Details for: CIMZIA
Company: UCB CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02331675 | CIMZIA | CERTOLIZUMAB PEGOL | 200 MG / ML | SOLUTION | SUBCUTANEOUS |
| 02465574 | CIMZIA | CERTOLIZUMAB PEGOL | 200 MG / ML | SOLUTION | SUBCUTANEOUS |
Summary Reports
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - Tumour Necrosis Factor (TNF) alpha blockers (SIMPONI and CIMZIA) - Assessing the Potential Risk of Liver Inflammation (Autoimmune Hepatitis)
Summary Safety Review - Tumour necrosis factor (TNF) blockers - Glioblastoma (brain tumour)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
CIMZIA is a medicine that is used to treat adults with:
- moderate to severe rheumatoid arthritis (RA)
- psoriatic arthritis (PsA)
- ankylosing spondylitis (AS)
- non-radiographic axial spondyloarthritis (nr-axSpA)
- plaque psoriasis (PsO)
Rheumatoid arthritis is an inflammatory disease of the joints. Psoriatic arthritis is an inflammatory disease of the joints and skin. Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. Psoriasis is an inflammatory disease of the skin and can also affect your scalp and nails. People with RA, PsA, AS, nr-axSpA or PsO may be given other medicines or treatments for their disease before they are given CIMZIA. If you do not respond well enough to these medicines, you will be given CIMZIA to reduce the signs and symptoms of your disease.
What it does
Because it blocks the action of a substance in your body called tumor necrosis factor (TNF) alpha (TNFα), you may hear CIMZIA referred to as a “TNF blocker”. People with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis or plaque psoriasis usually have too much TNFα in their bodies, which can lead to painful and swollen joints. CIMZIA can help reduce the amount of TNFα in the body to normal levels, helping to treat joint damage. CIMZIA helps to reduce the signs and symptoms of rheumatoid arthritis (such as pain, swollen joints, and fatigue), may help improve your ability to perform daily activities (such as dressing, walking and climbing stairs), and may help prevent further damage to your bones and joints. In addition, CIMZIA helps reduce the signs and symptoms of ankylosing spondylitis and non-radiographic axial spondyloarthritis (back pain and morning stiffness). CIMZIA also helps reduce the signs and symptoms of psoriasis (such as pain, itching and scaly patches on skin).
When it should not be used
You should not take CIMZIA if you have had an allergic reaction to CIMZIA or any of its ingredients. See the “medicinal ingredient” and “nonmedicinal ingredients” sections below for a list of all ingredients in CIMZIA. If you have a severe infection, such as sepsis (an infection in the bloodstream), abscess, tuberculosis, or other serious infection, you must not take CIMZIA. If you have heart failure that is moderate or severe, you must not take CIMZIA.
What the medicinal ingredient is
certolizumab pegol
What the non-medicinal ingredients are
Sodium acetate, sodium chloride (salt) and water (water for injection). No preservatives are present.
What dosage form it comes in
Single-use Pre-filled Syringe
CIMZIA is supplied as a solution for injection in a single-use pre-filled glass syringe (200 mg/mL).
Single-use Pre-filled Autoinjector
CIMZIA is supplied as a solution for injection in a single-use pre-filled autoinjector (200 mg/mL).
Warnings and precautions
Single-use Pre-filled Syringe
Single-use Pre-filled Autoinjector
Single-use Pre-filled Syringe
Before initiation, during and after treatment with CIMZIA, you should be evaluated for active or latent tuberculosis infection with, for example, a tuberculin skin test.
Any medicine can have side effects. Like all medicines that affect your immune system, CIMZIA can cause serious side effects. The possible serious side effects include:
Serious Warnings and Precautions
- Serious infections: Serious infections have been reported in patients receiving CIMZIA and other TNF blockers. Some of these cases have been life-threatening. Such infections include tuberculosis (TB), infections caused by bacteria or fungi, bacterial infections that have spread throughout the body (sepsis), and very rare cases of hepatitis B infection relapse.
- Cardiovascular system diseases: There have been rare cases of disorders called (congestive) heart failure that affect the people taking CIMZIA or other TNF blockers. Signs that you could be experiencing a problem affecting your cardiovascular system include: shortness of breath and swelling of the ankles or feet.
- Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported in patients receiving CIMZIA and other TNF blockers. Signs that you could be experiencing a problem affecting your nervous system include: numbness or tingling, problems with your vision, weakness in your legs, and dizziness.
- Malignancies: Very rare cases of certain kinds of cancer have been reported in patients receiving CIMZIA and other TNF blockers. Some patients receiving CIMZIA have developed types of cancer called non-melanoma skin cancer. Tell your doctor if new skin lesions appear during or after therapy with CIMZIA or existing skin lesions change appearance or you have a bump or open sore that does not heal. People with more serious RA 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. There have been cases of unusual cancers in children and teenage patients using TNF-blocking agents. If you take CIMZIA or other TNF blockers, your risk of getting lymphoma or other cancers may increase.
- Lupus-like symptoms: Some patients have developed lupus-like symptoms that got better after their treatment was stopped. If you have chest pains that do not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun, call your doctor right away.
- Allergic reactions: If you develop a severe rash, swollen face or difficulty breathing while taking CIMZIA, call your doctor right away.
Serious infections
CIMZIA is a medicine that affects your immune system. Because CIMZIA, like other anti-TNF therapies, may lower your immune function as a part of treating your condition you may be more likely to get a serious infection. These serious infections include tuberculosis (TB), legionellosis (a serious bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria) and other infections caused by viruses, fungi or bacteria that have spread throughout the body. Some of these infections may be fatal.
It is very important to tell your doctor immediately if you:
- have any symptoms of an infection including fever, cough, or any flu-like symptoms
- are currently being treated for an infection
- have any open cuts or sores on your body
- have a history of getting frequent infections
- have or have had a Hepatitis B infection
- are or have been infected with TB, or have been in close contact with someone who has TB. You can be infected with TB and have no symptoms whatsoever, so it’s important that your doctor give you a test for TB before you start CIMZIA therapy. If your doctor prescribes any medicine for the treatment of TB, you should start taking it before starting CIMZIA and take the full course of TB medicine prescribed. Cases of TB have been reported in patients receiving TNF blockers including CIMZIA despite previous or concurrent preventive treatment for TB
- were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
- have lived in or traveled to an area where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take CIMZIA. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
- develop signs and symptoms of lupus (persistent rash, fever, joint pain, and tiredness)
- are also being treated with other biologic medicines or have had a recent vaccination
If, at any time, while you are receiving treatment with CIMZIA, you have any signs or symptoms of an infection such as fever, cough, or flu-like symptoms, or develop any open cuts or sores on your body, call your doctor right away.
Some types of cancer
While rare, there have been reported cases of a cancer called lymphoma in patients on CIMZIA or other TNF blockers. People who have been treated with a TNF blocker like CIMZIA for a long period of time may have a higher risk of developing lymphoma. Cancers other than lymphoma have also been reported in patients treated with CIMZIA. It is not known whether there is an increased risk of cancer associated with CIMZIA treatment.
Heart failure
If you have been told that you have a heart problem called (congestive) heart failure and you are currently being treated with CIMZIA, you will need to be closely monitored by your doctor. Important symptoms to watch for include shortness of breath and swelling of the ankles or feet.
Hepatitis B virus reactivation
Your doctor should test you to see if you carry the Hepatitis B virus in your blood before starting treatment with CIMZIA. If you have had Hepatitis B, or know that you carry the virus, your doctor will need to monitor you during treatment to be sure the virus has not become active again.
Blood problems
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. Important symptoms to watch for include persistent fever, unusual bruising or bleeding and extremely pale skin.
Nervous system disorders
There have been rare cases of disorders that affect the nervous system of people taking CIMZIA or other TNF blockers. Signs that you could be experiencing a problem affecting your nervous system include: dizziness, numbness or tingling, problems with your vision, and weakness in your legs.
Allergic reactions
In rare cases, patients taking CIMZIA have had difficulty breathing, low blood pressure, and/or loss of consciousness, which may represent an allergic reaction. Allergic reactions can happen after your first dose or may not happen until after you have taken CIMZIA many times. Symptoms to watch for include skin rash, swollen face, or difficulty breathing. If you develop these symptoms, call your doctor and seek emergency care immediately.
Latex Sensitivity
The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex. The needle shield inside the removable cap does not come into direct contact with you or your injection administrator. Nevertheless, the potential risk of an allergic reaction cannot be completely excluded in people who are sensitive to latex. Tell your doctor if you have ever had an allergic reaction to latex or develop any allergic reaction to CIMZIA.
Immune reactions
Some patients on CIMZIA develop lupus-like symptoms including shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.
If you develop any of the above serious side effects while on CIMZIA, or any other unusual symptom, call your doctor right away. Your doctor may decide that your treatment with CIMZIA should be stopped.
Before taking CIMZIA and to help your doctor decide whether or not CIMZIA is right for you, you need to tell your doctor if you have or have had any of the following:
- an infection of any kind
- new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet)
- cancer (such as lymphoma)
- a blood disorder, or symptoms of a blood disorder such as persistent bruising, bleeding, or fever
- any numbness or tingling or a disease that affects your nervous system such as multiple sclerosis, Guillain-Barré syndrome or seizures
- an allergic reaction to latex. The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex.
Tell your doctor if you have had or are scheduled to have:
- major surgery
- any vaccination(s). You should not receive certain (live vaccines) while using CIMZIA
Tell your doctor if you are pregnant or breastfeeding; or if you and your partner are planning to conceive a child. There is limited experience with CIMZIA in pregnant and breastfeeding women. If you are a woman of childbearing potential, discuss with your doctor regarding the use of adequate contraception while using CIMZIA. For women planning pregnancy, contraception may be considered for 5 months after the last CIMZIA dose. If you are pregnant, breastfeeding, or planning to conceive a child, your doctor will help you decide whether or not to use CIMZIA.
If you received CIMZIA during your pregnancy, your baby may have a higher risk for getting an infection. Certain vaccinations may also cause infections. If you have received CIMZIA while you were pregnant, your baby may be at higher risk for getting such an infection. It is important that you tell your baby's doctors and other health care professionals about your CIMZIA use so they can decide when your baby should receive any vaccine.
Pregnancy Registry: If you become pregnant while taking CIMZIA, talk to your healthcare provider about registering in the pregnancy exposure registry for CIMZIA. You can enroll in this registry by calling 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. The purpose of this registry is to collect information about the safety of CIMZIA during pregnancy.
If you are not sure or have any questions about any of this information, ask your doctor.
Single-use Pre-filled Autoinjector
Before initiation, during and after treatment with CIMZIA, you should be evaluated for active or latent tuberculosis infection with, for example, a tuberculin skin test.
Any medicine can have side effects. Like all medicines that affect your immune system, CIMZIA can cause serious side effects. The possible serious side effects include:
Serious Warnings and Precautions
- Serious infections: Serious infections have been reported in patients receiving CIMZIA and other TNF blockers. Some of these cases have been life-threatening. Such infections include tuberculosis (TB), infections caused by bacteria or fungi, bacterial infections that have spread throughout the body (sepsis), and very rare cases of hepatitis B infection relapse.
- Cardiovascular system diseases: There have been rare cases of disorders called (congestive) heart failure that affect the people taking CIMZIA or other TNF blockers. Signs that you could be experiencing a problem affecting your cardiovascular system include: shortness of breath and swelling of the ankles or feet.
- Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported in patients receiving CIMZIA and other TNF blockers. Signs that you could be experiencing a problem affecting your nervous system include: numbness or tingling, problems with your vision, weakness in your legs, and dizziness.
- Malignancies: Very rare cases of certain kinds of cancer have been reported in patients receiving CIMZIA and other TNF blockers. Some patients receiving CIMZIA have developed types of cancer called non-melanoma skin cancer. Tell your doctor if new skin lesions appear during or after therapy with CIMZIA or existing skin lesions change appearance or you have a bump or open sore that does not heal. People with more serious RA 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. There have been cases of unusual cancers in children and teenage patients using TNF-blocking agents. If you take CIMZIA or other TNF blockers, your risk of getting lymphoma or other cancers may increase.
- Lupus-like symptoms: Some patients have developed lupus-like symptoms that got better after their treatment was stopped. If you have chest pains that do not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun, call your doctor right away.
- Allergic reactions: If you develop a severe rash, swollen face or difficulty breathing while taking CIMZIA, call your doctor right away.
Serious infections
CIMZIA is a medicine that affects your immune system. Because CIMZIA, like other anti-TNF therapies, may lower your immune function as a part of treating your condition you may be more likely to get a serious infection. These serious infections include tuberculosis (TB), legionellosis (a serious bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria) and other infections caused by viruses, fungi or bacteria that have spread throughout the body. Some of these infections may be fatal.
It is very important to tell your doctor immediately if you:
- have any symptoms of an infection including fever, cough, or any flu-like symptoms
- are currently being treated for an infection
- have any open cuts or sores on your body
- have a history of getting frequent infections
- have or have had a Hepatitis B infection
- are or have been infected with TB, or have been in close contact with someone who has TB. You can be infected with TB and have no symptoms whatsoever, so it’s important that your doctor give you a test for TB before you start CIMZIA therapy. If your doctor prescribes any medicine for the treatment of TB, you should start taking it before starting CIMZIA and take the full course of TB medicine prescribed. Cases of TB have been reported in patients receiving TNF blockers including CIMZIA despite previous or concurrent preventive treatment for TB
- were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
- have lived in or traveled to an area where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take CIMZIA. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
- develop signs and symptoms of lupus (persistent rash, fever, joint pain, and tiredness)
- are also being treated with other biologic medicines or have had a recent vaccination
If, at any time, while you are receiving treatment with CIMZIA, you have any signs or symptoms of an infection such as fever, cough, or flu-like symptoms, or develop any open cuts or sores on your body, call your doctor right away.
Some types of cancer
While rare, there have been reported cases of a cancer called lymphoma in patients on CIMZIA or other TNF blockers. People who have been treated with a TNF blocker like CIMZIA for a long period of time may have a higher risk of developing lymphoma. Cancers other than lymphoma have also been reported in patients treated with CIMZIA. It is not known whether there is an increased risk of cancer associated with CIMZIA treatment.
Heart failure
If you have been told that you have a heart problem called (congestive) heart failure and you are currently being treated with CIMZIA, you will need to be closely monitored by your doctor. Important symptoms to watch for include shortness of breath and swelling of the ankles or feet.
Hepatitis B virus reactivation
Your doctor should test you to see if you carry the Hepatitis B virus in your blood before starting treatment with CIMZIA. If you have had Hepatitis B, or know that you carry the virus, your doctor will need to monitor you during treatment to be sure the virus has not become active again.
Blood problems
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. Important symptoms to watch for include persistent fever, unusual bruising or bleeding and extremely pale skin.
Nervous system disorders
There have been rare cases of disorders that affect the nervous system of people taking CIMZIA or other TNF blockers. Signs that you could be experiencing a problem affecting your nervous system include: dizziness, numbness or tingling, problems with your vision, and weakness in your legs.
Allergic reactions
In rare cases, patients taking CIMZIA have had difficulty breathing, low blood pressure, and/or loss of consciousness, which may represent an allergic reaction. Allergic reactions can happen after your first dose or may not happen until after you have taken CIMZIA many times. Symptoms to watch for include skin rash, swollen face, or difficulty breathing. If you develop these symptoms, call your doctor and seek emergency care immediately.
Latex Sensitivity
The needle shield inside the removable cap of the CIMZIA pre-filled autoinjector contains a derivative of natural rubber latex. The needle shield inside the removable cap does not come into direct contact with you or your injection administrator. Nevertheless, the potential risk of an allergic reaction cannot be completely excluded in people who are sensitive to latex. Tell your doctor if you have ever had an allergic reaction to latex or develop any allergic reaction to CIMZIA.
Immune reactions
Some patients on CIMZIA develop lupus-like symptoms including shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.
If you develop any of the above serious side effects while on CIMZIA, or any other unusual symptom, call your doctor right away. Your doctor may decide that your treatment with CIMZIA should be stopped.
Before taking CIMZIA and to help your doctor decide whether or not CIMZIA is right for you, you need to tell your doctor if you have or have had any of the following:
- an infection of any kind
- new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet)
- cancer (such as lymphoma)
- a blood disorder, or symptoms of a blood disorder such as persistent bruising, bleeding, or fever
- any numbness or tingling or a disease that affects your nervous system such as multiple sclerosis, Guillain-Barré syndrome or seizures
- an allergic reaction to latex. The needle shield inside the removable cap of the CIMZIA pre-filled autoinjector contains a derivative of natural rubber latex.
Tell your doctor if you have had or are scheduled to have:
- major surgery
- any vaccination(s). You should not receive certain (live vaccines) while using CIMZIA
Tell your doctor if you are pregnant or breastfeeding; or if you and your partner are planning to conceive a child. There is limited experience with CIMZIA in pregnant and breastfeeding women. If you are a woman of childbearing potential, discuss with your doctor regarding the use of adequate contraception while using CIMZIA. For women planning pregnancy, contraception may be considered for 5 months after the last CIMZIA dose. If you are pregnant, breastfeeding, or planning to conceive a child, your doctor will help you decide whether or not to use CIMZIA.
If you received CIMZIA during your pregnancy, your baby may have a higher risk for getting an infection. Certain vaccinations may also cause infections. If you have received CIMZIA while you were pregnant, your baby may be at higher risk for getting such an infection. It is important that you tell your baby's doctors and other health care professionals about your CIMZIA use so they can decide when your baby should receive any vaccine.
Pregnancy Registry: If you become pregnant while taking CIMZIA, talk to your healthcare provider about registering in the pregnancy exposure registry for CIMZIA. You can enroll in this registry by calling 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. The purpose of this registry is to collect information about the safety of CIMZIA during pregnancy.
If you are not sure or have any questions about any of this information, ask your doctor.
Interactions with this medication
Be sure to also tell your doctor about all the medicines you take (both prescription and nonprescription), as well as about any vitamin or herbal supplements. Your doctor will tell you if you may take other medications or supplements while you are on CIMZIA therapy. It’s especially important to tell your doctor if you take other biologic medicines such as Kineret (anakinra) or Orencia (abatacept). Studies with another TNF blocker have shown that taking other biologic medicines while on TNF blocker therapy may increase your chances for developing serious infections or a low white blood cell count, with no additional health benefit.
Only you know all the medicines you are taking. Keep a list to show your doctor and your pharmacist each and every time you are prescribed a new medicine.
Proper use of this medication
Single-use Pre-filled Syringe
Single-use Pre-filled Autoinjector
Single-use Pre-filled Syringe
CIMZIA is given by an injection under the skin. Please use CIMZIA exactly as prescribed by your doctor, and use it only as often as prescribed. Ask your healthcare professional to show you how to inject CIMZIA before trying to do it yourself. When you are taking CIMZIA at home, you may want to have someone you know help you with your injection. You can call your doctor if you have any questions about giving yourself an injection.
Usual Dose
Rheumatoid Arthritis
The starting dose for adults with rheumatoid arthritis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week. For some patients, a maintenance dose of 400 mg of CIMZIA given every 4 weeks may be prescribed by your doctor.
Psoriatic Arthritis
The starting dose for adults with psoriatic arthritis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week. For some patients, a maintenance dose of 400 mg of CIMZIA given every 4 weeks may be prescribed by your doctor.
Ankylosing Spondylitis
The starting dose for adults with ankylosing spondylitis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week or 400 mg of CIMZIA given every 4 weeks.
Non-radiographic Axial Spondyloarthritis
The starting dose for adults with non-radiographic axial spondyloarthritis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week or 400 mg of CIMZIA given every 4 weeks.
Plaque Psoriasis
The starting dose for adults with plaque psoriasis is 400 mg every 2 weeks. However, if your doctor decides it is appropriate, he/she may prescribe a dose of 400 mg (given at weeks 0, 2 and 4), followed by a dose of 200 mg every 2 weeks (from week 6).
Overdose
If you take more CIMZIA than you were told to take, call your doctor.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
Be sure to take your medicine exactly as prescribed and do not miss any doses of CIMZIA. If you forget to take your dose of CIMZIA at your regularly scheduled time, do as follows: if your next scheduled dose is within 1 week, wait until your next scheduled dose. If your next scheduled dose is 1 week or longer away, inject the missed dose as soon as you become aware of it, then follow with your next scheduled dose.
Patient Instructions for Proper Use
What do I need to do to prepare and give an injection of CIMZIA?
Do not use the CIMZIA pre-filled syringe if:
- any name other than “CIMZIA” is on the package and prefilled syringe label
- the expiration date on the container has passed
- the packaging is torn or if the tamper evident seal is missing or broken when you receive it. If this is the case, contact your pharmacist.
- the pre-filled syringe is frozen or has been left in direct sunlight
- the medicine in the pre-filled syringe is not clear to pale yellow, or has large, colored particles in it
Preparing to use the CIMZIA pre-filled syringe
Each CIMZIA pre-filled syringe package comes with these items in a tray:
- 2 glass pre-filled syringes of CIMZIA. Each has a fixed needle.
- 2 alcohol swabs
For each injection you will use:
- 1 pre-filled syringe of CIMZIA with needle
- 1 alcohol swab
For each injection you will also need:
- 1 clean cotton ball or gauze pads. These are not included in the CIMZIA pre-filled syringe package.
- a puncture-proof container for disposing of used needles and syringes. (See the section entitled “How should I dispose of needles and syringes?”)
If you do not have all the supplies you need, talk to your pharmacist.
- Each pre-filled syringe contains the right dose of medicine for one injection (200 mg).
- Depending on the amount of CIMZIA prescribed by your doctor, you may need to take more than one injection.
- If you are prescribed to take 400 mg of CIMZIA, you will need to take two injections. You will need to use two CIMZIA prefilled syringes.
- CIMZIA may be injected into your abdomen or thigh area. If you are prescribed to take more than one injection, each injection should be given at a different injection site, in your abdomen and thigh.
- Take either one or two CIMZIA pre-filled syringes and alcohol swabs out of the refrigerator for injection, depending on your prescribed dose. If there is still a pre-filled syringe in the carton, put it back in the refrigerator right away. If both prefilled syringes are used, throw away the empty carton after you finish your injection.
- Let the medicine in the syringe come to room temperature before injection. This will take about 30 minutes.
- Wash your hands thoroughly.
- Choose a different site on your abdomen or thigh for each injection. Each new injection should be given at least one inch from a site you used before. If you choose the abdomen, avoid the 2 inches around your navel. Do not inject into areas where the skin is tender, bruised, red or hard or where you have scars or stretch marks. Change injection sites between your abdomen and thighs to reduce the risk of reaction. You may find it helpful to keep notes on the locations of injection sites you use.
- Use an alcohol swab to wipe over the site where you will inject CIMZIA. Do not touch the clean area again until you are ready for the injection.
- Remove the needle cover by pulling straight up on the plastic ring. Take care not to touch the needle and do not allow the needle to touch any surface. Place the needle cover to the side.
- Hold the syringe so the needle is pointing up. You may see air bubbles. This is normal. There is no need to remove air bubbles before giving your injection. Injecting the solution with air bubbles will not harm you.
- Hold the syringe with the needle facing down. Do not touch the needle with your fingers or let it touch any surface.
- Hold the syringe in one hand. Use the other hand to gently pinch a fold of cleaned area of skin. Insert the needle at about a 45 degree angle with a quick, short, “dart-like” motion.
- Release the skin pinch, keeping the syringe in position. If blood enters the syringe, this means you have entered a blood vessel. Do not inject CIMZIA. Pull the needle out and throw away the pre-filled syringe and needle in a puncture-proof container. Repeat the steps to prepare for an injection using a new pre-filled syringe. Do not use the same pre-filled syringe.
- If no blood appears, inject all of the medicine in the pre-filled syringe under the skin.
- When the syringe is empty, remove the needle from the skin and press the clean cotton ball or gauze pad over the injection site for ten seconds. Do not rub the injection site. You may have a slight amount of bleeding. This is normal.
- To avoid needle-stick injury, do not try to recap the needle. Throw away the used pre-filled syringe and needle in a special puncture-proof container. (See the section entitled “How should I dispose of needles and syringes?”)
- Repeat steps 5-13 above if you are prescribed to take a second injection of CIMZIA (total 400 mg dose).
For your protection, it’s important that you carefully follow these instructions:
Choosing and preparing an injection site
Using the CIMZIA pre-filled syringe
How should I dispose of needles and syringes?
To avoid needle-stick injury, do not try to recap the needle. Before you start injecting CIMZIA at home, check with your doctor for instructions on the right way to throw away your used needles and used pre-filled syringes.
Ask your doctor or pharmacist about how to get a puncture-proof container (“sharps” container) that will meet local requirements.
When the container is about two-thirds full, tape the lid closed. Dispose of the container as instructed by your doctor, nurse or pharmacist. Do not throw away the container in the trash or recycle.
Alcohol swabs may be placed in the trash, unless you are instructed otherwise.
Always keep CIMZIA, injection supplies, puncture-proof container, and all other medicines out of the reach of children.
Single-use Pre-filled Autoinjector
CIMZIA is given by an injection under the skin. Please use CIMZIA exactly as prescribed by your doctor, and use it only as often as prescribed. Ask your healthcare professional to show you how to inject CIMZIA before trying to do it yourself. When you are taking CIMZIA at home, you may want to have someone you know help you with your injection. You can call your doctor if you have any questions about giving yourself an injection.
Usual Dose
Rheumatoid Arthritis
The starting dose for adults with rheumatoid arthritis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week. For some patients, a maintenance dose of 400 mg of CIMZIA given every 4 weeks may be prescribed by your doctor.
Psoriatic Arthritis
The starting dose for adults with psoriatic arthritis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week. For some patients, a maintenance dose of 400 mg of CIMZIA given every 4 weeks may be prescribed by your doctor.
Ankylosing Spondylitis
The starting dose for adults with ankylosing spondylitis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week or 400 mg of CIMZIA given every 4 weeks.
Non-radiographic Axial Spondyloarthritis
The starting dose for adults with non-radiographic axial spondyloarthritis is 400 mg of CIMZIA given at weeks 0, 2, and 4. This is followed by a maintenance dose of 200 mg of CIMZIA given every other week or 400 mg of CIMZIA given every 4 weeks.
Plaque Psoriasis
The starting dose for adults with plaque psoriasis is 400 mg every 2 weeks. However, if your doctor decides it is appropriate, he/she may prescribe a dose of 400 mg (given at weeks 0, 2 and 4), followed by a dose of 200 mg every 2 weeks (from week 6).
Overdose
If you take more CIMZIA than you were told to take, call your doctor.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
Be sure to take your medicine exactly as prescribed and do not miss any doses of CIMZIA. If you forget to take your dose of CIMZIA at your regularly scheduled time, do as follows: if your next scheduled dose is within 1 week, wait until your next scheduled dose. If your next scheduled dose is 1 week or longer away, inject the missed dose as soon as you become aware of it, then follow with your next scheduled dose.
INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF CIMZIA USING A SINGLE USE AUTOINJECTOR
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 use the autoinjector 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.
Below is a diagram of the autoinjector.
1: Orange band
2: Viewing window
3: Black handle
4: Clear cap
1. Setting up
- Wash your hands thoroughly.
- Remove the CIMZIA pack from the refrigerator.
- Remove the following items from the CIMZIA pack and set them up on a clean flat surface:
- One autoinjector
- One alcohol wipe
- Look at the expiry date on the autoinjector and pack. Do not use CIMZIA after the expiry date which is stated on the pack and autoinjector after EXP. The expiry date refers to the last day of the month shown.
- Allow to reach room temperature. This will take 30-45 minutes. Do not try to warm the autoinjector in any other way. To minimise discomfort during injection, CIMZIA should be injected when the liquid is at room temperature.
- Do not remove the cap until you are ready to inject.
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
- The CIMZIA autoinjector is designed to work accurately and safely. However, if any of the following steps go wrong and/or if you feel unsure about the injection process, contact your doctor or pharmacist
- Do NOT shake the autoinjector.
- Check the medicine through the viewing window. Do not use the autoinjector if the solution is discoloured, cloudy or if you can see particles in it. You may see air bubbles. This is normal. There is no need to remove air bubbles before injection. Injecting the solution subcutaneously with air bubbles is harmless.
- Hold the autoinjector firmly with one hand around the black handle.
- Grasp the clear cap with the other hand and pull it straight out. Do not twist the cap while removing it; this could jam the internal mechanism.
- Inject within 5 minutes of removing the cap. Do not replace the cap.
- Although hidden from view the needle tip is now uncovered. Do not try to touch the needle as it could activate the autoinjector.
- Hold the autoinjector straight (at a 90° degree angle) against the skin that was previously cleaned (the “injection site”).
- Press the autoinjector firmly against the skin. The injection begins when a first “click” is heard and the orange band at the bottom of the autoinjector disappears.
- Continue to hold the autoinjector in place firmly against the skin until a second “click” is heard and the viewing window turns orange. This can take up to 15 seconds. At this time, the injection will be complete. If the viewing window turns orange and you hear a second click this means the injection has been completed. If you feel unsure about the injection process, please contact your doctor or pharmacist. Do not try to repeat the injection without speaking to your doctor or your pharmacist.
- The needle will automatically move back into the empty autoinjector. Do not try to touch the needle.
- You can now remove the used autoinjector by pulling the autoinjector straight up carefully from the skin.
- Using 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
- Do not re-use the autoinjector. Do not replace the cap.
- After injection, immediately throw away the used autoinjector in a special puncture-proof container as instructed by your doctor, nurse or pharmacist.
- Keep the container out of the sight and reach of children.
Always keep CIMZIA, injection supplies, puncture-proof container, and all other medicines out of the reach of children.
Side effects and what to do about them
The most common side effects reported by patients treated with CIMZIA were upper respiratory tract infections (such as flu, cold), fatigue, skin infections, and liver function elevations (from blood tests). Some patients may experience:
- a reaction at the site where the injection was given. These reactions are usually mild and may include pain, redness, rash, swelling, itching, or bruising.
- itchy reddish purple skin rash and/ or threadlike white-grey lines on mucous membranes (lichenoid reactions).
These are not all of the side effects that may be experienced with CIMZIA. Ask your doctor or pharmacist for more information and be sure to tell your doctor if you experience any side effects, including ones that are not listed in this leaflet.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common [in less than 10% of patients (less than one in 10)] |
|||
| Upper respiratory tract infections (such as flu, cold), other serious infections including pneumonia, bronchopneumonia, bronchitis, and herpes zoster (shingles) | ✔ | ||
| Uncommon [in less than 1% of patients (less than one in 100)] |
|||
| Tuberculosis Other serious infections, liver function elevations (from blood tests), localized form of lupus affecting the skin, infection affecting the lung lining (pleurisy), fungal infection of esophagus (esophageal candidiasis), appendicitis, hypersensitivity |
✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking CIMZIA, contact your doctor or pharmacist.
How to store
Single-use Pre-filled Syringe
- Keep CIMZIA in the refrigerator at 2ºC – 8ºC (36ºF – 46ºF).
- When necessary, CIMZIA may be stored at room temperature up to 25°C (77°F), for a single period of maximum 10 days with protection from light. At the end of this period CIMZIA must be used or discarded.
- Let CIMZIA come to room temperature before injecting it.
- Do not freeze CIMZIA.
- Protect CIMZIA from light. Store CIMZIA in the carton.
- Do not use CIMZIA if the medication is expired (today’s date is past the date printed on the pre-filled syringe or carton), or if the liquid looks cloudy or discoloured.
The pre-filled syringes are glass. Do not drop or crush them.
Always keep CIMZIA, injection supplies, puncture-proof container, and all other medicines out of the reach of children.
Single-use Pre-filled Autoinjector
- Keep CIMZIA in the refrigerator at 2ºC – 8ºC (36ºF – 46ºF).
- When necessary, CIMZIA may be stored at room temperature up to 25°C (77°F), for a single period of maximum 10 days with protection from light. At the end of this period CIMZIA must be used or discarded.
- Let CIMZIA come to room temperature before injecting it.
- Do not freeze CIMZIA.
- Protect CIMZIA from light. Store CIMZIA in the carton.
- Do not use CIMZIA if the medication is expired (today’s date is past the date printed on the autoinjector or carton), or if the liquid looks cloudy or discoloured.
Always keep CIMZIA, injection supplies, puncture-proof container, and all other medicines out of the reach of children.
Reporting side effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
Online: www.healthcanada.gc.ca/medeffect
Toll-free telephone: 1-866-234-2345
Toll-free fax: 1-866-678-6789
Postage Paid Mail: Canada Vigilance Program
Health Canada
AL 1908C
Ottawa, ON, K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the CIMZIA customer service support line toll free at: 1-800-908-5555.
This leaflet was prepared by UCB Canada Inc., Oakville, ON, L6H 5R7.
®CIMZIA is a registered trademark of the UCB Group of Companies.
Last revised: