Cimzia 200 mg solution for injection

Cimzia contains the active substance certolizumab pegol, a human antibody fragment. Antibodies are proteins that specifically recognise and bind to other proteins. Cimzia binds to a specific protein called tumour necrosis factor ? (TNF?). Thereby this TNF? is blocked by Cimzia and this decreases inflammation in rheumatoid arthritis. Medicines that bind to TNF? are also called TNF blockers.

Cimzia is used for the treatment of moderate to severe rheumatoid arthritis in adult patients, when other medicines fail to control your symptoms. Cimzia is usually used together with another medicine called methotrexate. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.

Do NOT use Cimzia

• If you are ALLERGIC (hypersensitive) to certolizumab pegol or any of the other ingredients of Cimzia
• If you have a severe infection, including active TUBERCULOSIS (TB).
• If you have moderate to severe HEART FAILURE. Tell your doctor if you have had or have a serious heart condition.

Take special care with Cimzia

Tell your doctor before treatment with Cimzia if any of the following applies to you: Allergic reactions

• If you experience ALLERGIC REACTIONS such as chest tightness, wheezing, dizziness, swelling or rash, stop using Cimzia and contact your doctor IMMEDIATELY.

Infections

• If you have had RECURRENT INFECTIONS or other conditions that increase the risk of infections (such as treatment with immunosuppressants, which are medicines that could reduce your ability to fight infections).
• If you have an infection or if you develop symptoms such as fever, wounds, tiredness or dental problems. You might get an infection more easily while you are being treated with Cimzia, including serious, or in rare cases, life-threatening infections.
• TUBERCULOSIS (TB) cases have been reported in patients treated with Cimzia, your doctor will check you for signs and symptoms of tuberculosis before starting Cimzia. This will include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on your Patient Alert Card. If latent (inactive) tuberculosis is diagnosed, you might be required to receive appropriate anti-tuberculosis medicines before starting Cimzia. It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy with Cimzia tell your doctor immediately.
• If you are at risk of or are a carrier of or have active HEPATITIS B VIRUS (HBV) infection, Cimzia may increase the risk of reactivation in people who carry this virus. If this occurs, you should stop using Cimzia.

Heart failure

• If you have mild HEART FAILURE and you are being treated with Cimzia, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath or swelling of your feet), you must contact your doctor immediately. Your doctor may decide to stop treatment with Cimzia.

Cancer

• It is uncommon, but cases of certain types of CANCER have been reported in patients treated with Cimzia or other TNF blockers. People with more severe rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma. If you take Cimzia, your risk of getting lymphoma or other cancers may increase. In addition, uncommon cases of non-melanoma skin cancer have been observed in patients taking Cimzia. If new skin lesions appear during or after therapy with Cimzia or existing skin lesions change appearance, tell your doctor. Patients with chronic obstructive pulmonary disease (COPD), or who are heavy smokers, may be at increased risk for cancer with Cimzia treatment. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
• There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death (see further down ?Children?).

Other disorders

• If you have a nervous system disorder, such as multiple sclerosis, your doctor will decide whether you should use Cimzia.
• 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 immediately. Your doctor may decide to stop treatment with Cimzia.
• It is uncommon, but symptoms of a disease called lupus (for example persistent rash, fever, joint pain and tiredness) may occur. If you experience these symptoms, contact your doctor. Your doctor may decide to stop treatment with Cimzia.

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 Cimzia.

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 Cimzia by showing them your Patient Alert Card.

Children

Cimzia is not recommended for use in children and adolescents under the age of 18 years.

Taking other medicines

You should NOT take Cimzia if you are using the following medicines used to treat rheumatoid arthritis:

• anakinra
• abatacept If you have questions, please ask your doctor.

Cimzia can be taken together with:

• methotrexate,
• corticosteroids, or
• pain medicines including nonsteroidal anti-inflammatory medicines (also called NSAIDs).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

There is a lack of experience with Cimzia in pregnant women. Therefore, Cimzia should NOT be used in pregnant women. Women of childbearing potential must use adequate contraception while using Cimzia and for at least 5 months after the last Cimzia treatment.

It is not known whether Cimzia passes into breast milk. You should talk to your doctor before breast-feeding during Cimzia treatment.

Driving and using machines
Cimzia may have a minor influence on your ability to drive and use machines. Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Cimzia.

Important information about some of the ingredients of Cimzia

This medicinal product contains less than 1 mmol sodium (23 mg) per 400 mg, i.e. essentially ?sodium-free?.

Always use Cimzia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure of how to use Cimzia.

The starting dose for adults with rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4. This is followed by a maintenance dose of 200 mg every other week starting at week 6. Methotrexate is continued while using Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.

Cimzia will usually be given to you by a specialist doctor or healthcare professional. You will be given Cimzia as either one (200 mg dose) or two injections (400 mg dose) under the skin (subcutaneous use). It is usually injected into the thigh or tummy.

Instructions for preparing and giving an injection of Cimzia

After suitable training, your doctor may also allow you to inject Cimzia yourself. Please read the instructions at the end of this leaflet on how to inject Cimzia.

th dose If your doctor has allowed you to self-inject, you should follow up with your doctor before the 7to have the doctor determine if Cimzia is working for you or if another treatment needs to be considered.

If you use more Cimzia than you should

If your doctor has allowed you to self-inject and you accidentally inject Cimzia more frequently than prescribed, you should tell your doctor. Always take the Patient Alert Card and the outer carton from the Cimzia package with you, even if it is empty.

If you forget to use Cimzia

If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject the next dose of Cimzia as soon as you remember. Then inject the following doses every 2 weeks as originally instructed.

If you stop using Cimzia

Do not stop using Cimzia without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Cimzia can cause side effects, although not everybody gets them.

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

• severe rash, hives or other signs of allergic reaction (urticaria)
• swollen face, hands, feet (angioedema)
• trouble breathing, swallowing (multiple causes for these symptoms)
• shortness of breath with exertion or upon lying down or swelling of the feet (heart failure)
• symptoms of blood disorders such as persistent fever, bruising, bleeding, paleness (pancytopaenia, anaemia, low platelet count, low white blood cell count)

Tell your doctor AS SOON AS POSSIBLE if you notice any of the following side effects:

• signs of infection such as fever, malaise, wounds, dental problems, burning on urination feeling weak or tired
• coughing.
• tingling
• numbness
• double vision
• arm or leg weakness
• bump or open sore that doesn't heal

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

Side effects may occur with certain frequencies, which are defined as follows:

• Very common: affects at least 1 user in 10.
• Common: affects at least 1 user in 100 but less than 10 users in 100.
• Uncommon: affects at least 1 user in 1,000 but less than 10 users in 1,000.
• Rare: affects at least 1 user in 10,000 but less than 10 users in 10,000.
• Very rare: affects less than 1 user in 10,000.
• not known: frequency cannot be estimated from the available data.

Common side effects:

• bacterial infections in any site (a collection of pus)
• viral infections (including cold sores, shingles, and influenza)
• fever
• high blood pressure
• rash or itching
• headaches (including migraines)
• sensory abnormalities such as numbness, tingling, burning sensation
• feeling weak and generally unwell
• pain
• blood disorders
• liver problems
• injection site reactions

Uncommon side effects:

• allergic conditions including allergic rhinitis and allergic reactions to the drug (including anaphylactic shock)
• blood and lymphatic system cancers like lymphoma and leukaemia
• solid organ cancers
• skin cancers, pre-cancers
• benign (non-cancerous) tumours and cysts (including those of the skin)
• heart problems including weakened heart muscle, heart failure, heart attack, chest discomfort or chest pressure, abnormal heart rhythm including irregular heart beats
• oedema (swelling in the face or legs)
• lupus (immune/connective tissue disease) symptoms (joint pain, skin rashes, photosensitivity and fever)
• inflammation of the blood vessels
• sepsis (serious infection which can result in organ failure, shock or death)
• tuberculosis infection
• fungal infections (occur when the ability to fight off infection is lessened)
• respiratory disorders and inflammation (including asthma, shortness of breath, cough, blocked sinuses, pleurisy, or difficulty breathing)
• stomach problems including abdominal fluid collection, ulcers (including oral ulcers), perforation, distension, inflammation heartburn, upset, dry mouth
• bile problems
• muscle problems including increased muscle enzymes
• changes in blood levels of different salts
• changes in cholesterol and fat levels in the blood
• blood clots in the veins or lungs
• bleeding or bruising
• changed numbers of blood cells, including low red cell count (anaemia), low platelet counts, increased platelet counts
• swollen lymph nodes
• flu-like symptoms, chills, altered temperature perception, night sweats, flushing
• anxiety and mood disorders such as depression, appetite disorders, weight change
• vertigo (dizziness)
• feeling faint, including loss of consciousness
• nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation, dizziness, tremor
• skin disorders such as new onset or worsening of psoriasis, sweat gland disorders, ulcers, photosensitivity, acne, hair loss, discoloration, nail separation, dry skin and injuries
• impaired healing
• kidney and urinary problems including impairment of kidney function, blood in the urine and urinary disturbances
• menstrual cycle (monthly period) disorders including lack of bleeding, or heavy or irregular bleeding
• breast disorders
• eye and eyelid inflammation, vision disturbances, problems with tears
• itching
• prolonged coagulation (clotting) test times

Rare side effects:

• gastrointestinal cancer, melanoma
• lung inflammation
• stroke, blockage in blood vessels
• enlarged spleen
• Formation of stones in the gall bladder
• immune disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of the fat tissue, angioneurotic oedema (swelling of the lips, face, throat)
• thyroid disorders (goitre, tiredness, weight loss)
• changes in blood levels of uric acid (increased)
• suicide attempt, mental impairment, delirium
• inflammation of the nerves for hearing, seeing, or of the face, impaired coordination or balance
• ringing in the ears
• increased gastrointestinal motility
• fistula (tract from one organ to another) (any site)
• oral disorders including pain on swallowing
• skin sloughing, blistering, hair texture disorder
• sexual dysfunction
• seizure

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

• Gastrointestinal stenosis (narrowing of part of the digestive system).
• Gastrointestinal obstructions (blockages of the digestive system).
• General physical health deterioration.
• Spontaneous abortion.
• Azoospermia (lack of sperm production).

When other TNF blockers have been used to treat rheumatoid arthritis, multiple sclerosis or Guillain-Barré syndrome have occurred. The risk of multiple sclerosis or Guillain-Barré syndrome with Cimzia is not known.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Cimzia after the expiry date which is stated on the pack and syringe after EXP. The expiry date refers to the last day of the month.

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.

What Cimzia contains

• The active substance is certolizumab pegol. Each pre-filled syringe contains 200 mg of certolizumab pegol in one ml.
• The other ingredients are: sodium acetate, sodium chloride and water for injections.

What Cimzia looks like and contents of the pack

One Cimzia pack contains:

• two pre-filled syringes of solution, and
• two alcohol wipes (for cleansing the areas chosen for injection).

None of the components of the syringe contain latex.
Packs of 2 syringes and 2 alcohol wipes, and a multipack containing 6 (3 packs of 2) syringes and 6 (3 packs of 2) alcohol wipes are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

UCB Pharma SA
Allée de la Recherche 60
B-1070 Bruxelles
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien UCB Pharma SANV TelTél 32 02 559 92 00 LuxembourgLuxemburg UCB Pharma SANV TélTel 32 02 559 92 00

Te. 359 0 2 962 30 49 Magyarország UCB Magyarország Kft. Tel. 36-1 391 0060

eská republika UCB s.r.o. Tel 420 221 773 411 Malta Pharmasud Ltd. Tel 356 21 37 64 36

Danmark UCB Nordic AS Tlf 45 32 46 24 00 Nederland UCB Pharma B.V. Tel. 31 076-573 11 40

Deutschland UCB Pharma GmbH Tel 49 0 2173 48 4848 Norge UCB Nordic AS Tlf 45 32 46 24 00

Eesti UCB Pharma Oy Finland Tel 358 10 234 6800 Österreich UCB Pharma GmbH Tel 43 1 291 80 00

UCB .. 30 2109974000 Polska UCB Pharma Sp. z o.o. Tel. 48 22 696 99 20

España UCB Pharma, S.A. Tel 34 91 570 34 44 Portugal UCB Pharma Produtos Farmacêuticos, Lda Tel 351 21 302 5300

France UCB Pharma S.A. Tél 33 01 47 29 44 35 România UCB Pharma Romania S.R.L. Tel 40 21 300 29 04

Ireland UCB Pharma Ireland Ltd. Tel 353 01-46 37 395 Slovenija Medis, d.o.o. Tel 386 1 589 69 00

Ísland Vistor hf. Tel 354 535 7000 Slovenská republika UCB s.r.o., organizaná zloka Tel 421 0 2 5920 2020

Italia UCB Pharma S.p.A. Tel 39 02 300 791 SuomiFinland UCB Pharma Oy Finland PuhTel 358 10 234 6800

Lifepharma Z.A.M. Ltd 357 22 34 74 40 Sverige UCB Nordic AS Tel 46 0 40 29 49 00

Latvija UCB Pharma Oy Finland Tel 358 10 234 6800 United Kingdom UCB Pharma Ltd. Tel 44 01753 534 655

Lietuva

UCB Pharma Oy Finland
Tel: + 358 10 234 6800

This leaflet was last approved in {MM/YYYY}

INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF CIMZIA

After proper training, the injection can be self-administered or given by another person, for example a family member or friend. The following instructions explain how to inject Cimzia. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or healthcare giver on the technique of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

This injection should not be mixed in the same syringe with any other medicine.

1. Setting up

• Wash your hands thoroughly.
• Remove the following items from the Cimzia carton and set them up on a clean surface:

One pre-filled syringe One alcohol wipe Look at the expiry date on the syringe and pack. Do not use Cimzia after the expiry date which is stated on the pack and syringe after EXP. The expiry date refers to the last day of the month shown. Allow the pre-filled syringe to reach room temperature. This will take up to 30 minutes. Do not try to warm up the syringe.

2. Choosing and preparing an injection site

• Choose a site on your thigh or tummy.
• Each new injection should be given on a separate site from the last injection site. - Do not inject in an area where the skin is reddened, bruised, or hard. - Wipe the injection site with the enclosed alcohol wipe, using a circular motion moving from the inside out. - Do not touch the area again before injecting.

3. Injection

• Do NOT shake the syringe.
• Remove the cap from the needle, being careful not to touch the needle or let the needle touch any surface.
• Hold the syringe with needle facing up.
• Tap the syringe to push any air bubbles to the top.
• Press the plunger slowly until you expel any air. Stop when a small drop appears at the tip of the needle.
• Gently grasp the cleaned area of skin with one hand and hold firmly.

With the other hand, hold syringe at a 45-degree angle to skin. With one quick, short motion, push the needle all the way into the skin. Push plunger to inject solution. It can take up to 10 seconds to empty the syringe. When the syringe is empty, carefully remove the needle from the skin at the same angle at which it was inserted. Release the skin with the first hand. Use a piece of gauze, apply pressure over the injection site for a few seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.

4. Throwing away supplies

• You must NOT re-use the syringe or re-cap the needle.
• After injection, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
• Keep the container out of the reach and sight of children.