For US healthcare professionals only
Q-code: Q5156

AVTOZMA delivers dosing continuity for patients transitioning from Actemra®1*

Dosing guidelines for adult and pediatric patients1

Adult patients
Pediatric patients (2 years and older)

DMARDs, disease-modifying anti-rheumatic drugs; IV, intravenous; MTX, methotrexate.

*AVTOZMA is FDA-approved for both intravenous and subcutaneous use; subcutaneous dosing is not yet available.

†Can increase to 8 mg/kg based on clinical response. Max 800 mg per infusion; may be used with or without MTX or other non-biologic DMARDs.

††Use in combination with a tapering course of glucocorticoids.

§If no clinical improvement after the first dose, up to 3 additional doses of AVTOZMA may be administered. The interval between consecutive doses should be at least 8 hours. AVTOZMA can be used with or without corticosteroids.

Administer over 60 minutes; max 800 mg per infusion. A second dose may be administered ≥8 hours later if clinical signs do not improve.

IV, intravenous.

*AVTOZMA is FDA-approved for both intravenous and subcutaneous use; subcutaneous dosing is not yet available.

†If no clinical improvement is seen after the first dose, up to 3 additional doses of AVTOZMA may be administered. The interval between consecutive doses should be at least 8 hours. AVTOZMA can be used with or without corticosteroids.

  • AVTOZMA has the same weight-based dosing regimen as Actemra and does not require retraining staff

Please see the recommended dosing modifications.

Dosing modifications are the same as those for Actemra1

Serious infections
If a patient develops a serious infection, hold AVTOZMA until the infection is controlled.1

Liver enzyme abnormalities1

ANC, absolute neutrophil count; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DMARDs, disease-modifying anti-rheumatic drugs; ULN, upper limit of normal.

Mild Abnormality (ALT/AST >1-3x ULN, ANC >1000, platelets 50-100K)
Severe Abnormality (ALT/AST >3-5x ULN, ANC 500-1000, platelets >100K)
Critical Abnormality (ALT/AST >5x ULN, ANC <500, platelets <50K)

Drug interactions with AVTOZMA1

Concomitant medications for adult indications

  • RA—No impact when used with MTX, NSAIDs, or corticosteroids. MTX exposure has no clinically significant effect when administered with a single IV dose of tocilizumab 10 mg/kg alongside MTX 10-25 mg once weekly; tocilizumab products have not been studied in combination with other DMARDs
  • GCA—no observed effect from concomitant corticosteroids

CYP450 interactions

  • IL-6 inhibition may restore CYP450 activities to higher levels than those in the absence of tocilizumab products, leading to increased metabolism of drugs that are CYP450 substrates. In vitro studies show tocilizumab can affect multiple CYP enzymes, including CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. The impact on CYP2C8 and drug transporters is unknown
  • In vivo studies with omeprazole (metabolized by CYP2C19 and CYP3A4) and simvastatin (metabolized by CYP3A4) showed a decrease in exposure up to 28% and 57%, respectively, one week following a single dose of tocilizumab. The effect of tocilizumab products on CYP enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index where the dose is individually adjusted. Upon initiation or discontinuation of AVTOZMA in patients being treated with these types of medications, perform therapeutic monitoring of the effect (eg, warfarin) or drug concentration (eg, cyclosporine or theophylline) and adjust the individual dose of the medication as needed. Exercise caution when coadministering AVTOZMA with CYP3A4 substrate drugs where a decrease in effectiveness is undesirable (eg, oral contraceptives, lovastatin, atorvastatin). The effect of tocilizumab products on CYP450 enzyme activity may persist for several weeks after stopping therapy

Vaccination guidance

  • Avoid concurrent use of live vaccines with AVTOZMA

References: 1. AVTOZMA Prescribing Information. Celltrion USA, Inc; 2025. 2. Actemra Prescribing Information. Genentech, Inc. 2024.

Like Actemra, AVTOZMA is dosed over 60 minutes.1,2

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS

Patients treated with tocilizumab products including AVTOZMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt AVTOZMA 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 AVTOZMA use and during therapy. Treatment for latent infection should be initiated prior to AVTOZMA 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 AVTOZMA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with AVTOZMA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Contraindications: Known hypersensitivity to tocilizumab products.

Serious Infections. Serious and sometimes fatal infections, including bacterial, mycobacterial, invasive fungal, viral, and opportunistic infections, have been reported with tocilizumab products, including AVTOZMA. Common serious infections include pneumonia, urinary tract infections, cellulitis, herpes zoster, and sepsis, while opportunistic infections such as tuberculosis and cryptococcus have also occurred. Patients with chronic or recurrent infections, tuberculosis exposure, or underlying conditions predisposing to infections should have the risks and benefits of AVTOZMA carefully evaluated. Monitor patients closely during and after treatment for signs of infection, and discontinue AVTOZMA if a serious infection develops, initiating appropriate antimicrobial therapy as needed.

Gastrointestinal (GI) Perforation. Gastrointestinal perforation events, primarily associated with diverticulitis, have been reported in clinical trials of tocilizumab. Use AVTOZMA cautiously in patients at increased risk for gastrointestinal perforation. Promptly evaluate any patient experiencing new abdominal symptoms to ensure early detection and management of this condition.

Hepatotoxicity. Serious hepatic injury, including cases of liver transplant and death, has occurred with tocilizumab products, with onset ranging from months to years. Some cases involved marked transaminase elevations (>5x ULN), while others presented with mild elevations and symptoms of liver dysfunction. Risk is higher with hepatotoxic drugs like methotrexate. Baseline and regular liver tests are required for RA, GCA, PJIA, and SJIA patients, with specific monitoring intervals based on the condition. Do not initiate AVTOZMA if ALT or AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19), and discontinue if ALT or AST >5x ULN. Evaluate symptoms of liver injury promptly, and only restart treatment if liver test abnormalities are resolved and attributed to another cause.

Changes in Laboratory Parameters. Treatment with tocilizumab products, including AVTOZMA, has been associated with neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities. Infections are uncommon with treatment-related neutropenia, but AVTOZMA should not be initiated in RA or GCA patients with ANC <2000/mm³ or platelet counts <100,000/mm³, and treatment is not recommended if ANC drops below 500/mm³ or platelets below 50,000/mm³. For COVID-19 patients, AVTOZMA is not recommended with ANC <1000/mm³ or platelets <50,000/mm³. Monitor neutrophils, platelets, and liver enzymes 4-8 weeks after starting therapy and every 3 months thereafter, adjusting treatment as needed. Lipid levels, including cholesterol and triglycerides, may increase and should be assessed 4-8 weeks after initiation, with management per clinical guidelines. A similar pattern is observed in PJIA and SJIA, requiring specific monitoring intervals for these populations. Refer to Dosage and Administration for modifications based on test results.

Immunosuppression. The effect of tocilizumab products on malignancy development is unknown, though malignancies were observed in clinical studies. As an immunosuppressant, AVTOZMA may increase the risk of malignancies.

Hypersensitivity Reactions, Including Anaphylaxis. Hypersensitivity reactions, including anaphylaxis and fatal events, have been reported with tocilizumab products. Anaphylaxis requiring discontinuation occurred in 0.1% to 0.7% of trial patients, with postmarketing cases reported at various doses, with or without premedication, and as early as the first infusion. AVTOZMA intravenous infusions must be administered by healthcare professionals equipped to manage anaphylaxis. For subcutaneous use, patients must seek immediate medical attention if hypersensitivity symptoms occur. Discontinue AVTOZMA permanently if anaphylaxis or other hypersensitivity reaction occurs. Do not use in patients with known hypersensitivity to tocilizumab products.

Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases like multiple sclerosis and polyneuropathy were reported in RA studies. Monitor for symptoms and use caution in patients with preexisting or recent demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.

Live Vaccines. Avoid concurrent use of live vaccines with AVTOZMA, as clinical safety and secondary transmission risk are unknown. Follow guidelines on timing between live vaccines and AVTOZMA.

Adverse Reactions reported in ≥5% of tocilizumab-treated patients include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

  • Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  • Giant Cell Arteritis (GCA): Adult patients with GCA.
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2+ years old with active PJIA.
  • Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2+ years old with active SJIA.
  • Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome
  • Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

  • Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  • Giant Cell Arteritis (GCA): Adult patients with GCA.
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2+ years old with active PJIA.
  • Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2+ years old with active SJIA.
  • Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome
  • Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS

Patients treated with tocilizumab products including AVTOZMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt AVTOZMA 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 AVTOZMA use and during therapy. Treatment for latent infection should be initiated prior to AVTOZMA 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 AVTOZMA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with AVTOZMA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Contraindications: Known hypersensitivity to tocilizumab products.

Serious Infections. Serious and sometimes fatal infections, including bacterial, mycobacterial, invasive fungal, viral, and opportunistic infections, have been reported with tocilizumab products, including AVTOZMA. Common serious infections include pneumonia, urinary tract infections, cellulitis, herpes zoster, and sepsis, while opportunistic infections such as tuberculosis and cryptococcus have also occurred. Patients with chronic or recurrent infections, tuberculosis exposure, or underlying conditions predisposing to infections should have the risks and benefits of AVTOZMA carefully evaluated. Monitor patients closely during and after treatment for signs of infection, and discontinue AVTOZMA if a serious infection develops, initiating appropriate antimicrobial therapy as needed.

Gastrointestinal (GI) Perforation. Gastrointestinal perforation events, primarily associated with diverticulitis, have been reported in clinical trials of tocilizumab. Use AVTOZMA cautiously in patients at increased risk for gastrointestinal perforation. Promptly evaluate any patient experiencing new abdominal symptoms to ensure early detection and management of this condition.

Hepatotoxicity. Serious hepatic injury, including cases of liver transplant and death, has occurred with tocilizumab products, with onset ranging from months to years. Some cases involved marked transaminase elevations (>5x ULN), while others presented with mild elevations and symptoms of liver dysfunction. Risk is higher with hepatotoxic drugs like methotrexate. Baseline and regular liver tests are required for RA, GCA, PJIA, and SJIA patients, with specific monitoring intervals based on the condition. Do not initiate AVTOZMA if ALT or AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19), and discontinue if ALT or AST >5x ULN. Evaluate symptoms of liver injury promptly, and only restart treatment if liver test abnormalities are resolved and attributed to another cause.

Changes in Laboratory Parameters. Treatment with tocilizumab products, including AVTOZMA, has been associated with neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities. Infections are uncommon with treatment-related neutropenia, but AVTOZMA should not be initiated in RA or GCA patients with ANC <2000/mm³ or platelet counts <100,000/mm³, and treatment is not recommended if ANC drops below 500/mm³ or platelets below 50,000/mm³. For COVID-19 patients, AVTOZMA is not recommended with ANC <1000/mm³ or platelets <50,000/mm³. Monitor neutrophils, platelets, and liver enzymes 4-8 weeks after starting therapy and every 3 months thereafter, adjusting treatment as needed. Lipid levels, including cholesterol and triglycerides, may increase and should be assessed 4-8 weeks after initiation, with management per clinical guidelines. A similar pattern is observed in PJIA and SJIA, requiring specific monitoring intervals for these populations. Refer to Dosage and Administration for modifications based on test results.

Immunosuppression. The effect of tocilizumab products on malignancy development is unknown, though malignancies were observed in clinical studies. As an immunosuppressant, AVTOZMA may increase the risk of malignancies.

Hypersensitivity Reactions, Including Anaphylaxis. Hypersensitivity reactions, including anaphylaxis and fatal events, have been reported with tocilizumab products. Anaphylaxis requiring discontinuation occurred in 0.1% to 0.7% of trial patients, with postmarketing cases reported at various doses, with or without premedication, and as early as the first infusion. AVTOZMA intravenous infusions must be administered by healthcare professionals equipped to manage anaphylaxis. For subcutaneous use, patients must seek immediate medical attention if hypersensitivity symptoms occur. Discontinue AVTOZMA permanently if anaphylaxis or other hypersensitivity reaction occurs. Do not use in patients with known hypersensitivity to tocilizumab products.

Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases like multiple sclerosis and polyneuropathy were reported in RA studies. Monitor for symptoms and use caution in patients with preexisting or recent demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.

Live Vaccines. Avoid concurrent use of live vaccines with AVTOZMA, as clinical safety and secondary transmission risk are unknown. Follow guidelines on timing between live vaccines and AVTOZMA.

Adverse Reactions reported in ≥5% of tocilizumab-treated patients include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

  • Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
  • Giant Cell Arteritis (GCA): Adult patients with GCA.
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2+ years old with active PJIA.
  • Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2+ years old with active SJIA.
  • Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome
  • Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).