Indicated for:

Crohn’s Disease:

• 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.

Rheumatoid Arthritis:

• Treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Psoriatic Arthritis:

• Treatment of adult patients with active psoriatic arthritis (PsA).

Ankylosing Spondylitis:

• Treatment of adults with active ankylosing spondylitis (AS).

Non-radiographic Axial Spondyloarthritis:

• Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Plaque Psoriasis:

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

CIMZIA may be used as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).

The use of CIMZIA in combination with biological DMARDs or other tumor necrosis factor (TNF) blocker therapy is not recommended.

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Before initiation of therapy with CIMZIA, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. The possibility of undetected latent tuberculosis should be considered in patients who have immigrated from or traveled to countries with a high prevalence of tuberculosis or had close contact with a person with active tuberculosis. Appropriate screening tests (e.g. tuberculin skin test and chest x-ray) should be performed in all patients.

Reported infections include:

• 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 should be discontinued if a patient develops a serious infection or sepsis. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

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.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.

Cases of acute and chronic leukemia have been reported in association with post-marketing TNF blocker use in RA and other indications. Even in the absence of TNF blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including CIMZIA.

Use of TNF blockers, including CIMZIA, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Use of TNF blockers, of which CIMZIA is a member, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of CIMZIA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA.

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) have been infrequently reported with CIMZIA.

Treatment with CIMZIA may result in the formation of autoantibodies and rarely, in the development of a lupus-like syndrome.

The following symptoms that could be compatible with hypersensitivity reactions have been reported rarely following CIMZIA administration to patients: angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria. Some of these reactions occurred after the first administration of CIMZIA.

Treatment with CIMZIA should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteroids or methotrexate) may be at a greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients:

• with chronic or recurrent infection
• who have been exposed to tuberculosis
• with a history of an opportunistic infection
• who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis
• with underlying conditions that may predispose them to infection

Avoid use of live (including attenuated) vaccines concurrently with CIMZIA.

The use of CIMZIA in combination with anakinra, abatacept, rituximab, or natalizumab is not recommended.

Serious infections were seen in clinical studies with concurrent use of anakinra (an interleukin-1 antagonist) and another TNF blocker, etanercept, with no added benefit compared to etanercept alone. A higher risk of serious infections was also observed in combination use of TNF blockers with abatacept and rituximab. Because of the nature of the adverse events seen with this combination therapy, similar toxicities may also result from the use of CIMZIA in this combination. Therefore, the use of CIMZIA in combination with other biological DMARDs is not recommended.

Due to its inhibition of TNFα, CIMZIA administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant.

Minimal certolizumab pegol concentrations were observed in breast milk. 

GoToSource

• Ulcerative colitis. GoToSource

• Severe plaque psoriasis. GoToSource

• Use in patients under the age of 18. GoToSource

• Inflammatory bowel disease, behçet’s disease, sarcoidosis and noninfectious uveitis. GoToSource

• Ocular inflammation. GoToSource

• Advanced endometrial adenocarcinoma. GoToSource

Lupus, vasculitis (inflammation of the blood vessels), interstitial lung disease, sarcoidosis (inflammatory disease causing small lumps to form in different parts of the body), autoimmune hepatitis (liver inflammation) and myopathy (disorder of the skeletal muscles). GoToSource

Hepatosplenic T-Cell lymphoma or HSTCL (rare cancer of white blood cells). GoToSource

Merkel cell carcinoma (rare type of skin cancer). GoToSource

Pulmonary and disseminated histoplasmosis (fungal infection), coccidioidomycosis (fungal disease of the lungs and other tissues), blastomycosis (fungal infection) and other opportunistic infections also deaths in patients with coccidioidomycosis and blastomycosis. GoToSource

Serious infections leading to hospitalization or death including tuberculosis, bacterial sepsis, legionella and listeria bacteria, invasive fungal infections and infections due to other opportunistic pathogens. GoToSource

Lymphoma (including hodgkin’s and non-hodgkin’s lymphoma), gastrointestinal perforations, pneumonia, cellulitis (infection of skin and the soft tissues), erysipelas (bacterial skin infection), urinary tract infection and breast cancer. GoToSource

New or worsening psoriasis psoriasiform lesions (skin disease marked by red, itchy, scaly patches). GoToSource

Lawsuits filed for lymphoma, tuberculosis, bacterial sepsis and histoplasmosis.