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Vpriv-Pm-En.Pdf PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrVPRIV® velaglucerase alfa Powder for Solution for Injection 400 U/vial, Intravenous Enzyme Replacement Therapy ATC code: A16AB10 Takeda Canada Inc. Date of Initial Approval: 22 Adelaide Street West, Suite 3800 October 1, 2010 Toronto Ontario M5H 4E3 Date of Revision: December 21, 2020 Submission Control No: 241844 VPRIV® and the VPRIV Logo® are registered trademarks of Shire Human Genetic Therapies, Inc. TAKEDA™ and the TAKEDA Logo® are trademarks of Takeda Pharmaceutical Company Limited, used under license. Page 1 of 24 RECENT MAJOR LABEL CHANGES Warnings and Precautions, Immunogenicity (8) 9/2020 Warnings and Precautions, Infusion-Related Reactions (8) 9/2020 Warnings and Precautions, Breast-feeding (8.1.2) 9/2020 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS .................................................................................................................4 2 CONTRAINDICATIONS ..................................................................................................4 4 DOSAGE AND ADMINISTRATION ................................................................................ 4 4.1 Dosing Considerations ..........................................................................................4 4.2 Recommended Dose and Dosage Adjustment ....................................................... 4 4.3 Administration .......................................................................................................4 4.4 Reconstitution ........................................................................................................4 4.5 Missed Dose ..........................................................................................................5 5 OVERDOSAGE ...............................................................................................................5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 5 7 DESCRIPTION ................................................................................................................6 8 WARNINGS AND PRECAUTIONS ................................................................................ 6 8.1 Special Populations ...............................................................................................7 8.1.1 Pregnant Women ............................................................................................. 7 8.1.2 Breast-feeding ................................................................................................... 8 8.1.3 Pediatrics .......................................................................................................... 8 8.1.4 Geriatrics ........................................................................................................... 8 9 ADVERSE REACTIONS ................................................................................................. 8 9.1 Adverse Reaction Overview ................................................................................... 8 9.2 Clinical Trial Adverse Reactions............................................................................. 9 9.6 Post-Market Adverse Reactions ........................................................................... 10 10 DRUG INTERACTIONS ................................................................................................ 11 10.1 Serious Drug Interactions Box .......................................................................... 11 10.2 Overview .......................................................................................................... 11 10.3 Drug-Drug Interactions ..................................................................................... 11 10.4 Drug-Food Interactions ..................................................................................... 11 10.5 Drug-Herb Interactions ..................................................................................... 11 10.6 Drug-Laboratory Test Interactions .................................................................... 11 11 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 11 11.1 Mechanism of Action ........................................................................................ 11 11.2 Pharmacodynamics .......................................................................................... 11 11.3 Pharmacokinetics ............................................................................................. 12 12 STORAGE, STABILITY AND DISPOSAL ..................................................................... 13 Page 2 of 24 13 SPECIAL HANDLING INSTRUCTIONS ........................................................................ 13 PART II: SCIENTIFIC INFORMATION ..................................................................................... 14 14 PHARMACEUTICAL INFORMATION ........................................................................... 14 15 CLINICAL TRIALS ........................................................................................................ 15 15.1 Trial Design and Study Demographics ............................................................. 15 15.2 Study Results ................................................................................................... 16 15.3 Comparative Bioavailability Studies .................................................................. 19 17 NON-CLINICAL TOXICOLOGY .................................................................................... 19 PATIENT MEDICATION INFORMATION ................................................................................. 21 Page 3 of 24 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS VPRIV (velaglucerase alfa) is indicated for • long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease. 2 CONTRAINDICATIONS VPRIV 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 listing, see DOSAGE FORMS, STRENGTHS, COMPOSITON AND PACKAGING. 4 DOSAGE AND ADMINISTRATION 4.1 Dosing Considerations VPRIV should be administered under the supervision of a healthcare professional. Home administration may be considered for patients who are tolerating their infusions well. • Patients currently being treated with other enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV using the same dose and frequency. 4.2 Recommended Dose and Dosage Adjustment The recommended dose is 60 U/kg administered every other week as a 60-minute intravenous (IV) infusion. Dosage adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals. Clinical studies have evaluated doses ranging from 15 to 60 U/kg every other week. 4.3 Administration VPRIV should be administered by IV infusion over a period of 60 minutes. 4.4 Reconstitution VPRIV should be prepared by and administered under the supervision of a healthcare professional. Use aseptic technique. VPRIV is a lyophilized powder, which requires reconstitution and dilution, and is intended for intravenous infusion only. VPRIV contains no preservatives and vials are single-use only. Discard any unused solution. VPRIV should be prepared as follows: 1. Determine the number of vials to be reconstituted based on the individual patient’s weight and the prescribed dose. Follow the instructions in Table 1 for reconstitution. Page 4 of 24 Table 1 - Reconstitution Volume of Diluent to Approximate Nominal Concentration per mL Vial Size be Added to Vial Available Volume 400 U/vial 4.3 mL 4.0 mL 100 U/mL 2. Upon reconstitution, mix vials gently. DO NOT SHAKE. 3. Prior to further dilution, visually inspect the solution in the vials; the solution should be clear to slightly opalescent and colorless; do not use if the solution is discolored or if foreign particles are present. 4. Withdraw the calculated volume of drug from the appropriate number of vials and dilute the total volume required in 100 mL of 0.9% sodium chloride solution suitable for IV administration. Mix gently. DO NOT SHAKE. Slight flocculation (described as white irregularly shaped particles) may occasionally occur. VPRIV should be administered through a 0.2 μm in-line filter over a period of 60 minutes. The infusion should be completed within 24 hours of reconstitution of vials. VPRIV should not be infused with other products in the same infusion tubing as the compatibility in solution with other products has not been evaluated. 4.5 Missed Dose If a scheduled infusion is missed, administer the dose as soon as possible if it can be given at least 7 days before the next scheduled dose. 5 OVERDOSAGE There is limited information available regarding overdose with VPRIV. However, in the event of accidental or intentional overdose, patients should be carefully observed and treatment should be symptomatic and supportive. There is no antidote available. For management of a suspected drug overdose, contact your regional Poison Control Centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific
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