deucravacitinib

General

Pronunciation:
doo-krav-a-sye-ti-nib

Trade Name(s)

• Sotyktu

Ther. Class.

antipsoriatics

Pharm. Class.

kinase inhibitors

Indications

Moderate-to-severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

Action

Acts as a inhibitor of tyrosine kinase 2. Its exact mechanism for effect in plaque psoriasis is unknown.

Therapeutic Effect(s):

Decreased formation and spread of plaques.

Pharmacokinetics

Absorption: Well absorbed (99%) following oral administration.

Distribution: Extensively distributed to tissues.

Protein Binding: 82–90%.

Metabolism and Excretion: Primarily metabolized by the liver via the CYP1A2 isoenzyme to form an active metabolite (BMT-153261). Also metabolized by CYP2B6, CYP2D6, carboxylesterase 2, and UGT1A9. 26% and 13% excreted in feces and urine, respectively, as unchanged drug.

Half-life: 10 hr.

TIME/ACTION PROFILE (plasma concentrations)

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity;
• Active or serious infection (including tuberculosis [TB] and hepatitis B/C);
• Severe hepatic impairment.

Use Cautiously in:

• Chronic or recurrent infection, exposure to tuberculosis, history of opportunistic infection, underlying conditions that predispose to infection;
• Malignancy (other than successfully treated non-melanoma skin cancer);
• OB:   Safety not established in pregnancy;
• Lactation:  Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
• Pedi:   Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

Derm: acne

GI: ↑ liver enzymes, mouth ulcers

Metabolic: hypertriglyceridemia

MS: ↑ creatine kinase, RHABDOMYOLYSIS

Misc: INFECTION, HYPERSENSITIVITY REACTIONS (including angioedema), MALIGNANCY (including lymphoma)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

Avoid concurrent use with  live vaccines.

Route/Dosage

PO (Adults): 6 mg once daily.

Availability

Tablets: 6 mg

Assessment

• Assess skin lesions and concurrent symptoms (absence of itch, pain, burning, stinging, and skin tightness) before and periodically during therapy.
• Monitor for signs and symptoms of hypersensitivity (feeling faint; swelling of face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash; hives). If symptoms occur, discontinue therapy.
• Assess for signs and symptoms of infection (fever, sweats, chills, muscle aches, weight loss, cough, shortness of breath, blood in phlegm [mucus], warm, red, or painful skin or sores on body different from psoriasis, diarrhea or stomach pain, burning during urination or urinating more often than normal, feeling very tired) during and after treatment. Administer diagnostic tests and begin antimicrobial therapy promptly. If serious infection occurs, discontinue therapy until infection resolved. May cause reactivation of herpes virus infection.

Lab Test Considerations:

May cause rhabdomyolysis and asymptomatic CK elevation. Discontinue deucravacitinib if markedly elevated CK levels occur or myopathy is diagnosed or suspected.

• Periodically evaluate serum triglycerides. May cause hyperlipidemia.
• Assess liver enzymes at baseline and periodically thereafter in patients with known or suspected liver disease. If increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt therapy until a diagnosis of liver injury is excluded.

Implementation

• Evaluate for acute and latent TB before starting therapy. If positive, begin therapy for TB before starting deucravacitinib.
• Update age-appropriate immunizations before starting therapy, including prophylactic herpes zoster vaccination. Avoid use of live vaccines during therapy.
• PO Administer tablet once daily without regard to food.  DNC: Swallow tablets whole, do not break, crush, or chew. 

Patient/Family Teaching

• Instruct patient to take deucravacitinib as directed. Advise patient to read  Medication Guide  before starting therapy and with each Rx refill in case of changes.
• Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
• Advise patient to avoid live vaccines during therapy.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Inform patients that medication may increase their risk of developing malignancies, including lymphomas.
• Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. If pregnancy occurs, report pregnancies to the Bristol-Myers Squibb Company's Adverse Event reporting line at 1-800-721-5072.
• Encourage patient to maintain follow-up lab tests to monitor blood levels.

Evaluation/Desired Outcomes

Absence or decrease in psoriatic symptoms (absence of itch, pain, burning, stinging, and skin tightness).