Deuruxolitinib

Class
Targeted therapy
Subclass
Janus kinase inhibitors
Substance name
Deuruxolitinib
Brand names
Leqselvi®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of alopecia areata • Severe
•
8 mg PO BID
Taken with or without food.
Indications for use
Labeled indications
Adults
•
Treatment of alopecia areata (severe)
Safety risks
Boxed warnings
Increased risk of mortality
•
Maintain a high level of suspicion, as another JAK inhibitor used in rheumatoid arthritis has been associated with an increased risk of all-cause mortality in patients aged ≥ 50 years with at least one cardiovascular risk factor.
Major cardiovascular events
•
Maintain a high level of suspicion, as another JAK inhibitor used in rheumatoid arthritis has been associated with an increased risk of major adverse cardiovascular events in patients aged ≥ 50 years with at least one cardiovascular risk factor. Weigh the risks against benefits in patients with cardiovascular risk factors, including current or past smoking status.
Malignancy
•
Maintain a high level of suspicion, as another JAK inhibitor used in rheumatoid arthritis has been associated with an increased risk of malignancy (excluding non-melanoma skin cancer). Non-melanoma skin cancers have also been reported in patients treated with deuruxolitinib. Obtain periodic skin examinations in patients at risk for skin cancer.
Serious infections
•
Avoid using deuruxolitinib in patients with active serious infections, including localized infections, active hepatitis B or C, or tuberculosis. Evaluate for tuberculosis and viral hepatitis, and treat latent tuberculosis before initiating treatment. Monitor all patients for active tuberculosis during treatment. Weigh the risks against benefits of deuruxolitinib treatment in patients with chronic or recurrent infections, a history of serious or opportunistic infections, underlying conditions increasing the risk of infections, and patients exposed to tuberculosis or residing in or recently traveled to areas of endemic tuberculosis or mycoses. Complete all necessary immunizations, including herpes zoster, according to the current immunization schedule. Avoid using live vaccines during or immediately before treatment.
Thrombosis
•
Maintain a high level of suspicion, as deuruxolitinib has been associated with an increased risk of thrombosis, including DVT, PE, and arterial thrombosis. Avoid using deuruxolitinib in patients at increased risk for thrombosis.
Contraindications
CYP2C9 poor metabolizers
•
Obtain CYP2C9 genotype determination before initiating treatment.
Concomitant use of immunosuppressants
•
Do not use deuruxolitinib with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
Warnings and precautions
Anemia, decreased blood neutrophil count, decreased blood lymphocyte count
•
Maintain a high level of suspicion, as deuruxolitinib has been associated with an increased risk of anemia, neutropenia, and lymphopenia. Obtain a CBC at baseline and periodically during treatment. Avoid or interrupt deuruxolitinib treatment in patients with hemoglobin < 8 g/dL, neutrophil count < 1,000/mcL, or lymphocyte count < 500/mcL.
Decreased serum deuruxolitinib levels
•
Use caution in patients taking potent CYP3A and moderate or potent CYP2C9 inducers. Avoid use if possible.
Gastrointestinal perforation
•
Maintain a high level of suspicion, as deuruxolitinib has been associated with an increased risk of gastrointestinal perforation. Monitor patients at risk for gastrointestinal perforation.
Hyperlipidemia
•
Maintain a high level of suspicion, as deuruxolitinib has been associated with increases in triglycerides and total cholesterol, including HDL-C and LDL-C. Obtain lipid profile assessment at baseline and periodically during treatment.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Consider safer alternatives. Evidence of fetal harm in animals. Advise on pregnancy planning and prevention for females of reproductive potential.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Acne, headache
Common 1-10%
•
Anemia, ↓ blood lymphocyte count, ↓ blood neutrophil count, herpes simplex virus infection, hyperlipidemia, ↑ platelet count, ↑ serum CK, nasopharyngitis, fatigue, asthenia, somnolence, lethargy, weight gain, skin and soft tissue infections
Uncommon < 1%
•
Herpes zoster, candidiasis, serious infections, thrombosis, gastrointestinal perforation, ↑ serum lipase, malignancy
Interactions
Drug(s)
Check Interactions
Reset

What did you think about this content?

Create free account

Sign up for free to access the full drug resource