IMPORTANT SAFETY INFORMATION

Indication and Clinical Use:

SOTYKTU (deucravacitinib tablets) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis
who are candidates for systemic therapy or phototherapy.

There are no data in pediatric patients, therefore, Health Canada has not authorized an indication for pediatric use.

Relevant Warnings and Precautions:

• No studies on the effects of SOTYKTU on ability to drive and use machinery. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
• Contains lactose. SOTYKTU should not be administered in patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
• Increased risk of infections. SOTYKTU should not be initiated in patients with any clinically important active infection until it resolves or is adequately treated.
• Pre-treatment evaluation of tuberculosis (TB). Do not administer SOTYKTU to patients with active TB.
• Avoid use of live vaccines with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
• Insufficient data to inform on risk in pregnant women.
• It is unknown if SOTYKTU is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk.
• Not recommended in patients with severe hepatic impairment (Child-Pugh Class C).

For More Information:

Please consult the Product Monograph at https://www.bms.com/assets/bms/ca/documents/productmonograph/SOTYKTU_EN_PM.pdf for adverse reactions, drug interactions, and dosing information. The Product Monograph is also available by calling 1-866-463-6267.