trutakna
Trutakna (Atacicept-Vymj) is a medication supplied as an injectable.
Atacicept-Vymj · by Vera Therapeutics Inc.
Key facts
- Active ingredient
- Atacicept-Vymj
- Form
- Injectable
- Strength
- ATACICEPT-VYMJ 150MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Vera Therapeutics Inc.
- FDA application
- BLA761486
What is Trutakna?
From the FDA label: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.
How to use
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…
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…
Warnings
Important safety information
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.
Who should not take Trutakna
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 )
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- Is there a coupon or discount for Trutakna?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Trutakna. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Trutakna?
- Trutakna is marketed by Vera Therapeutics Inc.. You can see Vera Therapeutics Inc.'s full profile, rating, and other products on pharmaranks.
- Is Trutakna a brand-name or generic drug?
- Trutakna is a brand-name product with the active ingredient Atacicept-Vymj.
- Is Trutakna available over the counter?
- No. Trutakna is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Trutakna come in?
- Trutakna is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Trutakna FDA-registered?
- Trutakna is on record with the U.S. FDA under application number BLA761486. You can verify this on its official FDA label.
- Is Trutakna safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Trutakna. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Trutakna?
- Trutakna's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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