Quick answers
- What is Tocilizumab used for?
- The FDA-approved label (Actemra, Genentech, Inc., December 16, 2025) says: “ACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) Adult patients with giant cell arteritis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tocilizumab have a boxed warning?
- Yes. The FDA label for Actemra has a boxed warning (“WARNING: RISK OF SERIOUS INFECTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tocilizumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tocilizumab been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 10, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Tocilizumab?
- 5 companies list prescription products of Tocilizumab in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Genentech, Inc. and CELLTRION USA, Inc..
What Tocilizumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) Adult patients with giant cell arteritis. …
— FDA label: Actemra, Genentech, Inc., effective December 16, 2025. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS INFECTIONS
. Read it on the full label →
6 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, solution, concentrate · Injection |
|---|---|
| Route | Intravenous · Subcutaneous |
| Prescription products | 22 in the FDA NDC Directory |
| Brand names | Tyenne, Tofidence, Actemra, Avtozma, Actemra Actpen |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tocilizumab 162 mg/0.9 mL injection, solution | Brand: Actemra ACTPen | $1,279.06 per mL |
| tocilizumab 162 mg/0.9 mL injection, solution | Brand: Tyenne | $821.27–$823.06 per mL 4 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC7 products
- Genentech, Inc.5 products
- CELLTRION USA, Inc.4 products
- Organon LLC3 products
- Biogen MA Inc.3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125276 ACTEMRA | Genentech | January 8, 2010 | 36, latest December 10, 2025 2025: Labeling · 2025: Efficacy · 2024: Labeling |
| BLA125472 ACTEMRA | Genentech | October 21, 2013 | 22, latest December 10, 2025 2025: Labeling · 2025: Labeling · 2024: Labeling |
| BLA761275 TYENNE | Fresenius Kabi USA | March 5, 2024 | 8, latest May 21, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
| BLA761354 TOFIDENCE | Biogen Ma | September 29, 2023 | 4, latest May 22, 2026 2026: BIOSIMILAR · 2025: Labeling · 2024: Labeling |
| BLA761420 AVTOZMA | Celltrion Inc | January 24, 2025 | 4, latest September 29, 2026 2026: BIOSIMILAR · 2026: Labeling · 2026: BIOSIMILAR |
| BLA761449 TYENNE | Fresenius Kabi USA | March 14, 2025 | 2, latest May 20, 2026 2026: Labeling · 2025: Labeling |
| BLA761498 AVTOZMA | Celltrion Inc | January 21, 2026 | 2, latest September 29, 2026 2026: Labeling · 2026: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 10, 2026 · Class I · Ongoing · D-0827-2026
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20. — Fresenius Kabi USA, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1441527, 1441530, 1657974, 1657976, 1657979, 1657980, 1657981, 1657982, 2106073, 2106075 … (+10) |
|---|---|
| SPL set ID of the quoted label | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 |
| FDA labels (SPL) | 6 |
| FDA applications | BLA125276, BLA125472, BLA761275, BLA761354, BLA761420, BLA761449, BLA761498 |
| Active ingredients (FDA) | TOCILIZUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Actemra, Genentech, Inc., effective December 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →