Product Monograph - Entyvio
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4
1 Indications .................................................................................................................. 4
1.1 Pediatrics ................................................................................................................ 4
1.2 Geriatrics ................................................................................................................ 4
2 CONTRAINDICATIONS ................................................................................................. 4
4 DOSAGE AND ADMINISTRATION ................................................................................. 4
4.1 Dosing Considerations ............................................................................................ 4
4.2 Recommended Dose and Dosage Adjustment (Adults ≥ 18 years) ......................... 5
4.3 Reconstitution (Entyvio® [IV]) ................................................................................. 7
4.4 Administration ........................................................................................................ 8
4.5 Missed Dose ........................................................................................................... 9
5 OVERDOSAGE .............................................................................................................. 9
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9
7 WARNINGS AND PRECAUTIONS ................................................................................ 10
7.1 Special Populations............................................................................................... 12
7.1.1 Pregnant Women ............................................................................................ 12
7.1.2 Breast-feeding ................................................................................................. 13
7.1.3 Pediatrics ......................................................................................................... 13
7.1.4 Geriatrics ......................................................................................................... 13
8 ADVERSE REACTIONS ................................................................................................ 13
8.1 Adverse Reaction Overview .................................................................................. 13
8.2 Clinical Trial Adverse Reactions ............................................................................ 13
8.3 Less Common Clinical Trial Adverse Reactions ..................................................... 19
8.5 Post-Market Adverse Reactions ........................................................................... 19
9 DRUG INTERACTIONS ................................................................................................ 19
9.4 Drug-Drug Interactions ......................................................................................... 19
9.5 Drug-Food Interactions ......................................................................................... 20
9.6 Drug-Herb Interactions ......................................................................................... 20
9.7 Drug-Laboratory Test Interactions ........................................................................ 20
10 CLINICAL PHARMACOLOGY ....................................................................................... 20
10.1 Mechanism of Action ...................................................................................... 20
10.2 Pharmacodynamics ........................................................................................ 21
10.3 Pharmacokinetics ........................................................................................... 21
11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 23
PART II: SCIENTIFIC INFORMATION ....................................................................................... 25
13 PHARMACEUTICAL INFORMATION ............................................................................ 25
14 Clinical Trials ............................................................................................................. 25
14.1 Trial Design and Study Demographics ............................................................ 25
14.2 Study Results .................................................................................................. 28
15 MICROBIOLOGY ........................................................................................................ 40
16 NON-CLINICAL TOXICOLOGY ..................................................................................... 40
PATIENT MEDICATION INFORMATION .................................................................................. 43
PART I: HEALTH PROFESSIONAL INFORMATION
1 INDICATIONS
ENTYVIO® (vedolizumab) is indicated for:
Ulcerative Colitis (Adults ≥ 18 years)
the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a tumor necrosis factor-alpha (TNFα) antagonist.
Crohn's Disease (Adults ≥ 18 years)
the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a TNFα antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids (see 14 Clinical Trials).
1.1 Pediatrics
- Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Entyvio® in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. (See 10.3 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions.)
1.2 Geriatrics
Clinical trials of Entyvio® did not include sufficient numbers of subjects aged 65 and over (46 patients 65 years of age or older were treated with intravenous Entyvio® in the Phase 3 clinical trials) to determine whether they respond differently from younger subjects. The efficacy and safety of vedolizumab should be interpreted with caution in patients older than 65 years of age.
2 CONTRAINDICATIONS
- Patients who are hypersensitive to vedolizumab or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
- Patients with active severe infections or opportunistic infections.
4 DOSAGE AND ADMINISTRATION
4.1 Dosing Considerations
Entyvio® [IV]
- Entyvio® is administered as an intravenous infusion over 30 minutes.