Prescription medicine
Tocilizumab Brand names: Tyenne, Tofidence, Actemra, Avtozma
Tocilizumab (Actemra) is a prescription medicine with an FDA approval on record since 2010. No generic is listed; pharmacies paid $821.00 per mL (Tyenne 162 mg/0.9 mL autoinjct) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the tocilizumab FDA label on DailyMed (effective December 16, 2025, Genentech, Inc.); the BLA 125276 record on Drugs@FDA; every tocilizumab label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS INFECTIONS.
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. […]
Used for
From the label: indications and usageACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) 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).
Forms and strengths
- 20 mg/ml
- 80 mg/4ml
- 162 mg/.9ml
- 200 mg/10ml
- 400 mg/20ml
Injection (solution); injection; injection (solution) (concentrate).
On the market
- Earliest approval on file
- January 8, 2010 Actemra, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 5 of which 0 under generic applications, 5 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $821.00 per mL Tyenne 162 mg/0.9 mL autoinjct
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 1 Class I among all firms' recalls; latest August 10, 2026
- FAERS reports
- 113,819 through July 30, 2026
What is tocilizumab used for?
From the label: indications and usageACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) 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) ( 1.2 ) Adult patients with giant cell arteritis. […]
Conditions named in the indications of tocilizumab's FDA labels, with every medicine labeled for each:
From other tocilizumab labelsRheumatoid arthritis: Arthritis (RA) ACTEMRA ® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs …
COVID-19: Coronavirus Disease 2019 (COVID-19) ACTEMRA® (tocilizumab) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids …
FDA pharmacologic class: Interleukin-6 Receptor Antagonist.
Source: FDA drug label (ACTEMRA), Genentech, Inc., effective December 16, 2025 (SPL set 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13), via openFDA; the full label on DailyMed
What does the patient leaflet for tocilizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ACTEMRA?ACTEMRA can cause serious side effects including: 1. Serious Infections. ACTEMRA is a medicine that affects your immune system. ACTEMRA can lower the ability of your immune system to fight infections. Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should assess you for TB before starting ACTEMRA (except if you have COVID-19). If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with ACTEMRA. Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with ACTEMRA. You should not start taking ACTEMRA if you have any kind of infection unless your healthcare provider says it is okay. Before starting ACTEMRA, tell your healthcare provider if you: think you have an infection or have symptoms of an infection, with or without a fever, such as: sweating or chills shortness of breath warm, red, or painful skin or sores on your body feel very tired muscle aches blood in phlegm diarrhea or stomach pain cough weight loss burning when you urinate or urinating more often than normal are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes, HIV, or a weak immune system. […]
Source: FDA drug label (ACTEMRA), Genentech, Inc., effective December 16, 2025 (SPL set 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13), via openFDA; the full label on DailyMed
Is there a generic for tocilizumab (Actemra)?
No generic tocilizumab is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tocilizumab (Actemra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $821.00 per mL (Tyenne 162 mg/0.9 mL autoinjct), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tyenne 162 mg/0.9 mL autoinjct (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Actemra actpen 162 mg/0.9 mL | Brand | $1,279.06 per mL | n/a | +0.4% |
| Tyenne 162 mg/0.9 mL autoinjct | Brand | $821.00 per mL | $738.90 per autoinj | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tocilizumab been recalled?
The FDA's Enforcement Report lists 1 recall naming tocilizumab since 2026: 1 Class I (the most serious), 0 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 10, 2026 | Class I | Fresenius Kabi USA, LLC | Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tocilizumab label say about other medicines?
The tocilizumab label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name tocilizumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | Exercise caution when coadministering ACTEMRA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy [see Clinical Pharmacology (12.3) … |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of ACTEMRA, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. |
| Lovastatin | drug interactions | Exercise caution when coadministering ACTEMRA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy [see Clinical Pharmacology (12.3) … |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Omeprazole | drug interactions | In vivo studies with omeprazole, metabolized by CYP2C19 and CYP3A4, and simvastatin, metabolized by CYP3A4, showed up to a 28% and 57% decrease in exposure one week following a single dose of ACTEMRA, respectively. |
| Simvastatin | drug interactions | In vivo studies with omeprazole, metabolized by CYP2C19 and CYP3A4, and simvastatin, metabolized by CYP3A4, showed up to a 28% and 57% decrease in exposure one week following a single dose of ACTEMRA, respectively. |
| Theophylline | drug interactions | Upon initiation or discontinuation of ACTEMRA, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. |
| Warfarin | drug interactions | Upon initiation or discontinuation of ACTEMRA, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. |
Other labels that name tocilizumab
Source: FDA drug label (ACTEMRA), Genentech, Inc., effective December 16, 2025 (SPL set 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13), via openFDA; the full label on DailyMed
What do FAERS reports show for tocilizumab?
The FDA Adverse Event Reporting System holds 113,819 reports that list tocilizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12,363 are coded as a death and 29,312 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tocilizumab?
3 other medicines are given the same way (intravenous) and in the same FDA class as tocilizumab or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Infliximab | Rheumatoid arthritis | none listed | n/a | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
| Golimumab | Rheumatoid arthritis | none listed | $12,890.32 per mL 50 mg/0.5 mL pen injec | No current entry |
Every medicine labeled for the same conditions as tocilizumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tocilizumab compare with medicines for the same use?
1 side-by-side page set tocilizumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tocilizumab
- 3 medicines for the same use
- Other interleukin-6 receptor antagonists
- the pharmacologic class, with prices and generics
- Tocilizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other