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AVTOZMA is a brand name for Tocilizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid Arthritis (RA) [IV or SC formulations] AVTOZMA (tocilizumab) is indicated for: • reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis. Tocilizumab (IV only) in combination with methotrexate has been shown to reduce the rate of progression of radiographic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations General • For adult patients with RA, AVTOZMA may be administered as an IV infusion or a SC injection. • For adult patients with GCA, AVTOZMA is administered as a SC injection. • For patients with pJIA and sJIA, AVTOZMA is administered as an IV infusion or a SC injection.
• For patients with CRS, AVTOZMA is administered as an IV infusion. • For adult patients with COVID-19, AVTOZMA is administered as an IV infusion. • For adult patients with COVID-19, AVTOZMA should not be administered in patients who are not receiving corticosteroids.
• IV infusion: Use a sterile needle and syringe to prepare AVTOZMA . See below for indication specific details. RHEUMATOID ARTHRITIS [IV OR SC FORMULATIONS] Dosing Considerations • It would be prudent not to use AVTOZMA in patients who are using azathioprine or cyclophosphamide.
• AVTOZMA has not been studied in combination with biological DMARDs such as TNF antagonists. • Treatment with biological DMARDs such as TNF inhibitors has been associated with reactivation of Hepatitis B and C. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with AVTOZMA.
In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded from the study • AVTOZMA treatment should be interrupted if a patient develops a serious infection until the infection is controlled. • Continuing therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
2 Recommended Dose and Dosage Adjustment RHEUMATOID ARTHRITIS [IV OR SC FORMULATIONS] AVTOZMA is to be given in combination with methotrexate (MTX) or other DMARDs; however, in cases of intolerance to MTX or where treatment with MTX is not appropriate AVTOZMA may also be given as monotherapy.
Recommended Intravenous (IV) Dose AvtozmaTM <tocilizumab> Page 7 Unclassified / Non classifié The recommended IV dose of AVTOZMA for adult patients with rheumatoid arthritis is 4 mg/kg followed by an increase to 8 mg/kg based on clinical response, given once every 4 weeks as an intravenous infusion over 1 hour.
6 mg/dL in male patients. 3 Pharmacokinetics). AVTOZMA IV formulation is not intended for subcutaneous administration. Recommended Subcutaneous (SC) Dose The recommended dose of AVTOZMA for adult patients with moderately to severely active rheumatoid arthritis is: Recommended Dose Patients less than 100 kg weight Starting dose of 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response Patients at or above 100 kg weight 162 mg administered every week Patients transitioning from AVTOZMA IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified healthcare professional.
1 Adverse Reaction Overview, Malignancies). 1 Adverse Reaction Overview, Malignancies). g. hypertension, hyperlipidaemia) managed as part of usual standard of care. 13 per 100 patient years IV all-exposure RA population) in long-term trials occurred in patients receiving tocilizumab, all at the higher dose (8 mg/kg) (see 8 ADVERSE REACTIONS).
Most events were transitory. Dependence/Tolerance No studies on the effects on the potential for tocilizumab to cause dependence have been performed. However, there is no evidence from the available data that tocilizumab treatment results in dependence.
Driving and Operating Machinery No studies on the effects on the ability to drive and use machinery have been performed. However, there is no evidence from the available data that treatment with tocilizumab affects the ability to drive and use machines.
However, given that dizziness has been reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has been resolved. Gastrointestinal Gastrointestinal perforations have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab.
Tocilizumab should be used with caution in patients at increased risk for gastrointestinal perforation, including those with a history of gastrointestinal ulceration, diverticulitis, concomitant corticosteroid use and age > 65 years.
31) vs. 77) per 100 patient years in the IV all-exposure RA population] (see 8 ADVERSE REACTIONS). Patients should be evaluated promptly for early identification of gastrointestinal perforation, especially since typical symptoms of diverticulitis or perforation such as pain, fever or leukocytosis may be attenuated or absent in immunocompromised patients.
In clinical studies with tocilizumab, patients with a history of diverticulitis, chronic ulcerative lower GI disease such as Crohn’s disease, ulcerative colitis or other symptomatic lower GI conditions were excluded. Hepatic/Biliary/Pancreatic Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab.
). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions RISK OF SERIOUS INFECTIONS Serious infections including sepsis, tuberculosis (TB), invasive fungal, and other opportunistic infections have been observed with the use of biologics agents, including AVTOZMA.
Hospitalization or fatal outcomes associated with infections have been reported. Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for both active and latent tuberculosis before AVTOZMA use and during therapy.
Treatment should be completed 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. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids, that, in addition to their rheumatoid arthritis could predispose them to infections.
Before starting treatment with AVTOZMA, all patients should be evaluated for both active and latent tuberculosis. Treatment with AVTOZMA should not be initiated in patients with active infections including chronic or localized infections.
If a serious infection develops, interrupt AVTOZMA until the infection is controlled. AvtozmaTM <tocilizumab> Page 6 Unclassified / Non classifié 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.
RISK OF HEPATOXICITY Serious cases of drug-induced liver injury (DILI) have been observed in patients treated with AVTOZMA. Some of these cases have resulted in acute liver failure requiring a liver transplant (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
AVTOZMA (tocilizumab) should not be administered to patients with known hypersensitivity to tocilizumab or any of its components. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
Patients with active infections, with the exception of COVID-19, as indicated (see also 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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AVTOZMA SC formulation is not intended for intravenous administration. Patients should be assessed for suitability for SC home use and instructed to inform a healthcare professional if they experience symptoms of allergic reaction before administering the next dose.
Patients should seek immediate medical attention if they develop any symptoms of serious allergic reactions (see 7 WARNINGS AND PRECAUTIONS). POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (pJIA) [IV OR SC FORMULATIONS] Recommended Dose Intravenous Dosing Regimen: The recommended dose of AVTOZMA IV for patients with pJIA is: • 10 mg/kg for patients below 30 kg • 8 mg/kg for patients ≥ 30 kg given in combination with MTX, once every four weeks as an IV infusion.
Subcutaneous Dosing Regimen:
The recommended dose of AVTOZMA SC for patients with pJIA is: • 162 mg once every three weeks for patients below 30 kg AvtozmaTM <tocilizumab> Page 8 Unclassified / Non classifié • 162 mg once every two weeks for patients ≥ 30 kg given in combination with MTX.
The pre-filled syringe with needle safety guard (PFS-S) can be used to treat pediatric patients of all approved ages. The autoinjector should not be used to treat pediatric patients < 12 years of age. AVTOZMA may also be given as monotherapy in cases of intolerance to MTX or where treatment with MTX is not appropriate.
A change in dose should only be based on a consistent change in the patient’s body weight over time. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) [IV AND SC FORMULATIONS] A change in dose should only be based on a consistent change in the patient’s body weight over time. AVTOZMA can be used alone or in combination with MTX.
Recommended Dose Intravenous Dosing Regimen:
The recommended dose of AVTOZMA for patients with sJIA • 12 mg/kg for patients below 30 kg • 8 mg/kg for patients ≥ 30 kg given once every two weeks as an IV infusion over 1 hour Subcutaneous Dosing Regimen: The recommended dose of AVTOZMA SC for patients with sJIA is: • 162 mg once every two weeks for patients below 30 kg, • 162 mg once every week for patients ≥ 30 kg The PFS-S can be used to treat pediatric patients of all approved ages.
The autoinjector should not be used to treat pediatric patients < 12 years of age. GIANT CELL ARTERITIS (GCA) [SC FORMULATION ONLY] For adult patients with GCA, the recommended dose of AVTOZMA is […]
Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from 2 weeks to over 5 years after treatment initiation with tocilizumab. While most cases presented with marked elevations of transaminases (> 5 times ULN), some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases.
During randomized controlled studies, treatment with tocilizumab was associated with a higher incidence of transaminase elevations. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data - Liver Enzyme Elevations).
AvtozmaTM <tocilizumab> Page 16 Unclassified / Non classifié For RA, GCA, pJIA, and sJIA patients, obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating tocilizumab, every 4 to 8 weeks after start of therapy for the first 6 months of treatment and every 3 months thereafter.
5 x ULN. In RA, GCA, pJIA and sJIA patients who develop elevated ALT or AST greater than 5 x ULN, discontinue tocilizumab. 2 Recommended Dose and Dosage Adjustment - Dose Adjustments for RA and GCA). Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
, ALT greater than three times the upper limit of the reference range, serum total bilirubin greater than two times the upper limit of the reference range), tocilizumab treatment should be interrupted and investigation done to establish the probable cause.
Tocilizumab should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests. A similar pattern of liver enzyme elevation is noted with tocilizumab treatment in the pJIA and sJIA populations.
Monitor liver test panel prior to the initiation of treatment at the time of the second administration and thereafter every 2 to 4 weeks for pJIA and sJIA. 2 Recommended Dose and Dosage Adjustment - Dose Adjustments for pJIA and sJIA.
Treatment with tocilizumab is not recommended in patients with active hepatic disease or hepatic impairment. 1 Adverse Reaction Overview, Infusion Reactions). 7 % (19 out of 2644) of patients in the 6-month controlled […]
1 Dosing Considerations General • For adult patients with RA, AVTOZMA may be administered as an IV infusion or a SC injection. • For adult patients with GCA, AVTOZMA is administered as a SC injection. • For patients with pJIA and sJIA, AVTOZMA is administered as an IV infusion or a SC injection.
• For patients with CRS, AVTOZMA is administered as an IV infusion. • For adult patients with COVID-19, AVTOZMA is administered as an IV infusion. • For adult patients with COVID-19, AVTOZMA should not be administered in patients who are not receiving corticosteroids.
• IV infusion: Use a sterile needle and syringe to prepare AVTOZMA . See below for indication specific details. RHEUMATOID ARTHRITIS [IV OR SC FORMULATIONS] Dosing Considerations • It would be prudent not to use AVTOZMA in patients who are using azathioprine or cyclophosphamide.
• AVTOZMA has not been studied in combination with biological DMARDs such as TNF antagonists. • Treatment with biological DMARDs such as TNF inhibitors has been associated with reactivation of Hepatitis B and C. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with AVTOZMA.
In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded from the study • AVTOZMA treatment should be interrupted if a patient develops a serious infection until the infection is controlled. • Continuing therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
2 Recommended Dose and Dosage Adjustment RHEUMATOID ARTHRITIS [IV OR SC FORMULATIONS] AVTOZMA is to be given in combination with methotrexate (MTX) or other DMARDs; however, in cases of intolerance to MTX or where treatment with MTX is not appropriate AVTOZMA may also be given as monotherapy.
Recommended Intravenous (IV) Dose AvtozmaTM <tocilizumab> Page 7 Unclassified / Non classifié The recommended IV dose of AVTOZMA for adult patients with rheumatoid arthritis is 4 mg/kg followed by an increase to 8 mg/kg based on clinical response, given once every 4 weeks as an intravenous infusion over 1 hour.
6 mg/dL in male patients. 3 Pharmacokinetics). AVTOZMA IV formulation is not intended for subcutaneous administration. Recommended Subcutaneous (SC) Dose The recommended dose of AVTOZMA for adult patients with moderately to severely active rheumatoid arthritis is: Recommended Dose Patients less than 100 kg weight Starting dose of 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response Patients at or above 100 kg weight 162 mg administered every week Patients transitioning from AVTOZMA IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified healthcare professional.
AVTOZMA SC formulation is not intended for intravenous administration. Patients should be assessed for suitability for SC home use and instructed to inform a healthcare professional if they experience symptoms of allergic reaction before administering the next dose.
Patients should seek immediate medical attention if they develop any symptoms of serious allergic reactions (see 7 WARNINGS AND PRECAUTIONS). POLYARTICULAR JUVENILE IDIOPATHIC […]