FDA-filed SPL labeling · retrieved through openFDA

Abatacept Injection

Abatacept injection (Orencia) is a biologic medication used to treat rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and to help prevent a serious complication called graft versus host disease after stem cell transplants.

Brand name Orencia
Drug class ⓘ Selective T Cell Costimulation Modulator
Rx Form 1 Routes Subcutaneous · Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveNov 13, 2025
AvailabilityRx
Earliest approval/marketing year ⓘ2005
FDA-listed product records ⓘ14
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Abatacept Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Orencia (abatacept) is a biologic injection that dials down overactive immune activity to treat rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and to prevent a serious post-transplant complication called acute graft versus host disease. It works well for many people but does lower the immune system's defenses, so staying current on screenings for infections like TB and hepatitis — and watching for signs of infection — is essential. Work closely with your care team to make sure it stays safe and effective for you.

📖 Abatacept Injection: Patient Information Guide

A plain-language walkthrough of Abatacept Injection — 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▾

Abatacept injection (Orencia) is a biologic approved for several immune-related conditions across adults and children.

  • Rheumatoid arthritis (RA) in adults: Orencia — given intravenously or subcutaneously — treats moderately to severely active RA.
  • Polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years and older: Orencia intravenous infusion is approved for patients 6 years and older; Orencia subcutaneous injection is approved for patients 2 years and older.
  • Psoriatic arthritis (PsA) in patients 2 years and older: Orencia subcutaneous injection is approved for adults and children 2–17 years old. Orencia intravenous has not been established for PsA in pediatric patients.
  • Prevention of acute graft versus host disease (aGVHD) in adults and children 2 years and older: Orencia intravenous is used alongside a calcineurin inhibitor and methotrexate in patients undergoing stem cell transplant from a matched or partially mismatched unrelated donor.
⚙️How it works▾

Abatacept is a selective T-cell costimulation modulator — meaning it selectively blocks a key step needed to fully activate T lymphocytes (immune cells that drive inflammation). It does this by binding to proteins called CD80 and CD86, which prevents them from connecting with a receptor called CD28 on T cells. Without this co-stimulation signal, T cells cannot become fully activated and are less able to produce inflammatory chemicals like TNF-alpha, interferon-gamma, and interleukin-2. In diseases like RA, pJIA, and PsA, overactive T cells are found right in the joint lining (synovium) and contribute heavily to joint damage — so calming them down reduces inflammation and helps protect the joints.

💊How it's taken▾

Orencia is given either as an intravenous (IV) infusion at a clinic or infusion center, or as a subcutaneous (under-the-skin) injection that patients can learn to give at home. The IV infusion takes about 30 minutes. For adult RA and adult PsA, IV doses are typically given at the start, then at 2 and 4 weeks, and every 4 weeks after that. Subcutaneous Orencia for adult RA is given once weekly. For pJIA and aGVHD prevention, the schedule depends on the patient's age, weight, and clinical situation.

  • Dosing for children is based on body weight — your child's care team will determine the right amount and schedule.
  • If switching from IV to subcutaneous Orencia, the first subcutaneous injection replaces what would have been the next IV dose.
  • Always follow your prescriber's exact instructions; do not change your dose or schedule on your own.
🤒Side effects — in detail▾

The most common side effects reported with Orencia include:

  • Headache
  • Upper respiratory tract infections and nasopharyngitis (cold-like symptoms)
  • Nausea
  • Dizziness
  • High blood pressure (hypertension)
  • Cough
  • Back pain
  • Urinary tract infection

More serious reactions to watch for include signs of infection (fever, chills, persistent cough), severe allergic reactions (trouble breathing, throat swelling, hives), and — especially in transplant patients — reactivation of viruses like CMV or EBV. Contact your doctor or seek emergency care right away if any of these occur.

⚠️Warnings & precautions▾
  • Serious infections: Orencia suppresses part of the immune system. Bacterial, viral, and fungal infections can become severe. The risk is even higher when combined with a TNF antagonist — a combination that is not recommended. Patients with a history of recurring infections need close monitoring.
  • TB and hepatitis screening: All patients must be screened for latent tuberculosis and viral hepatitis before starting Orencia. Latent TB must be treated before beginning therapy.
  • Allergic and infusion-related reactions: Reactions during or shortly after IV infusion have been reported, including rare cases of anaphylaxis (life-threatening allergic reaction). Most are mild to moderate, but any symptoms of a severe reaction require immediate medical attention.
  • Vaccinations: Live vaccines must not be given while on Orencia or within 3 months of stopping. Update all vaccines before starting. Orencia may reduce how well some vaccines work.
  • COPD patients may experience more frequent respiratory side effects.
  • Cancer risk: A potential increased risk of lymphoma and lung cancer has been observed. Patients with RA already have a higher baseline risk of lymphoma.
  • Virus reactivation in transplant patients: CMV and Epstein-Barr virus reactivation have been reported in patients receiving Orencia for aGVHD prevention and require monitoring.
🔀What it interacts with▾

Orencia can interact with several types of medications — always tell your doctor and pharmacist everything you take:

  • TNF antagonists (adalimumab, etanercept, infliximab, others) — combining with Orencia greatly increases the risk of serious infections with no added benefit; not recommended.
  • Other biologic RA/PsA medicines and JAK inhibitors (such as tofacitinib, baricitinib) — concurrent use is not recommended due to heightened infection risk.
  • Live vaccines — must not be given during Orencia treatment or for at least 3 months after stopping; Orencia can blunt their effectiveness or cause infection from the live virus.
  • GDH-PQQ blood glucose test strips — intravenous Orencia contains maltose, which can cause falsely high blood sugar readings. Use an alternative testing method (GDH-NAD, glucose oxidase, or glucose hexokinase) on days you receive an IV infusion. This concern does not apply to subcutaneous Orencia.

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▾
  • Tell your doctor about any active or recurring infections — Orencia may make them harder to fight.
  • Get screened for latent TB before starting; if positive, TB treatment comes first.
  • Get screened for hepatitis B and C before starting.
  • Make sure all vaccines are up to date; live vaccines cannot be given during treatment or within 3 months of stopping.
  • If you have COPD, discuss the respiratory risks with your doctor.
  • If you are pregnant or planning to become pregnant, talk to your doctor — safety in pregnancy has not been established, and babies exposed in the womb may need special vaccine precautions.
  • If you are breastfeeding, discuss with your doctor — it is unknown whether abatacept passes into human milk.
  • Orencia is not approved for children under 2 years of age for any indication.
  • Older adults (65+) should use Orencia with caution — rates of serious infections and cancer are higher in this age group.
🚑If you take too much▾

In clinical experience, Orencia doses up to five times the maximum recommended dose have been given intravenously without clear toxic effects. If an overdose is suspected, the patient should be monitored closely for any signs or symptoms of adverse reactions, and supportive treatment should be started as needed.

📡Pharmacodynamics — effects in the body▾

In clinical trials, Orencia reduced blood levels of several markers of inflammation and immune activity — including interleukin-6 (IL-6), C-reactive protein (CRP), TNF-alpha, and rheumatoid factor (RF). These are proteins the body produces during active inflammation and joint damage. Lowering them reflects the drug calming the overactive immune response, though the exact relationship between these measurable changes and the clinical benefits patients experience is not fully understood.

🔬Pharmacokinetics — how your body processes it▾

After IV infusion, abatacept reaches peak blood levels quickly and has a half-life of about 13–17 days in adults — meaning it stays active in the body for a considerable time after each dose. The body processes and clears abatacept at a rate that increases with body weight, which is why dosing is weight-based. Subcutaneous injection delivers about 79% of the drug compared to the IV route, and the half-life is similar (about 14 days). Steady, stable blood levels are typically reached within about 60 days of starting regular dosing. Common medications taken alongside Orencia — such as methotrexate, NSAIDs, and corticosteroids — do not meaningfully change how the body handles it.

📦How to store it▾

Refrigerate ORENCIA lyophilized powder supplied in a vial at 2°C to 8°C (36°F to 46°F). storing in the original package until time of use. Refrigerate ORENCIA solution supplied in a prefilled syringe or ClickJect autoinjector at 2°C to 8°C (36°F to 46°F).

📄 Written from Abatacept Injection’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 →

53

Supplements & herbs that interact with Abatacept Injection

53 supplements and herbal products have documented interactions with Abatacept Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 52
  • Minor · 1
Every supplement checked against Abatacept Injection — ranked by severity The full interaction hub: 52 moderate · 1 minor · every one linked to its full report. Check Abatacept Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Abatacept Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Orencia used for, and is it a steroid? ▾
Orencia is not a steroid. It's a biologic — a medicine made from proteins — that selectively calms down overactive immune cells called T cells. Your doctor may have prescribed it for rheumatoid arthritis, psoriatic arthritis, or juvenile idiopathic arthritis, or to help prevent a serious immune reaction after a stem cell transplant called graft versus host disease. It works differently from steroids and from older arthritis drugs.
Can I give myself the injection at home, or do I always have to go to a clinic? ▾
It depends on which form your doctor prescribed. The subcutaneous (under-the-skin) form of Orencia is designed to be injected at home, usually once a week. The intravenous (IV) form has to be given at an infusion center or clinic, since it goes directly into a vein and takes about 30 minutes. Your care team will walk you through the subcutaneous injection technique if that's your form.
I'm worried about getting sick more easily. How real is that risk? ▾
It's a real and important concern. Orencia works by quieting part of your immune system, which means your body may not fight off infections as effectively. The most common infections reported were things like colds, sinus infections, urinary tract infections, and bronchitis. Serious infections can also occur, though they're less common. If you develop a fever, persistent cough, or other signs of infection, call your doctor right away rather than waiting to see if it passes.
Do I need to avoid any vaccines while I'm on Orencia? ▾
Yes — live vaccines are off the table while you're on Orencia, and for at least 3 months after you stop. Live vaccines include things like the MMR, live flu nasal spray, shingles vaccine (the older live version), and yellow fever vaccine. Non-live (inactivated) vaccines are generally still okay, though Orencia may reduce how well they work. The important thing is to get your vaccines up to date before you start treatment — bring this up with your doctor if you haven't already.
I check my blood sugar regularly. Is there anything I need to know about Orencia affecting those readings? ▾
If you receive Orencia as an IV infusion, yes — this is worth knowing. The IV form contains a sugar called maltose, which can interfere with certain glucose test strips and give you a falsely high blood sugar reading on the day of your infusion. The strips to avoid are those using a method called GDH-PQQ. Ask your pharmacist or doctor about switching to a monitor that uses GDH-NAD, glucose oxidase, or glucose hexokinase on infusion days. The subcutaneous form of Orencia does not contain maltose, so this issue does not apply if you're using injections.
Is it safe to take Orencia if I'm pregnant or trying to get pregnant? ▾
This is something to discuss closely with your doctor. There isn't enough data from human studies to know for certain whether Orencia is safe during pregnancy. Animal studies didn't show direct harm to the fetus, but there were some immune changes in offspring at higher doses. If you become pregnant while on Orencia, let your doctor know right away. There's also a specific consideration for newborns — if a baby was exposed to Orencia in the womb, doctors will want to think carefully before giving that baby any live vaccines.
Is Abatacept Injection available over the counter? ▾
Abatacept Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Abatacept Injection first available? ▾
Abatacept Injection has been available in the United States since at least 2005, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Abatacept Injection? ▾
Abatacept Injection is supplied by 3 manufacturers listed in the FDA NDC Directory, including E.R. Squibb & Sons, L.L.C., Bristol-Myers Squibb Company, Patheon Italia S.p.A..

💬 Answers drafted from Abatacept Injection’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 Abatacept Injection comes

Abatacept Injection 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

By injection · Into a vein · Under the skin
Brands Orencia
How this form is used
What it may be used for
  • Orencia intravenous infusion is used to treat moderately to severely active rheumatoid arthritis in adults
  • Orencia intravenous infusion is used to treat moderately to severely active polyarticular juvenile idiopathic arthritis in patients 6 years and older
  • Orencia intravenous infusion is used to prevent acute graft versus host disease in adults and children 2 years and older undergoing stem cell transplant from an unrelated donor
  • Orencia subcutaneous injection is used to treat moderately to severely active rheumatoid arthritis in adults, active psoriatic arthritis in patients 2 years and older, and polyarticular juvenile idiopathic arthritis in patients 2 years and older
Important instructions
  • Orencia intravenous infusion is administered over 30 minutes, typically on a schedule starting with doses at weeks 0, 2, and 4, then every 4 weeks for RA and PsA in adults
  • Orencia subcutaneous injection for adult RA is given once weekly; an optional single IV loading dose may be given before starting the weekly subcutaneous injections
  • Patients switching from Orencia IV to subcutaneous should give the first subcutaneous dose in place of the next scheduled IV dose — ask your care team to walk you through the transition
  • Orencia intravenous formulation contains maltose; if you monitor blood glucose, use a glucose testing method that does not react with maltose (such as GDH-NAD, glucose oxidase, or glucose hexokinase) on infusion days — the subcutaneous form does not contain maltose and does not affect glucose monitoring
Available strengths 5 strengths
14 FDA-listed product records ⓘ

📊 Abatacept Injection across the U.S. market

How Abatacept Injection 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.

1
Dose forms ⓘ
3
Manufacturers
1
Brand names
14
FDA-listed product records ⓘ
2005
First marketed ⓘ
E.R. Squibb & Sons, L.L.C.86%
Bristol-Myers Squibb Company7%
Patheon Italia S.p.A.7%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Abatacept Injection is used

A general measure of how commonly Abatacept Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Abatacept Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

55,268
Medicaid prescriptions filled (Q1–Q4 2025)
$267.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Abatacept Injection prescribed? Of the 1,596 medications we measure, Abatacept Injection ranks #617 by Medicaid prescriptions — more than 61% of them.

Where Abatacept Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Abatacept Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mL / 125 mg/mL auto-injector is the most-dispensed Abatacept Injection product — about 52% of these Medicaid prescriptions.

1 ML abatacept 125 MG/ML Auto-Injector Most dispensed

28,725 Medicaid prescriptions (Q1–Q4 2025) 52% of Abatacept Injection prescriptions shown $171.2M gross reimbursement (before rebates) ≈ $5,959 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1799228

abatacept 250 MG Injection

22,121 Medicaid prescriptions (Q1–Q4 2025) 40% of Abatacept Injection prescriptions shown $69.3M gross reimbursement (before rebates) ≈ $3,134 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616015

1 ML abatacept 125 MG/ML Prefilled Syringe

4,313 Medicaid prescriptions (Q1–Q4 2025) 8% of Abatacept Injection prescriptions shown $26.2M gross reimbursement (before rebates) ≈ $6,076 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1145929

0.7 ML abatacept 125 MG/ML Prefilled Syringe

109 Medicaid prescriptions (Q1–Q4 2025) <1% of Abatacept Injection prescriptions shown $606,833 gross reimbursement (before rebates) ≈ $5,567 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1925256

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Abatacept Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 7 listed Abatacept Injection NDCs with Medicaid activity.

🔍 Compare Abatacept Injection products

A representative set of FDA-listed product records for Abatacept Injection — 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
1 kg/kg — Bristol-Myers Squibb Company BULK INGREDIENT View NDC →
50 mg/0.4 mL Subcutaneous E.R. Squibb & Sons, L.L.C. × 3 listings BLA View NDC →
87.5 mg/0.7 mL Subcutaneous E.R. Squibb & Sons, L.L.C. × 3 listings BLA View NDC →
125 mg/mL Subcutaneous E.R. Squibb & Sons, L.L.C. × 3 listings BLA View NDC →
250 mg/15 mL Intravenous E.R. Squibb & Sons, L.L.C. × 3 listings BLA View NDC →
250 mg/15 mL — Patheon Italia S.p.A. DRUG FOR FURTHER PROCESSING View NDC →

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Abatacept Injection NDCs →

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.

Ingredient (IN) Abatacept Injection RxCUI 614391 3 dose forms · 5 strengths
  1. Dose form (SCDF) Auto-Injector RxCUI 1799227 In current FDA listings
    Clinical drug / strength (SCD) 1 ML abatacept 125 MG/ML RxCUI 1799228
  2. Dose form (SCDF) Injection RxCUI 1659772 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 616015

Look up RxCUI 614391 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.

🏷️ Sold under these brand names

Orencia

🏭 Manufacturers & labelers

E.R. Squibb & Sons, L.L.C. 12 Bristol-Myers Squibb Company 1 Patheon Italia S.p.A. 1

🔬 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 13, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Abatacept Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Abatacept Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
14
Distinct labelers/manufacturers represented
3
Linked representative label ⓘ
E.R. Squibb & Sons, L.L.C.
Linked label effective
Nov 13, 2025
Composite sections available
24
Linked SPL Set ID
0836c6ac-ee37-5640-2fed-a3185a0b16eb
Linked SPL Document ID
962695b7-21f5-44bb-80e0-cb3b48c80be6
Open the linked representative label on DailyMed ↗

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.

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. E.R. Squibb & Sons, L.L.C. 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.