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Ocrevus (Ocrelizumab) PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrOCREVUS® Ocrelizumab for injection Concentrate for intravenous infusion 300 mg/10 mL (30 mg/mL) Selective Immunomodulator OCREVUS® has been issued marketing authorization without conditions for the treatment of: adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features OCREVUS® has been issued marketing authorization with conditions, pending the generation of additional data to further support the promising evidence of clinical benefit demonstrated in the PPMS pivotal study WA25046. Patients should be advised of the nature of the authorization. For further information for OCREVUS®, please refer to Health Canada’s Notice of Compliance with conditions - drug products website: http://www.hc- sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/index-eng.php OCREVUS® is indicated for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity. Treatment with OCREVUS (ocrelizumab) should be initiated and supervised by neurologists experienced in the treatment of patients with MS and who have fully familiarized themselves with the efficacy and safety profile of OCREVUS. Hoffmann-La Roche Limited Date of Initial 7070 Mississauga Road Authorization: Mississauga, Ontario August 14, 2017 L5N 5M8 www.rochecanada.com Date of Revision: April 1, 2021 Submission Control No: 238774 OCREVUS® Registered trade-mark of F. Hoffmann-La Roche AG, used under license © Copyright 2021, Hoffmann-La Roche Limited Page 1 of 43 This product has been authorized under the Notice of Compliance with Conditions (NOC/c) policy for one of its indicated uses. What is a Notice of Compliance with Conditions (NOC/c)? An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products approved under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame. What will be different about this Product Monograph? The following Product Monograph will contain boxed text at the beginning of each major section clearly stating the nature of the market authorization. Sections for which NOC/c status holds particular significance will be identified in the left margin by the symbol NOC/c. These sections may include, but are not limited to, the following: - Indications and Clinical Uses; - Action; - Warnings and Precautions; - Adverse Reactions; - Dosage and Administration; and - Clinical Trials. Adverse Drug Reaction Reporting and Re-Issuance of the Product Monograph Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada’s Canada Vigilance Program at 1- 866-234-2345. The Product Monograph will be re-issued in the event of serious safety concerns previously unidentified or at such time as the sponsor provides the additional data in support of the product’s clinical benefit. Once the latter has occurred, and in accordance with the NOC/c policy, the conditions associated with market authorization will be removed. Page 2 of 43 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 DESCRIPTION.............................................................................................................. 4 INDICATIONS AND CLINICAL USE ........................................................................ 5 CONTRAINDICATIONS ............................................................................................. 5 WARNINGS AND PRECAUTIONS ............................................................................ 6 ADVERSE REACTIONS ............................................................................................ 12 DRUG INTERACTIONS ............................................................................................ 17 DOSAGE AND ADMINISTRATION ........................................................................ 18 OVERDOSAGE .......................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ...................................................... 21 STORAGE AND STABILITY .................................................................................... 22 SPECIAL HANDLING INSTRUCTIONS ................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ....................................... 23 PART II: SCIENTIFIC INFORMATION .......................................................................... 24 PHARMACEUTICAL INFORMATION .................................................................... 24 CLINICAL TRIALS .................................................................................................... 25 DETAILED PHARMACOLOGY ............................................................................... 32 MICROBIOLOGY ...................................................................................................... 32 TOXICOLOGY ........................................................................................................... 32 REFERENCES ............................................................................................................ 34 PART III: PATIENT MEDICATION INFORMATION .................................................. 35 Page 3 of 43 PrOCREVUS® ocrelizumab PART I: HEALTH PROFESSIONAL INFORMATION OCREVUS® has been issued marketing authorization without conditions for the treatment of: adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features OCREVUS® has been issued marketing authorization with conditions, pending the generation of additional data to further support the promising evidence of clinical benefit demonstrated in the PPMS pivotal study WA25046. Patients should be advised of the nature of the authorization. For further information for OCREVUS®, please refer to Health Canada’s Notice of Compliance with conditions - drug products website: http://www.hc- sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/index-eng.php OCREVUS® is indicated for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity. SUMMARY PRODUCT INFORMATION Route of Dosage Form / Clinically Relevant Nonmedicinal Administration Strength Ingredients None 300 mg per vial (30 For a complete listing of nonmedicinal Intravenous mg/mL concentrate for ingredients, see Dosage Forms, Composition solution for infusion) and Packaging section. DESCRIPTION OCREVUS (ocrelizumab) is a recombinant humanized monoclonal antibody that selectively targets CD20-expressing B-cells. Page 4 of 43 INDICATIONS AND CLINICAL USE Relapsing Remitting Multiple Sclerosis (RRMS) OCREVUS (ocrelizumab) is indicated: for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features (see CLINICAL TRIALS). Primary Progressive Multiple Sclerosis (PPMS) NOC/c OCREVUS (ocrelizumab) is indicated: for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity (see CLINICAL TRIALS). OCREVUS treatment should be initiated and supervised by neurologists experienced in the treatment of patients with MS and who are familiar with the efficacy and safety profile of OCREVUS (see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION sections). Specific pre-medication should be administered before injecting OCREVUS (see DOSAGE AND ADMINISTRATION). Resources for the treatment of hypersensitivity and anaphylactic reactions should be immediately available. Patients treated with OCREVUS must be informed about the risks of OCREVUS. Geriatrics (> 55 years of age): The safety and efficacy of OCREVUS in patients > 55 years of age has not been established. Pediatrics (< 18 years of age): The safety and efficacy of OCREVUS in children and adolescents (<18 years of age) has not been studied. NOC/c CONTRAINDICATIONS OCREVUS (ocrelizumab) is contraindicated in patients: Who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete list of ingredients see DOSAGE FORMS, COMPOSITION AND PACKAGING. With a history of life-threatening infusion reaction to OCREVUS (see WARNINGS AND PRECAUTIONS) With active HBV infection (see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS)
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