TM Owner Organon (acquired US rights from Biogen, Apr 2025)
Tofidence 80mg/4ml Injection
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Indications & Clinical Uses
- Tofidence 80 mg/4 mL (tocilizumab-bavi) is a biosimilar of the reference biologic Actemra (tocilizumab), an interleukin-6 (IL-6) receptor-blocking monoclonal antibody given only as an intravenous infusion in a hospital or infusion clinic - never self-injected.
- It was developed by Biogen and, since April 2025, its US regulatory and commercial rights are held by Organon, while the original developer Bio-Thera Solutions retains manufacturing.
- It is approved in the US for moderately to severely active rheumatoid arthritis in adults who have not responded well to one or more disease-modifying antirheumatic drugs (DMARDs), often combined with methotrexate; for giant cell arteritis in adults; for active polyarticular and systemic juvenile idiopathic arthritis in patients 2 years and older; and for cytokine release syndrome linked to CAR T-cell therapy, plus hospitalized COVID-19 needing extra oxygen or ventilation.
- It is supplied in single-dose vials of 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL, and is interchangeable with Actemra for its licensed uses.
Side Effects
- Common reactions with Tofidence, seen in more than 1 in 20 people in clinical trials, include upper respiratory tract infections, headache, raised blood pressure, infusion-site reactions, and abnormal liver enzymes.
- Tofidence carries the same boxed warning as its reference product Actemra: serious, sometimes fatal infections, including tuberculosis and invasive fungal, bacterial, viral and other opportunistic infections, have occurred in patients receiving tocilizumab products, so patients are screened for tuberculosis before starting and monitored throughout treatment.
- Other serious risks include gastrointestinal perforation (more likely in people also taking NSAIDs or corticosteroids, or with diverticulitis), low neutrophil and platelet counts, raised cholesterol, and hypersensitivity reactions including anaphylaxis during or shortly after infusion.
- Report fever, persistent cough, severe stomach pain, unusual bleeding, or allergic symptoms to the infusion team immediately.
Precautions & Warnings
- Because Tofidence lowers the immune system's ability to fight infection, it must not be started in anyone with an active, serious infection, and live vaccines should be avoided during treatment; vaccinations should be brought up to date beforehand.
- Routine blood tests for neutrophils, platelets, liver enzymes and lipids are required before each dose, especially in the first months of treatment.
- Use is not recommended in active hepatic disease or significant liver enzyme elevation, and caution is needed with a history of diverticulitis or bowel ulcers because of the perforation risk.
- Tofidence is given only by intravenous infusion over about 60 minutes by a healthcare professional after dilution in 0.9% sodium chloride - it is never given as a bolus injection or self-administered at home.
- Safety in pregnancy is not established; discuss contraception and breastfeeding individually with your healthcare provider.
Avoid Interactions
- Tell your healthcare provider about all medicines, including other biologic DMARDs, before starting Tofidence: combining it with other biologic disease-modifying drugs such as TNF inhibitors, abatacept, rituximab or other IL-6 pathway agents is not recommended because of a possible increase in infection risk.
- Live and live-attenuated vaccines should be avoided during and shortly after treatment because immune suppression can reduce their safety and effectiveness.
- Tocilizumab can normalize CYP450 enzyme activity that inflammation had suppressed, which may lower blood levels of drugs metabolised by CYP3A4, CYP1A2 or CYP2C9, including some statins, calcium-channel blockers, theophylline, warfarin and oral contraceptives, so their effectiveness should be monitored, especially around starting or stopping Tofidence.
- There are no known food interactions since it is given only intravenously.
References
Frequently Asked Questions
Tofidence (tocilizumab-bavi) is a biosimilar of Actemra used to treat rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis in adults and children from age 2. It's also used for CAR T-cell therapy-related cytokine release syndrome and for hospitalized COVID-19 patients needing extra oxygen. It blocks interleukin-6 to reduce inflammation.
A healthcare provider gives Tofidence as an intravenous infusion over about 60 minutes - it's never self-injected. For rheumatoid arthritis it's usually given every 4 weeks; systemic juvenile idiopathic arthritis uses a 2-week schedule. Your dose and frequency depend on your condition, so follow your clinic's treatment schedule.
Common effects include upper respiratory infections, headache, and raised blood pressure. Tofidence carries a boxed warning for serious, sometimes fatal infections such as tuberculosis and fungal infections, because it weakens immune defenses. Tell your care team about fever, persistent cough, or severe stomach pain right away.
Avoid live vaccines while on Tofidence, since your immune response may be reduced. Combining it with other biologic arthritis drugs, such as TNF inhibitors, raises infection risk and isn't recommended. Tell your provider about all medicines, since Tofidence can change blood levels of drugs like warfarin and some statins.
Each Tofidence infusion takes about an hour and is given into a vein by trained staff, who watch for allergic reactions during and after. Blood tests for neutrophils, platelets, liver enzymes and cholesterol are checked before each dose, especially early in treatment, to catch problems before they become serious.
Tofidence is a biosimilar - it has the same amino-acid sequence and mechanism as the reference biologic Actemra (tocilizumab) and is approved as interchangeable with it. It works the same way and carries the same boxed warning for serious infections; only the marketer and brand name differ.
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