Trutakna

Trutakna is an FDA-registered drug product whose active ingredient is ATACICEPT. It is labelled by Vera Therapeutics, Inc taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 85052-101, application BLA761486, label effective 20260805. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ATACICEPT are most often described in connection with: indicated reduce, proteinuria adults, primary immunoglobulin, nephropathy igan, disease progression, indication approved, accelerated approval, based reduction. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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.

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 )

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.

What is Trutakna used 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 whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this …

Who makes Trutakna?
Vera Therapeutics, Inc is the labeler of record for Trutakna.

What form does Trutakna come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Trutakna prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Trutakna been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.