IMPORTANT SAFETY INFORMATION
Patients treated with AMJEVITA 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 AMJEVITA 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
AMJEVITA use and during therapy. Initiate treatment for latent TB prior to AMJEVITA 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 AMJEVITA prior to initiating therapy
in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of
opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. 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 AMJEVITA, including the possible development of TB in
patients who tested negative for latent TB infection prior to initiating therapy.
- Do not start AMJEVITA 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.
- Drug interactions with biologic products: A higher rate of serious infections has been
observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with
a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers
with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant
administration of AMJEVITA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is
not recommended based on the possible increased risk for infections and other potential pharmacological
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent
patients treated with TNF
blockers including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare
T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These
have had a very aggressive disease course and have been fatal. The majority of reported TNF-blocker cases have
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
prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF
combination with these other immunosuppressants.
- Consider the risks and benefits of AMJEVITA prior to initiating or continuing therapy in a
patient with known malignancy.
- In clinical trials of some TNF blockers, including adalimumab products, more cases of
malignancies were observed among TNF-blocker-treated patients compared to control patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated
patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA
therapy, for the presence of NMSC prior to and during treatment with AMJEVITA.
- In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma
than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly
those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher
risk of lymphoma than the general population, even in the absence of TNF blockers.
- Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use.
Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults
receiving TNF blockers were lymphomas; other cases included rare malignancies associated with
immunosuppression and malignancies not usually observed in children and adolescents.
Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab
products. If a serious allergic reaction occurs, stop AMJEVITA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including AMJEVITA, may increase the risk of reactivation of hepatitis B
virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV
infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in
patients who are carriers of HBV and monitor them during and after AMJEVITA treatment. Discontinue AMJEVITA and
begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming AMJEVITA after
TNF blockers, including adalimumab products, have been associated with rare cases of new onset
or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis,
optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering AMJEVITA for patients with these
disorders; discontinuation of AMJEVITA should be considered if any of these disorders develop.
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers.
Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping
AMJEVITA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
Worsening or new onset congestive heart failure (CHF) has been reported with TNF blockers.
Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.
Treatment with adalimumab products 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.
Patients on AMJEVITA should not receive live vaccines. Pediatric patients, if possible, should
be brought up to date with all immunizations before initiating AMJEVITA therapy. Adalimumab is actively
transferred across the placenta during the third trimester of pregnancy and may affect immune response in the
in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed
to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating
(live or live-attenuated) exposed infants.
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections
(e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
Please see the accompanying AMJEVITA full Prescribing Information,
including Medication Guide.
AMJEVITA is indicated for:
reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural
damage, and improving physical function in adult patients with moderately to severely active rheumatoid
arthritis, alone or in combination with methotrexate or other non-biologic DMARDs.
- reducing signs and symptoms of moderately to severely active polyarticular juvenile
idiopathic arthritis in patients 2 years of age and older, alone or in combination with methotrexate.
reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical
function in adult patients with active psoriatic arthritis, alone or in combination with non-biologic
reducing signs and symptoms in adult patients with active ankylosing spondylitis.
the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years
of age and older.
the treatment of moderately to severely active ulcerative colitis in adult patients. The effectiveness
of adalimumab products has not been established in patients who have lost response to or were intolerant
to TNF blockers.
the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for
systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
AMJEVITA™ should only be administered to patients who will be closely monitored and have regular
follow-up visits with a physician.
the treatment of moderate to severe hidradenitis suppurativa in adult patients.