Sotyktu Deucravacitinib Tablets

1. Indications and Usage
Plaque Psoriasis:
Indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY. Swallow tablets whole; do not cut, crush, or chew.
Recommended Dosage:
Standard Dose: 6 mg once daily.
Administration Instructions:
Can be taken with or without food.
Missed Dose: Take as soon as possible on the same day and resume the normal schedule the following day.
Dose Adjustments:
Renal Impairment: No dosage adjustment is recommended for patients with any degree of renal impairment.
Hepatic Impairment: No dosage adjustment is recommended for mild or moderate hepatic impairment. Not recommended for patients with severe hepatic impairment (Child-Pugh Class C).
3. Mechanism of Action
TYK2 Allosteric Inhibition:
Deucravacitinib is a potent, oral, allosteric, and selective inhibitor of TYK2.
Blocking Signaling Pathways:
TYK2 is a member of the Janus kinase (JAK) family. By selectively inhibiting TYK2, deucravacitinib blocks the signaling of cytokines (such as IL-23 and type I interferons) that drive the pathogenesis of psoriasis.
Distinction: Unlike traditional JAK inhibitors that bind to the catalytic site (orthosteric), deucravacitinib binds to the pseudokinase domain (allosteric site) of TYK2, offering higher selectivity and potentially fewer off-target effects .
4. Safety and Warnings
Infections:
Serious infections (e.g., tuberculosis, pneumonia, sepsis) have been reported. Screen for tuberculosis (TB) prior to initiation. Avoid use in patients with active serious infections.
Malignancy:
Potential risk of malignancies (e.g., lymphoma, skin cancer) due to immunosuppression.
Vaccinations:
Avoid administration of live vaccines concurrently. Ensure all age-appropriate vaccinations are up to date before initiating therapy.
Laboratory Abnormalities:
Monitor for increased creatine phosphokinase (CPK), lipids (triglycerides), and liver enzymes (ALT/AST).
5.Adverse Reactions
Most Common (Incidence ≥1% and greater than placebo):
Upper respiratory tract infections (e.g., nasopharyngitis, pharyngitis), herpes simplex, oral ulcers, folliculitis, acne, increased CPK, and pyrexia.
6.Drug Interactions
CYP450 System:
Deucravacitinib is not a substrate, inhibitor, or inducer of CYP enzymes. No significant drug-drug interactions are expected.
Immunosuppressants:
Concomitant use with potent immunosuppressants is not recommended due to increased infection risk.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Deucravacitinib.
Available Strength: 6 mg tablets (Pink, round, biconvex).
Storage: Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F).