CIBINQO 1 Health Professional Information

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CIBINQO (abrocitinib) is indicated for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable.

CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.

Limitations of Use: Use of CIBINQO in combination with other JAK inhibitors, biologic immunomodulators, or potent immunosuppressants such as methotrexate and cyclosporine has not been studied and is not recommended (see 7 WARNINGS AND PRECAUTIONS, Immune).

1.1 Pediatrics

Pediatrics (12-17 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of CIBINQO in pediatric patients 12-17 years of age has been established for treatment of moderate to severe atopic dermatitis.

Pediatrics under 12 years of age: The safety and efficacy of CIBINQO in pediatric patients under 12 years of age have not yet been established. Therefore, Health Canada has not authorized an indication for pediatric use in pediatric patients under 12 years of age.

1.2 Geriatrics

Geriatrics ≥65 years of age: Caution should be used when treating geriatric patients with CIBINQO. There are limited data in patients 75 years of age and older. Clinical study results indicated that elderly patients were at increased risk for specific serious adverse events. (see 4.2 Recommended Dose and Dosage Adjustment, and 7.1.4 Geriatrics).