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Cimzia

Pronunciation: CIM-zee-uh
Generic name: certolizumabSER-toe-LIZ-oo-mab ]
Dosage form: injection
Drug class: TNF alfa inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Dec 9, 2024.

What is Cimzia?

Cimzia injection is used to treat Crohn's disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-radiographic axial spondyloarthritis in certain patients. Cimzia works to reduce inflammation and improve symptoms by blocking a protein called TNFα (tumor necrosis factor alpha).  Cimzia (certolizumab  pegol) belongs to the drug class TNF alfa inhibitors.

In autoimmune conditions, like Crohn's disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis inflammation can be caused or worsened when TNF is released in the body. By Cimzia blocking TNFα there is less inflammation so symptoms of the condition improve.

Cimzia first received FDA approval on April 22, 2008, for moderate to severe active Crohn’s disease in adults who have an inadequate response to conventional therapy to reduce signs and symptoms of the disease and to maintain clinical response. Since then, it has also been approved for specific adult patients with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

Cimzia Indications

Cimzia FDA-approved indications for adults are 

Cimzia FDA-approved indication for patients 2 years of age and older is 

Cimzia side effects

Common Cimzia side effects may include rash, pain or burning when you urinate, and cold symptoms such as stuffy nose, sneezing, and a sore throat.

Serious Cimzia side effects

Get emergency medical help if you have signs of an allergic reaction to Cimzia: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Cimzia. Tell your doctor if you have signs of infection, such as fever, chills, cough, sweating, muscle pain, open sores or skin wounds, unusual tiredness, feeling short of breath, painful urination, diarrhea, or weight loss.

Call your doctor right away if you have any of these symptoms of lymphoma:

Stop using Cimzia and call your doctor at once if you have Cimzia side effect symptoms of:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Cimzia affects your immune system. Serious and sometimes fatal infections may occur.

Your risk of infection may be higher if you have diabetes, HIV, a weak immune system, hepatitis B, chronic infections, if you use certain medications, or if you live in or travel to certain areas.

Call your doctor at once if you have symptoms such as fever, chills, cough, diarrhea, night sweats, flu symptoms, or skin sores.

Using Cimzia may also increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal.

Do not receive a "live" vaccine while you are being treated with Cimzia.

Do NOT use this medicine if you have had a serious hypersensitivity reaction to certolizumab pegol or to any of the inactive ingredients. 

Before taking this medicine

You should not use Cimzia if you are allergic to certolizumab. You may not be able to use Cimzia if you have symptoms of an infection such as fever, chills, cough, skin sores, shortness of breath, weight loss, diarrhea, or painful urination.

Tell your doctor if you have ever had tuberculosis, or anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Cimzia may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Tell your doctor if you have ever had:

It is not known whether Cimzia will harm an unborn baby. Tell your doctor if you are pregnant. Your name may be listed on a pregnancy registry to track the effects of Cimzia on the baby.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Cimzia is not approved for use by anyone younger than 18 years old.

How is Cimzia given?

Cimzia is injected under the skin. A healthcare provider may teach you how to use the medication by yourself properly.

Cimzia is usually given every 2 to 4 weeks. You may need to use more than 1 injection to get a full dose. Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Cimzia if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Cimzia can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.

Store Cimzia in its original carton in the refrigerator. Protect from light and do not freeze.

Take the syringe out of the refrigerator and let it reach room temperature before injecting your dose.

Unopened prefilled syringes may also be stored at room temperature for up to 7 days, away from heat and light. Throw away any prefilled syringe not used within 7 days. Do not put it back in the refrigerator.

Each prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you've ever had hepatitis B, using Cimzia can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Before you start treatment with Cimzia, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Dosing information

Usual Adult Cimzia Dose for Rheumatoid Arthritis

Initial Cimzia dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Maintenance Cimzia dose: 400 mg subcutaneously every 4 weeks can be considered
Use: For the treatment of adults with moderately to severely active rheumatoid arthritis (RA)

Usual Adult Cimzia Dose for Psoriatic Arthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Use: For the treatment of adult patients with active psoriatic arthritis (PsA)

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks
Use: For the treatment of adults with active ankylosing spondylitis

Usual Adult Cimzia Dose for Crohn's Disease

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4
Maintenance dose: 400 mg subcutaneously every 4 weeks
Use: For reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

Usual Adult Dose for Plaque Psoriasis

Initial dose: 400 mg subcutaneously (given as 2 subcutaneous injections or 200 mg) every other week
For certain patients with body weight <=90 kg: 400 mg (given as 2 subcutaneous injections or 200 mg) at weeks 0, 2, and 4 followed by 200 mg every other week can be considered
Use: For the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks
Use: For the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Usual dose for Polyarticular Juvenile Idiopathic Arthritis  patients 2 years of age and older)

Dose is weight dependant, every other week:

10 kg (22 lbs) to less than 20 kg (44 lbs): dose 100 mg initially and at week 2 and 4, followed by maintenance dose of 50 mg every other week
20 kg (44 lbs) to less than 40 kg (88 lbs): dose 200 mg initially and at week 2 and 4, followed by a maintenance dose of 100 mg every other week
Greater than or equal to 40 kg (88 lbs): dose 400 mg initially and at week 2 and 4, followed by  a maintenance dose of 200 mg every other week 

General Cimzia Dosing Information

Cimzia is available as 200 mg lyophilized powder in a single-dose vial and 200 mg/mL solution in a single-dose prefilled syringe

Entyvio, Otezla, Taltz, prednisone, naproxen, methotrexate, dexamethasone, hydroxychloroquine, hydrocortisone, budesonide

Withdrawal from Cimzia

Your healthcare profession will guide you on how long you will use Cimzia.
Withdrawal from Cimzia may be required if you have severe allergic reactions.  Clinical trials have also studied reducing the dose of Cimza and stopping Cimza after sustained low disease activity in treating rheumatoid arthritis. However, the NCT01521923 clinical study failed to meet its primary endpoint.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Cimzia.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Cimzia?

Avoid injecting Cimzia into scars or stretch marks, or into skin that is red, bruised, swollen, hard, or tender.

Ask your doctor before receiving any vaccine while you are being treated with Cimzia.

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What other drugs will affect Cimzia?

Tell your doctor about all your other medicines, especially:

This list is not complete. Other drugs may interact with certolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Does Cimzia interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Cimzia Package Insert

This is not all the information you need to know about Cimzia (certolizumab pegol) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the Cimzia Package Insert here, and discuss this medicine and any questions you have with your doctor or other health care provider.

Ingredients

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. 

Storage

Company

Manufactured by: UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080.

Cimzia Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Cimzia.

Cimzia (certolizumab pegol) - UCB, Inc.
Formulation type Strength
Pre-Filled Syringe 200 mg/mL
Single-Dose Vial 200 mg

Popular FAQ

Are Cimzia injections painful?

When you inject Cimzia you may get pain when the needle goes into your skin, this is usually just a quick pinch and does not last very long. Injection or infusion site reactions are when you get painful swelling, bruising or redness at the site and are less common than injection site pain. In a clinical study using Cimzia for rheumatoid arthritis, injection or infusion site reactions affected:

  • 5.8% of patients using Cimzia
  • 1% of patients using placebo

In this clinical study patients used Cimzia every 2 weeks, 400mg on for the first 3 doses, then 200mg Cimzia after that.

Does Cimzia lower your immune system?

Yes, Cimzia is an immunosuppressant and may lower your ability to fight infections. Serious or deadly infections may occur. Do not start Cimzia if you have any infection unless approved by your healthcare provider. Contact your doctor if you develop any symptoms of a viral, fungal, bacterial, tuberculosis (TB) or hepatitis B virus infection. Your doctor should test you for TB before you start treatment and monitor you closely. There is also the possible risk of certain cancers while receiving Cimzia.

How long can Cimzia be out of the fridge?

Cimzia prefilled syringes can stay at room temperature for a single period of up to 7 days, not to exceed 25°C (77°F) and left in the original carton. Do not put the medicine back in the refrigerator if you have stored it at room temperature. Once removed from the refrigerator, write the new expiration date on the package. Throw the prefilled syringe away if not used within the 7-day period.

How long does Cimzia stay in your system?

Cimzia may stay in your system for up to 56 to 70 days before it is fully eliminated. This medicine’s half-life is 14 days. A half-life is the time it takes a dose of the drug to be reduced by one-half. It takes on average 4 to 5 half-lives for a drug to be fully eliminated, but this can vary based on your age, weight, genetics, kidney or liver function, drug interactions, and even medical conditions.

How long does Cimzia take to work?

Cimzia injection can work as fast as 1 or 2 weeks in some people for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Its full effectiveness can range from 4 months to 1 year based on your specific medical condition. Continue reading

What's the difference between Cimzia and Humira?

Cimzia (certolizumab pegol) and Humira (adalimumab) are two different medicines but they are from the same class of medications called tumor necrosis factor (TNF) inhibitors or blockers. Both medicines are approved to treat rheumatoid arthritis, Crohn's disease, plaque psoriasis, and psoriatic arthritis, but Humira also treats several other autoimmune inflammatory diseases as well. For some diseases, Humira is safe for children, while Cimzia is only indicated for adults. Continue reading

How and where is the Cimzia injection given?

Cimzia prefilled syringes can be self-injected at home or administered by a healthcare professional at their clinic or office. Cimzia is injected subcutaneously (this means just under the skin) and there are 2 main areas where Cimzia can be injected:

  • The stomach area (your belly) except for a 2-inch circle around your navel (belly button)
  • The top and outer part of your thighs, but not your inner thighs or anywhere close to your knee.

The easiest way to inject Cimzia under the skin is to pinch up a fold of skin using your thumb and forefinger on your stomach or thigh. More detailed instructions are below. Your healthcare professional can also show you how to inject Cimzia. Continue reading

Does Cimzia cause hair loss?

Cimzia (certolizumab) may cause a type of hair loss known as alopecia totalis, a complete loss of hair on the scalp. This is not a common side effect but the incidence is not reported. The cause for the hair loss may be due to an immune-system reaction while using Cimzia. Continue reading

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.