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Cimzia

Cimzia

(certolizumab pegol)

Cimzia (Certolizumab pegol) belongs to a family of medications known as biological response modifiers ("biologics") or TNF blockers. It is used alone or in combination with another medication, Methotrexate, to treat moderately-to-severely active Rheumatoid Arthritis (RA).

Available form

Dosage

Injectable Syringe

200MG/1ML

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Cimzia information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

Cimzia (Certolizumab pegol) is given by subcutaneous (under the skin) injection usually in the front of the thigh or abdomen. The usual starting dose is 400 mg (2 injections of 200 mg, given at the same time in different areas of the body) at weeks 0, 2, and 4. After this, the usual dose is 200 mg every other week. Some people may eventually use 400 mg every 4 weeks except in the case of plaque psoriasis, where the usual maintenance dose is 200 mg every 2 weeks.

Cimzia (Certolizumab pegol) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses) and can teach you how to give yourself the injection at home. Do not attempt to inject Cimzia (Certolizumab pegol) on your own until you completely understand how to inject a dose. If you are unsure of how to prepare or administer a dose, ask a health care professional to clarify for you. If you are having difficulty giving yourself injections, ask a family member or other caregiver for help if they are willing to become involved with your treatment and are willing to learn how to give you your injections.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that Cimzia (Certolizumab pegol) be used exactly as prescribed by your doctor. If you miss a dose and your next dose is not for another 7 days (i.e., one week) or longer, take it as soon as possible and continue with your regular schedule. If the next dose is due within one week (i.e., less than 7 days), skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Before injecting the medication, check the solution to ensure that it is clear, colourless, and has no particles in it. If the solution is not clear and colourless, discard the syringe safely and use a new one.

Store Cimzia (Certolizumab pegol) in the refrigerator, protect it from light, and keep it out of the reach of children. Do not freeze. If necessary, Cimzia (Certolizumab pegol) may be stored at room temperature, protected from light, just one time, for up to 10 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Cimzia (Certolizumab pegol). If you are concerned about side effects, discuss the risks and benefits of Cimzia (Certolizumab pegol) with your doctor.

The following side effects have been reported by at least 1% of people taking Cimzia (Certolizumab pegol). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

dizziness
rash
redness, pain, swelling, itching, warmth, and bruising at the injection site
tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

flu-like symptoms (sudden lack of energy, Fever, cough, sore throat)
itchy, reddish purple skin rash and/or threadlike white-grey lines on mucous membranes
symptoms of heart failure (shortness of breath or swelling of the feet or legs)
symptoms of Lupus (rash on the cheeks or other body areas; sun sensitivity; joint or muscle pain; fatigue; chest pain; shortness of breath; or swelling of the feet, ankles, or legs)
symptoms of nervous system problems (such as arm or leg weakness, vision changes, dizziness, or numbness or tingling in any part of the body)
symptoms of Shingles (herpes zoster infection; e.g., pain, burning, numbness, or tingling to areas of the skin on one side of the body; sensitivity to touch; red rash; itching; fluid-filled blisters)

Stop taking the medication and seek immediate medical attention if any of the following occur:

symptoms of a serious allergic reaction (e.g., Hives, face swelling, difficulty breathing or swallowing)
symptoms of a serious infection (e.g., fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in sputum, shortness of breath, night sweats, weight loss, nausea or vomiting, Diarrhea, joint swelling, Cold Sores, tooth pain, new or worsening pain in any part of the body)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Cimzia (Certolizumab pegol).

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Cimzia (Certolizumab pegol).

Anemia: Cimzia (Certolizumab pegol) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Cimzia (Certolizumab pegol) may affect your body's ability to produce enough of certain types of blood cells, including the ones that help you stop bleeding. If your experience unusual bruising or bleeding, increased nosebleeds, bleeding gums, or you notice blood in your urine, contact your doctor as soon as possible. If you notice signs of bleeding in the stomach such as bloody, black, or tarry stools, or vomiting blood or material that looks like coffee grounds, get medical attention immediately.

If you have an increased risk of bleeding, your doctor should closely monitor your blood counts while you are using Cimzia (Certolizumab pegol).

Cancer: Rarely, cases of cancer (including Skin Cancer, Leukemia [blood cancer], and lymphoma) have been reported among people taking Cimzia (Certolizumab pegol). Talk to your doctor about cancer screening and your risk of cancer, and see your doctor if you have a bump or sore that does not heal.

Congestive Heart Failure (CHF): People taking medications in the same family as Cimzia (Certolizumab pegol) may develop CHF or find that their CHF gets worse. If you have a history of CHF or are at risk of developing CHF, discuss with your doctor how Cimzia (Certolizumab pegol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cimzia (Certolizumab pegol), and whether any special monitoring is needed.

Tell your doctor if you have CHF. If you develop shortness of breath or swelling of the legs or feet (symptoms of CHF), contact your doctor right away.

Dizziness: Cimzia (Certolizumab pegol) may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Cimzia (Certolizumab pegol).

Hepatitis B: Cimzia (Certolizumab pegol), like other tumour necrosis factor blockers, has been associated with reactivation of hepatitis B infections, which can be fatal. If you have a history of hepatitis B infections, discuss with your doctor how Cimzia (Certolizumab pegol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Immune system problems: Rarely, people taking medications in the same family as Cimzia (Certolizumab pegol) may develop symptoms similar to the symptoms of lupus (rash on the cheeks or other body areas; sun sensitivity; joint or muscle pain; fatigue; chest pain; shortness of breath; or swelling of the feet, ankles, or legs). Contact your doctor if you develop these symptoms.

Laboratory tests: Cimzia (Certolizumab pegol) may interfere with certain laboratory tests. If you are scheduled for lab tests, let your doctor know that you are using Cimzia (Certolizumab pegol).

Liver function: People taking Cimzia (Certolizumab pegol) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Cimzia (Certolizumab pegol).

Neurological effects: Rarely, people taking medications in the same family as Cimzia (Certolizumab pegol) may develop nervous system diseases such as Multiple Sclerosis (MS). Contact your doctor right away if you notice vision changes, dizziness, arm or leg weakness, and numbness or tingling in any part of your body.

Serious infections: Cimzia (Certolizumab pegol) can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking certolizumab with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal.

If you have a history of chronic or frequent infections, discuss with your doctor how Cimzia (Certolizumab pegol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cimzia (Certolizumab pegol), and whether any special monitoring is needed.

Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, and new or worsening pain in any part of the body.

Severe allergy: Cimzia (Certolizumab pegol) is known to cause severe allergic reactions. Contact your doctor immediately if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Surgery: If you have surgery planned, let your surgeon and other health care professionals know that you are taking Cimzia (Certolizumab pegol).

Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using Cimzia (Certolizumab pegol). If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how Cimzia (Certolizumab pegol) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cimzia (Certolizumab pegol), and whether any special monitoring is needed.

Vaccinations: People taking Cimzia (Certolizumab pegol) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with Cimzia (Certolizumab pegol).

Pregnancy: Cimzia (Certolizumab pegol) should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant while using Cimzia (Certolizumab pegol) should use effective birth control while using Cimzia (Certolizumab pegol) and for 5 months after the last dose. If you become pregnant while taking Cimzia (Certolizumab pegol), contact your doctor immediately.

Breast-feeding: It is not known if Cimzia (Certolizumab pegol) passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

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