Cimzia

Generic name: certolizumab (SER toe LIZ oo mab)
Brand name: Cimzia
Drug class: TNF alfa inhibitors

Cimzia (certolizumab)reduces the effects of a substance in the body that can cause inflammation.

Cimzia is used to treat the symptoms of Crohn's disease after other treatments have failed.

Cimzia is also used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

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.

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:

• 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.

How is Cimzia given?

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

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

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.

Dosing information

Usual Adult Dose for Rheumatoid 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
Maintenance dose: 400 mg subcutaneously every 4 weeks in patients who obtain a clinical response

Comments:
-Injection sites should be rotated and injections should not be given in areas where the skin 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.

Use: For treatment of adults with moderately to severely active rheumatoid arthritis (RA)

Usual Adult 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
Maintenance dose: 400 mg subcutaneously every 4 weeks in patients who obtain a clinical response

Comments:
-Injection sites should be rotated and injections should not be given in areas where the skin 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 in case of intolerance to methotrexate (MTX) or when continued treatment with methotrexate is inappropriate.
-MTX should be continued during treatment with this drug where appropriate.
-Injection sites should be rotated and injections should not be given in areas where the skin 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.

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

Comments:
-Injection sites should be rotated and injections should not be given in areas where the skin 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.

Use: For the treatment of adults with active ankylosing spondylitis

Usual Adult 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 in patients who obtain a clinical response

Comments:
-Injection sites should be rotated and injections should not be given in areas where the skin 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.

Use: For reducing signs 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

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.

Cimzia side effects

Get emergency medical help if you have signs of an allergic reaction ti 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:

• 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.

Common Cimzia side effects may include:

• pain or burning when you urinate;
• rash; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

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.