Cimzia

• Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

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 (
  
  1.1)
  
• Treatment of adults with moderately to severely active rheumatoid arthritis (
  
  1.2)
  
• Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older (
  
  1.3)
  
• Treatment of adult patients with active psoriatic arthritis. (
  
  1.4)
  
• Treatment of adults with active ankylosing spondylitis (
  
  1.5)
  
• Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation (
  
  1.6)
  

Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy (
1.7)

CIMZIA is administered by subcutaneous injection

The solution should be carefully inspected visually for particulate matter and discoloration prior to administration. The solution should be a clear to opalescent, colorless to yellow liquid, essentially free from particulates and should not be used if cloudy or if foreign particulate matter is present. CIMZIA does not contain preservatives; therefore, unused portions of drug remaining in the syringe or vial should be discarded.

• For injection: 200 mg lyophilized powder in a single-dose vial (
  
  3)
  
• Injection: 200 mg/mL solution in a single-dose prefilled syringe (
  
  3)
  

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIMZIA during pregnancy. For more information, healthcare providers or patients can contact:

MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS). The OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit