FOR US HEALTHCARE PROFESSIONALS ONLY.
INDICATION
[TRUTAKNA] (atacicept) is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of 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 in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
[TRUTAKNA] is contraindicated in patients with a known hypersensitivity to atacicept-xxxx or any excipients of [TRUTAKNA].
WARNINGS AND PRECAUTIONS
Infections
Infections were reported in 32% of [TRUTAKNA] patients compared with 28% of placebo patients. The most common (>5%) infections reported were respiratory tract infections (12%) and nasopharyngitis (8%), which were mild or moderate in severity.
Delay [TRUTAKNA] administration in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with chronic infection or history of recurrent infection, consider the risks and benefits prior to prescribing [TRUTAKNA]. Patients who develop a new infection while undergoing [TRUTAKNA] treatment should be monitored closely. Consider interrupting [TRUTAKNA] therapy if a patient develops a serious infection.
Immunizations
Prior to initiating [TRUTAKNA], complete all age-appropriate immunizations in agreement with current immunization guidelines. Patients on [TRUTAKNA] may receive concurrent vaccinations, except for live vaccines.
ADVERSE REACTIONS
The most common (≥5%) adverse reaction was injection site reactions.
Drug Interactions
Concomitant use of [TRUTAKNA] and:
• other immune-modulating therapies in patients with IgAN have not been evaluated.
• drugs that affect the immune system, including systemic corticosteroids, may increase the risk of infection.
USE IN SPECIFIC POPULATIONS
Pregnancy
Available data on [TRUTAKNA] used in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Atacicept-xxxx is known to cross the placenta of animals. In embryo-fetal development studies in mice and rabbits, no fetal malformations were observed. Females of childbearing potential should use effective contraception while receiving [TRUTAKNA].
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Vera Therapeutics at 1-833-MED-VERA or medinfo@veratx.com.
Please see Important Safety Information throughout and Full Prescribing Information here.
