SOTYKTU
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOTYKTU (SOTYKTU).
Tyrosine kinase 2 (TYK2) inhibitor; selectively binds to the regulatory pseudokinase domain of TYK2, inhibiting cytokine signaling pathways mediated by IL-12, IL-23, and type I interferons.
| Metabolism | Primarily metabolized by CYP1A2; minor contributions from CYP2C19 and CYP3A4. |
| Excretion | Approximately 70% of the dose is excreted in feces as unchanged drug, and 30% in urine as unchanged drug. |
| Half-life | 6.7 hours (range 4.4–10.3 hours) in healthy subjects; supports once-daily dosing. |
| Protein binding | >99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 850 L (central volume 130 L, peripheral volume 720 L); extensive tissue distribution. |
| Bioavailability | Oral bioavailability is 94%. |
| Onset of Action | Improvement in itch as early as 2 weeks; clinical response (PASI75) observed by 4–8 weeks. |
| Duration of Action | Sustained efficacy with continuous once-daily dosing; no data on duration after discontinuation. |
6 mg orally once daily.
| Dosage form | TABLET |
| Renal impairment | No dosage adjustment required for mild, moderate, or severe renal impairment including end-stage renal disease. |
| Liver impairment | No dosage adjustment required for mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Not recommended for severe (Child-Pugh C) hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. |
| Geriatric use | No specific dosage adjustment recommended; clinical studies included patients aged 65 and older with no overall differences in safety or efficacy observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOTYKTU (SOTYKTU).
| Breastfeeding | No data available on presence in human milk, effects on breastfed infant, or milk production. Deucravacitinib is present in rat milk. M/P ratio unknown. Due to potential for serious adverse reactions (e.g., immunosuppression) in nursing infants, advise not to breastfeed during treatment and for at least 24 hours after the last dose (based on half-life ~10 hours). |
| Teratogenic Risk | SOTYKTU (deucravacitinib) is a tyrosine kinase 2 (TYK2) inhibitor. Based on animal studies, there is potential for fetal harm. In rat and rabbit studies, deucravacitinib was teratogenic (malformations, embryolethality) at exposures similar to or less than the maximum recommended human dose (MRHD). No adequate human data exist. First trimester: highest risk for major malformations; second and third trimesters: risk for fetal growth impairment and potential TYK2-mediated developmental effects. Use is contraindicated in pregnancy unless no alternative. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to deucravacitinib or any excipients"]
| Precautions | ["Hypersensitivity reactions (angioedema, urticaria)","Infections (including tuberculosis, opportunistic infections)","Elevated liver enzymes; monitor hepatic function","Lipid elevations; monitor triglycerides and cholesterol"] |
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| Fetal Monitoring | Pregnancy test prior to initiation and periodically during treatment. Monitor for fetal growth via ultrasound if exposure occurs during pregnancy. Monitor maternal liver function, lipid profile, and complete blood count regularly as per standard prescribing information (non-pregnancy specific: LFTs at baseline and periodically, lipids at baseline and 4 weeks after initiation). For pregnant patients, additional monitoring for gestational diabetes and hypertension due to potential drug effects. |
| Fertility Effects | In animal studies, no adverse effects on male or female fertility at exposures up to 2 times the MRHD. Human data lacking. However, TYK2 inhibitors theoretically could impair fertility via cytokine modulation; effect unknown. Advise patients of unknown risk and consider fertility preservation if indicated. |