Cimzia

Generic name: Certolizumab
Dosage form: injection
Drug class: TNF alfa inhibitors

Usage of Cimzia

Cimzia injection is used to treat Crohn's disease, rheumatoid arthritis, plaque psoriasis, psoriatic 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) 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 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:

chest pain, cough, feeling short of breath;

swelling in your neck, underarm, or groin (this swelling may come and go);

fever, night sweats, itching, weight loss, feeling tired;

feeling full after eating only a small amount; or

pain in your upper stomach that may spread to your back or shoulder.

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

shortness of breath (even with mild exertion), swelling, rapid weight gain;

pale skin, easy bruising or bleeding;

a new growth on your skin (may be red or purple), or any change in the size or color of a mole, freckle, or bump on your skin;

nerve problems - vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;

liver problems - loss of appetite, right-sided stomach pain, tiredness, jaundice (yellowing of the skin or eyes); or

new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

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.

Before taking Cimzia

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:

a chronic infection;

hepatitis B (or if you are a carrier of the virus);

lymphoma or other types of cancer;

a blood cell disorder;

congestive heart failure;

a seizure;

an allergy to latex;

numbness or tingling, or a nervous system disorder such as multiple sclerosis; or

if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

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.

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How to use Cimzia

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 - Maintenance:

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

General Cimzia Dosing Information

Rotate injection sites.

Do not inject into skin that is tender, bruised, red, or hard.

When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.

This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).

The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

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

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.

What other drugs will affect Cimzia

Tell your doctor about all your other medicines, especially:

abatacept;

adalimumab;

anakinra;

etanercept;

golimumab;

infliximab;

natalizumab; or

rituximab.

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.

Popular FAQ

When you inject 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. Continue reading

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.

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.

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.

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

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

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

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

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