Certolizumab pegol is used to treat various inflammatory diseases such as:
- ankylosing spondylitis (inflammation in the joints of your spine)
- moderate to severe Crohn's disease (a long-term inflammatory disease of the digestive tract that usually affects the small intestine and colon)
- severe non-radiographic axial spondyloarthritis (a rare type of joint inflammation in the spine)
- moderate to severe plaque psoriasis (a type of skin disease that allows the skin cells to rapidly build up causing itchy patches of thick, red skin and silvery scale)
- moderate to severe Crohn's disease (long-term inflammatory disease of the digestive tract)
This medicine may be used on its own or together with other medicines to treat moderate to severe rheumatoid arthritis (inflammation of the joints), and psoriatic arthritis (joint pain and inflammation that affects individuals with psoriasis).
Certolizumab pegol may be used to treat other conditions as decided by your doctor.
Certolizumab pegol is to be injected subcutaneously (into the fatty layer under the skin, usually in the thigh or abdomen area). Do not inject it in an area where the skin is tender, swollen, bruised, or hard.
Your doctor or nurse will administer the injection for you. If you or your caregiver had been given the proper training on the preparation and injection techniques of this medicine, you or your caregiver may do the administration.
Use Certolizumab pegol exactly as directed by your doctor or according to the instructions on the label. Do not administer more or less than instructed by your doctor.
Remember to rotate the injection sites. Do not inject into the same area all the time. New injection sites should be at least 1 inch away from the previous injection site. Do not inject within 2 inches around your navel (belly button), and into areas where the skin is tender, bruised, red, hard, scarred, or affected by psoriasis.
Certolizumab pegol is available as a single-dose vial, pre-filled pen or syringe, or dose-dispenser cartridge. Make sure you know how to use the specific device you have been given. If you have problems or do not understand the instructions, ask your doctor or pharmacist.
The single-dose vial is intended to be used only if you are in the hospital or at the doctor’s clinic.
The dose of this medicine will be decided by your doctor. Your doctor will advise you on the course of treatment depending on the type of your condition and your response to the medication.
Certolizumab pegol must be used regularly for it to be effective. Continue using this medicine even when you feel better. Do not stop using it suddenly as this may worsen your condition.
Ensure that you keep all appointments with your doctor so that you do not miss any doses. Your doctor also needs to regularly monitor your response to Certolizumab pegol.
If you miss an appointment or miss an injection, alert your doctor or nurse. A replacement appointment or injection should be given as soon as possible.
If you or a caregiver had been trained to administer this medicine and missed a dose, inject the missed dose as soon as you remember and return to your normal dosing schedule.
DO NOT double a dose under any circumstances.
Inform your doctor or pharmacist immediately if you forgot to administer your dose.
Do not use Certolizumab pegol if you ever had an allergic reaction (e.g. rashes, breathlessness, swollen eyes) to this medicine.
Alert your doctor if you have the following conditions:
- moderate to severe heart failure (weakness and inability of the heart to pump blood)
- active TB (lung infection known as tuberculosis) or other severe infections
as Certolizumab pegol may not be suitable for you.
Alert your doctor if you have been recently vaccinated. You must avoid any vaccinations without consulting with your doctor.
Do not use Certolizumab pegol with other medicines used to treat rheumatoid arthritis, such as anakinra, abatacept, etanercept, or rituximab.
Inform your doctor if you have the following conditions:
- history of allergic reactions to similar medicines
- history of a serious infection or an infection that keeps on coming back
- history of TB or hepatitis B infection, or have been in close contact with someone with these conditions
- current or history of cancer
- chronic obstructive pulmonary disease (a long-term lung disease that causes airflow obstruction making it hard to breathe)
- blood disorders
- demyelinating disorders (condition that leads to damage in the protective covering of nerve fibres in the brain or spinal cord)
- HIV infection
- mild heart failure
- kidney disease
Let your doctor know if you are pregnant or breastfeeding. Women of childbearing potential must use proven birth control methods during therapy and for 5 months after stopping the treatment.
Be sure to check with your doctor or pharmacist before giving Certolizumab pegol to the elderly. They may be more sensitive to the side effects.
If you are going to have certain laboratory tests (e.g. blood coagulation test, TB test), inform your doctor that you are using Certolizumab pegol.
If you are going to have an operation, including minor surgery and dental work, inform your doctor or dentist that you are using this medicine.
Why is it important to keep my appointments with the doctor?
Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.
- Screening tests for TB, hepatitis B or C, or HIV, may be done before treatment to know if this medicine is suitable for you to use.
- Routine tests (e.g. complete blood count) may also be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
- Regular monitoring for signs and symptoms of infection and allergic reactions may also be needed.
Certolizumab pegol may cause dizziness with sensations of spinning, or some problems with your eyesight. If affected, do not drive, or take part in any activity in which you need to be alert or need to see clearly.
Other side effects include any of the following: headache, nausea, vomiting, diarrhoea, indigestion, stomach pain, weight change, joint pain, involuntary shaking of the hands or legs, ringing in the ears, cough, hair loss, dry skin or nails, pimple, rash, itching, and swelling, pain, redness or itching at the injection site.
Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:
- signs and symptoms of allergic reactions e.g. rashes, breathlessness, swelling of the face, throat, and lips
- signs and symptoms of heart problems e.g. chest pain, shortness of breath, abnormal heartbeat, swelling of ankles or feet
- change in your vision (e.g. temporary vision loss), numbness or tingling sensation in any part of the body
- unusual changes in mood or behaviour (being too depressed, agitated, or having compulsive and impulsive behaviour)
- yellowing of the skin or eyes, abdominal pain, dark-coloured urine, tiredness, swelling in the legs and ankles
This medicine may cause the level of your red blood cells, white blood cells, and platelets to drop.
Red blood cells carry oxygen around your body. A fall in the level of red blood cells may make you feel tired and worn out.
White blood cells help your body fight infections. A fall in the level of your white blood cells may put you at higher risk for infections, such as coughs, colds, and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Inform your doctor if you have a fever, cough, or flu that does not go away.
Platelets help your blood to clot when there is a cut in the skin. A fall in the level of your platelets may put you at risk of bleeding more than usual. Do not take part in activities where you may fall or get injured, such as contact sports. Inform your doctor if you get any unusual bruising (large bruises or several bruises, especially if the bruises appeared on their own) or bleeding that takes a long time to stop (for example, too much bleeding when you floss or brush your teeth).
Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.
Do not use Certolizumab pegol with other medicines used to treat rheumatoid arthritis, such as anakinra, abatacept, etanercept, or rituximab.
Avoid vaccinations with live vaccines during treatment with this medicine. Alert your doctor if you have been recently vaccinated or if you are planning to get vaccinated.
Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.
Avoid alcohol.
Store in the refrigerator, between 2-8°C. Do not allow Certolizumab pegol to freeze. If frozen, this medicine will become ineffective and should not be used.
Keep the pre-filled pen or syringe in its original carton to protect from light.
If needed, you may store the pre-filled pen or syringe at room temperature (up to 25°C) for up to 10 days. Protect from light. Once removed from the refrigerator for room temperature storage, the pen or syringe must be used within 10 days.
If you notice that the injection has changed colour or has become cloudy, do not use it. Throw it away and use a new injection.
Medicines must not be used past the expiry date.
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