Sotyktu

Question 1

Is SOTYKTU safe to use during pregnancy?

Accepted Answer

Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development were observed with oral administration of deucravacitinib to rats and rabbits during organogenesis at doses that were at least 91 times the maximum recommended human dose (MRHD) of 6 mg once daily. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

Question 2

Can SOTYKTU be used during lactation?

Accepted Answer

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 SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.

Question 3

Is SOTYKTU safe for use in pediatric patients?

Accepted Answer

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

Question 4

Is SOTYKTU safe for use in elderly patients?

Accepted Answer

No overall differences in effectiveness of SOTYKTU have been observed between patients 65 years of age and older and younger adult patients. However, during the Week 0-16 period, for those subjects who received SOTYKTU without switching treatment arms, there was a higher rate of overall serious adverse reactions, including serious infections, and discontinuations due to adverse reactions compared with younger adults.

Question 5

Is dosage adjustment necessary for patients with renal impairment?

Accepted Answer

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

Question 6

Is dosage adjustment necessary for patients with hepatic impairment?

Accepted Answer

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