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Adalimumab Injection PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrHUMIRA® adalimumab injection 40 mg in 0.8 mL sterile solution (50 mg/mL) subcutaneous injection 10 mg in 0.1 mL sterile solution (100 mg/mL) subcutaneous injection 20 mg in 0.2 mL sterile solution (100 mg/mL) subcutaneous injection 40 mg in 0.4 mL sterile solution (100 mg/mL) subcutaneous injection 80 mg in 0.8 mL sterile solution (100 mg/mL) subcutaneous injection Biological Response Modifier Humira (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric (13 to 17 years of age weighing ≥ 40 kg) Crohn’s disease, adult and pediatric (5 to 17 years of age) ulcerative colitis, adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa, psoriasis or adult and pediatric uveitis, and familiar with the Humira efficacy and safety profile. Date of Initial Approval: September 24, 2004 Date of Previous Revision: March 19, 2021 AbbVie Corporation Date of Revision: 8401 Trans-Canada Highway April 21, 2021 St-Laurent, QC H4S 1Z1 Submission Control No: 239280 HUMIRA Product Monograph Page 1 of 192 Date of Revision: April 21, 2021 and Control No. 239280 RECENT MAJOR LABEL CHANGES Dosage and Administration, Recommended Dose and Dosage Adjustment (4.2) 06/2019 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................... 5 1. INDICATIONS ..................................................................................................................... 5 1.1 Pediatrics (< 18 years of age) ...................................................................................... 7 1.2 Geriatrics (> 65 years of age) ....................................................................................... 7 2. CONTRAINDICATIONS ..................................................................................................... 8 3. SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 8 4. DOSAGE AND ADMINISTRATION ................................................................................... 9 4.1 Dosing Considerations ................................................................................................. 9 4.2 Recommended Dose and Dosage Adjustment .......................................................... 11 4.3 Administration ............................................................................................................. 17 4.4 Reconstitution ............................................................................................................. 17 4.5 Missed Dose ............................................................................................................... 17 5. OVERDOSAGE ................................................................................................................ 18 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 18 7. DESCRIPTION ................................................................................................................. 19 8. WARNINGS AND PRECAUTIONS .................................................................................. 20 8.1 Special Populations .................................................................................................... 27 8.1.1 Pregnant Women ........................................................................................................ 27 8.1.2 Breast-feeding ............................................................................................................ 27 8.1.3 Pediatrics (< 18 years of age) .................................................................................... 28 8.1.4 Geriatrics (> 65 years of age) ..................................................................................... 28 9. ADVERSE REACTIONS .................................................................................................. 28 9.1 Adverse Drug Reaction Overview .............................................................................. 28 9.2 Clinical Trial Adverse Drug Reactions ....................................................................... 36 9.3 Less Common Clinical Trial Adverse Reactions (< 1%) ............................................ 52 9.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .............................................................................................................. 54 9.5 Clinical Trial Adverse Reactions (Pediatrics) ............................................................. 54 9.6 Post-Market Adverse Drug Reactions ........................................................................ 69 10. DRUG INTERACTIONS ................................................................................................ 70 10.1 Serious Drug Interactions Box ................................................................................ 70 10.2 Overview ................................................................................................................. 70 10.3 Drug-Drug Interactions ........................................................................................... 71 10.4 Drug-Food Interactions ........................................................................................... 71 10.5 Drug-Herb Interactions ........................................................................................... 71 10.6 Drug-Laboratory Test Interactions .......................................................................... 72 10.7 Drug-Lifestyle Interactions ...................................................................................... 72 11. ACTION AND CLINICAL PHARMACOLOGY .............................................................. 72 11.1 Mechanism of Action............................................................................................... 72 HUMIRA Product Monograph Page 2 of 192 Date of Revision: April 21, 2021 and Control No. 239280 11.2 Pharmacodynamics ................................................................................................ 72 11.3 Pharmacokinetics .................................................................................................... 73 12. STORAGE, STABILITY AND DISPOSAL .................................................................... 77 13. SPECIAL HANDLING INSTRUCTIONS ....................................................................... 77 PART II: SCIENTIFIC INFORMATION ........................................................................................ 79 14. PHARMACEUTICAL INFORMATION .......................................................................... 79 15. CLINICAL TRIALS ........................................................................................................ 80 15.1 a. Trial Design and Study Demographics – Rheumatoid Arthritis ......................... 80 15.2 a. Study Results – Rheumatoid Arthritis................................................................. 82 15.1 b. Trial Design and Study Demographics – Psoriatic Arthritis ............................... 90 15.2 b. Study Results – Psoriatic Arthritis ...................................................................... 91 15.1 c. Trial Design and Study Demographics – Ankylosing Spondylitis ...................... 96 15.2 c. Study Results – Ankylosing Spondylitis ............................................................. 96 15.1 d. Trial Design and Study Demographics – Crohn’s Disease ................................ 98 15.2 d. Study Results – Crohn’s Disease ..................................................................... 101 15.1 e. Trial Design and Study Demographics – Ulcerative Colitis ............................. 105 15.2 e. Study Results – Ulcerative Colitis .................................................................... 107 15.1 f. Trial Design and Study Demographics – Hidradenitis Suppurativa .................. 109 15.2 f. Study Results – Hidradenitis Suppurativa ......................................................... 110 15.1 g. Trial Design and Study Demographics – Plaque Psoriasis ............................. 111 15.2 g. Study Results – Plaque Psoriasis .................................................................... 114 15.1 h. Trial Design and Study Demographics – Uveitis .............................................. 117 15.2 h. Study Results – Uveitis ..................................................................................... 118 15.1 i. Trial Design and Study Demographics – Polyarticular Juvenile Idiopathic Arthritis 120 15.2 i. Study Results – Polyarticular Juvenile Idiopathic Arthritis ................................ 123 15.1 j. Trial Design and Study Demographics – Pediatric Crohn’s Disease ................ 123 15.2 j. Study Results – Pediatric Crohn’s Disease ....................................................... 124 15.1 k. Trial Design and Study Demographics – Adolescent Hidradenitis Suppurativa (HS) 125 15.2 k. Study Results – Adolescent Hidradenitis Suppurativa (HS) ............................ 125 15.1 l. Trial Design and Study Demographics – Pediatric Uveitis................................ 125 15.2 l. Study Results – Pediatric Uveitis ....................................................................... 126 15.1 m. Trial Design
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