoms of your disease,
• Improve your physical function and development of daily tasks.

Psoriatic Arthritis

Cimzia is used for the treatment of active psoriatic arthritis. Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medications, usually methotrexate. If you do not respond well to these medications, you will be given Cimzia in combination with methotrexate to:

• Reduce the signs and symptoms of your disease,
• Improve your physical function and development of daily tasks.

If your doctor determines that methotrexate is not the appropriate treatment, Cimzia may be administered alone.

Plaque Psoriasis

Cimzia is used for the treatment of moderate to severe plaque psoriasis. Plaque psoriasis is an inflammatory disease of the skin, which may also affect the scalp and nails.

Cimzia is used to reduce the inflammation of the skin and other signs and symptoms of the disease.

Do not use Cimzia

• If you areALLERGIC(hypersensitive) to certolizumab pegol or any of the other components of this medication (listed in section 6).
• If you have a severe infection, includingTUBERCULOSIS(TB).
• If you haveHEART FAILUREof moderate to severe severity. Inform your doctor if you have had or have any severe heart problems.

Warnings and precautions

Before starting treatment with Cimzia, inform your doctor if:

Allergic reactions

• If you experienceALLERGIC REACTIONSsuch as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop using Cimzia and contact your doctorIMMEDIATELY. Some of these reactions may occur after the first administration of Cimzia.
• If you have ever had an allergic reaction to latex.

Infections

• If you have hadRECURRENT OR OPPORTUNISTIC INFECTIONSor other conditions that increase the risk of infections (such as treatment with immunosuppressants, which can reduce your ability to fight infections).
• If you have any infection or develop symptoms such as fever, wounds, fatigue, or dental problems. While taking Cimzia, you may be more susceptible to infections, including severe ones, or in rare cases, life-threatening infections.
• Cases ofTUBERCULOSIS (TB)have been reported in patients taking Cimzia. Your doctor will examine you for signs or symptoms of tuberculosis before starting treatment with Cimzia. This will include a detailed medical history, chest X-ray, and tuberculin test. These tests should be noted on your "Patient Information Card". If you are diagnosed with latent tuberculosis (inactive), you may need to receive the appropriate tuberculosis medication before starting Cimzia. In rare cases, tuberculosis can develop during treatment, even if you have received preventive treatment for tuberculosis. It is essential to inform your doctor if you have had tuberculosis or have been in contact with a patient with tuberculosis. If you experience symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection during or after treatment with Cimzia, contact your doctor immediately.
• If you are at risk of contractingHEPATITIS B VIRUS (HBV), if you are a carrier of HBV, or if you have an active HBV infection, Cimzia may increase the risk of HBV reactivation in individuals who are carriers of this virus. If this occurs, you should stop using Cimzia. Your doctor should perform HBV tests before starting treatment with Cimzia.

Heart failure

• If you haveHEART FAILURE, your doctor should closely monitor your heart failure. It is essential to inform your doctor if you have had or have severe heart problems. If you develop new symptoms of heart failure or worsening existing ones (e.g., difficulty breathing or swelling of the feet), contact your doctor immediately. Your doctor will decide whether to stop treatment with Cimzia.

Cancer

• Cases of certain types ofCANCERhave been observed in patients treated with Cimzia or other TNF blockers. Individuals with severe rheumatoid arthritis and a long history of the disease may have a higher risk than average of developing lymphoma, a type of cancer that affects the lymphatic system. Taking Cimzia may increase the risk of contracting lymphoma or other types of cancer. Rare cases of non-melanoma skin cancer have been reported in patients using Cimzia. Inform your doctor if you develop new skin lesions or if existing lesions change in appearance during or after treatment with Cimzia. There have been cases of cancer, including rare types, in children and adolescents taking TNF blockers, which in some cases have been fatal (see "Use in children and adolescents" below).

Other diseases

• Patients with chronic obstructive pulmonary disease (COPD) or heavy smokers may have a higher risk of developing cancer with Cimzia treatment. If you have COPD or smoke heavily, consult your doctor to determine if TNF blocker treatment is suitable for you.
• If you have a neurological disease, such as multiple sclerosis, your doctor will decide whether to use Cimzia.
• In some patients, the body may be unable to produce enough blood cells that help the body fight infections or those that contribute to stopping bleeding.If you have persistent fever, petechiae, or easy bruising, or are extremely pale, contact your doctor immediately. Your doctor may decide to stop treatment with Cimzia.
• Rare cases of a disease called lupus (e.g., persistent rash, fever, joint pain, and fatigue) have been reported. Contact your doctor if you experience these symptoms. Your doctor may decide to stop treatment with Cimzia.

Vaccines

• Inform your doctor if you have received or will receive a vaccine. Some live vaccines should not be administered while taking Cimzia.

-Some vaccines can cause infections. If you received Cimzia treatment during pregnancy, your baby may be at higher risk of contracting these infections until approximately five months after your last dose received during pregnancy. It is essential to inform your baby's doctors and other healthcare professionals about your Cimzia treatment to help them decide when your baby should be vaccinated.

Surgical or dental interventions

-Inform your doctor if you are to undergo a surgical or dental intervention. Inform the surgeon or dentist performing the intervention that you are taking Cimzia and show them your Patient Information Card.

Children and adolescents

Cimzia is not recommended for patients under 18 years of age.

Use of Cimzia with other medications

Do notuse Cimzia if you are taking the following medications for rheumatoid arthritis:

- anakinra

- abatacept

Consult your doctor if you have any doubts.

Cimzia can be used with:

- methotrexate,

- corticosteroids, or

- pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs).

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Cimzia should only be used during pregnancy if clearly necessary. If you are a woman of childbearing age, consult your doctor about using appropriate birth control measures while taking Cimzia. For women who plan to become pregnant, contraception may be considered during the five months after the last Cimzia dose.

If you received Cimzia treatment during pregnancy, your baby may be at higher risk of contracting an infection. It is essential to inform your baby's doctors and other healthcare professionals about your Cimzia treatment before your baby is vaccinated (see "Vaccines" section).

Cimzia can be used during breastfeeding.

Driving and operating machinery

The influence of Cimzia on your ability to drive and operate machinery is small. Dizziness (including feeling like the room is spinning, blurred vision, and fatigue) may occur after taking Cimzia.

Cimzia containssodium acetate and sodium chloride

This medication contains less than 23 mg (1 mmol) of sodium per 400 mg, making it essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Rheumatoid Arthritis

• The starting dose for adults with rheumatoid arthritis is 400 mg administered in weeks 0, 2, and 4.
• This dose is followed by a maintenance dose of 200 mg every two weeks. If you respond to the medication, your doctor may prescribe an alternative maintenance dose of 400 mg every four weeks.
• Treatment with methotrexate is maintained during the use of Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia may be administered alone.

Axial Spondyloarthritis

• The starting dose for adults with axial spondyloarthritis is 400 mg administered in weeks 0, 2, and 4.

• This dose is followed by a maintenance dose of 200 mg every two weeks (from week 6) or 400 mg every four weeks (from week 8), as indicated by your doctor.If you have received Cimzia for at least 1 year and respond to the medication, your doctor may prescribe a reduced maintenance dose of 200 mg every four weeks.

Psoriatic Arthritis

• The starting dose for adults with psoriatic arthritis is 400 mg administered in weeks 0, 2, and 4.
• This dose is followed by a maintenance dose of 200 mg every two weeks. If you respond to the medication, your doctor may prescribe an alternative maintenance dose of 400 mg every four weeks.
• Treatment with methotrexate is maintained during the use of Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia may be administered alone.

Plaque Psoriasis

• The initial dose for adults with plaque psoriasis is 400 mg every two weeks administered in weeks 0, 2, and 4.
• Continue with a maintenance dose of 200 mg every two weeks or 400 mg every two weeks, as indicated by your doctor.

How to Use Cimzia

Cimzia will usually be administered by a specialist doctor or healthcare professional. Cimzia will be administered as an injection (200 mg dose) or 2 injections (400 mg dose) under the skin (subcutaneously, abbreviated as: SC). It is usually injected in the thigh or abdomen.

However, it should not be injected in areas where the skin is red or presents hematomas or hardness.

Instructions for Self-Administration of Cimzia

After proper training, your doctor may also allow you to self-administer Cimzia. Read the instructions on how to inject Cimzia at the end of this leaflet.

If your doctor has considered that you can inject this medication, you should follow up with them before continuing to self-administer:

• After 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis, or psoriatic arthritis; or
• After 16 weeks if you have plaque psoriasis.

This is to allow your doctor to determine if Cimzia is working for you or if another treatment should be considered.

If You Use More Cimzia Than You Should

If your doctor has considered that you can inject this medication and you accidentally inject Cimzia more frequently than prescribed, you should inform your doctor. Always carry the Patient Information Leaflet and the medication box with you, even if it is empty.

If You Forget to Use Cimzia

If your doctor has considered that you can inject this medication and you forget to administer an injection, inject the next dose of Cimzia as soon as you remember. Then, inject the next doses as indicated. Talk to your doctor and inject the next doses following the instructions they give you.

If You Interrupt Treatment with Cimzia

Do not interrupt treatment with Cimzia without consulting your doctor first.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

ReportIMMEDIATELYto your doctor if you notice any of the following side effects:

• severe rash, hives, or other signs of allergic reaction (urticaria)
• swelling of the face, hands, or feet (angioedema)
• breathing or swallowing problems (multiple causes for these symptoms)
• difficulty breathing (dyspnea) with exertion or lying down, or swelling of the feet (heart failure)
• symptoms of blood disorders such as persistent fever, bruising, bleeding, or pale skin (pancytopenia, anemia, low platelet count, low white blood cell count)
• severe skin eruptions. These may appear as macules or circular patches of red color in a lacy pattern, often with central blisters on the trunk, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)

Report to your doctorAS SOON AS POSSIBLEif you notice any of the following side effects:

• signs of infection such as fever, malaise, wounds, dental problems, or burning urination
• feeling weak or tired
• cough
• tingling
• numbness
• double vision
• weakness in arms or legs
• unhealed cuts or bruises

The symptoms described above may be due to some of the side effects listed below, which have been observed with Cimzia:

Common (may affect up to 1 in 10 patients):

• bacterial infections in any location (pus accumulation)
• viral infections (including cold sores, shingles, and flu)
• fever
• high blood pressure
• skin rash or itching
• headaches (including migraines)
• abnormal sensations such as numbness, tingling, or burning
• feeling weak and unwell
• pain
• blood disorders
• liver problems
• reactions at the injection site
• nausea

Uncommon (may affect up to 1 in 100 patients):

• allergic diseases including rhinitis and medication reactions (including anaphylactic shock)
• antibodies directed against normal tissue
• lymphoma and leukemia of the blood and lymphatic system
• solid tumors
• skin cancers, precancerous skin lesions
• benign (non-cancerous) tumors and cysts (including skin)
• heart problems including weakened heart muscle, heart failure, myocardial infarction, chest discomfort or pressure, abnormal heart rhythm (including irregular heartbeats)
• swelling (edema) in the face or legs
• symptoms of lupus (a disease that affects the connective tissue): joint pain, skin eruptions, photosensitivity, and fever
• inflammation of blood vessels
• sepsis (a severe infection that can lead to organ failure, shock, or death)
• tuberculosis infection
• fungus infections (occurring when the ability to fight infections is reduced)
• respiratory and inflammatory disorders (including asthma, shortness of breath, cough, blockage of sinuses, pleuritis, or difficulty breathing)
• stomach problems including fluid accumulation, ulcers (including mouth ulcers), perforation, distension, inflammation, burning, stomach discomfort, dry mouth
• bile problems
• muscle problems including increased muscle enzymes
• changes in blood levels of different salts
• changes in blood levels of cholesterol and lipids
• blood clots in veins or lungs
• bleeding or bruising
• changes in the number of blood cells, including anemia, low platelet count, high platelet count
• swollen lymph nodes
• flu-like symptoms, chills, altered perception of temperature, night sweats, flushing
• anxiety and mood disorders such as depression, appetite disorders, weight changes
• dizziness (vertigo)
• ringing in the ears
• syncope (fainting), including loss of consciousness
• nerve disorders in the extremities including numbness, tingling, burning, dizziness, tremors
• skin disorders such as a newepisode or worsening of psoriasis, skin inflammation (eczema), sweat gland disorders, ulcers, photosensitivity, acne, hair loss, skin color changes, nail separation, dry skin, and wounds
• wound healing problems
• kidney problems and urinary disorders including altered kidney function, blood in urine, and urinary changes
• menstrual cycle disorders (monthly period) including absence of bleeding or excessive bleeding, or irregular bleeding
• breast problems
• inflammation of the eye and eyelid, vision changes, tear problems
• increased levels of certain blood parameters (increased alkaline phosphatase)
• prolonged coagulation times

Rare (may affect up to 1 in 1,000 patients):

• gastrointestinal cancer, melanoma
• inflammation of the lung (interstitial lung disease, pulmonary inflammation)
• stroke, blockage of blood vessels (arteriosclerosis), poor blood circulation causing numbness and pale skin of the fingers and toes (Raynaud's phenomenon), purple spots, skin discoloration, small veins near the skin surface may become visible
• pericarditis (inflammation of the pericardium)
• arrhythmia
• enlarged spleen
• increased red blood cell mass
• abnormal morphology of white blood cells
• formation of gallstones
• kidney problems (including nephritis)
• immunological disorders such as sarcoidosis (rash, joint pain, fever), serum disease, inflammation of fatty tissue, angioneurotic edema (swelling of lips, face, throat)
• thyroid disorders (goiter, fatigue, weight loss)
• increased iron levels in the body
• increased blood levels of uric acid
• suicidal attempt, mental disorder, delirium
• inflammation of the auditory nerve, vision, or face, altered coordination or balance
• increased gastrointestinal motility
• fistula (a connection between organs) (in any area)
• oral changes including difficulty swallowing
• skin peeling, vesicular disorders, hair texture changes
• sexual dysfunction
• crisis
• worsening of a disease called dermatomyositis (which appears as muscle weakness accompanied by a skin rash)
• Stevens-Johnson syndrome (a severe skin disease in which the first symptoms include general malaise, fever, headache, and rash)
• erythema multiforme (inflammatory skin eruption)
• lichenoid reactions (pruritic, red-purple rash and/or thick white-gray lines on mucous membranes)

Unknown (frequency cannot be estimated from available data):

• multiple sclerosis*
• Guillain-Barré syndrome*
• Merkel cell carcinoma (a type of skin cancer)*
• Kaposi's sarcoma (a rare cancer related to infection with human herpesvirus type 8. Kaposi's sarcoma usually manifests as purple skin lesions).

*These events have been associated with this class of medications, but the incidence in Cimzia is unknown.

Other side effects

When Cimzia has been used to treat other diseases, the following rare side effects have occurred:

• gastrointestinal stenosis (narrowing of part of the digestive tract).
• gastrointestinal obstruction (blockage of the digestive tract).
• general decline in physical health.
• spontaneous abortion.
• azoospermia (lack of sperm production).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus. You can also report them directly through the national notification system included intheAppendixV.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD and on the syringe after EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (2 °C-8 °C).

Do not freeze.

Store the pre-filled syringe in the outer packaging to protect it from light.

Pre-filled syringes can be stored at room temperature (not above 25 °C) for a maximum period of 10days protected from light. At the end of this period, pre-filled syringesmust be used or discarded.

Do not use this medication if the solution is discolored, cloudy, or if you can see particles in it.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Cimzia

• The active ingredient is certolizumab pegol. Each pre-filled syringe contains200mg of certolizumab pegol in 1 ml.
• The other components are: sodium acetate, sodium chloride, and water for injections (see “Cimzia contains sodium acetate and sodium chloride” in section2).

Appearance of the product and contents of the pack

Cimzia is supplied as a ready-to-use injectable solution in a pre-filled syringe. The solution is clear to opalescent, colourless to yellowish.

A pack of Cimzia contains:

• two pre-filled syringes containing a solution and
• two alcohol wipes (for cleaning the areas chosen for injection).

Multi-packs containing2pre-filled syringes and2alcohol wipes, multi-packs containing6pre-filled syringes (3packs of2) and6alcohol wipes (3packs of2) and multi-packs containing10pre-filled syringes (5packs of2) and10alcohol wipes (5packs of2) are also available.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

UCB Pharma SA

Allée de la Recherche60

B-1070Brussels

Belgium

Manufacturer

UCB Pharma S.A.

Chemin du Foriest

B-1420Braine l'Alleud

Belgium

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:{MM/YYYY}.

Other sources of information

Further detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

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INSTRUCTIONS FOR INJECTING CIMZIA WITH A PRE-FILLED SYRINGE

After proper training, you can inject yourself or have someone else, such as a family member or friend, inject you. The following instructions explain how to inject Cimzia. Read them carefully and follow them step by step. Your doctor or another healthcare professional will teach you how to administer the injection yourself. Do not attempt to administer the injection before you are sure you understand how to prepare and administer it.

Do not mix the contents in the same syringe or vial with any other medicine.

1.Preparation

• Take the Cimzia pack out of the refrigerator.

-If the seal(s) is/are not intact or is/are broken – do not use it and contact your pharmacist.

• Remove the following items from the Cimzia pack and place them on a flat and clean surface:

• -One or two pre-filled syringes, depending on your prescribed dose.
• -One or two alcohol wipes

• Check the expiration date of the syringe and the pack. Do not use Cimzia after the expiration date that appears on the pack after CAD and on the syringe after EXP. The expiration date is the last day of the month indicated.
• Leave the pre-filled syringe to reach room temperature. This will take30minutes. This will help reduce any discomfort during the injection.

-Do not heat the pre-filled syringe – let it come to room temperature on its own.

• Do not remove the cap until you are ready to inject.
• Wash your hands thoroughly.

2.Choosing and preparing the injection site

• Choose a site on your thigh or abdomen.

• Each new injection must be given in a separate area from the site of the last injection.

• Do not inject in an area where the skin is red, bruised or hardened.
• Clean the injection site with the alcohol wipe provided, following a circular motion from the inside out.
• Do not touch this area before the injection.

3.Injection

• Do not shake the syringe.

Check the medicine in the syringe body.

-Do not use if the solution is discoloured, cloudy or if you can see particles in it.

-You may see air bubbles. This is normal. Injecting a subcutaneous solution containing air bubbles is harmless.

• Remove the cap from the needle without tilting it, being careful not to touch the needle or let it come into contact with any surface. Do not bend the needle.
• Inject within5minutes of removing the cap from the needle.
• Gently pinch the clean skin area with one hand and hold it firmly.

• Hold the syringe in the other hand at an angle of45degrees to the skin.
• With a short and quick movement, insert the entire needle into the skin.
• Push the plunger to inject the solution. It may take10seconds to empty the syringe.
• When the syringe is empty, carefully remove the needle from the skin at the same angle that it was inserted.
• Release the skin area that you were holding with your first hand.
• Using a small piece of cotton, press on the injection site for a few seconds.

-Do not rub the injection site.

-You may cover the injection site with a sticking plaster if necessary.

4.After use

• Do not re-use the syringe or put the cap back on the needle.
• After the injection, dispose of the used syringe immediately in a special container as explained by your doctor, nurse or pharmacist.

• Keep the container out of sight and reach of children.
• If you need to administer a second injection as prescribed by your doctor, repeat the injection process starting from step2.