SILIQ

1 Dosing Considerations SILIQ (brodalumab injection) is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject SILIQ when deemed appropriate by a healthcare professional and after proper training in subcutaneous injection technique using the prefilled syringe.

Patients should be instructed to inject the full dose of SILIQ according to the instructions provided in the package leaflet. Comprehensive instructions for administration are PrSILIQ® Product Monograph Page 5 of 35 given in the package leaflet (see PATIENT MEDICATION INFORMATION).

If an adequate response has not been achieved after 12 to 16 weeks of treatment with SILIQ, consider discontinuing therapy. Continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.

2 Recommended Dose and Dosage Adjustment The recommended SILIQ dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. 5 mL). 4 Administration SILIQ is administered subcutaneously (SC).

Each prefilled syringe is for single use only. Do not inject SILIQ into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Instruction on Injection Technique • Advise patients to read the ‘Instructions for Use’ before administration.

• Instruct the patient to perform the first self-injection under the guidance and supervision of a qualified healthcare professional for proper training in subcutaneous injection technique. Assess a patient or their caregiver’s ability to inject subcutaneously (see PATIENT MEDICATION INFORMATION).

• Instruct patients who are self-administering to inject the full dose of SILIQ (see PATIENT MEDICATION INFORMATION).

1 Adverse Reaction Overview The most commonly reported adverse reactions in SILIQ-treated patients were headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea (see Table 1). The proportion of SILIQ- treated patients who discontinued treatment in the first 12 weeks of treatment due to adverse events was similar (about 1%) in all treatment arms.

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 to 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. Data from three phase 3 clinical trials and one phase 2 trial in plaque psoriasis were pooled to evaluate the safety of SILIQ (brodalumab injection) in comparison to placebo up to 12 weeks after treatment initiation (see 14 CLINICAL TRIALS).

6 patient-years of exposure. Of these, 4461 patients received at least one dose of SILIQ, 3072 patients were exposed for at least 1 year. 7% in patients who received placebo. 5) Suicidal Ideation and Behaviour During the 12-week randomized treatment period in the pooled trials, one subject in the SILIQ group attempted suicide and none in the placebo or ustekinumab groups.

4 per 100 subject-years) treated with ustekinumab. 37 per 100 subject-years). Eight of the 10 subjects who attempted or completed suicide had a history of depression and/or suicidal ideation or behavior. 4% of patients treated with placebo.

The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, and influenza, which did not necessitate treatment discontinuation. 2% of patients treated with placebo.

, Immune, Hypersensitivity 10/2023 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 ..................................................................

4 1 INDICATIONS ................................................................................................................... 1 Pediatrics (< 18 years of age) ................................................................................

2 Geriatrics (≥ 65 years of age) ................................................................................ 4 2 CONTRAINDICATIONS ....................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................... 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ...........................................................................................

2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ........................................................................................................ 5 5 OVERDOSAGE .................................................................................................................

5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................... 6 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations ...............................................................................................

SILIQ (brodalumab) is contraindicated in: • patients who are hypersensitive to brodalumab or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.

• patients with Crohn’s disease (see 7 WARNINGS AND PRECAUTIONS).