Leqselvi (Deuruxolitinib) | Severe Alopecia Areata | DengYue

Deuruxolitinib Application Scope

 

Leqselvi is approved for the treatment of severe alopecia areata in adults.

 

Deuruxolitinib Characteristics

• Ingredients:

  • Active: Deuruxolitinib phosphate

  • Inactive: Colloidal silicon dioxide, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone; film coat contains carmine, FD&C Blue #2 aluminum lake, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide

• Properties:​ Janus kinase (JAK) 1 and 2 inhibitor

• Packaging Specification:​ 8mg tablets, supplied in bottles with a child-resistant cap

• Storage: Store at room temperature between 68°F to 77°F (20°C to 25°C); protect from moisture

• Expiry Date: ​Refer to the packaging for the specific expiration date

• Executive Standard: ​FDA-approved labeling

• Approval Number: NDA 217900

• Date of Revision: ​July 2024

• Manufacturer: Manufactured for Sun Pharmaceutical Industries, Inc. by Halo Pharmaceutical Inc., Whippany, NJ, USA

Guidelines for the Use of Deuruxolitinib

• Dosage and Administration:

  • Recommended dosage is 8 mg orally twice daily, with or without food

  • If a dose is missed, skip the missed dose and resume at the next scheduled time

• Adverse Reactions:

  • Common (≥1%): Headache, acne, nasopharyngitis, increased blood creatine phosphokinase, hyperlipidemia, fatigue, weight gain, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, herpes

• Contraindications:

  • Patients who are CYP2C9 poor metabolizers

  • Concurrent use with moderate or strong CYP2C9 inhibitors

• Precautions:

  • Increased risk of serious infections, including tuberculosis; screen for latent TB before initiating therapy

  • Higher rates of malignancies and major adverse cardiovascular events (MACE) have been observed with JAK inhibitors

  • Monitor for gastrointestinal perforations, laboratory abnormalities (e.g., anemia, neutropenia), and lipid elevations

  • Avoid use of live vaccines during or immediately prior to treatment

Deuruxolitinib Interactions

• Drug Interactions:​

• Avoid concomitant use with strong CYP3A and moderate or strong CYP2C9 inducers, as they may decrease deuruxolitinib efficacy

• Contraindicated with moderate or strong CYP2C9 inhibitors due to increased risk of adverse reactions

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.