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)

ROUTEONSETPEAKDURATION
POunknown2–3 hr24 hr

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 nonmelanoma 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: ↑ CK, 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 (angioedema).  If symptoms occur,  discontinue therapy.
  • Assess for signs and symptoms of infection, especially pneumonia and COVID-19, during and after treatment.  If serious infection occurs,  discontinue therapy until infection resolved.  If viral reactivation of herpes zoster or hepatitis B/C occurs,  consult specialist.

Lab Test Considerations:

May cause rhabdomyolysis and asymptomatic CK ↑.  If markedly ↑ CK occurs or myopathy suspected,  discontinue deucravacitinib.

  • Periodically evaluate serum triglycerides during therapy. May ↑ triglycerides.
  • Consider viral hepatitis screening and monitoring for reactivation at baseline and during therapy.
  • Assess liver enzymes at baseline and periodically during therapy in patients with known or suspected liver disease.  If drug-induced ↑ in liver enzymes occurs,  interrupt therapy until a diagnosis of liver injury is excluded.

Implementation

  • Evaluate for acute and latent TB before starting therapy.  For latent TB,  initiate treatment before starting deucravacitinib.  For active TB,  do not administer deucravacitinib.
  • Update age-appropriate immunizations before starting therapy, including 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

  • Explain purpose and side effects of medication. Advise patient to read  Patient Information  before starting therapy.
  • Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
  • Advise patient to notify health care professional and stop deucravacitinib immediately for serious hypersensitivity reactions (difficulty breathing; swelling of face, mouth, or neck).
  • 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 patient that medication may ↑ risk of malignancy, including lymphomas.
  • Caution patient to avoid crowds and persons with known infections. Notify health care professional immediately if symptoms of infection occur.
  • Rep:  Advise women 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: 1-800-721-5072.

Evaluation/Desired Outcomes

Absence or decrease in psoriatic symptoms.