Avtozma TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: tocilizumab
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringeWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to slightly opalescent, colourless to yellowish sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 12 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 400 mg/20 mL injection concentrated vialWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only) Avtozma has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous Infusion
- clear to slightly opalescent, colourless to pale yellow sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 200 mg/10 mL injection concentrated vialWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only) Avtozma has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous Infusion
- clear to slightly opalescent, colourless to pale yellow sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, AVTPen AutoinjectorWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to slightly opalescent, colourless to yellowish sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 12 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 200 mg/10 mL injection concentrated vialWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only) Avtozma has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous Infusion
- clear to slightly opalescent, colourless to pale yellow sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 80 mg/4 mL injection concentrated vialWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only) Avtozma has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous Infusion
- clear to slightly opalescent, colourless to pale yellow sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, AVTPen AutoinjectorWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to slightly opalescent, colourless to yellowish sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 12 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 400 mg/20 mL injection concentrated vialWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only) Avtozma has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous Infusion
- clear to slightly opalescent, colourless to pale yellow sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringeWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to slightly opalescent, colourless to yellowish sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 12 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, AVTPen AutoinjectorWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to slightly opalescent, colourless to yellowish sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 12 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringeWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to slightly opalescent, colourless to yellowish sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 12 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: AVTOZMA tocilizumab (rch) 80 mg/4 mL injection concentrated vialWhat this medicine is used for
(ARTG)
Rheumatoid Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. Avtozma is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Giant Cell Arteritis (SC formulations only) Avtozma is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations) Avtozma is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Avtozma can be given alone or in combination with MTX. Systemic Juvenile Idiopathic Arthritis (IV and SC formulations) Intravenous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Avtozma IV and SC can be given alone or in combination with methotrexate (MTX). Cytokine Release Syndrome (CRS) (IV formulation only) Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only) Avtozma has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous Infusion
- clear to slightly opalescent, colourless to pale yellow sterile solution
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- See Product information for shelf life
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 1 pack
- 4 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient tocilizumab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme