"April 14, 2010 -- Patients with moderate to severe Crohn's disease are most likely to get better if treated with a combination of biologic and immune-suppressing therapies, a clinical trial suggests.
It's a "landmark trial," says gastr"...
(certolizumab pegol) Lyophilized Powder or Solution for Subcutaneous Use
Read the Medication Guide that comes with CIMZIA before you start using it, and before each injection of CIMZIA. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about CIMZIA?
CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.
- Your healthcare provider should test you for TB before starting CIMZIA.
- Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with CIMZIA.
You should not start receiving CIMZIA if you have any kind of infection unless your healthcare provider says it is okay.
Before you receive CIMZIA, tell your healthcare provider if you:
- Think you have an infection, flu-like symptoms, or have any other symptoms of an infection such as:
- blood in phlegm
- fever, sweat, or chills
- weight loss
- muscle aches
- warm, red, or painful skin or sores on your body
- shortness of breath
- diarrhea or stomach pain
- feeling very tired
- burning when you urinate or urinate more often than normal
- are being treated for an infection
- get a lot of infections or have infections that keep coming back
- have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
- have tuberculosis (TB), or have been in close contact with someone with TB
- were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
- live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) 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 healthcare provider.
- have or have had hepatitis B
- use the medicine Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or Tysabri® (natalizumab)
After starting CIMZIA, if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your healthcare provider right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse.
- For people taking TNF-blocker medicines, including CIMZIA, the chances of getting lymphoma or other cancers may increase.
- There have been cases of cancers in children, teenagers, and young adults who received TNF-blocker medicine that do not usually happen in people this age.
- People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
- Some people receiving TNF-blocker medicines, including CIMZIA, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers and young adult males with Crohn's disease or ulcerative colitis. Also, most of these people had been treated with both a TNF-blocker medicine and another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6-MP).
- If you use TNF-blocker medicine, including CIMZIA, your chance of developing certain kinds of skin cancer may increase. Tell your healthcare provider if any changes in the appearance of your skin, including growths on your skin, happen during or after your treatment.
What is CIMZIA?
CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. CIMZIA is used in adult patients to:
- Lessen the signs and symptoms of moderately to severely active Crohn's disease (CD) in patients who have not been helped enough by usual treatments
- Treat moderately to severely active rheumatoid arthritis (RA)
- Treat active psoriatic arthritis
- Treat active ankylosing spondylitis
What should I tell my healthcare provider before starting treatment with CIMZIA?
CIMZIA may not be right for you. Before starting CIMZIA, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection. (See, “What is the most important information I should know about CIMZIA?”)
- have or have had any type of cancer.
- have congestive heart failure.
- have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis.
- are scheduled to receive a vaccine. Do not receive a live vaccine while taking CIMZIA.
- are allergic to any of the ingredients in CIMZIA. See the end of this Medication Guide for a list of the ingredients in CIMZIA.
- are pregnant or planning to become pregnant. It is not
known if CIMZIA will harm your unborn baby. Tell your healthcare provider right
away if you become pregnant while receiving CIMZIA.
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. The purpose of this registry is to collect information about the safety of CIMZIA during pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if CIMZIA passes into your breast milk. You and your healthcare provider should decide if you will receive CIMZIA or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take the following medicines due to a higher chance for serious infections:
- Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or Tysabri® (natalizumab).
- medicines called Tumor Necrosis Factor (TNF) blockers such as Remicade® (infliximab), Humira® (adalimumab), Enbrel® (etanercept), or Simponi® (golimumab).
Ask your healthcare provider if you are not sure.
You should not take CIMZIA while you take any of these medicines.
How should I receive CIMZIA?
- CIMZIA comes as lyophilized powder or as a solution in a prefilled syringe for injection.
- If your healthcare provider prescribes the CIMZIA powder, your CIMZIA should be injected by a healthcare provider. Each dose of CIMZIA will be given as 1 or 2 separate injections under the skin in your stomach area or upper thighs.
- If your healthcare provider prescribes the CIMZIA prefilled syringe, you will be trained on how to inject CIMZIA.
- You will receive a CIMZIA Prefilled Syringe Kit including a complete “Instructions for Use” booklet for the right way to inject CIMZIA.
- Read the detailed Instructions for Use booklet for instructions about how to prepare and inject your dose of CIMZIA, and how to properly throw away used syringes containing the needle.
- Do not give yourself an injection of CIMZIA unless you have been shown by your healthcare provider. A family member or friend can also be trained to help you give your injection. Talk to your healthcare provider if you have questions.
- CIMZIA is given by an injection under the skin. Your healthcare provider will tell you how much and how often to inject CIMZIA. Do not use more CIMZIA or inject more often than prescribed.
- You may need more than 1 injection at a time depending on your prescribed dose of CIMZIA.
- CIMZIA may be injected into your stomach or upper thighs. If you are prescribed more than 1 injection, each injection should be given at a different site in your stomach or upper thighs.
- Make sure the solution in the prefilled syringe is clear and colorless to yellow and free from particles. Do not use the CIMZIA prefilled syringe if the medicine is cloudy, discolored, or contains particles.
- Do not miss any doses of CIMZIA. If you miss a dose, call your healthcare provider or pharmacist for instructions.
- Make sure to keep all follow-up appointments with your healthcare provider.
What are the possible side effects of CIMZIA?
CIMZIA can cause serious side effects including:
- See “What is the most important information I should know about CIMZIA?”
- Heart Failure including new heart failure or worsening of heart failure you already have. Symptoms include shortness of breath, swelling of your ankles or feet, or sudden weight gain.
- Allergic Reactions. Signs of an allergic reaction include a skin rash, swelling or itching of the face, tongue, lips, or throat, or trouble breathing.
- Hepatitis B virus reactivation in patients who carry
the virus in their blood. In some cases patients have died as a
result of hepatitis B virus being reactivated. Your healthcare provider should
monitor you carefully before and during treatment with CIMZIA to see if you
carry the hepatitis B virus in your blood. Tell your healthcare provider if you
have any of the following symptoms:
- feel unwell
- skin or eyes look yellow
- tiredness (fatigue)
- poor appetite or vomiting
- pain on the right side of your stomach (abdomen)
- New or worsening nervous system problems, such as
multiple sclerosis (MS), Guillain-Barre syndrome, seizures, or inflammation of
the nerves of the eyes. Symptoms may include:
- numbness or tingling
- problems with your vision
- weakness in your arms or legs
- Blood Problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
- Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.
Call your healthcare provider right away if you have any serious side effects listed above.
The most common side effects of CIMZIA include:
Tell your healthcare provider about any side effect that bothers you or does not go away.
These are not all of the possible side effects of CIMZIA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store CIMZIA?
- Keep CIMZIA in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Do not freeze CIMZIA.
- Protect CIMZIA from light. Store CIMZIA in the carton it came in.
- Do not use CIMZIA if the medicine is expired. Check the expiration date on the prefilled syringe or carton.
- The CIMZIA prefilled syringe is made of glass. Do not drop or crush the syringe.
Keep CIMZIA and all medicines out of the reach of children.
General information about the safe and effective use of CIMZIA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIMZIA for a condition for which it was not prescribed. Do not give CIMZIA to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about CIMZIA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about CIMZIA that is written for health professionals.
For more information, go to www.CIMZIA.com or call 1-866-424-6942.
What are the ingredients in CIMZIA?
CIMZIA lyophilized powder:
Active ingredient: certolizumab pegol
Inactive ingredients: lactic acid, polysorbate, sucrose
CIMZIA lyophilized powder is mixed with sterile Water for Injection.
CIMZIA prefilled syringe:
Active ingredient: certolizumab pegol
Inactive ingredients: sodium acetate, sodium chloride, Water for Injection CIMZIA has no preservatives.
Instructions for Use
(certolizumab pegol) solution for subcutaneous use Prefilled Syringes
Read this Instructions for Use booklet that comes with CIMZIA before you start receiving it, and before each injection of CIMZIA. This Instructions for Use booklet does not take the place of talking with your healthcare provider about your medical condition or treatment. These instructions are for 1 injection only. You may need more than 1 injection at a time depending on your prescribed dose of CIMZIA.
Do not share your CIMZIA Prefilled Syringe with needle attached with another person. You may give another person an infection or get an infection from them.
Supplies you will need to give your CIMZIA injection: See Figure A and Figure B.
Figure A and Figure B
- 1 CIMZIA prefilled syringe with needle attached. You may need 2 CIMZIA prefilled syringes with needles attached to give higher doses.
- 1 or 2 alcohol swabs
- 1 or 2 clean cotton balls or gauze pads
- 1 puncture-resistant sharps disposal container. See “Disposal of your syringes with needles attached” at the end of this Instructions for Use booklet.
CIMZIA comes in a tray containing 2 prefilled glass syringes. Use a new CIMZIA syringe for each injection.
Setting up for your CIMZIA injection:
Take the carton containing the prefilled syringes of CIMZIA out of the refrigerator. Check the expiration date on the syringe carton and label. See Figure C.
If the expiration date has passed, do not use the syringe. Call your pharmacist for questions about the expiration date. Do not use CIMZIA if the tamper evident seals are missing or broken on the top or bottom of the carton when you receive it. If the tamper evident seals are missing or broken, contact your pharmacist.
Remove the prefilled syringe from the carton and let it warm to room temperature. Do not warm the syringe in any other way. If you are not using the second syringe, put the carton containing the remaining prefilled syringe back in the refrigerator.
Find a clean, flat work surface, such as a table.
Make sure the liquid medicine in the prefilled syringe is clear and colorless to yellow and free from particles. Do not inject the medicine if it is cloudy, discolored, or contains particles. Call your healthcare provider or pharmacist if you have any questions about your CIMZIA prefilled syringe.
Gather all the supplies you will need for your injection.
Wash your hands with soap and warm water and dry with a clean towel.
Selecting and preparing your injection site:
Choose your injection site(s) on your stomach or upper thighs. See Figure D.
- Choose a new injection site each time you use CIMZIA.
- Each new injection should be given at least 1 inch from the site you used before. If you choose your stomach, avoid the 2 inches around your belly button (navel).
- Do not inject into areas where your skin is tender, bruised, red or hard, or where you have scars or stretch marks.
- Change injection sites between your stomach and upper thighs to reduce the chance of having a skin reaction.
- You may want to write down the site you use for your injection to help you remember to use a different site each time you inject.
Clean your injection site with an alcohol swab. Let the area dry completely.
Giving your CIMZIA injection:
Pick up the prefilled syringe with 1 hand and hold it with the needle 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. With your other hand, remove the plastic ring needle cover by pulling straight upon the plastic ring. See Figure E.
Do not touch the needle and do not let the needle touch any surface. Do not bend the needle. Place the plastic ring needle cover to the side.
With your other hand, gently pinch a fold of skin at the cleaned injection site. See Figure F.
With a quick, “dart-like” motion, insert the needle into your skin at about a 45 degree angle. Release the pinched skin, keeping the syringe in position. Slowly push on the plunger all the way down until the syringe is empty. See Figure G
When the syringe is empty, pull the needle out of your skin while carefully keeping the needle at the same angle as inserted. See Figure H.
Place a dry cotton ball or gauze pad over the injection site for several seconds. See Figure I.
Do not rub the injection site. Do not use an alcohol swab as it may cause stinging. If there is a little bleeding, cover the injection site with a small bandage.
To avoid a needle-stick injury, do not try to recap the needle. Do not reuse any of your injection supplies.
Disposal of your syringes with needles attached:
Put your used syringes with needle attached in a FDA-cleared sharps disposal container right away after use. See Figure J.
Do not throw away (dispose of) loose syringes and needles in your household trash.
- If you do not have a
FDA-cleared sharps disposal container, you may use a household container that
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- properly labeled to warn of hazardous waste inside the container
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Preparation and Administration of Lyophilized Powder for Injection (200 mg/vial)
CIMZIA Lyophilized powder should be prepared and administered by a health care professional.
Contents: 2 vials of CIMZIA (200 mg each); 2 injection kits/disposal trays each containing 1 vial of sterile water for injection, USP (1 mL), 1 single-use plastic syringe, 4 alcohol swabs, two reconstitution needles, and one dosing needle.
Refrigerate intact carton at 2 to 8°C (36 to 46°F). DO NOT FREEZE. Do not separate contents of carton prior to use. Do not use beyond expiration date on container.
Remove CIMZIA from the refrigerator and allow the vial(s) to sit at room temperature for 30 minutes before reconstituting. Do not warm the vial in any other way. Using appropriate aseptic technique, reconstitute each lyophilized vial of CIMZIA with 1 mL of sterile water for injection using a syringe with a fresh 20-gauge needle. The sterile water for injection should be directed at the vial wall rather than directly on CIMZIA. (See Figure 1.)
The resultant solution will contain 200 mg/mL.
Gently swirl each vial of CIMZIA for about one minute without shaking, ensuring that all of the powder comes into contact with the Sterile Water for Injection. The swirling should be as gentle as possible in order to avoid creating a foaming effect. (See Figure 2.)
Continue swirling every 5 minutes as long as non-dissolved particles are observed. Full reconstitution may take as long as 30 minutes. The final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to pale yellow liquid and essentially free from particulates.
Once reconstituted, CIMZIA can be stored in the vials for up to 24 hours between 2° to 8° C (36° to 46° F) prior to injection. Do not freeze.
When ready to inject, reconstituted CIMZIA should be at room temperature. Do not leave reconstituted CIMZIA at room temperature for more than 2 hours prior to administration.
Withdraw the reconstituted solution into a separate syringe for each vial using a new 20-gauge needle for each vial so that each syringe contains 1mL of CIMZIA (200mg of certolizumab pegol). (see Figure 3)
Replace the 20-gauge needle(s) on the syringes with a 23-gauge needle(s) for administration. (See Figure 4.)
Inject the full contents of the syringe(s) subcutaneously, by pinching the skin of the abdomen (See Figure 5) or thigh (See Figure 6). Where a 400 mg dose is required, two injections are required. Therefore, separate sites should be used for each 200mg injection.
Figure 5 and Figure 6
You can also visit the CIMZIA Web site at www.CIMZIA.com
Last reviewed on RxList: 5/9/2016
This monograph has been modified to include the generic and brand name in many instances.
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