Adalimumab (Warnings)

In this article, we will discuss about Adalimumab (Warnings). So, let’s get started.

Warnings

• Serious infections – Do not start Adalimumab (HUMIRA®) during an active infection. If an infection develops, monitor carefully, and stop Adalimumab (HUMIRA®) if infection becomes serious

• Invasive fungal infections – For patients who develop a systemic illness on Adalimumab (HUMIRA®), consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic.

• Malignancies – The incidence of malignancies was greater in
Adalimumab (HUMIRA®)-treated patients than in controls.

• Anaphylaxis or serious allergic reactions may occur.

• Hepatitis B virus reactivation – monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Adalimumab (HUMIRA®) and begin anti-viral therapy.

• Demyelinating disease exacerbation or new onset, may occur.

• Cytopenias, pancytopenia – advise patients to seek immediate medical
attention if symptoms develop, and consider stopping Adalimumab (HUMIRA®).

• Heart failure, worsening or new onset, may occur.

• Lupus-like syndrome – Stop Adalimumab (HUMIRA®) if syndrome develops.

Some more information regarding Adalimumab (Warnings)

Serious Infections

Patients treated with Adalimumab (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. Adalimumab (HUMIRA®) should be discontinued 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. Patients should be tested for latent TB before Adalimumab (HUMIRA®) use and during therapy. Treatment for latent TB should be initiated prior to Adalimumab (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. Empirie anti-fungal therapy should be considered 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.

The risks and benefits of treatment with Adalimumab (HUMIRA®) should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Adalimumab (HUMIRA®), including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been
reported in patients treated with TNF blockers including Adalimumab (HUMIRA®). These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases has occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all 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.

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