Atacicept

TRUTAKNA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. TRUTAKNA is a B-lymphocyte stimulator (BLyS)-specific inhibitor and A Proliferation Inducing Ligand (APRIL) blocker indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on a reduction of proteinuria.

Atacicept-vymj, a BLyS-specific inhibitor and APRIL blocker, is a TACI-Fc fusion glycoprotein that binds B cell activating factor (BAFF) and APRIL with dissociation constants (Kd) of 106 pM and 33 pM, respectively, and reduces BAFF- and APRIL-mediated signaling. BAFF is also known as BlyS. Reduction in BAFF- and APRIL-mediated signaling decreases production of serum galactose deficient IgA1 (Gd-IgA1), which is implicated in the pathophysiology of IgAN.

150 mg once weekly by subcutaneous injection. Recommended Dosage The recommended dosage of TRUTAKNA is 150 mg injected subcutaneously (SC) once weekly. Missed Doses If a dose is missed, administer the missed dose as soon as possible and then resume once weekly dosing thereafter, one week from administration of the missed dose.

TRUTAKNA is contraindicated in patients with serious hypersensitivity to atacicept-vymj or any excipients of TRUTAKNA. Serious hypersensitivity to any of the ingredients in TRUTAKNA.

Immunosuppression and Increased Risk of Infections: Delay initiation of TRUTAKNA during an active infection. During treatment, monitor for signs and symptoms of infections and consider interrupting TRUTAKNA if the infection becomes serious. Immunosuppression and Immunization Risks: Live vaccines not recommended within 30 days prior to initiation of TRUTAKNA or during treatment.

The following clinically significant adverse reactions are described elsewhere in the labeling: Immunosuppression and Increased Risk of Infections Immunosuppression and Immunization Risks The most common adverse reactions with TRUTAKNA (incidence ≥5% and greater than placebo) were upper respiratory tract infection, injection site reaction and injection site erythema.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. If needed, TRUTAKNA autoinjector may be stored at room temperature up to 25°C (77°F), for a single period of 3 days (72 hours). Once TRUTAKNA has been stored at room temperature, it should not be placed back into the refrigerator. Do not freeze. Do not shake.