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ACTEMRA 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: 10/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 10/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 10/2022 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 11/2022 7 WARNINGS AND PRECAUTIONS 10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 11/2022 7 WARNINGS AND PRECAUTIONS 10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 3 Reconstitution ...................................................................................................
4 Administration................................................................................................... 11 5 OVERDOSAGE .............................................................................................................
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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 ACTEMRA, 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 ACTEMRA to cause dependence have been performed. However, there is no evidence from the available data that ACTEMRA 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 ACTEMRA 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 ACTEMRA.
ACTEMRA 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 ACTEMRA, 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 ACTEMRA.
10/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 3 Reconstitution ...................................................................................................
4 Administration................................................................................................... 11 5 OVERDOSAGE .............................................................................................................
13 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 14 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ............................................................................................
22 8 ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions ..........................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................
5 Post-Market Adverse Reactions.......................................................................... 92 9 DRUG INTERACTIONS.................................................................................................. 2 Drug Interactions Overview................................................................................
3 Drug-Drug Interactions ...................................................................................... 93 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action....................................................................................
ACTEMRA (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.
Other brands of Tocilizumab in Canada.
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Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged Page 16 of 153 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 ACTEMRA was associated with a higher incidence of transaminase elevations. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data - Liver Enzyme Elevations).
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 ACTEMRA, 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 ACTEMRA. 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), ACTEMRA treatment should be interrupted and investigation done to establish the probable cause.
ACTEMRA 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 ACTEMRA 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 ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment. 1 Adverse Reaction Overview, Infusion Reactions). 7% (8 out of 1068) in the subcutaneous 6-month […]
2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics......................................................................................... 95 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
101 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 101 PART II: SCIENTIFIC INFORMATION ......................................................................................
102 13 PHARMACEUTICAL INFORMATION............................................................................ 102 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 102 15 MICROBIOLOGY ........................................................................................................ 123 16 NON-CLINICAL TOXICOLOGY .....................................................................................
124 PATIENT MEDICATION INFORMATION ................................................................................. 130 Page 4 of 153 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Rheumatoid Arthritis (RA) [IV or SC formulations] ACTEMRA (tocilizumab) is indicated for: reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis.
ACTEMRA (IV only) in combination with methotrexate has been shown to reduce the rate of progression of radiographic joint damage at Week 52. ACTEMRA 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 ACTEMRA may also be given as monotherapy.
Giant Cell Arteritis (GCA) [SC formulation only] ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (pJIA) [IV or SC formulations] ACTEMRA is indicated for the treatment of signs and symptoms of active polyarticular […]