- There is an increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (e.g., histoplasmosis) and infections due to other opportunistic pathogens. If these develop, discontinue the drug.
- Patients should be tested for latent TB prior to starting drug and during therapy. Treatment for latent TB should be initiated prior to starting the drug. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with the drug, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent TB is needed prior to initiating the drug, even for patients previously vaccinated with bacillus Calmette-Guerin (BCG).
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNFi’s.
Warnings & Precautions
- Do not start adalimumab during an active infection. If an infection develops, monitor carefully and stop adalimumab if the infection becomes serious.
- Invasive fungal infections—for patients who develop a systemic illness on adalimumab, consider empiric anti-fungal therapy for those at high risk who reside in or travel to regions where mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis, are endemic.
- The risks and benefits of treatment with TNFi’s, including adalimumab, should be considered prior to initiating therapy in patients with a known malignancy, other than a successfully treated non-melanoma skin cancer, or when considering continuing a TNF blocker in patients who develop a malignancy.
- Anaphylaxis or serious allergic reactions may occur.
- Hepatitis B virus (HBV) reactivation can occur. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop adalimumab and begin anti-viral therapy.
- Demyelinating disease, exacerbation or new onset, may occur.
- Cytopenias, pancytopenia—advise patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on adalimumab. Consider discontinuation of therapy in patients with confirmed significant hematologic abnormalities.
- Heart failure, worsening or new onset, may occur.
- Lupus-like syndrome—stop adalimumab if the syndrome develops.
Dosage & Administration
Adalimumab is administered by SQ injection. The recommended dose is 40 mg every other week with or without methotrexate (MTX). Some RA patients not receiving MTX may benefit from increasing the frequency to 40 mg every week.
Commentary
The approval of adalimumab was based on four randomized, double-blind, clinical studies in more than 2,000 patients who had active RA. In all four studies, adalimumab showed significantly greater improvement than placebo on the disability index of the Health Assessment Questionnaire from baseline to the end of the study, and significantly greater improvement than placebo in health outcomes as assessed by the Short Form Health Survey. Improvement was also seen in both the physical and mental component summaries. The most common adverse reactions (≥10%) were infections (e.g., upper respiratory, sinusitis), injection-site reactions, headache and rash.
Certolizumab pegol (Cimzia):13 injection
Drug class: DMARD, TNFi
Boxed warning: Refer to *ISI (p. 14)
Warnings & Precautions
