Certolizumab

Cimzia is the brand name of the prescription drug certolizumab. It's used to treat certain autoimmune disorders, including:

• Rheumatoid arthritis (a condition in which the body attacks its own joints)
• Psoriatic arthritis (a condition that causes joint pain and scaly skin)
• Ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas)
• Crohn's disease (a condition in which the body attacks the lining of the digestive tract)

Cimzia belongs to a class of drugs called tumor necrosis factor (TNF) inhibitors. It works by blocking TNF, a substance that causes inflammation in the body.

The U.S. Food and Drug Administration (FDA) approved Cimzia in 2008. It's manufactured by UCB, Inc.

Cimzia Warnings

Cimzia contains a black box warning because it could increase your risk of developing a severe or life-threatening infection, and lower your body's ability to fight infections.

Tell your doctor if you're prone to getting infections, or if you currently have an infection, including a minor one, such as a cut or sore.

Tell your healthcare provider if you live in, have lived in, or have traveled to the Mississippi or Ohio River valleys. Severe fungal infections are more common in these regions.

Before starting on Cimzia, let your doctor know if you're taking any medication that affects the immune system, such as:

• Orencia (abatacept)
• Humira (adalimumab)
• Kineret (anakinra)
• Enbrel (etanercept)
• Remicade (infliximab)
• Rheumatrex or Trexall (methotrexate)
• Decadron or Dexpak (dexamethasone)
• Medrol (methylprednisolone)
• Sterapred (prednisone)
• Rituxan (rituximab)
• Xeljanz (tofacitinib)
• Actemra (tocilizumab)
• Simponi (golimumab)
• Tysabri (natalizumab)

Avoid being around people who are sick or have infections while you're taking Cimzia.

Call your doctor right away if you experience any symptoms of infection while using this medicine, which may include:

• Fever, sweating, or chills
• Sore throat
• Difficulty breathing
• Cough
• Weight loss
• Diarrhea
• Stomach pain
• Blood in phlegm
• Extreme tiredness or fatigue
• Muscle aches
• Red, warm, or painful skin
• Frequent urination, or burning during urination
• Sores on the skin or around the mouth

Before taking this drug, let your doctor know if you have, or have ever had:

• Diabetes
• HIV/AIDS
• Any other condition that affects your immune system

If you have active tuberculosis (TB) or hepatitis B (a type of liver disease), Cimzia may raise the risk of the infection becoming worse, since it can impair your body's ability to contain these infections.

You could have TB or hepatitis B and not know it since you may not have symptoms.

Your doctor will order tests to determine whether you have inactive forms of these conditions, so that they can be treated before you start on Cimzia.

Tell your doctor if you have or have ever tested positive for TB (by a blood or skin test), had TB, have been around someone with TB, or have traveled to areas where TB is common.

During your treatment with Cimzia, let your healthcare provider know right away if you experience any symptoms of TB, which may include:

• Cough
• Chest pain
• Coughing up blood or mucus
• Weight loss
• Loss of appetite
• Loss of muscle tone
• Weakness
• Tiredness
• Chills
• Fever
• Night sweats

Also, tell your doctor if you've ever had hepatitis B or if you experience any symptoms of the disease during or after your use of Cimzia.

Common symptoms of hepatitis B include:

• Yellowing of the skin or eyes (jaundice)
• Loss of appetite
• Nausea or vomiting
• Dark-colored urine
• Clay-colored stools
• Muscle aches
• Fever
• Chills
• Stomach pain
• Rash
• Excessive tiredness

This drug also contains a black box warning because some children, teenagers, and young adults who took medicines similar to Cimzia developed serious or life-threatening cancers, including lymphoma, a type of cancer that begins in the blood cells that fight infection.

Usually, children and teenagers shouldn't take Cimzia. But your doctor may decide that the benefits of the treatment outweigh the risks in a given situation.

Tell your doctor right away if you or your child develops any of the following symptoms during treatment with Cimzia:

• Swollen glands in the neck, groin, or underarms
• Unexplained weight loss
• Easy bruising or bleeding

Let your healthcare provider know you're taking this medicine before having any type of medical test or surgery, including a dental procedure.

Don't receive any vaccines while taking Cimzia without first discussing it with your doctor.

Before using Cimzia, tell your doctor if you have, or have ever had:

• Cancer
• Any condition that affects your nervous system, such as multiple sclerosis (MS)
• Guillain-Barré syndrome (a condition that causes weakness, tingling, and sometimes paralysis)
• Seizures
• Blood disorders or any type of bleeding problem
• Optic neuritis (inflammation of the nerve that sends messages from the eye to the brain)
• Tingling in any part of your body
• Heart failure
• Abnormal blood cell counts

Keep all appointments with your doctor and laboratory while taking Cimzia. You'll need to undergo frequent tests to check your body's response to the medicine.

Pregnancy and Cimzia

It's not known whether Cimzia could harm an unborn baby.

Tell your doctor if you're pregnant or might become pregnant while using this medicine.

It's also not known whether Cimzia could pass into breast milk or hurt a breastfeeding baby. Don't breastfeed while using this drug.

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those listed in the Cimzia Warnings section above.

Cimzia

Yes

There are no adequate studies of certolizumab in pregnant women.

It is not known whether certolizumab is excreted in breast milk.

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Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially, tell your doctor if you take:

• Kineret (anakinra), Orencia (abatacept), Rituxan (rituximab), Tysabri (natalizumab). You have a higher chance for serious infections when taking certolizumab with these medications.
• A TNF blocker such as Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept), or Simponi (golimumab).

This is not a complete list of certolizumab drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if certolizumab is excreted in human breast milk or if it will harm your nursing baby.

You should not use certolizumab if you are allergic to it.

Some people using this medicine have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using certolizumab or similar medicines to treat Crohn's disease or ulcerative colitis.

However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

You may not be able to use certolizumab if you have symptoms of an infection such as fever, chills, cough, diarrhea, or painful urination.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

To make sure certolizumab is safe for you, tell your doctor if you have ever had:

• a chronic infection;

• diabetes;

• HIV or a weak immune system;

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

• cancer (especially skin cancer);

• congestive heart failure;

• epilepsy or seizure disorder;

• numbness or tingling, or a disease that affects your nerves or muscles (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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of certolizumab on the baby.

It is not known whether certolizumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

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.

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