Deucravacitinib

Deucravatinib is produced by Lucius and has a specification of 6mg*30 tablets with a shelf life of 24 months. It should be taken within the shelf life.

Deucravacitinib provides a new treatment option for patients with moderate to severe plaque psoriasis.

As the only approved TYK2 allosteric inhibitor in the world, Deucravacitinib has significant efficacy in improving skin lesion clearance in patients with moderate to severe plaque psoriasis, and has good safety and tolerability.

1.Main components

Deucravacitinib

2. Adapt to the population

Suitable for adult patients with moderate to severe plaque psoriasis who require systemic treatment or phototherapy.

3.Medication for special populations

3.1Pregnant

Available data from case reports on Deucravacitinib use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

3.2Lactation

There are no data on the presence of deucravacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Deucravacitinib is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Deucravacitinib and any potential adverse effects on the breastfed infant from Deucravacitinib or from the underlying maternal condition.

3.4 Pediatric Use

The safety and effectiveness of Deucravacitinib in pediatric patients have not been established.

3.5 Geriatric Use

No overall differences in effectiveness of Deucravacitinib have been observed between patients 65 years of age and older and younger adult patients.

3.6 Renal Impairment

No dose adjustment of Deucravacitinib is recommended in patients with mild, moderate, or severe renal impairment or in patients with end stage renal disease (ESRD) on dialysis.

3.7 Hepatic Impairment

No dose adjustment of Deucravacitinib is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Deucravacitinib is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).

4.Drug overdose

There is no experience regarding human overdosage with Deucravacitinib. The extent of deucravacitinib elimination by hemodialysis was small (5.4% of dose per dialysis treatment), and thus hemodialysis for treatment of overdose with Deucravacitinib is limited.

5. Drug storage

Store Deucravacitinib tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).

6.Pharmacokinetics

The absolute oral bioavailability of deucravacitinib was 99% and the median Tmax ranged from 2 to 3 hours in healthy subjects.

from FDA，2022.09