IMPORTANT SAFETY INFORMATION1
Patients treated with HUMIRA 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 HUMIRA 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 HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA 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 HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
- Do not start HUMIRA in patients with 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.
- Consider the risks and benefits of treatment in patients with chronic or recurrent infection or with underlying conditions which may predispose them to infection, patients who have been exposed to TB, patients with a history of opportunistic infection, or patients who have resided or traveled in regions where TB or mycoses are endemic.
- Patients who develop a new infection should undergo a prompt and complete diagnostic workup, and appropriate antimicrobial therapy should be initiated.
- Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis patients treated with rituximab who received subsequent treatment with a TNF blocker. Concurrent use of HUMIRA with 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 interactions.
Lymphoma and other malignancies, some fatal, have been reported in children
and adolescent patients treated with TNF blockers, including HUMIRA.
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 HUMIRA.
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. It is uncertain whether the occurrence
of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with
these other immunosuppressants.
- Consider the risks and benefits of HUMIRA treatment prior to initiating
or continuing therapy in a patient with known malignancy.
- More cases of malignancies were observed among HUMIRA-treated patients compared
to control patients in clinical trials.
- Non-melanoma skin cancer (NMSC) has been reported during clinical trials for HUMIRA-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 HUMIRA.
- In HUMIRA 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 HUMIRA administration.
- If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
- Use of TNF blockers, including HUMIRA, 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 treatment with HUMIRA.
- Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation.
- Exercise caution when considering resumption of HUMIRA therapy after appropriate treatment for HBV.
- TNF blockers, including HUMIRA, have been associated in rare cases with 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 HUMIRA for patients with these disorders.
- Rare reports of pancytopenia, including aplastic anemia, have been reported with
TNF blockers. Medically significant cytopenia (e.g., thrombocytopenia, leukopenia)
has been infrequently reported with HUMIRA.
- Consider stopping HUMIRA in patients with significant hematologic abnormalities.
CONGESTIVE HEART FAILURE
- Worsening or new onset congestive heart failure (CHF) may occur.
- Exercise caution in patients with CHF and monitor them
- Treatment with HUMIRA 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 HUMIRA should not receive live vaccines.
- It is recommended that juvenile idiopathic arthritis patients, if possible, be brought
up to date with all immunizations in agreement with current immunization guidelines
prior to initiating HUMIRA therapy.
- The most common adverse reactions in HUMIRA clinical trials (incidence >10%)
were: infections (e.g., upper respiratory, sinusitis), injection site reactions,
headache, and rash.
- Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, 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.
- Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 4 years of age and older.
- Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
- Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
- Crohn's Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
- Ulcerative Colitis: HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.
- Plaque Psoriasis: HUMIRA is indicated for 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. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
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