200 mg injection , solution in prefilled pen
certolizumab pegol
1. What Cimzia is and what it is used for
Cimzia contains the active substance certolizumab pegol, which is part of a human antibody. Antibodies are proteins that specifically recognize and bind to other proteins. Cimzia binds to a specific protein called tumor necrosis factor α (TNFα) and this reduces inflammation in diseases such as rheumatoid arthritis, axial spondylitis, psoriatic arthritis, and psoriasis. Drugs that bind to TNFα are also called TNFinhibitors.
Cimzia is used in adults for the following inflammatory diseases:
- rheumatoid arthritis,
- axial spondylarthritis (including ankylosing spondylitis and axial spondylarthritis without radiographic evidence of ankylosing spondylitis ),
- psoriatic arthritis
- plaque psoriasis .
Rheumatoid arthritis
Cimzia is used to treat rheumatoid arthritis. Rheumatoid arthritis is an inflammatorydisease of the joints. If you have moderate to severe, active rheumatoid arthritis, you may first be given other medicines, usually methotrexate. If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to treat your rheumatoid arthritis. If your doctor thinks methotrexate is inappropriate, Cimzia can be given alone.
Cimzia in combination with methotrexate can also be used to treat severe, active, and progressive rheumatoid arthritis without the prior use of methotrexate or other drugs.
Cimzia, which you should take in combination with methotrexate, is used to:
- reduce the signs and symptoms of your disease,
- slow damage to cartilage and bone in the joints caused by the disease,
- improve your physical function and ability to perform daily tasks.
Ankylosing spondylitis and axial spondylarthritis without radiographic evidence of ankylosing spondylitis
Cimzia is used to treat severe, active ankylosing spondylitis and axial spondylarthritis without radiographic signs of ankylosing spondylitis (sometimes called non-radiographic axial spondylarthritis). These diseases are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondylarthritis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cimzia to:
- reduce the signs and symptoms of your disease,
- improve your physical function, and ability to perform daily tasks.
Psoriatic arthritis
Cimzia is used to treat active psoriatic arthritis. Psoriatic arthritis is an inflammatorydisease of the joints, usually associated with psoriasis . If you have active psoriatic arthritis, you will first be given other medicines, usually methotrexate. If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to:
- reduce the signs and symptoms of your disease,
- improve your physical function and ability to perform daily tasks.
If your doctor thinks methotrexate is inappropriate, Cimzia can be given alone.
Plaque psoriasis
Cimzia is used to treat moderate to severe plaque psoriasis. Plaque psoriasis is an inflammatory skin disease, a disease that can also affect the scalp and nails.
Cimzia is used to reduce skin inflammation and other signs and symptoms of your disease.
2. What you need to know before using Cimzia
DO NOT use Cimzia
- if you are ALLERGIC (hypersensitive) to certolizumabpegol or any of the other ingredients of this medicine (listed in section 6).
- if you have a severe infection including active TUBERCULOSIS (TB)
- if you have moderate to severe heart failure. Tell your doctor if you have or have had a severe heart condition.
Warnings and cautions
Tell your doctor before taking Cimzia if any of the following apply 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. Some of these reactions may occur after the first administration of Cimzia.
- If you have ever had an allergic reaction to latex.
Infection is
- If you have had recurring or opportunistic INFECTION ER or other conditions that increase the risk of infection you (such as treatment with immunosuppressants, which are medicines that could reduce your ability to resist infection s).
- If you have an infection or if you develop symptoms such as fever, sores, fatigue, or dental problems. You can more easily get an infection while you are being treated with Cimzia, including severe or, in rare cases, life-threatening infections.
- Cases of TUBERCULOSIS (TB) have been reported in patients treated with Cimzia. Your doctor will check if you have signs or symptoms of tuberculosis before starting treatment with Cimzia. This includes a thorough review of medical history, chest X-ray, and tuberculin test. The performance of these tests should be noted on your reminder card. If latent (inactive) tuberculosis is diagnosed, you may need to be given the appropriate medicine for tuberculosis before starting treatment with Cimzia. In rare cases, tuberculosis can develop during treatment, even though you have received preventive treatment for tuberculosis. It is very important that you tell your doctor if you have had it before tuberculosis or if you have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, lethargy/lethargy, mild fever) or any other infection occurs during or after treatment with Cimzia, tell your doctor immediately.
- If you are at risk for or have a carrier of or have an active HEPATIT B VIRUS (HBV) infection, Cimzia may increase the risk of recurrence in people who carry this virus. If this happens, stop using Cimzia. Your doctor should check if you have HBV before starting treatment with Cimzia.
Heart failure
- If you have mild heart failure and you are being treated with Cimzia, your heart failure should be closely monitored by your doctor. It is important to tell your doctor if you have or have had a serious heart condition. If you develop new or worsening symptoms of heart failure (eg shortness of breath or swelling in your feet), you must contact your doctor immediately. Your doctor may decide to stop your treatment with Cimzia.
Cancer
- It is less common, but cases of certain types of CANCER have been reported in patients treated with Cimzia or other TNF inhibitors. People with more severe rheumatoid arthritis who have had the disease for a long time may have a higher-than-average risk of developing a type of cancer that affects the lymphatic system, called lymphoma. Using Cimzia may increase the risk of getting lymphoma or other cancers. In addition, less common causes of skin cancer other than melanoma have been observed in patients receiving Cimzia. If new skin changes occur during or after treatment with Cimzia or if existing skin changes change, tell your doctor.
- There have been cases of cancer, including unusual forms, in children and adolescents who have taken TNF inhibitors, which have sometimes led to death (see below under “Children and adolescents”).
Other diseases
- Patients with chronic obstructive pulmonary disease (COPD) or who are heavy smokers may be at increased risk of cancer during treatment with Cimzia. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF inhibitor is suitable for you.
- If you have a disease of the nervous system such as multiple sclerosis, your doctor will decide whether to use Cimzia.
- In some patients, the body cannot produce enough of the blood cells that help the body resist infection or stop bleeding. If you develop a fever that does not go away, get bruises, or bleed very easily or become very pale, you should contact a doctor immediately. Your doctor may decide to stop your treatment with Cimzia.
- It is less common, but symptoms of a disease called lupus (eg, persistent rash, fever, joint pain, and fatigue) may occur. If you experience these symptoms, consult a doctor. Your doctor may decide to stop your treatment with Cimzia.
Vaccinations
- Discuss with your doctor if you have had or will soon receive a vaccination. You should not take certain (live) vaccines during treatment with Cimzia.
- Some vaccinations can cause infection. If you received Cimzia when you were pregnant, your baby may be at increased risk of getting such an infection for about five months after the last dose you received during pregnancy. It is important that you tell your child’s doctor and other healthcare professionals about your use of Cimza so that they can decide when your child should be vaccinated.
Operations and dental treatments
- Discuss with your doctor if you are going to have any surgery or dental treatment. Tell the surgeon or dentist who will perform the treatment that you are being treated with Cimzia by showing your reminder card.
Children and young people
Cimzia is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Cimzia
You should NOT use Cimzia if you are using the following medicines to treat rheumatoid arthritis:
- anakinra
- abatacept.
If you have any further questions, ask your doctor.
Cimzia can be taken with:
- methotrexate
- corticosteroid is or
- painkillers including non-steroidal anti-inflammatory drugs (also called NSAIDs ).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
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.
There is limited experience with Cimzia in pregnant women.
Cimzia should only be used during pregnancy if really needed. If you are a woman of childbearing potential, consult your doctor about using an effective method of contraception during treatment with Cimzia. For women planning to have children, continued use of the contraceptive method may be considered for 5 months after the last dose of Cimzia.
If you received Cimzia during pregnancy, your baby may be at increased risk of getting an infection. It is important that you tell your child’s doctor and other healthcare professionals about your use of Cimzia before the child receives any vaccine (for more information see the section on vaccinations).
Cimzia can be used during breast-feeding.
Driving and using machines
Cimzia may have a minor effect on your ability to drive and use machines. Dizziness (including a feeling of dizziness, blurred vision, and tiredness) may occur after taking Cimzia.
Cimzia contains sodium acetate and sodium chloride
This medicine contains less than 1 mmol sodium (23 mg) per 400 mg, ie essentially ‘sodium-free’.
3. How to use Cimzia
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Rheumatoid arthritis
- The starting dose for adults with rheumatoid arthritis is 400 mg week 0, 2, and 4.
- This dose is followed by a maintenance dose of 200 mg every two weeks. If you respond to treatment, your doctor may prescribe an alternative maintenance dose of 400 mg every four weeks.
- Methotrexate treatment is continued while you are taking Cimzia. If your doctor decides that methotrexate is inappropriate, Cimzia can be given alone.
Axial spondylarthritis
- The starting dose for adults with axial spondyloarthritis is 400 mg and is given at 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), according to your doctor’s instructions. If you have been taking Cimzia for at least one year and respond to treatment, your doctor may prescribe a lower maintenance dose of 200 mg every four weeks.
Psoriatic arthritis
- The starting dose for adults with psoriatic arthritis is 400 mg given at weeks 0, 2, and 4.
- This is followed by a maintenance dose of 200 mg every two weeks. If you respond to treatment, your doctor may prescribe an alternative maintenance dose of 400 mg every four weeks.
- Methotrexate treatment is continued while you are taking Cimzia. If your doctor thinks methotrexate is inappropriate, Cimzia can be given alone.
Plaque psoriasis
- The starting dose for adults with plaque psoriasis is 400 mg every two weeks (given at weeks 0, 2, and 4).
- This is followed by a maintenance dose of 200 mg every other week or 400 mg every other week, according to your doctor’s instructions.
How Cimzia should be given
Cimzia is usually given by a specialist or healthcare professional. You will receive Cimzia either as one ( 200 mg dose ) or two ( 400 mg dose ) injection (s) under the skin ( subcutaneously, abbreviated sc). An injection is usually given in the thigh or abdomen. However, do not inject into an area where the skin is red, hard, or bruised
Instructions for injecting Cimzia yourself
After appropriate training, your doctor may also allow you to inject Cimzia yourself. Read the instructions on how to inject Cimzia at the end of this leaflet.
If your doctor has allowed you to inject yourself, follow up with your doctor before continuing to inject yourself:
- after 12 weeks if you have rheumatoid arthritis, axial spondylarthritis or psoriatic arthritis, or
- after 16 weeks if you have plaque psoriasis.
Your doctor will then decide if Cimzia works for you or if other treatment needs to be considered.
If you use more Cimzia than you should
If your doctor has allowed you to inject yourself and you have accidentally injected Cimzia more often than prescribed, talk to your doctor. Always bring the Cimzia reminder card and outer carton, even if it is empty.
If you forget to use Cimzia
If your doctor has allowed you to inject yourself and you forget to give yourself an injection, inject the next dose of Cimzia as soon as you remember. Then talk to your doctor and inject the following dose as 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 product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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 an allergic reaction ( urticaria )
- swelling of the face, hands, feet ( angioedema )
- difficulty breathing or swallowing (several causes of these symptoms)
- shortness of breath during exertion or lying down, or swollen feet ( heart failure )
- symptoms of blood diseases such as persistent fever, bruising, bleeding, pallor (pancytopenia, anemia, low platelet count, low white blood cell count ).
- severe skin rash. These can appear as reddish target-like or round spots on the torso, often with blisters in the middle, scaly skin, sores in the mouth, throat, nose, genitals, and eyes and may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome ).
Tell your doctor as soon as possible if you notice any of the following side effects:
- signs of infection such as fever, malaise, sores, dental problems, burning when urinating
- the feeling of weakness or fatigue
- cough
- knitting
- numbness
- double vision
- weakness in arms or legs
- lumps or open wounds that do not heal.
The symptoms described above may be due to some of the side effects listed below, which have been observed with Cimzia:
Common side effects (may affect up to 1 in 10 people):
- bacterial infection somewhere (warning collection)
- viral infections (including cold sores, shingles, and flu )
- fever
- high blood pressure
- rash or itching
- headache (including migraine )
- emotional disturbances such as numbness, tingling, burning
- a feeling of weakness and the general feeling of illness
- pain
- blood disorders
- liver problem
- injection site reactions
- nausea
Uncommon side effects (may affect up to 1 in 100 people):
- allergic conditions including allergic rhinitis and allergic reactions to the drug (including anaphylactic shock )
- Antibodies are directed against normal body tissue
- cancer of the blood and lymphatic systems such as lymphoma and leukemia
- cancer of solid organs
- skin cancer, skin changes (precursors to cancer)
- benign tumors and cysts (including in the skin)
- heart problems including weakened heart muscle, heart failure, heart attack, discomfort or pressure over the chest, abnormal heart rhythm including irregular heartbeat
- edema (swelling of the face or legs)
- symptoms of lupus (immunological connective tissue disease) (joint pain, rash, photosensitivity, and fever)
- inflammation of blood vessels
- blood poisoning (serious infection that can cause organ failure, shock, or death)
- tuberculosis infection
- fungal infections (occurs when the resistance to infection is reduced)
- Respiratory disorders and inflammation (including asthma, shortness of breath, cough, blocked sinuses, pneumonia or difficulty breathing)
- Stomach problems including fluid in the abdominal cavity, ulcers (including ulcers in the oral mucosa), holes in the gastrointestinal tract, distension, inflammation, heartburn, upset stomach, dry mouth
- problems with bile
- muscle problems including increased muscle enzymes
- changes in the levels of various salts in the blood
- changes in cholesterol and fat levels in the blood
- blood clots in veins or lungs
- bleeding or bruising
- change in the number of blood cells including a low number of red blood cells ( anemia ), low or high number of platelets
- swollen lymph nodes
- flu-like symptoms, chills, altered temperature sensation, night sweats, flushing redness
- anxiety and mood swings such as depression, appetite disturbances, weight change
- tinnitus (ringing in the ears)
- fraud (dizziness)
- fainting sensation including unconsciousness
- nerve disorders in the arms and legs including symptoms such as numbness, tingling, burning, dizziness, tremors
- skin disorders such as new onset or worsening psoriasis, inflammation of the skin (such as eczema ), disorders of the sweat glands, ulcers, photosensitivity, acne, hair loss, discoloration, nail loss, dry skin, and damage
- impaired healing
- kidney and urinary problems including renal impairment, blood in the urine, and urinary disorders
- menstrual cycle disorders including no bleeding or heavy or irregular bleeding
- breast diseases
- inflammation of the eyes and eyelids, visual disturbances, problems with tear production
- increase in certain blood levels (increase in alkaline phosphatase in the blood)
- prolonged coagulation time in blood tests
Rare side effects (may affect up to 1 in 1,000 people):
- cancer of the gastrointestinal tract, melanoma
- pneumonia (interstitial lung disease, pneumonia )
- stroke, blockage in the blood vessels ( arteriosclerosis ), poor blood circulation that makes toes and fingers pale and numb (Raynaud’s phenomenon), discoloration of the skin in the form of purple spots, small vessels under the skin may become visible
- pericarditis
- cardiac arrhythmia
- enlarged spleen
- the increased amount of red blood cells
- abnormal appearance of white blood cells
- gallstone
- kidney problems (including kidney inflammation)
- immune system disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of adipose tissue, angioneurotic edema (swollen lips, face, throat)
- thyroid disorders ( goiter , fatigue, weight loss)
- increased level of iron in the body
- increased level of uric acid in the blood
- suicide attempt, impaired mental function, delirium
- inflammation of the auditory nerve, optic nerve, or facial nerves, impaired coordination or balance
- increased bowel movements
- fistulas (channel from one organ to another) (anywhere in the body)
- disorders of the oral cavity including pain when swallowing
- flaking of the skin, the formation of blisters, changes in hair texture
- sexual disorders
- (cramp) seizures
- worsening of a condition called dermatomyositis (skin rash accompanied by muscle weakness)
- Stevens-Johnson syndrome (a serious condition of the skin where early symptoms include malaise, fever, headache, and rash)
- inflammatory skin rash (erythema multiforme)
- lichenoid reactions (itchy red-purple rash and/or thread-like white ‑ gray lines on mucous membranes)
Has been reported (occurs in an unknown number of users):
- multiple sclerosis*
- Guillain-Barré syndrome *
- Merkel cell carcinoma (a type of skin cancer) *
- Kaposi’s sarcoma , rare cancer associated with infection with human herpesvirus 8 Kaposi sarcoma occurs most often as purple spots on the skin.
* These side effects have been linked to this group of drugs but the prevalence of Cimzia is unknown.
Other side effects are
When Cimzia has been used to treat other diseases, the following less common side effects have occurred:
- stenosis of the gastrointestinal tract (narrowing of the gastrointestinal tract)
- obstruction of the gastrointestinal tract (blockage of the gastrointestinal tract)
- general deterioration of physical health
- miscarriage
- azoospermia (lack of sperm production)
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information
5. How to store Cimzia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Keep the pre-filled pen in the outer carton. Sensitive to light.
The pre-filled pens can be stored at room temperature (maximum 25 ° C) for a single period of not more than 10 days with light protection. At the end of this period, the pre-filled pens must be used or discarded .
Do not use this medicine if the solution is discolored, cloudy, or if you see particles in it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is certolizumabpegol. Each pre-filled pen contains 200 mg of certolizumab pegol in 1 ml.
- The other ingredients are Sodium acetate, sodium chloride, and water for injections (see “Cimzia contains sodium acetate and sodium chloride” in section 2).
What the medicine looks like and the contents of the pack
Cimzia provided as an injection solution in a pre-filled pen (AutoClicks) ready to use. The solution is clear to opalescent, colorless to yellow.
A Cimzia package contains:
- 2 AutoClick pre-filled pens with solution and
- 2 disinfectant wipes (for cleaning the injection site).
Packs of 2 pre-filled pens and 2 disinfectant wipes, multi-pack of 6 (3 packs of 2) pre-filled pens and 6 (3 packs of 2) disinfectant wipes and multi-pack of 10 (5 packs of 2) pre-filled pens and 10 (5 packs of 2) disinfectant wipes are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
UCB Pharma SA
Research Avenue 60
B-1070 Brussels
Belgium
Manufacturer
UCB Pharma SA
Chemin du Foriest
B-1420 Braine l’Alleud
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine: