Deucravacitinib

What is Deucravacitinib?

• Deucravacitinib (Sotyktu) is a tyrosine kinase 2 (TYK2) inhibitor.

Deucravacitinib

Deucravacitinib CH3 groups

What are the uses of this medicine?

• Deucravacitinib (Sotyktu) is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

How does this medicine work?

• 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 therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to deucravacitinib or any of the ingredients in Sotyktu.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Deucravacitinib (Sotyktu) received its first approval in the USA on 9 September 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

How should this medicine be used?

• Evaluate patients for active and latent tuberculosis (TB) infection prior to initiating treatment with Sotyktu. If positive, start treatment for TB prior to Sotyktu use.
• Update immunizations according to current immunization guidelines.

Recommended dosage:

• The recommended dosage of Sotyktu is 6 mg taken orally once daily, with or without food.

Recommended Dosage in Patients with Hepatic Impairment:

• Sotyktu is not recommended in patients with severe hepatic impairment.
• No dosage adjustment is needed for patients with mild to moderate hepatic impairment.

Administration:

• Take Sotyktu exactly as your healthcare provider tells you to take it.
• Take Sotyktu 1 time every day.
• Take Sotyktu with or without food.
• Do not crush, cut, or chew the Sotyktu tablets.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 6 mg

This medicine is available in fallowing brand namesː

• Sotyktu

What side effects can this medication cause?

The most common side effects of this medicine may include:

• upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne

Less common, but serious side effects may include:

• Serious allergic reactions
• Infections
• Cancer
• rhabdomyolysis

What special precautions should I follow?

• Hypersensitivity reactions such as angioedema have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs.
• 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.
• Evaluate patients for latent and active TB infection prior to initiating treatment with Sotyktu. Do not administer Sotyktu to patients with active TB. Initiate treatment of latent TB prior to administering Sotyktu.
• Malignancies including lymphomas were observed in clinical trials with Sotyktu. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Sotyktu, particularly in patients with a known malignancy.
• Inform patients that Sotyktu may increase their risk of developing rhabdomyolysis. Instruct patients to immediately inform their healthcare provider if they develop unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
• Inform patients that Sotyktu may affect certain lab tests, and that blood tests may be required before and during Sotyktu treatment.
• Advise patients that vaccination with live vaccines is not recommended during Sotyktu treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform the healthcare practitioner that they are taking Sotyktu prior to a potential vaccination.
• It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of JAK inhibition. Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis (RA) patients. Sotyktu is not approved for use in RA.
• It is not known if Sotyktu passes into your breast milk.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no experience regarding human overdosage with Sotyktu.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• The extent of deucravacitinib elimination by hemodialysis was small (5.4% of dose per dialysis treatment), and thus hemodialysis for treatment of overdose with Sotyktu is limited.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: deucravacitinib.
• Inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose and silicon dioxide. In addition, the film coating Opadry® II Pink contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red and yellow.

Who manufactures and distributes this medicine?

Distributed by:

• Bristol-Myers Squibb Company
• Princeton, New Jersey USA

What should I know about storage and disposal of this medication?

• Store Sotyktu at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Deucravacitinib
• FDA Deucravacitinib

Deucravacitinib Resources
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