Abrilada

Abrilada is a prescription medication used to relieve the symptoms of certain autoimmune disorders. It is used to treat certain kinds of arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and ulcerative colitis. The United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada as a biosimilar to Humira, meaning that there are no clinically meaningful differences between the biosimilar product and the reference product.

Abrilada belongs to a group of drugs called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. 

This medication comes in an injectable form in prefilled syringes. Abrilada is injected just under the skin (subcutaneously) once every other week.

Common side effects include infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS
Patients treated with adalimumab products including ABRILADA 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 ABRILADA 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

  ABRILADA use and during therapy. Initiate treatment for latent TB prior to ABRILADA 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 ABRILADA 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 ABRILADA, 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 including adalimumab products. 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 products. 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 these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) 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.