Tyrosine Kinase 2 InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Sotyktu
DEUCRAVACITINIB
1 INDICATIONS AND USAGE SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: • the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants. • the treatment of active psoriatic arthritis in adults. ( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are can...
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Brand names:SOTYKTU
Quick Reference
Medicine ClassTyrosine Kinase 2 Inhibitor
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DEUCRAVACITINIB
- Medicine class
- Tyrosine Kinase 2 Inhibitor
- Brand names
- SOTYKTU
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of deucravacitinib was 10 hours
- FDA approved
- Yes
What Is Sotyktu?
1 INDICATIONS AND USAGE SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: • the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants. • the treatment of active psoriatic arthritis in adults. ( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are can...
Sotyktu (DEUCRAVACITINIB) belongs to the Tyrosine Kinase 2 Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Sotyktu. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Sotyktu with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Sotyktu is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for: • the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants.
• the treatment of active psoriatic arthritis in adults.
( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use : SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
1.2 Psoriatic Arthritis SOTYKTU is indicated for the treatment of active psoriatic arthritis in adults.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION • For recommended evaluation prior to SOTYKTU initiation, see Full Prescribing Information. (2.1) • Recommended dosage is 6 mg orally once daily, with or without food. (2.2) 2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation Evaluate patients for active and latent tuberculosis (TB) infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Start treatment for latent TB prior to initiation of SOTYKTU use [see Warnings and Precautions (5.3) ]. Complete all immunizations according to current immunization guidelines [see Warnings and Precautions (5.7) ] . 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. 2.3 Recommended Dosage in Patients with Hepatic Impairment SOTYKTU is not recommended in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7) and C
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of labeling: • Infections [see Warnings and Precautions (5.2) ] • Malignancy including Lymphomas [see Warnings and Precautions (5.4) ] • Elevated CPK [see Warnings and Precautions (5.5) ] • Laboratory Abnormalities [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥ 1%) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne.
- (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Plaque Psoriasis Clinical Trials The safety of SOTYKTU was evaluated in two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) and an open-label extension trial in which subjects who completed Trial PSO-1 or Trial PSO-2 could enroll [see Clinical Studies (14.1) ].
- In these clinical trials, a total of 1,519 subjects with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy received SOTYKTU 6 mg orally once daily.
- Of these, 1,141 subjects were exposed to SOTYKTU for at least one year.
- In Trials PSO-1 and PSO-2, 1,681 subjects were randomized to receive SOTYKTU 6 mg once daily (840 subjects), placebo (419 subjects), or apremilast 30 mg twice daily (422 subjects).
Serious
- 5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Hypersensitivity reactions, such as angioedema, have been reported.
- Discontinue if a clinically significant hypersensitivity reaction occurs.
- (5.1) • Infections: SOTYKTU may increase the risk of infection.
- Avoid use in patients with active or serious infection.
- If a serious infection develops, discontinue SOTYKTU until the infection resolves.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Hypersensitivity reactions, such as angioedema, have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs. (5.1) • Infections: SOTYKTU may increase the risk of infection. Avoid use in patients with active or serious infection. If a serious infection develops, discontinue SOTYKTU until the infection resolves
How Sotyktu Works
12.1 Mechanism of Action Deucravacitinib is an inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Deucravacitinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. JAK kinases, including TYK2, function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to treatment of
Pharmacokinetics
Absorption
Absorption The absolute oral bioavailability of deucravacitinib was 99% and the median T max ranged from 2 to 3 hours in healthy subjects
Half-Life
half-life of deucravacitinib was 10 hours
Metabolism
metabolite, BMT‑153261, were comparable between healthy subjects and subjects with plaque psoriasis
Excretion
Excretion After a single dose of radiolabeled deucravacitinib, approximately 13% and 26% of the dose was recovered as unchanged in urine and feces, respectively
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Sotyktuwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Sotyktu side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Sotyktu
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.