How does it work?

Cimzia injection contains the active ingredient certolizumab pegol, which is a type of medicine called a tumour necrosis factor alpha (TNF alpha) blocker. It works by suppressing the process of inflammation.

TNF alpha is a protein produced by the body that is involved in causing inflammation. It controls the activity of other inflammatory chemicals.

TNF alpha is found in increased levels in various inflammatory conditions. It is found in the inflamed joints of people with rheumatoid arthritis and in the joints of people who have a type of arthritis affecting the spine, called ankylosing spondylitis. It is also found in increased levels in skin affected by psoriasis, as well as in the joints of people who have a type of of arthritis called psoriatic arthritis, which can occur in people with psoriasis.

Inflammation occurs when TNF alpha acts on TNF receptors that are found on the surface of cells. Certolizumab pegol works by stopping TNF alpha from acting on these receptors. This prevents the inflammatory responses TNF alpha causes.

In arthritic conditions, treatment with certolizumab pegol reduces the movement of inflammatory cells into inflamed areas of the joints. This reduces the signs and symptoms of the arthritis, improves physical function of the joints and reduces the rate of joint damage. When treating arthritis, certolizumab pegol is referred to as a disease-modifying antirheumatic drug (DMARD).

Certolizumab pegol is only prescribed by specialists experienced with treating rheumatoid arthritis.It is administered as an injection under the skin (subcutaneously) once everyother week.

Improvements in the symptoms of rheumatoid arthritis should be seen within 12 weeks of starting treatment.

What is it used for?

• Moderate to severe rheumatoid arthritis.

Certolizumab pegol is used in combination with methotrexate, when otherDMARDs, for example sulfasalazine, methotrexatehave not been effective. It can also be used for people with severe activeprogressive rheumatoid arthritis who have not previously been treated withmethotrexate. Certolizumab pegol can also be used on its own for people who can’t takemethotrexate, or when continued treatment with methotrexate isinappropriate.

Warning!

• This medicine can compromise the body's ability to fight infections. Cases of tuberculosis (TB) and other serious infections have been seen in people treated with this medicine. You should be tested for TB before treatment is started. Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, or in the five months after your treatment has finished, as these can be symptoms of TB.
• It is important to try and avoid exposure to infections during your treatment. Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay. This also applies for five months after you stop using this medicine, as this is how long it may take for the medicine to be fully removed from the body. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled.
• This medicine may decrease the number of certain blood cells in the blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you should tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) other signs of infection, or looking pale, feeling tired, breathless, or generally unwell. Your doctor may need to take a blood test to check the levels of blood cells in your blood.
• If you develop new or worsening symptoms of heart failure during treatment with this medicine, for example shortness of breath or swelling of your feet or ankles, you should tell your doctor immediately.
• Consult your doctor immediately if you experience any of the following symptoms while receiving treatment with this medicine: unexplained confusion, numbness, changes in vision or difficulty walking.
• Certain types of cancer have uncommonly been reported in people treated with this medicine, or with other TNF blockers. This risk is increased in heavy smokers. It is important to discuss with your doctor your risk of cancer relative to the potential benefit to you of this medicine, before you start treatment.
• If you are due to have any surgery or dental procedures, it is important to tell your doctor or dentist that you are having treatment with this medicine.
• Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment with this medicine and for at least five months after their last injection. Seek medical advice from your doctor.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• People with a history of hepatitis B.
• Dormant tuberculosis infection.
• People with a history of recurrent infections.
• People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
• Mild heart failure.
• Demyelinating disorders such as multiple sclerosis.
• People who are due to have a joint surgically repaired.
• History of or current cancer.
• Heavy smokers.
• Chronic obstructive pulmonary disease (COPD).
• Allergy to latex (the needle cover of the syringe contains latex).

Not to be used in

• Children and adolescents under 18 years of age.
• Active tuberculosis.
• People with severe infections, eg abscesses, leg ulcers.
• People with infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
• People with infections due to lowered resistance of the body (opportunistic infections).
• Moderate to severe heart failure.
• Pregnancy.
• Breastfeeding.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• There is no information about the safety of this medicine during pregnancy. It is not recommended for use during pregnancy as it could potentially be harmful to a developing baby. Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and for at least five months after their last injection. If you think you could be pregnant at any point during treatment you should tell your doctor straight away. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk, however it is possible that it does. It should only be used to treat women who are breastfeeding if the benefits to the mother outweigh any possible risk to the nursing infant. It is important to seek further medical advice from your doctor before breastfeeding if you are being treated with this medicine.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Bacterial, viral or fungal infections, sometimes serious.
• Reactions such as pain, swelling, redness, bruising, bleeding or itching at the injection site.
• Decreased numbers of red blood cells, white blood cells or platelets in the blood.
• Headache.
• Fever.
• Increased blood pressure.
• Inflammation of the liver (hepatitis).
• Rash and itching of skin.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Allergic reactions.
• Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
• Cancer of solid organs.
• Benign tumours or cysts.
• Skin cancer or precancerous lesions.
• Anxiety.
• Mood changes.
• Inflammation of blood vessels.
• Dizziness.
• Eye disorders.
• Heart problems.
• Blood clot in a blood vessel (deep vein thrombosis or pulmonary embolism).
• Cough.
• Asthma.
• Skin reactions such as eczema, psoriasis, acne, discolouration, photosensitivity.
• Hair loss.
• Muscle disorders.
• Flu-like symptoms.
• Inflammation of the gut.
• Changes in menstrual cycle.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Lymphoma.
• Cancer of the gut.
• Thyroid disorders.
• Mental disturbances, such as suicide attempts, delirium.
• Ringing in the ear (tinnitus).
• Sarcoidosis.
• Sexual dysfunction.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.

For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Certolizumab pegol is not recommended for use in combination withanakinra or abatacept, as this combination may increase the risk of serious infections,without an increase in efficacy against the disease treated.

This medicine suppresses part of the immune system. This meansthat vaccines may potentially be less effective if given during treatment, andlive vaccines may cause serious infections. Live vaccines include: measles,mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It isrecommended that live vaccines are not given to people being treated with thismedicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain certolizumab pegol as the active ingredient.