Deuruxolitinib

Deuruxolitinib is a prescription medication indicated for the treatment of adults with severe alopecia areata.

Deuruxolitinib is available under the following different brand names: Leqselvi.

Common side effects of Deuruxolitinib include:

• headache
• acne 
• pain or swelling of the nose or throat (nasopharyngitis)  
• increased blood creatine phosphokinase 
• increased blood cholesterol 
• tiredness 
• weight gain 
• increased platelets in blood (thrombocytosis) 
• low red blood cell count (anemia) 
• skin and soft tissue infections 
• low white blood cell count (neutropenia) 
• herpes simplex including cold sores

Serious side effects of Deuruxolitinib include:

• serious infections caused by bacteria, fungi, or viruses: symptoms may include fever, sweating, or chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red, or painful skin or sores on the body, diarrhea or stomach pain, feeling very tired, burning when urinating or increased frequency
• increased risk of major cardiovascular events such as heart attack, stroke, or death: symptoms may include discomfort in the center of the chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in the chest, throat, neck, or jaw, pain or discomfort in the arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of the body, slurred speech
• blood clots in the veins of the legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or brain (cerebral venous sinus thrombosis, CVT): symptoms may include swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing, severe headaches
• tears (perforation) in the stomach or intestines: symptoms may include stomach area pain, fever, chills, nausea or vomiting
• changes in certain laboratory test results: increased fat (lipid) levels in the blood (triglycerides and cholesterol), low red blood cell counts, and low lymphocyte or neutrophil counts

Rare side effects of Deuruxolitinib 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, lightheadedness, 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

• 8 mg

Alopecia areata

Adult dosage

• 8 mg orally twice daily

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, health care provider, or pharmacist first.

• Deuruxolitinib has no noted severe interactions with any other drugs
• Deuruxolitinib has no noted serious interactions with any other drugs
• Deuruxolitinib has no noted moderate interactions with any other drugs
• Deuruxolitinib has no noted minor interactions with any 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

• CYP2C9 poor metabolizers
• Test patients for CYP2C9 variants before starting therapy
• Concomitant use with moderate or strong CYP2C9 inhibitors
• May increase risk of serious adverse reactions (eg, thrombosis)

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Infection
  • Avoid use in patients with active, serious infections including localized infections 
  • If an infection occurs, hold therapy until the infection is controlled and start complete diagnostic testing appropriate for an immunocompromised patient; begin appropriate antimicrobial therapy as indicated
  • Risk factors for developing severe infection
  • Chronic or recurrent infection
  • History of serious or opportunistic infection
• Exposure to tuberculosis (TB)
  • Resides in or traveled to areas of endemic TB or endemic mycoses
  • Underlying conditions that predispose a patient to infection
• TB
  • Avoid use in patients with active TB; treat patients with latent TB before starting Deuruxolitinib 
  • Consult with a specialist to determine whether to start anti-TB therapy in patients with previously untreated latent TB, active TB in whom an adequate course of treatment cannot be confirmed, or a negative test for latent TB with risk factors for developing infection
• Viral reactivation
  • Viral reactivation (eg, herpes zoster) has been reported; consider holding therapy until the infection resolves if viral reactivation occurs
  • Screen patients for viral hepatitis before therapy; avoid use in patients with active hepatitis B or hepatitis C
  • Monitor for reactivation or start prophylactic treatment in patients with nonactive hepatitis B infection
• Gastrointestinal (GI) perforation
  • GI perforation can occur
  • Monitor patients at increased risk for GI perforation (eg, history of diverticulitis); promptly evaluate patient reports of new-onset abdominal symptoms
• Hyperlipidemia
  • Increases in triglyceride and total cholesterol levels can occur
  • Evaluate lipid parameters (eg, HDL-C, LDL-C) at baseline and periodically during therapy; manage according to clinical guidelines
• Myelosuppression
  • Anemia, neutropenia, and thrombocytopenia may occur
  • Obtain complete blood counts before and periodically during therapy
  • Avoid or hold therapy in patients with absolute lymphocyte count below 500/mm3, platelet count below 100,000/mm3, or Hgb level below 8 g/dL
• Drug interaction overview
  • CYP450 isoenzymes
  • Deuruxolitinib is a substrate of CYP2C9 and CYP3A
    • Concomitant use with moderate or strong CYP2C9 inhibitors is contraindicated due to the risk of increased Deuruxolitinib exposure and toxicity (eg, thrombosis)
    • Avoid concomitant use with strong CYP3A and moderate or strong CYP2C9 inducers due to the risk of decreased Deuruxolitinib exposure and reduced efficacy
  • Vaccines
    • Avoid use of live vaccines during or immediately before therapy
    • Complete immunizations (eg, varicella zoster, prophylactic herpes zoster vaccinations) in accordance with current immunization guidelines prior to therapy

Pregnancy and Lactation

• Data are insufficient to evaluate drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Lactation
  • There are no data on the presence of deuruxolitinib in human milk, the effects on the breast-fed infant, or the effects on milk production.