Tofidence: Uses, Dosage & Side Effects
A biosimilar interleukin-6 (IL-6) receptor antagonist used to reduce inflammation in rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, and severe COVID-19
Tofidence (tocilizumab-bavi) is a biosimilar of tocilizumab, a humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor. By interrupting IL-6 signaling, Tofidence reduces the excessive inflammation that drives several serious immune-mediated diseases. It is approved for moderate to severe rheumatoid arthritis, giant cell arteritis, polyarticular and systemic juvenile idiopathic arthritis, and for hospitalized adults with severe COVID-19. Tofidence is administered as an intravenous infusion in a supervised healthcare setting. As a biosimilar, it offers the same clinical benefits as the reference biologic while expanding treatment access. It requires a specialist prescription and careful pre-treatment screening, particularly for latent tuberculosis.
Quick Facts: Tofidence
Key Takeaways
- Tofidence (tocilizumab-bavi) is a biosimilar of tocilizumab, a monoclonal antibody that blocks the interleukin-6 (IL-6) receptor and dampens the inflammation that drives several autoimmune and inflammatory diseases.
- It is approved for rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular and systemic juvenile idiopathic arthritis (PJIA, SJIA), and hospitalized adults with severe COVID-19 requiring systemic corticosteroids plus supplemental oxygen or ventilation.
- Serious infections (including tuberculosis, invasive fungal and bacterial infections) are the most important safety concern; all patients must be screened for latent tuberculosis before treatment and monitored closely throughout therapy.
- Tofidence is administered as an intravenous infusion over 60 minutes, typically every 2 to 4 weeks depending on the indication, and is given in a hospital or specialized clinic setting.
- As a biosimilar approved under rigorous comparability standards, Tofidence is expected to match the reference tocilizumab in safety, efficacy, and immunogenicity, while supporting broader access to IL-6 blockade therapy.
What Is Tofidence and What Is It Used For?
Tofidence contains the active substance tocilizumab-bavi, a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody directed against the human interleukin-6 receptor (IL-6R). It is a biosimilar of tocilizumab, meaning it is a biologic medicine that has been shown to be highly similar to an already-approved reference biologic (known internationally as Actemra or RoActemra) with no clinically meaningful differences in safety, purity, or potency. Biosimilars undergo extensive analytical, non-clinical, and clinical comparability testing before regulatory approval and expand patient access to complex biologic therapies.
Interleukin-6 is a pleiotropic pro-inflammatory cytokine produced by many cell types, including T-cells, B-cells, monocytes, fibroblasts, and synovial cells. IL-6 drives a wide range of biological processes relevant to autoimmune and inflammatory diseases: it stimulates acute-phase protein synthesis in the liver (such as C-reactive protein and fibrinogen), promotes differentiation of B-cells into antibody-producing plasma cells, supports T-helper cell polarization, mediates fever, and contributes to bone and cartilage destruction in inflammatory arthritis. Chronic overproduction of IL-6 is a central driver of joint damage in rheumatoid arthritis, vessel wall inflammation in giant cell arteritis, and the hyperinflammatory state seen in severe COVID-19 and cytokine release syndrome.
Tocilizumab-bavi binds with high affinity to both soluble (sIL-6R) and membrane-bound (mIL-6R) forms of the IL-6 receptor. This binding prevents IL-6 from engaging its receptor and signaling through the shared gp130 subunit via the JAK-STAT intracellular pathway. By interrupting this signaling cascade, Tofidence reduces systemic inflammation, decreases levels of inflammatory markers such as C-reactive protein (CRP) and serum amyloid A, and improves clinical symptoms in IL-6-driven diseases. The suppression of CRP is typically rapid and can be useful as a pharmacodynamic indicator of biological effect, although it may also mask early signs of serious infection.
Tofidence is approved for use in the following conditions:
- Rheumatoid arthritis (RA): Tofidence is indicated for moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It can be used as monotherapy when methotrexate is inappropriate, or in combination with methotrexate or other conventional DMARDs. Treatment reduces inflammatory disease activity, relieves pain and joint swelling, improves physical function, and slows the progression of structural joint damage.
- Giant cell arteritis (GCA): Tofidence is used to treat giant cell arteritis in adult patients. GCA is a large-vessel vasculitis that can cause sudden blindness and aortic complications if not treated promptly. IL-6 blockade enables substantial corticosteroid tapering and improves sustained remission rates compared with steroids alone.
- Polyarticular juvenile idiopathic arthritis (PJIA): Tofidence is indicated for the treatment of active polyarticular JIA in patients 2 years of age and older, either alone or in combination with methotrexate, when response to previous therapy with methotrexate has been inadequate.
- Systemic juvenile idiopathic arthritis (SJIA): Tofidence is used to treat active systemic JIA in patients 2 years of age and older who have had an inadequate response to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids. SJIA is a severe inflammatory disease characterized by fever, rash, and arthritis, with a high risk of macrophage activation syndrome.
- COVID-19: Tofidence is authorized for hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Clinical trials and WHO meta-analyses demonstrated that IL-6 blockade reduces mortality and progression to invasive ventilation in this setting.
Rheumatoid arthritis is a chronic autoimmune disease characterized by persistent synovial inflammation that eventually leads to cartilage destruction, bone erosions, and joint deformity. Giant cell arteritis is the most common form of systemic vasculitis in people over 50, affecting large and medium-sized arteries. Juvenile idiopathic arthritis is the most common form of chronic arthritis in children. In all of these conditions, IL-6 plays a central pathogenic role, making IL-6 receptor blockade with tocilizumab a highly effective targeted therapy when first-line treatments have failed or are contraindicated.
Unlike small-molecule generic drugs, biosimilars are not exact copies of the reference biologic. Biologics are large, complex proteins produced in living cells, so minor heterogeneity is unavoidable. Regulatory agencies (FDA, EMA) require biosimilars to demonstrate no clinically meaningful differences from the reference product in analytical characterization, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity through a structured comparability exercise. Tofidence was approved through this pathway as a biosimilar to tocilizumab.
What Should You Know Before Receiving Tofidence?
Contraindications
Certain situations absolutely preclude the use of Tofidence. Identifying these before the first infusion is essential for patient safety.
- Hypersensitivity: Do not receive Tofidence if you have a known allergy to tocilizumab-bavi, tocilizumab, or any of the excipients (including polysorbate 80). Severe hypersensitivity reactions, including anaphylaxis, have been reported.
- Active, severe infections: Tofidence must not be started in patients with active, severe infections, including untreated active tuberculosis, active hepatitis B, or other serious bacterial, fungal, or viral infections. Treat the infection first, then reassess.
Warnings and Precautions
Serious infections, including tuberculosis reactivation, invasive fungal infections (such as candidiasis, aspergillosis, pneumocystis, and cryptococcosis), bacterial infections (including sepsis), and opportunistic viral infections, have occurred in patients receiving tocilizumab. Some of these infections have been fatal. Screen all patients for latent tuberculosis before starting and annually thereafter. Avoid Tofidence in patients with active infections. Stop treatment if a serious infection develops until it is controlled.
Your rheumatologist or prescribing specialist will assess several clinical domains before and during Tofidence therapy:
- Tuberculosis screening: All patients must be evaluated for latent and active tuberculosis (TB) before the first infusion, using a tuberculin skin test or interferon-gamma release assay (IGRA), plus a chest radiograph. Patients with latent TB must begin anti-TB treatment before Tofidence is started. Clinicians should remain vigilant for symptoms of active TB (persistent cough, night sweats, fever, unintentional weight loss) throughout therapy.
- Hepatitis B screening: Screening for hepatitis B virus (HBV) is recommended before initiation, because IL-6 blockade can cause reactivation of latent HBV. HBsAg and anti-HBc status should be assessed, and antiviral prophylaxis may be needed for some carriers.
- Gastrointestinal perforation: Perforation has been reported, most often in patients with a history of diverticulitis or concurrent corticosteroid or NSAID use. Promptly evaluate any new or worsening abdominal pain, fever, or change in bowel habits.
- Hepatotoxicity: Elevations of ALT and AST are very common and are usually mild to moderate and asymptomatic. However, serious drug-induced liver injury, including cases requiring liver transplantation and rarely fatal outcomes, has been reported. Baseline and periodic liver function tests are required.
- Hematological effects: Neutropenia (including severe neutropenia) and thrombocytopenia can occur and may increase infection or bleeding risk. Complete blood counts should be checked at baseline, 4 to 8 weeks after starting, and periodically thereafter.
- Lipid abnormalities: Elevations in total cholesterol, LDL, HDL, and triglycerides are very common and usually begin within 4 to 6 weeks. Monitor a lipid panel at baseline, at 4 to 8 weeks, and roughly every 6 months. Manage dyslipidaemia according to local cardiovascular prevention guidelines.
- Infusion-related and hypersensitivity reactions: Reactions typically occur during or within 24 hours of the infusion. Most are mild but anaphylaxis is possible. Stop the infusion immediately and provide emergency treatment if severe reactions occur.
- Macrophage activation syndrome (MAS): In patients with systemic JIA, be alert for signs of MAS (persistent fever, hepatosplenomegaly, cytopenias, hyperferritinaemia, coagulopathy), which is a life-threatening hyperinflammatory complication.
- Demyelinating disorders: Rare cases of central demyelinating disorders (including multiple sclerosis and optic neuritis) have been reported. Patients with pre-existing demyelinating disease should be monitored carefully.
- Malignancies: Immunomodulatory therapies theoretically increase the risk of some malignancies. Long-term observational data for tocilizumab have not shown a clear increased rate beyond that expected in the underlying rheumatic disease population, but vigilance is appropriate.
- Vaccinations: All age-appropriate immunizations, especially live vaccines, should ideally be brought up to date before starting Tofidence. Live or live-attenuated vaccines must not be given during treatment.
Your healthcare team will request laboratory monitoring throughout treatment. Typical monitoring includes liver enzymes, complete blood count, lipid panel, and clinical review for infection, every 4 to 8 weeks initially and then periodically as stable.
Other Medications
Tell your doctor and pharmacist about all medications you are currently taking or have recently taken, including prescription drugs, over-the-counter products, and herbal supplements. Tocilizumab does not undergo CYP450 metabolism itself but can influence CYP enzyme expression indirectly by reducing IL-6-mediated suppression. This may lower exposure to other medications metabolized by CYP3A4, CYP1A2, CYP2C9, CYP2C19, and CYP2D6 (see the Drug Interactions section below).
Pregnancy and Breastfeeding
Data on the use of tocilizumab products, including Tofidence, during human pregnancy are limited. As an IgG1 monoclonal antibody, tocilizumab is expected to cross the placenta, particularly during the second and third trimesters, and may affect neonatal immune function. Animal studies at very high exposures have shown no teratogenicity but have demonstrated increased abortion and embryo-foetal death. Tofidence should only be used during pregnancy if the potential benefit justifies the potential risk, and the decision must be individualized with a rheumatologist and obstetrician.
Women of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose. If you become pregnant while receiving Tofidence, inform your doctor immediately to discuss whether continuation, dose adjustment, or discontinuation is appropriate. Tell your doctor about any plans to conceive.
Endogenous maternal IgG is known to be excreted in human breast milk. It is not known to what extent tocilizumab-bavi is present in milk, but oral absorption of intact antibody by a breastfed infant is expected to be very limited because IgG is degraded in the infant gastrointestinal tract. A decision should be made whether to discontinue breastfeeding or Tofidence, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the mother.
There is no specific guidance on paternal exposure. Men are not required to use contraception from a tocilizumab-specific standpoint, but should always discuss fertility planning with their specialist.
Driving and Operating Machinery
Tofidence is not expected to impair the ability to drive or operate machinery in most patients. However, dizziness and fatigue are common and may affect performance. If you feel dizzy, fatigued, or unwell following an infusion, avoid driving and operating heavy machinery until symptoms resolve.
Important Information About Ingredients
Tofidence contains polysorbate 80, which can cause allergic reactions. Inform your doctor if you have a known allergy to polysorbate. The product also contains sodium; the exact amount per vial is specified in the Summary of Product Characteristics and should be considered in patients on a sodium-restricted diet, although the quantity per infusion is small.
How Does Tofidence Interact with Other Drugs?
Drug interactions with Tofidence arise from two main mechanisms. First, as a biologic immunomodulator, combining it with other drugs that suppress the immune system increases the risk of serious infections. Second, high levels of IL-6 characteristic of chronic inflammatory diseases suppress several hepatic cytochrome P450 (CYP) enzymes. When IL-6 signaling is blocked, CYP activity can return toward normal levels within about 1 to 2 weeks, which may reduce plasma concentrations of some coadministered drugs and lower their therapeutic effect.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Other biologic DMARDs (TNF inhibitors, abatacept, rituximab, anakinra) | Additive immunosuppression, markedly increased risk of serious infections | Avoid combination |
| Janus kinase (JAK) inhibitors (tofacitinib, baricitinib, upadacitinib) | Additive immunosuppression, overlapping toxicity | Avoid combination |
| Live or live-attenuated vaccines (MMR, varicella, yellow fever, BCG, oral polio, intranasal influenza) | Potential vaccine-strain infection due to immunosuppression | Contraindicated during treatment; complete before starting if possible |
| Simvastatin and other CYP3A4 substrates | Up to ~57% decrease in simvastatin exposure at steady state | Monitor LDL response; may need higher statin dose or alternative statin |
| Warfarin (CYP2C9 substrate) | Possible decreased warfarin effect, variable INR | Monitor INR closely, particularly after starting or stopping Tofidence |
| Oral contraceptives (CYP3A4 substrates) | Possible reduced hormone exposure; contraceptive failure theoretical but not confirmed | Consider backup contraception, particularly during dose changes |
Minor and Supportive Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Methotrexate | No clinically significant pharmacokinetic interaction | Commonly combined; standard RA co-therapy |
| Corticosteroids (e.g., prednisolone) | Additive immunosuppression; concurrent NSAID use increases GI perforation risk | Commonly co-administered; taper corticosteroids as IL-6 blockade takes effect |
| Phenytoin, ciclosporin, theophylline (narrow therapeutic index CYP substrates) | Possible decreased plasma levels via CYP normalization | Monitor drug levels where available; adjust dose as clinically indicated |
| Atorvastatin | Modest decrease in plasma exposure | Monitor lipid response and adjust dose if needed |
| Inactivated vaccines (e.g., influenza injection, pneumococcal, hepatitis B, most COVID-19 vaccines) | Safe to co-administer; immune response may be somewhat attenuated | Recommended; ideally administer before initiation when possible |
Always provide your complete medication list to every clinician involved in your care, including dentists and pharmacists. Carry a biologic therapy card identifying that you receive Tofidence, the date of your most recent infusion, and emergency contact information. Special care is needed around surgery: your rheumatologist will advise you on whether and how to adjust your infusion schedule to balance infection risk and disease control.
What Is the Correct Dosage of Tofidence?
Tofidence is always given as an intravenous infusion over 60 minutes, prepared and administered by healthcare professionals in a hospital, infusion center, or specialist clinic. Self-administration is not possible with the IV formulation. The dose is calculated based on body weight and indication. Never attempt to adjust your own dose or infusion schedule.
Adults: Rheumatoid Arthritis
Tofidence for Adult Rheumatoid Arthritis
Recommended dose: 4 mg/kg IV every 4 weeks, with increase to 8 mg/kg every 4 weeks based on clinical response.
Maximum dose: 800 mg per infusion.
Use: May be given as monotherapy or in combination with methotrexate or other conventional DMARDs. Many international guidelines (EULAR, ACR) recommend combination with methotrexate where tolerated for optimal long-term outcomes.
Adults: Giant Cell Arteritis
Tofidence for Giant Cell Arteritis
Recommended dose: 6 mg/kg IV every 4 weeks (when the IV route is used; note that the subcutaneous formulation is used more commonly in GCA and is not Tofidence).
Maximum dose: 600 mg per infusion.
Use: In combination with a tapering course of glucocorticoids. IL-6 blockade enables more rapid steroid tapering and improved sustained remission compared with steroids alone.
Children and Adolescents
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years and older weighing less than 30 kg: 10 mg/kg IV every 4 weeks.
Patients 2 years and older weighing 30 kg or more: 8 mg/kg IV every 4 weeks.
Use: Alone or in combination with methotrexate. Safety and efficacy in children under 2 years have not been established.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years and older weighing less than 30 kg: 12 mg/kg IV every 2 weeks.
Patients 2 years and older weighing 30 kg or more: 8 mg/kg IV every 2 weeks.
Use: In patients who have had an inadequate response to NSAIDs and systemic corticosteroids. Close monitoring for macrophage activation syndrome is essential in SJIA.
Adults: COVID-19
Tofidence for Hospitalized Adults with COVID-19
Recommended dose: 8 mg/kg IV over 60 minutes as a single dose (maximum 800 mg).
Optional second dose: A second infusion may be given at least 8 hours after the first if clinical signs or symptoms worsen or do not improve.
Use: Must be given in combination with systemic corticosteroids (typically dexamethasone) in patients requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, older adults are more likely to have comorbidities, polypharmacy, and baseline infection risk, so extra caution is warranted. Clinicians should monitor closely for infections, liver function abnormalities, cytopenias, and gastrointestinal events in patients over 65 years.
Renal and Hepatic Impairment
No dose adjustment is required in patients with mild renal impairment. Tofidence has not been formally studied in moderate to severe renal impairment; clinical judgement should be applied. In patients with pre-existing hepatic impairment or abnormal liver enzymes at baseline, initiation is generally not recommended if ALT or AST is greater than 1.5 times the upper limit of normal. Treatment must be stopped for significant transaminase elevations (typically more than 5 times ULN) and resumed cautiously, if at all, once values normalize.
Missed Dose
Because Tofidence is given by a healthcare professional in a clinic setting, missed infusions are rare. If you miss a scheduled infusion, contact your clinic as soon as possible to reschedule. Do not try to double up on a later dose to make up for a missed one. Your clinician will advise whether to give the next dose at the earliest convenient time or to realign with the original schedule, depending on how much time has elapsed and your disease activity.
Overdose
There is limited clinical experience with Tofidence overdose. One case of unintentional overdose with 40 mg/kg tocilizumab in a multiple myeloma patient was reported without adverse reactions. In volunteers dosed at up to 28 mg/kg, dose-limiting neutropenia was observed. In the event of overdose, monitor closely for adverse reactions, particularly infections, cytopenias, and hepatic abnormalities, and provide symptomatic and supportive care. There is no specific antidote; tocilizumab is not removed by haemodialysis.
How Tofidence Is Given
Tofidence is supplied as a clear to opalescent colorless to pale yellow sterile solution at 20 mg/mL in single-dose vials of 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. Before administration, the appropriate volume of the vial contents is withdrawn and diluted into a 100 mL (for adults) or weight-based volume (for pediatric patients) infusion bag of 0.9% sodium chloride injection to achieve a total volume suitable for infusion. The diluted solution is then infused intravenously over 60 minutes through dedicated tubing.
Do not administer Tofidence by intravenous push or bolus. Do not mix the infusion with other drugs. After dilution, the infusion should ideally be used immediately; if this is not possible, it may be stored at 2 to 8°C for up to 24 hours (or at room temperature for a shorter specified period, per product labeling), protected from light. Inspect the solution visually before use and discard if particulates or discoloration are present.
Tofidence is always prepared and administered by trained healthcare professionals. You will not self-administer this medication at home. Each infusion is calculated based on body weight and indication, and you will be monitored during and after the infusion for signs of hypersensitivity or other adverse reactions. Tell your nurse immediately if you develop rash, breathing difficulty, swelling, chest discomfort, or any other unusual symptom during the infusion.
What Are the Side Effects of Tofidence?
As with all biologic medicines, Tofidence can cause side effects that range from mild and transient to serious and potentially life-threatening. The safety profile is well-characterized through extensive clinical trial and post-marketing experience with tocilizumab. As a biosimilar, Tofidence is expected to show the same safety pattern as the reference product. Your healthcare team will monitor you closely and manage any side effects as they arise.
Infusion-Related Reactions
Infusion-related reactions (defined as adverse events occurring during or within 24 hours of infusion) are reported in a substantial proportion of patients. Most reactions during infusion are mild, presenting as headache, skin flushing, elevated blood pressure, rash, or itch. Reactions within 24 hours after infusion are often mild skin and mucocutaneous events. Severe reactions, including anaphylaxis, can occur but are rare. Pre-medication is not routinely required, but may be considered if a patient has previously experienced a reaction. If anaphylaxis or another severe reaction occurs, the infusion must be stopped immediately and appropriate emergency treatment administered; Tofidence should then be permanently discontinued.
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Upper respiratory tract infections (e.g., common cold, sinusitis)
- Nasopharyngitis (inflammation of the nose and throat)
- Elevated blood cholesterol (hypercholesterolaemia)
- Elevated liver enzymes (ALT and AST)
- Headache
- High blood pressure (hypertension)
- Injection/infusion reactions (in some patients receiving IV administration, counted as IRRs)
Common
May affect up to 1 in 10 people
- Cellulitis (skin infection)
- Pneumonia
- Oral herpes simplex (cold sores)
- Herpes zoster (shingles)
- Leukopenia (low white blood cells)
- Neutropenia (low neutrophils)
- Hypothyroidism (underactive thyroid)
- Hypertriglyceridaemia (elevated triglycerides)
- Dizziness
- Conjunctivitis
- Abdominal pain, mouth ulceration, gastritis
- Rash, pruritus (itch), urticaria (hives)
- Peripheral oedema (swelling of ankles/feet)
- Elevated bilirubin (mild)
- Weight gain
- Cough
Uncommon
May affect up to 1 in 100 people
- Diverticulitis
- Stomatitis
- Gastric ulcer
- Hypersensitivity reactions during or shortly after infusion
- Hypertriglyceridaemia requiring intervention
- Nephrolithiasis (kidney stones)
- Gastrointestinal perforation
Rare
May affect up to 1 in 1,000 people
- Stevens-Johnson syndrome and other severe skin reactions
- Anaphylaxis (potentially fatal)
- Serious drug-induced liver injury, including cases requiring liver transplantation
- Fatal infections
Not Known
Frequency cannot be estimated from available data
- Reactivation of latent infections including tuberculosis and hepatitis B
- Demyelinating disorders (including multiple sclerosis and optic neuritis)
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Hepatic failure and fulminant hepatitis
Side Effects in Children
In children with polyarticular or systemic JIA, the safety profile is similar to that in adults, with upper respiratory infections, nasopharyngitis, headache, transaminase elevations, and injection/infusion reactions among the most common events. Infusion-related reactions can occur more frequently in SJIA patients, particularly at higher body-weight-adjusted doses. Macrophage activation syndrome is an important concern in SJIA; although tocilizumab can be used as part of MAS management in some cases, it may also mask or modify presentation.
Regular blood tests are required throughout Tofidence therapy. Typical monitoring includes liver function tests, complete blood counts, and lipid panels at baseline, 4 to 8 weeks after initiation, and then roughly every 3 to 6 months (more frequently if abnormalities emerge). Report any new infection symptoms, unexplained fatigue, jaundice, persistent abdominal pain, or unusual bruising or bleeding to your healthcare team promptly.
If you experience any side effect, including effects not listed here, tell your doctor, nurse, or pharmacist. You can also report suspected side effects directly to your national pharmacovigilance authority (for example, the FDA MedWatch program in the United States, the EMA EudraVigilance system in the European Union, or the MHRA Yellow Card Scheme in the United Kingdom). Patient reports help monitor the ongoing benefit-risk profile of biologic medicines including biosimilars.
How Should Tofidence Be Stored?
Keep this medicine out of the sight and reach of children. Do not use after the expiry date stated on the vial label and outer carton. The expiry date refers to the last day of that month.
- Unopened vials: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Light protection: Keep the vial in the original outer carton to protect from light.
- Diluted infusion solution: Should preferably be used immediately. If not used immediately, the diluted solution may be stored refrigerated at 2 to 8°C for up to 24 hours (or at room temperature for a shorter time as specified in the approved labeling). Protect from light during storage.
- Inspection: Before use, inspect the vial and the diluted solution visually. Do not use if you see particles, discoloration, or damage to the vial.
- Disposal: Do not dispose of medicines via wastewater or household waste. Your hospital pharmacy will dispose of unused solution according to local regulations to protect the environment.
Because Tofidence is prepared and administered in a hospital or specialist clinic, storage and handling are managed by your healthcare team and pharmacy. Patients do not need to store vials at home.
What Does Tofidence Contain?
Active Substance
The active substance is tocilizumab-bavi, a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody of the IgG1 kappa subclass, produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Each milliliter of the solution contains 20 mg of tocilizumab-bavi. Each vial contains 80 mg (4 mL), 200 mg (10 mL), or 400 mg (20 mL).
Inactive Ingredients (Excipients)
- L-histidine and L-histidine hydrochloride monohydrate (buffering agents)
- L-arginine and L-arginine hydrochloride (stabilizer)
- Polysorbate 80 (surfactant)
- Water for injection
The exact qualitative and quantitative composition of excipients may vary slightly by product presentation and is detailed in the approved Prescribing Information / Summary of Product Characteristics.
Appearance
Tofidence is supplied as a clear to opalescent, colorless to pale yellow sterile solution for infusion, provided in single-dose glass vials. Each vial is intended for dilution before intravenous administration.
Manufacturer and Marketing Authorization
Tofidence is marketed by Biogen Inc. It is the first tocilizumab biosimilar to receive approval from the U.S. Food and Drug Administration (approved September 2023). The product is manufactured under Good Manufacturing Practice (GMP) conditions and subject to the same pharmacovigilance, lot release, and comparability oversight as other biologic medicines.
Frequently Asked Questions About Tofidence
Tofidence (tocilizumab-bavi) is a biosimilar of tocilizumab used to treat moderately to severely active rheumatoid arthritis (RA) in adults, giant cell arteritis (GCA) in adults, polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years and older, systemic juvenile idiopathic arthritis (SJIA) in patients 2 years and older, and hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. It works by blocking the interleukin-6 (IL-6) receptor to reduce inflammation.
Tofidence is a biosimilar of Actemra (tocilizumab), not the identical product. Under strict regulatory comparability standards, the FDA confirmed no clinically meaningful differences between Tofidence and the reference product in safety, purity, or potency. Approved in September 2023, Tofidence was the first tocilizumab biosimilar available in the United States. For the vast majority of clinical situations, Tofidence can be expected to perform like the reference tocilizumab. Transitioning between tocilizumab products should be done under the guidance of your treating specialist.
Many patients begin to experience symptom relief within 2 to 4 weeks after the first infusion, with further improvement over subsequent infusions. Inflammatory markers such as C-reactive protein (CRP) typically fall rapidly within days of the first dose. Maximum clinical benefit in rheumatoid arthritis is usually evaluated after 12 to 24 weeks of therapy. If no meaningful response is seen by that time, your rheumatologist may consider alternative therapies. For COVID-19 and giant cell arteritis, the timing and endpoints differ by indication.
IL-6 blockade with tocilizumab weakens part of the immune response against certain infections, including tuberculosis (TB). Patients with latent (asymptomatic) TB can progress to active TB if started on Tofidence without first treating the latent infection. All patients therefore undergo screening with a tuberculin skin test or IGRA blood test and a chest X-ray before their first infusion. If latent TB is identified, anti-TB prophylaxis is started before Tofidence, in line with national guidelines. Your clinician will also monitor for new symptoms of TB (persistent cough, night sweats, weight loss, fever) throughout treatment.
Live or live-attenuated vaccines (including MMR, varicella / chickenpox, yellow fever, oral polio, BCG, and intranasal influenza) must not be given during Tofidence therapy. Inactivated vaccines (such as the injectable influenza vaccine, pneumococcal vaccines, hepatitis B, and most COVID-19 vaccines) are safe and recommended, although the immune response may be somewhat reduced compared with non-immunosuppressed individuals. Ideally, bring all age-appropriate vaccinations up to date before starting Tofidence. For household contacts of severely immunosuppressed patients, some live vaccines may still be appropriate, but specific guidance should be sought from your clinician.
Yes. Tofidence is commonly combined with methotrexate or another conventional synthetic DMARD for rheumatoid arthritis and polyarticular JIA. The combination produces greater disease activity reductions and better long-term joint protection than either drug alone. Tofidence can also be given as monotherapy if methotrexate is not tolerated or contraindicated. What must be avoided is combination with other biologic DMARDs (such as TNF inhibitors, rituximab, abatacept, anakinra) or Janus kinase (JAK) inhibitors, due to additive immunosuppression and increased infection risk.
Data on tocilizumab use in pregnancy are limited. As a monoclonal antibody, it can cross the placenta, especially during the second and third trimesters, and may affect neonatal immune development. Tofidence should only be used during pregnancy if the potential benefit clearly outweighs the risk, and only after individualized discussion with a rheumatologist and obstetrician. Women of reproductive potential should use effective contraception during treatment and for at least 3 months after the last infusion. If you are pregnant, think you may be pregnant, or plan to conceive, tell your doctor as soon as possible so the safest plan can be developed.
Tocilizumab is among the most effective biologic DMARDs for rheumatoid arthritis. Pivotal trials of the reference product showed ACR20 response rates of approximately 50 to 70% at 24 weeks, with ACR50 and ACR70 responses (indicating deeper disease control) also significantly higher than placebo or methotrexate monotherapy. Radiographic progression of joint damage is slowed. As a biosimilar, Tofidence has demonstrated comparable efficacy to the reference tocilizumab in comparability studies. Individual response varies, and your rheumatologist will assess your response using objective disease activity measures (such as DAS28 or CDAI) and laboratory markers.
References
- U.S. Food and Drug Administration (FDA). Tofidence (tocilizumab-bavi) Prescribing Information. Initial U.S. approval 2023; current revision 2024. Available from: FDA Drug Label Database.
- European Medicines Agency (EMA). RoActemra (tocilizumab) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18. doi:10.1136/ard-2022-223356.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2021;73(7):1108–1123. doi:10.1002/art.41752.
- Stone JH, Tuckwell K, Dimonaco S, et al. Trial of Tocilizumab in Giant-Cell Arteritis (GiACTA). N Engl J Med. 2017;377(4):317–328. doi:10.1056/NEJMoa1613849.
- De Benedetti F, Brunner HI, Ruperto N, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis (TENDER). N Engl J Med. 2012;367(25):2385–2395. doi:10.1056/NEJMoa1112802.
- Brunner HI, Ruperto N, Zuber Z, et al. Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis (CHERISH). Ann Rheum Dis. 2015;74(6):1110–1117.
- RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021;397(10285):1637–1645. doi:10.1016/S0140-6736(21)00676-0.
- WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group. Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis. JAMA. 2021;326(6):499–518. doi:10.1001/jama.2021.11330.
- World Health Organization (WHO). Therapeutics and COVID-19: living guideline. Geneva: WHO; 2023.
- Kang S, Tanaka T, Narazaki M, Kishimoto T. Targeting Interleukin-6 Signaling in Clinic. Immunity. 2019;50(4):1007–1023. doi:10.1016/j.immuni.2019.03.026.
- U.S. Food and Drug Administration. Biosimilars: Regulatory, Clinical, and Business Considerations. Rockville, MD: FDA; 2023.
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