Medicine guide

Trutakna

150 mg · Injection, Solution

Prescription only

Active substance: Atacicept
Made by: Vera Therapeutics, Inc
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-08-05

Used for

TRUTAKNA is indicated to reduce proteinuria in

The label’s usual adult dose

150 mg once weekly by subcutaneous injection.

Full directions ↓

Do not take it if

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 )

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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.

From the official label · 2026-08-05 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Half-life40 days

Mostly cleared after≈ 29 weeksfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-05

Do not take it if

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 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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.
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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Available data on TRUTAKNA use 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.
Based on mechanism of action, TRUTAKNA may cause immunosuppression in the in utero-exposed infant [see Warnings and Precautions ( 5.1 and 5.2 ), Clinical Pharmacology ( 12.1 ) and Clinical Considerations ] .
There are risks to the mother and infant with untreated IgAN nephropathy in pregnancy (see Clinical Considerations ) .
In animal reproduction studies, no treatment-related malformations were observed in mice and rabbits at atacicept-vymj exposures approximately up to 12 times and 4 times, respectively, the clinical exposure at the recommended human dose (RHD) (see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Pregnant women exposed to TRUTAKNA, or their healthcare providers, should report TRUTAKNA exposure by calling 1-833-633-8372.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk IgAN in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight.
Fetal/Neonatal Adverse Reactions Based on mechanism of action, TRUTAKNA may cause immunosuppression in the in utero exposed infant.
The potential clinical impact of TRUTAKNA exposure in infants exposed in utero should be considered.
Data Animal Data In pregnant mice, SC administration of atacicept-vymj once every two days (0, 5, 20, and 80 mg/kg) throughout organogenesis from gestation day (GD) 6 to 15 did not result in any adverse effects on embryofetal development at up to 80 mg/kg, approximately 12 times the clinical exposure at the RHD based on area under the concentration curve (AUC).
In pregnant rabbits, SC administration of atacicept-vymj once every two days (0, 5, 20, and 80 mg/kg) throughout organogenesis from GD 6 to 18 resulted in early and late resorptions, reduced number of live fetuses, and decreased mean fetal weight at ≥20 mg/kg, doses that resulted in maternal toxicity (reduced body weight gain).
Exposures at these doses were ≥4 times the clinical exposure at the RHD, based on AUC.
Embryofetal malformations (enlarged bregmatic fontanella, severe reduction of ossification of parietal or frontal bones, and unossified interparietal bones) were observed at 80 mg/kg (maternally toxic dose), approximately 11 times the clinical exposure at the RHD, based on AUC.
No treatment-related malformations were observed at up to 20 mg/kg, approximately 4 times the clinical exposure at the RHD, based on AUC.
In a pre- and post-natal development study in mice, SC administration of atacicept-vymj once every two days (0, 5, 20, or 80 mg/kg) throughout pregnancy and lactation (GD 6 to lactation day 21) did not result in adverse effects on maternal function or development of offspring at up to 80 mg/kg, approximately 12 times the clinical exposure at the RHD based on AUC.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary Available data on TRUTAKNA use 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.
Based on mechanism of action, TRUTAKNA may cause immunosuppression in the in utero-exposed infant [see Warnings and Precautions ( 5.1 and 5.2 ), Clinical Pharmacology ( 12.1 ) and Clinical Considerations ] .
There are risks to the mother and infant with untreated IgAN nephropathy in pregnancy (see Clinical Considerations ) .
In animal reproduction studies, no treatment-related malformations were observed in mice and rabbits at atacicept-vymj exposures approximately up to 12 times and 4 times, respectively, the clinical exposure at the recommended human dose (RHD) (see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Pregnant women exposed to TRUTAKNA, or their healthcare providers, should report TRUTAKNA exposure by calling 1-833-633-8372.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk IgAN in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight.
Fetal/Neonatal Adverse Reactions Based on mechanism of action, TRUTAKNA may cause immunosuppression in the in utero exposed infant.
The potential clinical impact of TRUTAKNA exposure in infants exposed in utero should be considered.
Data Animal Data In pregnant mice, SC administration of atacicept-vymj once every two days (0, 5, 20, and 80 mg/kg) throughout organogenesis from gestation day (GD) 6 to 15 did not result in any adverse effects on embryofetal development at up to 80 mg/kg, approximately 12 times the clinical exposure at the RHD based on area under the concentration curve (AUC).
In pregnant rabbits, SC administration of atacicept-vymj once every two days (0, 5, 20, and 80 mg/kg) throughout organogenesis from GD 6 to 18 resulted in early and late resorptions, reduced number of live fetuses, and decreased mean fetal weight at ≥20 mg/kg, doses that resulted in maternal toxicity (reduced body weight gain).
Exposures at these doses were ≥4 times the clinical exposure at the RHD, based on AUC.
Embryofetal malformations (enlarged bregmatic fontanella, severe reduction of ossification of parietal or frontal bones, and unossified interparietal bones) were observed at 80 mg/kg (maternally toxic dose), approximately 11 times the clinical exposure at the RHD, based on AUC.
No treatment-related malformations were observed at up to 20 mg/kg, approximately 4 times the clinical exposure at the RHD, based on AUC.
In a pre- and post-natal development study in mice, SC administration of atacicept-vymj once every two days (0, 5, 20, or 80 mg/kg) throughout pregnancy and lactation (GD 6 to lactation day 21) did not result in adverse effects on maternal function or development of offspring at up to 80 mg/kg, approximately 12 times the clinical exposure at the RHD based on AUC.
8.2 Lactation Risk Summary There are no data regarding the presence of atacicept-vymj in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRUTAKNA and any potential adverse effects on the breastfed child from TRUTAKNA or from the underlying maternal condition.
8.4 Pediatric Use The safety and effectiveness of TRUTAKNA in pediatric patients have not been established.
8.5 Geriatric Use Clinical studies of TRUTAKNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.
No clinically meaningful differences in the pharmacokinetics of TRUTAKNA were observed in patients aged 65 and over compared to younger adult patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

The safety and effectiveness of TRUTAKNA in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of TRUTAKNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.
No clinically meaningful differences in the pharmacokinetics of TRUTAKNA were observed in patients aged 65 and over compared to younger adult patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

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.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.1 How Supplied TRUTAKNA (atacicept-vymj) injection is a sterile, preservative-free, clear to slightly opalescent, brownish-yellow solution, free of visible particles for subcutaneous administration supplied as a single-dose autoinjector.
The autoinjector is not made with natural rubber latex.
TRUTAKNA is supplied as follows:
Pre-filled autoinjector:
Carton contains four 150 mg/mL single-dose autoinjectors:
NDC 85052-101-04
16.2 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 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.
Do not freeze.
Do not shake.
Do not expose to heat.
TRUTAKNA (atacicept-vymj) injection is a sterile, preservative-free, clear to slightly opalescent, brownish-yellow solution, free of visible particles for subcutaneous administration supplied as a single-dose autoinjector.
The autoinjector is not made with natural rubber latex.
TRUTAKNA is supplied as follows:
Pre-filled autoinjector:
Carton contains four 150 mg/mL single-dose autoinjectors:
NDC 85052-101-04

Quoted from the official label, section “How Supplied”.

How to store it

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.
Discard the autoinjector if not used within this 72‑hour period.
Do not freeze.
Do not shake.
Do not expose to heat.

Quoted from the official label, section “Storage and Handling”.

What is in it

Atacicept-vymj, a B-lymphocyte stimulator (Blys)-specific inhibitor and A Proliferation Inducing Ligand (APRIL) blocker, is a soluble recombinant fusion glycoprotein consisting of two parts:
the extracellular ligand binding portion of the human transmembrane activator, calcium modulator, and cyclophilin ligand interactor (TACI) receptor and the Fc portion of human IgG1 (TACI Fc), which has been modified to reduce Fc receptor-mediated effector functions.
Atacicept-vymj is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.
The molecular weight of atacicept-vymj is 73.5 kDa (kilodaltons) based on the homodimeric form of the protein, which is composed of two identical monomers.
TRUTAKNA (atacicept-vymj) injection is supplied as a sterile, preservative-free, clear to slightly opalescent, brownish yellow solution for subcutaneous injection.
It is supplied in a 1 mL single-dose pre-filled autoinjector with a 27-gauge needle with a needle guard.
Each 1 mL contains 150 mg of atacicept-vymj, 0.82 mg sodium acetate, 79.98 mg trehalose, and Water for Injection.
Sodium hydroxide and acetic acid are included to adjust the pH to 5.0.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Details

Made by	Vera Therapeutics, Inc
Active substance	Atacicept
Strength	150 mg
Form	Injection, Solution
Route	Subcutaneous
Packs	4 SYRINGE, GLASS in 1 CARTON / 1 INJECTION, SOLUTION in 1 SYRINGE, GLASS
NDC	85052-101

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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