Important Safety Information
Indications
CIMZIA (certolizumab pegol) is indicated for the treatment of adults
with moderate-to-severe plaque psoriasis who are candidates for
systemic therapy or phototherapy.
CIMZIA is indicated for the treatment of adults with active
psoriatic arthritis.
CONTRAINDICATIONS
CIMZIA is contraindicated in patients with a history of
hypersensitivity reaction to certolizumab pegol or to any of the
excipients. Reactions have included angioedema, anaphylaxis, serum
sickness, and urticaria.
SERIOUS INFECTIONS
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.
Discontinue
CIMZIA if a patient develops a serious infection or sepsis.
Reported
infections include:
Active tuberculosis (TB), including reactivation of latent TB.
Patients with TB have frequently presented with disseminated or
extrapulmonary disease. Test patients for latent TB before CIMZIA
use and during therapy. Initiate treatment for latent TB 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. Consider
empiric anti-fungal therapy 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.
Carefully consider the risks and benefits of treatment with
CIMZIA prior to initiating therapy in the following patients: with
chronic or recurrent infection; who have been exposed to TB; with a
history of opportunistic infection; who resided in or traveled in
regions where mycoses are endemic; with underlying conditions that
may predispose them to infection. Monitor patients closely for the
development of signs and symptoms of infection during and after
treatment with CIMZIA, including the possible development of TB in
patients who tested negative for latent TB infection prior to
initiating therapy.
Do not start CIMZIA during an active infection, including localized
infections.
Patients older than 65 years, patients with co-morbid conditions,
and/or patients taking concomitant immunosuppressants may be at
greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate
therapy.
MALIGNANCY
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.
Consider the risks and benefits of CIMZIA treatment prior to
initiating or continuing therapy in a patient with known malignancy.
In clinical trials, more cases of malignancies were observed among
CIMZIA-treated patients compared to control patients.
In CIMZIA clinical trials, there was an approximately 2-fold higher
rate of lymphoma than expected in the general U.S. population.
Patients with rheumatoid arthritis, particularly those with highly
active disease, are at a higher risk of lymphoma than the general
population.
Malignancies, some fatal, have been reported among children,
adolescents, and young adults being treated with TNF blockers.
Approximately half of the cases were lymphoma, while the rest were
other types of malignancies, including rare types associated with
immunosuppression and malignancies not usually seen in this patient
population.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare
type of T-cell lymphoma, have been reported in patients treated with
TNF blockers, including CIMZIA. These cases have had a very
aggressive disease course and have been fatal. The majority of
reported TNF blocker cases have occurred in patients with Crohn’s
disease or ulcerative colitis, and the majority were in adolescent
and young adult males. Almost all of these patients had received
treatment with azathioprine or 6-mercaptopurine concomitantly with a
TNF blocker at or prior to diagnosis. Carefully assess the risks and
benefits of treating with CIMZIA in these patient types.
Cases of acute and chronic leukemia were reported with TNF blocker
use.
HEART FAILURE
Worsening and new onset congestive heart failure (CHF) have been
reported with TNF blockers. Exercise caution and monitor carefully.
HYPERSENSITIVITY
Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness,
and urticaria have been reported following CIMZIA administration. If
a serious allergic reaction occurs, stop CIMZIA and institute
appropriate therapy. The needle shield inside the removable cap of
the CIMZIA prefilled syringe contains a derivative of natural rubber
latex which may cause an allergic reaction in individuals sensitive
to latex.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including CIMZIA, may increase the risk of
reactivation of hepatitis B virus (HBV) in patients who are chronic
carriers. Some cases have been fatal.
Test patients for HBV infection before initiating treatment with
CIMZIA.
Exercise caution in patients who are carriers of HBV and monitor
them before and during CIMZIA treatment.
Discontinue CIMZIA and begin antiviral therapy in patients who
develop HBV reactivation. Exercise caution when resuming CIMZIA
after HBV treatment.
NEUROLOGIC REACTIONS
TNF blockers, including CIMZIA, have been associated with rare cases
of new onset or exacerbation of central nervous system and
peripheral demyelinating diseases, including multiple sclerosis,
seizure disorder, optic neuritis, peripheral neuropathy, and
Guillain-Barré syndrome.
HEMATOLOGIC REACTIONS
Rare reports of pancytopenia, including aplastic anemia, have been
reported with TNF blockers. Medically significant cytopenia has been
infrequently reported with CIMZIA.
Consider stopping CIMZIA if significant hematologic abnormalities
occur.
DRUG INTERACTIONS
Do not use CIMZIA in combination with other biological DMARDs.
AUTOIMMUNITY
Treatment with CIMZIA may result in the formation of autoantibodies
and, rarely, in development of a lupus-like syndrome. Discontinue
treatment if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
Patients on CIMZIA should not receive live or live-attenuated
vaccines.
ADVERSE REACTIONS
The most common adverse reactions in CIMZIA clinical trials (≥8%)
were upper respiratory infections (18%), rash (9%), and urinary
tract infections (8%).
Please see full Prescribing Information by
visiting
cimziahcp.com.
