Deucravacitinib

Deucravacitinib is a prescription medication used for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

• Deucravacitinib is available under the following different brand names: Sotyktu

Common side effects of Deucravacitinib include:

• acne
• cold symptoms
• sore throat
• sinus infection
• cold sores
• mouth sores
• inflamed hair pores

Serious side effects of Deucravacitinib include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• tiredness
• fever
• dark-colored urine
• muscle pain or tenderness
• muscle weakness

Rare side effects of Deucravacitinib include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 6 mg

Plaque psoriasis

Adult dosage

• 6 mg orally once a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Deucravacitinib has severe interactions with no other drugs.
• Deucravacitinib has serious interactions with the following drug:
  • ublituximab
• Deucravacitinib has moderate interactions with no other drugs.
• Deucravacitinib has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to Deucravacitinib or any of the excipients in drug product

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Deucravacitinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Deucravacitinib?”

Cautions

• Hypersensitivity reactions (eg, angioedema) have been reported; discontinue therapy if a clinically significant reaction occurs
• Evaluate for tuberculosis before initiating
• Malignancies, including lymphomas, were observed; consider the benefits and risks for individuals, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancer) and patients who develop a malignancy during treatment
• Cases of rhabdomyolysis reported resulting in interrupting or discontinuing therapy; discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed or suspected; advise patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever
• May increase triglyceride levels; monitor and manage according to clinical guidelines for hyperlipidemia
• Elevated liver enzymes have been reported; evaluate liver enzymes at baseline and then monitor in patients with known or suspected liver disease; if liver enzymes increase or drug-induced liver injury is suspected; interrupt therapy until the liver injury is ruled out
• Before initiating, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination
• Infections
  • May increase infection risk; avoid use with active or serious infections, including localized infections
  • Closely monitor for developing signs and symptoms of infection during and after treatment
  • If an infection develops, promptly evaluate and complete diagnostic testing
  • Initiate appropriate antimicrobial therapy and closely monitor
  • Interrupt therapy if a serious infection develops; do not resume until the infection resolves or is adequately treated.
  • Consider the risks and benefits of therapy before initiating it in patients
  • With chronic or recurrent infection
  • Who has been exposed to tuberculosis
  • With a history of a serious or an opportunistic infection
  • With underlying conditions that may predispose them to infection
• Viral reactivation
  • Herpes virus reactivation (eg, herpes zoster, herpes simplex) was reported
  • Effect on chronic viral hepatitis reactivation is unknown
  • Patients who tested positive for hepatitis B or C, chronic hepatitis B, or untreated hepatitis C were excluded from clinical trials
  • Consider viral hepatitis screening and monitoring for reactivation by clinical guidelines before initiating and during therapy
  • If signs of reactivation occur, consult a hepatitis specialist
  • Not recommended for use in patients with active hepatitis B or hepatitis C
  • Potential risks related to Janus kinase (JAK) inhibitors
  • Unknown whether TYK2 inhibition may be associated with the observed or potential adverse reactions of JAK inhibition
  • In a safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients older than 50 years with at least one cardiovascular risk factor, 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 the JAK inhibitor
  • Not approved for use in RA
• Drug interaction overview
  • Vaccinations
    • Live vaccines: Avoid the use
    • Response to live or non-live vaccines not evaluated

Pregnancy and Lactation

• Insufficient data are available from case reports on use during pregnancy to evaluate a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Report pregnancies to Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072
• Lactation
  • There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production
  • Present in rat milk; when a drug is present in animal milk, it will likely be present in human milk