Psoriasis is an immune-mediated chronic, systemic, and inflammatory disease, with its core pathogenesis pathway regulated by the Janus kinase (JAK) family mediated JAK-STAT pathway.

Ⅰ. Drug name

Product Name: SOTYKTU ™

Common name: Deucravatinib

Ⅱ. indication

Used to treat moderate to severe plaque psoriasis in adults suitable for systemic therapy or phototherapy.

Ⅲ. Specifications and characteristics

Specification: 6mg tablets

Ⅳ. main ingredients

Active ingredient: Deucravatinib

Ⅴ. Usage and Dosage

Recommended dosage: once daily, 6mg each time, orally, can be taken with or without food.

Usage: Swallow the whole tablet, do not crush, cut or chew.

Ⅵ. Dose adjustment

Patients with liver dysfunction: Mild to moderate liver dysfunction (Child Pugh A or B grade) do not require dose adjustment; Not recommended for severe liver dysfunction (Child Pugh C grade).

Patients with renal insufficiency: dose adjustment based on renal function is not necessary, including patients with end-stage renal disease (ESRD) undergoing dialysis.

Ⅶ. Medication precautions

Before and after meals: can be taken with or without food.

Missing medication: If missed, it should be replenished as soon as possible; If it is close to the next medication time, skip the missed dose and take the medication according to the normal plan. Do not take double the dose at once.

Vomiting: If vomiting occurs after taking medication, do not take the medication again and continue with the next dose according to the normal plan.

Ⅷ. Medication for special populations

Pregnant women: Animal studies have not shown any adverse effects on embryo fetal development, but data is limited, and pregnancy should be reported during medication.

Breastfeeding women: It is not yet clear whether deuterium can be secreted into human milk, and the benefits and potential risks of breastfeeding should be considered during medication.

Children: Safety and efficacy have not yet been established in pediatric patients.

Elderly: Patients aged 65 and above should be cautious when using it, as elderly patients are more prone to serious adverse reactions.

Ⅸ. adverse reaction

The most common adverse reactions (≥ 1%) are upper respiratory tract infection, elevated creatine kinase, herpes simplex, oral ulcers, folliculitis, and acne.

Serious adverse reactions: including infection, malignant tumors (including lymphoma), rhabdomyolysis, elevated CPK, laboratory abnormalities (such as elevated triglycerides, elevated liver enzymes), etc.

Ⅹ. contraindication

It is contraindicated for patients with a history of hypersensitivity reactions to any excipients in deuteroxenib or SOTYKTU.

Ⅺ. Drug interactions

Not recommended for combination with potent immunosuppressants.

When combined with CYP1A2, CYP2B6, CYP2D6, CES2, UGT1A9 inhibitors or inducers, there is no significant difference in clinical pharmacokinetics.

No significant clinical pharmacokinetic differences were observed when combined with oral contraceptives, rosuvastatin, methotrexate, and other medications.

Ⅻ. Storage method

Stored in an environment of 20 ° C to 25 ° C (68 ° F to 77 ° F), with a permissible temperature fluctuation range of 15 ° C to 30 ° C (59 ° F to 86 ° F).

Deucravacitinibinformation