Selective TYK2 Inhibitor (Allosteric — Regulatory Domain Binding) Pregnancy: US label §8.1: available data from case reports on 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 to rats and rabbits during organogenesis at doses at least 72 times the maximum recommended human dose of 6 mg once daily. (US labelling — verify against the UK SPC §4.6.)

Deucravacitinib (TYK2 Inhibitor — Psoriatic Arthritis/Psoriasis)

Brand names: Sotyktu

Deucravacitinib is an oral selective TYK2 inhibitor used in rheumatology and dermatology for moderate-to-severe plaque psoriasis and psoriatic arthritis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 6 mg orally once daily, with or without food

Route: Oral — swallow the tablet whole; do not crush, cut or chew

Frequency: Once daily

Max: 6 mg once daily — the label describes 6 mg once daily as the maximum recommended human dose (MRHD)

NO UK SPC (eMC) WAS RETRIEVED IN THIS BUNDLE — the regimen above is taken from the US FDA prescribing information for SOTYKTU (E.R. Squibb & Sons, L.L.C.; label date 2026-06-30; https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=73204bef-9921-40ed-9230-ba35953c99c4). VERBATIM (§2.2 Recommended Dosage): 'The recommended dosage of SOTYKTU is 6 mg taken orally once daily, with or without food. Do not crush, cut, or chew the tablets.' Supplied as 6 mg tablets only. NO DOSE TITRATION AND NO INDICATION-SPECIFIC DOSE VARIATION IS STATED — the same 6 mg once-daily dose appears for the adult populations described in the label (plaque psoriasis and active psoriatic arthritis; the §1 Indications section was not retrieved in this bundle, so the clinician should confirm the licensed indications, which differ between the US and UK). EVALUATIONS BEFORE STARTING (§2.1): evaluate patients for active and latent tuberculosis — do not administer in active TB, and start treatment for latent TB before initiating; complete all immunisations according to current immunisation guidelines. HEPATIC IMPAIRMENT (§2.3): 'SOTYKTU is not recommended in patients with severe hepatic impairment (Child-Pugh C). No dosage adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.' MONITORING (§5.5–5.6): discontinue if markedly elevated CPK levels occur or myopathy is diagnosed or suspected; periodically evaluate serum triglycerides; evaluate liver enzymes at baseline and during treatment in patients with known or suspected liver disease. IMMUNISATION (§5.7): avoid use with live vaccines. PAEDIATRIC (§8.4): 'The safety and effectiveness of SOTYKTU in pediatric patients have not been established' — no paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. ELDERLY (§8.5): no dose adjustment is stated, but during weeks 0–16 of the psoriasis trials subjects ≥ 65 years had a higher incidence of serious adverse reactions, including serious infections, and of discontinuations, than younger adults. NO §7 DRUG INTERACTIONS SECTION AND NO RENAL DOSING SECTION WERE RETRIEVED IN THIS BUNDLE. Some sections of the fetched US label were truncated at the source-fetch limit — clinician to confirm against the full label and the UK SPC before publication.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

History of hypersensitivity reaction to deucravacitinib or to any of the excipients

Side effects

Upper respiratory infections (most common, ≥ 1%)
Blood creatine phosphokinase increased — discontinue if markedly elevated CPK occurs or myopathy is diagnosed or suspected
Herpes simplex and folliculitis
Mouth ulcers
Acne
Also flagged in §5: serious infections, tuberculosis reactivation, malignancy including lymphoma, rhabdomyolysis, and laboratory abnormalities (raised triglycerides, raised liver enzymes)

Clinical monograph

How it works

It selectively binds the regulatory domain of tyrosine kinase 2 (TYK2), allosterically inhibiting signalling of interleukin-23, interleukin-12 and type-I interferons that drive psoriatic inflammation.

Prescribing in practice

As an immunomodulator it increases infection risk — screen for and treat latent tuberculosis and other infections before starting and avoid live vaccines.
Assess hepatic function and triglycerides, and avoid use in clinically significant active infection.
Prescribe under specialist supervision in line with the SPC and current prescribing references.

Monitoring

Monitor for signs of infection, and check liver function and lipids as clinically indicated during treatment.

Counselling the patient

Report fever, persistent cough or other signs of infection.
Ensure vaccinations are up to date before starting and avoid live vaccines.
Take regularly as prescribed and attend reviews.

Evidence & guidelines

Efficacy in moderate-to-severe plaque psoriasis is supported by phase 3 randomised controlled trials.

Reference: Armstrong et al. NEJM 2023 (POETYK PSO-1/PSO-2); MHRA Approval Sotyktu 2023; NICE Appraisal pending; Phase 3 POETYK PsA trial (ongoing); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways