Atacicept
Atacicept is a protein-based injectable medicine used to reduce excess protein in the urine in adults with primary IgA nephropathy (a kidney disease), where uncontrolled disease can lead to worsening kidney function.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Atacicept: Patient Information Guide
A plain-language walkthrough of Atacicept — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Atacicept (as Trutakna) is currently approved for one specific use in adults:
- Trutakna is used to reduce proteinuria (excess protein in the urine) in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. This approval is based on reduction of urine protein under the FDA's accelerated approval pathway. Whether Trutakna slows long-term kidney function decline has not yet been established, and continued approval depends on a confirmatory clinical trial.
⚙️How it works▾
IgAN is driven in part by an abnormal form of the antibody IgA — called Gd-IgA1 — that builds up and causes inflammation in the kidneys. Trutakna works by blocking two signaling proteins, BAFF (also called BLyS) and APRIL, that normally activate B cells (immune cells that make antibodies). By blocking both of these signals, Trutakna reduces the B cells' production of Gd-IgA1, as well as overall IgA, IgG, and IgM antibody levels — which helps lower the amount of protein leaking into the urine.
💊How it's taken▾
Trutakna is given as a subcutaneous injection (a shot just under the skin) once a week using a prefilled autoinjector. It is designed for self-administration or caregiver administration at home. Injections should be rotated between the abdomen and thigh.
- Let the autoinjector warm to room temperature for 15–30 minutes before using — do not heat it artificially
- If a dose is missed, give it as soon as possible, then resume your regular once-weekly schedule one week from that make-up dose
- If stored at room temperature, Trutakna must be used within 72 hours — do not put it back in the refrigerator after it has been removed
Your prescriber and the Instructions for Use guide included with Trutakna provide the most accurate, personalized instructions for your situation.
🤒Side effects — in detail▾
Most side effects seen with Trutakna in clinical trials were mild to moderate and did not require stopping treatment.
- Upper respiratory tract infection (like a cold) — most common infection reported
- Injection site reaction — pain, swelling, or discomfort where the shot was given
- Injection site redness (erythema)
- Infections in general — occurred in about 32% of Trutakna users vs. 28% on placebo
More serious infections can occur because Trutakna suppresses the immune system — contact your doctor promptly if you develop fever, chills, difficulty breathing, or other signs of a serious or worsening infection.
⚠️Warnings & precautions▾
- Increased infection risk: Trutakna lowers antibody production, which weakens your ability to fight infections. People with chronic or recurring infections are especially vulnerable. Your doctor should check for active infections before you start and monitor you throughout treatment. If a serious infection develops, Trutakna may need to be paused.
- Vaccine safety: Trutakna may reduce how well your body responds to vaccines and can make live vaccines dangerous. Get all age-appropriate vaccines up to date before starting. Avoid live vaccines within 30 days before starting Trutakna and during treatment.
- Use with other immune-suppressing medicines: Combining Trutakna with drugs that affect the immune system — including corticosteroids — has not been studied and may further raise your infection risk. Tell your doctor about all medications you take.
🔀What it interacts with▾
Trutakna affects the immune system, so combining it with certain medicines or vaccines requires caution:
- Immune-suppressing medicines (including corticosteroids): Using Trutakna alongside other drugs that suppress the immune system may increase the risk of serious infection — the combination has not been formally studied
- Live vaccines: Should not be given within 30 days before starting Trutakna or at any point during treatment, as the weakened live pathogen in the vaccine could cause active infection when immunity is reduced
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active infection: Trutakna should not be started while you have an active infection — wait until it is treated or resolved
- Chronic or recurring infections: Tell your doctor, as your risk of serious infection on Trutakna may be higher
- Pregnancy: The effects of Trutakna on a developing baby are not fully known; it may cause immune suppression in an infant exposed in the womb. Report any pregnancy during treatment by calling 1-833-633-8372
- Breastfeeding: It is not known whether Trutakna passes into breast milk; discuss the benefits and risks with your doctor
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults (65+): Not enough older patients were included in studies to draw firm conclusions, though no pharmacokinetic differences were identified in those who did participate
- Serious allergic reaction to atacicept or any Trutakna ingredient: Trutakna is contraindicated if you've had a serious allergic (hypersensitivity) reaction to it
📡Pharmacodynamics — effects in the body▾
Trutakna measurably reduces several key antibodies in the blood. In patients treated once weekly in a clinical study, levels of Gd-IgA1 (the abnormal antibody central to IgAN), IgA, IgG, and IgM all began falling within 4 weeks. By week 36, average levels had dropped substantially — Gd-IgA1 by 68%, IgA by 64%, IgM by 75%, and IgG by 36% — and these reductions were sustained throughout the treatment period.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, Trutakna reaches its peak concentration in the bloodstream about 36 hours later. With once-weekly dosing, steady-state levels — where the amount entering and leaving the body is balanced — are reached after roughly 24 weeks. The drug has a long elimination half-life of approximately 40 days, meaning it stays in the body for an extended period after each dose. Trutakna is a protein, so the body breaks it down into small peptides and amino acids through normal protein-degradation processes, not through the liver enzymes that metabolize most small-molecule drugs. No clinically meaningful differences in how the body handles Trutakna were seen based on age, sex, weight, race, or degree of kidney impairment (from mild to severe).
📦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. stored at room temperature up to 25°C (77°F), for a single period of 3 days (72 hours). stored at room temperature, it should not be placed back into the refrigerator.
📄 Written from Atacicept’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Atacicept — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Trutakna treating in my kidneys? ▾
How do I give myself the injection, and does it hurt? ▾
Am I going to be more likely to get sick while taking this? ▾
Can I get my vaccines while taking Trutakna? ▾
Is it safe to take Trutakna if I'm pregnant or trying to get pregnant? ▾
What if I miss a dose? ▾
Is Atacicept available over the counter? ▾
When was Atacicept first available? ▾
💬 Answers drafted from Atacicept’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Atacicept comes
Atacicept is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Trutakna is used to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression
- Trutakna is approved under accelerated approval based on reduction of urine protein; long-term kidney function benefit is still being confirmed
- Trutakna is injected subcutaneously (under the skin) once weekly, using an autoinjector designed for home use by patients or caregivers
- Trutakna autoinjector should be removed from the refrigerator and allowed to sit at room temperature for 15–30 minutes before injecting — do not use external heat sources
- Trutakna injections should be given at a different site each time; recommended sites are the abdomen and thigh
- Trutakna autoinjector stored at room temperature can only be kept out for up to 72 hours (3 days) and should be discarded if not used within that window — do not return it to the refrigerator once it has been stored at room temperature
📊 Atacicept across the U.S. market
How Atacicept appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Atacicept products
A representative set of FDA-listed product records for Atacicept — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 150 mg | Subcutaneous | Vera Therapeutics, Inc × 2 listings | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Atacicept NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Atacicept — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Atacicept in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Atacicept went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2747209 1 dose form · 1 strength
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Dose form (SCDF) Auto-Injector RxCUI 2747234In current FDA listingsClinical drug / strength (SCD) 1 ML atacicept-vymj 150 MG/MLRxCUI 2747237
Look up RxCUI 2747209 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Atacicept is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Vera Therapeutics, Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.