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SKYRIZI is a brand name for Risankizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 10/2024 1 INDICATIONS, 1.1 Pediatrics 10/2024 1 INDICATIONS, 1.2 Geriatrics 10/2024 4 DOSAGE AND ADMINISTRATION 10/2024 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, Crohn’s Disease 04/2024 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, Ulcerative Colitis 10/2024 4 DOSAGE AND ADMINISTRATION, 4.2…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
5 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 5 2 CONTRAINDICATIONS ................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ........................................................................................................ 4 Administration .......................................................................................................
5 Missed Dose ......................................................................................................... 10 5 OVERDOSAGE..........................................................................................................
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1 Adverse Reaction Overview The most frequently reported (≥10%) adverse drug reactions were upper respiratory tract infections. Most of the reactions were mild or moderate in severity. 4% in placebo-treated patients in psoriatic arthritis studies.
4% of placebo-treated patients in psoriatic arthritis studies. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared with the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. SKYRIZI (risankizumab) Page 15 of 82 Adverse Reactions in Plaque Psoriasis Trials A total of 2234 patients were treated with Skyrizi in clinical development studies in plaque psoriasis, representing 2167 patient years of exposure.
Of these, 1208 (54%) patients with psoriasis were exposed to Skyrizi for at least one year. Safety results from 111 patients exposed to Skyrizi for 104 weeks in the IMMHANCE study are consistent with the safety profile of Skyrizi in other psoriasis studies.
Data from placebo- and active-controlled studies were pooled to evaluate the safety of Skyrizi for up to 16 weeks. In total, 1306 patients were evaluated in the Skyrizi 150 mg group. Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Skyrizi group than the placebo group during the 16-week controlled period of pooled clinical studies.
3) 1 Includes data from ULTIMMA-1, ULTIMMA-2, IMMHANCE and IMMVENT studies. Patients received Skyrizi 150 mg at Week 0 and Week 4. 2 Includes data from ULTIMMA-1, ULTIMMA-2 and IMMHANCE studies. Patients received placebo at Week 0 and Week 4.
3 Pediatrics 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
5 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 5 2 CONTRAINDICATIONS ................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ........................................................................................................ 4 Administration .......................................................................................................
5 Missed Dose ......................................................................................................... 10 5 OVERDOSAGE..........................................................................................................
Skyrizi is contraindicated in patients who are hypersensitive to risankizumab or to any ingredient in the formulation or component of the container. 0 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 Includes data from ULTIMMA-1 and ULTIMMA-2 studies. Patients received a weight-based dose of ustekinumab: 45 mg (weight ≤ 100 kg) or 90 mg (weight > 100 kg) at Week 0 and Week 4. 4 Includes data from IMMVENT study. Patients received adalimumab 80 mg at Week 0, 40 mg at Week 1, then every other week (q2wk) thereafter.
5 Includes: fatigue, asthenia 6 Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth 7 Includes: respiratory tract infection (viral, bacterial, or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis 8 Includes: tinea pedis, tinea cruris, body tinea, tinea versicolour, tinea manuum, tinea infection, onychomycosis 9 Includes: headache, tension headache, sinus headache, cervicogenic headache SKYRIZI (risankizumab) Page 16 of 82 Adverse Reactions in Psoriatic Arthritis Trials Overall, the safety profile observed in patients with psoriatic arthritis treated with Skyrizi was consistent with the safety profile observed in patients with plaque psoriasis.
The safety profile of Skyrizi with up to 52 weeks of exposure was consistent with the profile observed up to 24 weeks. A total of 1,407 patients were treated with Skyrizi in Phase 3 clinical development studies in psoriatic arthritis.
Data from two placebo- controlled studies, KEEPSAKE1 and KEEPSAKE2, were pooled to evaluate the safety of Skyrizi for up to 24 weeks. Table 3 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Skyrizi group than the placebo group during the 24-week controlled period of pooled studies KEEPSAKE1 and KEEPSAKE2.
6) 1 includes: acute sinusitis, nasopharyngitis, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, upper respiratory tract infection bacterial, viral pharyngitis, viral upper respiratory tract infection Adverse Reactions in Crohn’s Disease Trials The adverse drug reaction profile observed in patients with Crohn’s disease treated with Skyrizi was generally consistent with the adverse drug reaction profile observed in patients with plaque psoriasis.
Elevated liver enzymes have been reported in patients with Crohn’s disease during induction. Consider monitoring liver enzymes as clinically indicated. Adverse Reactions in Ulcerative Colitis Trials The adverse drug reaction profile observed in patients with ulcerative colitis treated with Skyrizi was consistent with the adverse drug reaction profile observed in patients across […]
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 10 7 WARNINGS AND PRECAUTIONS ............................................................................... 1 Special Populations ..............................................................................................
1 Pregnant Women ............................................................................................. 2 Breast-feeding .................................................................................................. 3 Pediatrics (< 18 years of age) ...........................................................................
4 Geriatrics (≥ 65 years of age) ........................................................................... 14 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview .................................................................................
2 Clinical Trial Adverse Reactions ........................................................................... 3 Less Common Clinical Trial Adverse Reactions .................................................... 5 Post-Market Adverse Reactions...........................................................................
19 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions .............................................................................
4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions ........................................................................................
7 Drug-Laboratory Test Interactions....................................................................... 20 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ...........................................................................................
2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics ................................................................................................. 20 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
23 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 24 PART II: SCIENTIFIC INFORMATION ..................................................................................... 25 13 PHARMACEUTICAL INFORMATION ..........................................................................
25 SKYRIZI (risankizumab) Page 4 of 82 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ..................................................................................
26 Plaque Psoriasis................................................................................................................ 26 Psoriatic Arthritis .............................................................................................................
32 Crohn’s Disease ................................................................................................................ 37 Ulcerative Colitis ..............................................................................................................
41 15 MICROBIOLOGY […]