Trutakna (atacicept-vymj) is filed as BAFF/APRIL dual inhibitor. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE 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. ( 1 ). This indication is approved under accelerated approval based on a 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.
12.1 Mechanism of Action 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.
5 WARNINGS AND PRECAUTIONS 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. ( 5.1 ) Immunosuppression and Immunization Risks : Live vaccines not recommended within 30 days prior to initiation of TRUTAKNA or during treatment. ( 5.2 ) 5.1 Immunosuppression and Increased Risk of Infections TRUTAKNA suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with a chronic infection or recurring infections may have an increased risk of serious infection. In clinical trials, infections were reported in 32% of patients in the TRUTAKNA group compared with 28% of participants in the placebo group [ see Adverse Reactions ( 6.1 ) ]. Before initiating TRUTAKNA, assess patients for active infections. Delay TRUTAKNA administration in patients with active infection until the infection resolves or is adequately treated. During treatment, monitor patients for signs and symptoms of infection. If a serious infection develops, consider interrupting TRUTAKNA until the infection is controlled. The concomitant use of TRUTAKNA and other immune-modulating therapies has not been evaluated. Concomitant use of TRUTAKNA with drugs that affect the immune system, including systemic corticosteroids, may increase the risk of infection. 5.2 Immunosuppression and Immunization Risks TRUTAKNA may interfere with the immune responses to vaccines and increase the risk of infection from live vaccines. Prior to initiating treatment with TRUTAKNA, complete all age appropriate immunizations according to current immunization guidelines. Live vaccines are not recommended within 30 days prior to initiation of TRUTAKNA or during treatment with TRUTAKNA as safety of coadministration has not been established.
4 CONTRAINDICATIONS 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. ( 4 )
Upper respiratory tract infection (≥5%); Injection site reaction (≥5%); Injection site erythema (≥5%)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Immunosuppression and Increased Risk of Infections [see Warnings and Precautions ( 5.1 )] Immunosuppression and Immunization Risks [see Warnings and Precautions ( 5.2 )] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vera Therapeutics at 1-833-633-8372 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TRUTAKNA was evaluated in a randomized, double-blind, placebo-controlled clinical study in 428 adults with IgAN (Origin 3). The median duration of exposure was 34 weeks in the 214 patients treated with TRUTAKNA and 31 weeks in the 214 patients administered placebo [see Clinical Studies ( 14 )] . The most common adverse reactions (reported in ≥5% of patients treated with TRUTAKNA and at a higher incidence than placebo) in patients treated with TRUTAKNA and placebo, respectively, were infections (32% vs. 28%) and local administration reactions (30% vs. 5%). The most common infection was upper respiratory tract infection (12% vs. 9%), and the most common local administration reactions were injection site reaction (19% vs. 2%) and injection site erythema (6% vs. 1%). Most adverse reactions observed in the TRUTAKNA group were mild or moderate in severity and resolved without treatment interruption or discontinuation.
2 DOSAGE AND ADMINISTRATION 150 mg once weekly by subcutaneous injection. ( 2.2 ) 2.1 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. 2.2 Preparation and Administration Instructions TRUTAKNA autoinjector is intended for SC administration by patients/caregivers at home. The TRUTAKNA “Instructions for Use” contains more detailed instructions on the preparation and administration of TRUTAKNA [see Instructions for Use ] . Remove TRUTAKNA autoinjector from the refrigerator and allow it to sit for 15 to 30 minutes at room temperature between 15°C to 25°C (60°F to 77°F) prior to injecting. Do not use an external heat source to heat TRUTAKNA, because heat may damage the product. 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. Discard the autoinjector if not used within this 72‑hour period. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. TRUTAKNA should appear as a clear to slightly opalescent, brownish-yellow solution. Do not use if the liquid contains particles or is cloudy. Administer each injection at a different location than the previous injection. Sites for injections include the abdomen and thigh.
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Infections Inform patients that TRUTAKNA may decrease the ability of their immune system to fight infections. Advise patients to contact their healthcare provider if they develop signs or symptoms of infection [see Warnings and Precautions ( 5.1 )] Hypersensitivity and other Administration Reactions Advise patients to immediately seek medical attention for any signs and symptoms of hypersensitivity or systemic administration-related reactions. Inform patients that local injection-site reactions may occur and to report any severe reactions [see Contraindications ( 4 ) and Adverse Reactions ( 6.1 )] . Immunization Recommend that patients complete any required vaccinations prior to initiating treatment with TRUTAKNA. [see Warnings and Precautions ( 5.2 )] . Pregnancy Advise patients who are exposed to TRUTAKNA during pregnancy to contact 1-833-633-8372 [see Use in Specific Populations ( 8.1 )] . Disposal of Autoinjectors Advise patients to follow disposal procedures in the Instructions for Use. A puncture-resistant container for disposal of needles and syringes should be used. Instruct patients that they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container. Instruct patients not to recycle their used sharps disposal container. Manufactured by: Vera Therapeutics, Inc. Brisbane, CA 94005 U.S. License No. 2386 TRUTAKNA™ is a trademark of Vera Therapeutics, Inc © 2026 Vera Therapeutics, Inc.
According to its FDA label, Trutakna (atacicept-vymj) is approved for: 1 INDICATIONS AND USAGE 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 wh… For medical advice, please talk to your prescriber or pharmacist.
Trutakna (atacicept-vymj) belongs to the BAFF/APRIL dual inhibitor class of medications.
The FDA label lists Trutakna (atacicept-vymj) as: 3 DOSAGE FORMS AND STRENGTHS TRUTAKNA is a clear to slightly opalescent, brownish-yellow solution, free of visible particles, available as follows: Injection: 150 mg/mL in a single-dose pre-filled autoinjector Injection: 150 mg/mL in a single-dose pre-filled autoinjector. ( 3 ); subcutaneous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Trutakna. Availability changes as patents expire.
Our ingest of the FDA label for Trutakna (atacicept-vymj) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Trutakna (atacicept-vymj) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Trutakna (atacicept-vymj) as 2026-07-07.
The FDA label lists Vera Therapeutics, Inc as a labeler/manufacturer of Trutakna (atacicept-vymj). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling 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…" Follow the packaging insert for the authoritative guidance.
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