CIMZIA®

Bullet Point
CIMZIA® (certolizumab pegol)
UCB, Inc
1% 400MG KIT
Item # 33593
NDC: 50474-0700-62 
HCPCS CODE: J0717
 Net 60 Day Terms
Credit Card

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CIMZIA® Receives New Indication

CIMZIA is a tumor necrosis factor (TNF) blocker indicated 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
  • Treatment of adults with moderately to severely active rheumatoid arthritis
  • Treatment of adult patients with active psoriatic arthritis
  • Treatment of adults with active ankylosing spondylitis
  • Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy 
Important Safety Information
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
See full prescribing information for complete boxed warning.
  • Increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
  • CIMZIA should be discontinued if a patient develops a serious infection or sepsis.
  • Perform test for latent TB; if positive, start treatment for TB prior to starting CIMZIA.
  • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. 
  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.


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, 
including 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: 
    • fever, sweat, or chills
    • weight loss 
    • muscle aches
    • warm, red, or painful skin or sores on your body
    • cough
    • diarrhea or stomach pain
    • shortness of breath
    • burning when you urinate or urinate more often than normal
    • blood in phlegm
    • feeling very tired
  • are being treated for an infection, or 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 of 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. 

Certain Types of Cancer
There have been cases of unusual cancers in children and teenage patients using TNF-blocking 
agents. CIMZIA is not approved for use in pediatric patients. For people taking TNF-blocker 
medicines, including CIMZIA, the chances for getting lymphoma or other cancers may increase. 
People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer 
called lymphoma.

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 (PsA).
  • Treat active ankylosing spondylitis (AS)
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
  • 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
  • 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 a lyophilized powder or a solution in a prefilled syringe for injection. If your 
healthcare provider prescribes the CIMZIA powder, CIMZIA should be injected by a healthcare 
provider. If your healthcare provider prescribes the prefilled syringe, you will be trained on how 
to inject CIMZIA. See the booklet called “Instructions for Use” packaged in your CIMZIA prefilled 
syringe kit for complete instructions for use. Do not give yourself an injection of CIMZIA unless 
you have been shown by your healthcare provider, or they can train someone you know to help 
you with your injection. 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.

What are the possible side effects of CIMZIA? CIMZIA can cause serious side effects including:
  • 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
    • poor appetite or vomiting
    • skin or eyes look yellow
    • pain on the right side of your stomach (abdomen)
    • tiredness (fatigue)
  • 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:
    • dizziness
    • problems with your vision
    • numbness or tingling
    • 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 doesn’t 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 side effects listed above. The most common side effects of CIMZIA include: upper respiratory infections (flu, cold), rash, and urinary tract infections (bladder infections).
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. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1.800.FDA.1088.

Please see the Medication Guide for CIMZIA and discuss it with your healthcare provider. 

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