• Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.
  • Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteriods or methotrexate) may be at a greater rish of infection.
  • Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including children, adolescents, and young adults. Acute and chronic cases of leukemia have also been reported.
  • Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.
  • Anaphylaxis or serious allergic reactions may occur. Hypersensitivity reactions have been reported rarely following CIMZIA administration.
  • Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus.
  • Treatment with TNF blockers, including CIMZIA, may rarely result in new onset or exacerbation of clinical symptoms and/or radiographic evidence of central or peripheral nervous system demyelinating disease, as well as the development of a lupus-like syndrome.
  • Rare reports of blood dyscrasias have been reported with CIMZIA; patients should be advised to seek medical attention if they develop.
  • Concurrent administration of CIMZIA with certain biological DMARDs, including anakinra, abatacept, and rituximab, is not recommended due to an increased risk of serious infections.
  • In pre-marketing controlled trials of all patient populations combined, the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

Warnings and Precautions to Pass on to Your Patients

Before starting CIMZIA, tell your doctor if you:

  • think you have an infection, you should not start taking CIMZIA if you have any kind of infection
  • are being treated for an infection
  • have signs of an infection, such as a fever, cough, flu-like symptoms
  • have any open cuts or sores on your body
  • get a lot of infections or have infections that keep coming back
  • have diabetes
  • have HIV
  • 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 doctor 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, or 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, cocciodioidomycosis, or blastomycosis is common, ask your doctor.
  • have or have had hepatitis B
  • 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 pregnant, planning to become pregnant, or breastfeeding. CIMZIA has not been studied in pregnant or nursing women.
  • are allergic to any of the ingredients in CIMZIA
  • are taking any medicines, including prescription and nonprescription medicines, vitamins and herbal supplements. Your doctor will tell you if it is okay to take your other medicines while taking CIMZIA
  • Especially tell your doctor if you take: Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), Tysabri® (natalizumab). You have a higher chance of serious infections when taking CIMZIA with these medicines. A TNF blocker: Remicade® (infliximab), Humira® (adalimumab), Enbrel® (etanercept) or Simponi® (golimumab)

After starting CIMZIA, if you have 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 doctor right away. CIMZIA can make you more likely to get infections or make any infection that you have worse.

What should I tell my doctor before starting treatment with CIMZIA?

CIMZIA may not be right for you. Before starting CIMZIA, tell your doctor about all of your medical conditions, including if you:

  • have an infection (See, "What is the most important information I should know about CIMZIA?")
  • have or have had any type of cancer
  • have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis
  • have heart failure
  • are scheduled to receive a vaccine. Patients should not receive a live vaccine while taking CIMZIA

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. CIMZIA has not been studied in pregnant or nursing women.

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

Your doctor will tell you if it is okay to take your other medicines while taking CIMZIA. Especially, tell your doctor if you take:

  • Kineret® (anakinra). You have a higher chance for serious infections when taking CIMZIA with Kineret®.
Also see additional side effects.

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