Safety Considerations regarding Humira

Ankylosing Spondylitis: HUMIRA is indicated for the treatment of adults with severe, active ankylosing spondylitis, who have had inadequate response to conventional therapy.

To date, HUMIRA has been approved in 65 countries and prescribed to more than 150,000 patients worldwide. Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

Common adverse events (occurring in 1-10%) at least possibly related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), urinary tract infection, herpetic viral infection (including simplex and zoster), influenza, superficial fungal infections (including skin, nail and foot), lymphopenia, anemia, headache, dizziness, paraesthesias, hypertension, cough, nasopharyngeal pain, nasal congestion, nausea, abdominal pain, diarrhea, dyspepsia, mouth ulceration, rash erythematous, rash pruritic, hair loss, arthritis, fatigue (including asthenia and malaise), influenza like illness, hepatic enzymes increased (including alanine aminotransferase and aspartate aminotransferase), rash and pruritis.

Upper respiratory infection and injection site reaction (including pain, swelling, redness or pruritis) were reported by more than 10% of patients.

Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until their infection is controlled.

Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections. TNF antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease.

Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders.

Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA.