Trutakna

Trutakna (atacicept-vymj) is a once-weekly injection used to reduce protein in the urine (proteinuria) in adults with primary IgA nephropathy (IgAN) who are at risk of their kidney disease getting worse. It works by blocking the two immune-system proteins, BAFF and APRIL, to reduce the production of abnormal IgA antibodies, which helps slow IgAN disease progression.

IgA nephropathy is an autoimmune kidney condition in which a faulty form of an antibody builds up in the kidneys, causing inflammation and, over time, damage to the filters that clean the blood. Proteinuria (protein leaking) into the urine is one of the main signs that the kidneys are under strain.

Trutakna is administered as an injection under the skin (subcutaneous) using a single-dose pre-filled autoinjector that patients or caregivers can use at home.

Trutakna belongs to a class of medicines called BLyS-specific inhibitors and APRIL blockers. It is a fusion protein (a TACI-Fc protein) that binds to two signalling proteins in the immune system: B cell activating factor (BAFF, also called BLyS) and A proliferation inducing ligand (APRIL).

By binding these two proteins, Trutakna lowers the signals that tell certain immune cells to produce antibodies. This reduces the amount of a faulty antibody Gd-IgA1, which is thought to be a key driver of IgA nephropathy. Lowering levels of the abnormal IgA antibody is believed to be how the medicine reduces protein in the urine.

Trutakna is FDA approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. It is used alongside standard background treatment for the kidneys, such as blood-pressure medicines that protect kidney function.

Trutakna accelerated FDA approval was granted on on July 7, 2026, based on a reduction of proteinuria in the clinical trials ORIGIN 3 (NCT04716231). It has not been established whether Trutakna slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication is dependent on confirmation on clinical benefit in further clinical trials.

Trutakna has not been studied in children, so it is not approved for anyone under 18 years of age.

Increased risk of infection

Trutakna lowers the activity of the immune system by reducing antibody production, which can raise the risk of infection. People with a long-term or repeated infection may be at higher risk of a serious infection. Treatment should be delayed if there is an active infection until it clears or is properly treated, and a healthcare provider may pause Trutakna if a serious infection develops.

Using Trutakna together with other medicines that affect the immune system, including steroids (systemic corticosteroids), may further increase infection risk.

Vaccines

Trutakna may reduce how well vaccines work and may increase the risk of infection from live vaccines. Complete all age-appropriate vaccinations before starting treatment. Live vaccines are not recommended within 30 days before starting Trutakna or during treatment.

Who should not use Trutakna

Trutakna should not be used by anyone who has had a serious allergic reaction (hypersensitivity) to atacicept-vymj or to any of the other ingredients in the product.

In a clinical study, people taking Trutakna had a 46% drop in protein in their urine after 36 weeks, compared with a 7% drop for those taking a placebo (an inactive injection). That is a 42% greater reduction in proteinuria with Trutakna, and lower protein in the urine is a sign that the kidneys are under less strain.

Trutakna was studied in a randomized, double-blind, placebo-controlled trial called Origin 3, which enrolled 428 adults with biopsy-confirmed IgA nephropathy. Participants were already on stable, maximally-tolerated background kidney treatment. They were assigned to receive either Trutakna 150 mg or a placebo, once a week by injection.

The main measure was the percentage reduction in the urine protein-to-creatinine ratio (UPCR), a standard measure of proteinuria, after 36 weeks of treatment, in the first 203 patients to reach that visit.

This difference was statistically significant (95% confidence interval 29% to 52%; p value less than 0.0001). The benefit was generally consistent across age, sex, race and baseline disease characteristics, and was similar whether or not patients were also taking an SGLT2 inhibitor.

Effect on antibody levels

In the same study, antibody levels dropped within the first 4 weeks of treatment and stayed lower through Week 36. By Week 36, average blood levels had fallen from the starting point as follows:

• Gd-IgA1 (the faulty antibody linked to IgAN): reduced by about 68%
• Immunoglobulin A (IgA): reduced by about 64%
• Immunoglobulin M (IgM): reduced by about 75%
• Immunoglobulin G (IgG): reduced by about 36%

Inform your healthcare provider of your complete medical history before beginning treatment with Trutakna. In particular, tell your healthcare provider if you:

• have a current or suspected infection, or experience infections that recur
• have recently received a vaccine or are due to receive one. Trutakna may reduce how effectively your immune system responds to vaccines and may increase the risk of infection from live vaccines. All vaccinations should be brought up to date before treatment begins, and live vaccines should be avoided in the 30 days prior to the first dose and throughout treatment.
• are pregnant or intend to become pregnant. It is not known whether Trutakna can harm a developing baby. Because of the way the medicine affects the immune system, a baby exposed to it before birth may have a weakened immune system. IgA nephropathy during pregnancy also carries its own risks, so discuss the potential benefits and risks with your healthcare provider. Anyone who uses Trutakna during pregnancy is encouraged to call 1-833-633-8372.
• are breastfeeding or intend to breastfeed. It is not known whether Trutakna passes into breast milk, or what effect it may have on a breastfed baby or on milk supply. Discuss the most appropriate way to feed your baby during treatment with your healthcare provider.

As with any medicine, Trutakna can cause side effects. In clinical trials, most side effects were mild or moderate and cleared up without needing to stop or interrupt treatment. Trutakna can also cause serious side effects.

Serious side effects

Trutakna can cause serious side effects, including a weakened immune system and an increased risk of infections (immunosuppression). Trutakna weakens your immune system, which may raise your risk of getting an infection. Your healthcare provider will check you for signs and symptoms of infection before you start and while you are being treated with Trutakna.

Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Trutakna, including:

• fever
• flu-like symptoms
• chills
• aches and pains
• feeling tired
• warm, red, or painful skin

Most common side effects

The most common side effects of Trutakna are injection site reactions, upper respiratory tract infections (common cold type), and injection site redness (erythema).

The table below shows how often these and the broader side effect categories occurred in the clinical study, compared with placebo:

This is not a complete list of side effects. Report side effects to Vera Therapeutics at 1-833-633-8372 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Trutakna recommended dosage

The recommended dose of Trutakna is 150 mg injected under the skin (subcutaneously) once a week. It is designed to be self-injected at home using the pre-filled autoinjector, following the detailed Instructions for Use that come with the medicine.

Where to inject

Inject into the abdomen (stomach area) at least 2 inches away from the belly button or the front of the thigh. Use a different spot for each injection rather than the same place each time.

Forms and strengths

Trutakna is available as a 150 mg/mL solution in a single-dose pre-filled autoinjector. Each autoinjector delivers one 150 mg dose.

Preparing the autoinjector

• Take the autoinjector out of the refrigerator and let it sit at room temperature (15°C to 25°C, or 60°F to 77°F) for 15 to 30 minutes before injecting.
• Do not use an external heat source to warm it, as heat can damage the medicine.
• Check the liquid before use. It should look clear to slightly cloudy and brownish-yellow. Do not use it if it contains particles or looks cloudy.

If you miss a dose

If a dose is missed, inject it as soon as possible. Then continue with once-weekly dosing, counting one week from the day of the missed dose.

• Store in the refrigerator at 2°C to 8°C (36°F to 46°F), in the original carton to protect it from light.
• If needed, it can be kept at room temperature up to 25°C (77°F) for a single period of 3 days (72 hours). Once it has been at room temperature, do not put it back in the refrigerator, and discard it if it is not used within 72 hours.
• Do not freeze, do not shake, and do not expose it to heat.

Active ingredients: atacicept-vymj

Inactive ingredients: acetic acid, sodium acetate, sodium hydroxide, trehalose, and Water for Injection.

The autoinjector is not made with natural rubber latex.

Manufactured by: Vera Therapeutics, Inc., Brisbane, CA 94005.