DEURUXOLITINIB TAB,ORAL
Clinical Criteria Summary
Document 857: MON Deuruxolitinib LEQSELVI in Alopecia Areata Monograph May 2026
Indication & Patient Population
- Adults with severe alopecia areata (AA).
- Severe AA defined as ≥ 50% scalp hair loss (Severity of Alopecia Tool / SALT score ≥ 50).
- Current episode of AA scalp hair loss lasting 6 months to 10 years.
Dosage & Administration
- 8 mg twice daily with or without food.
- Initial and maintenance dosages are the same (8 mg twice daily).
- Not recommended in combination with other JAKis, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
Pretreatment Evaluations & Screening
- Determine CYP2C9 genotype; contraindicated in CYP2C9 poor metabolizers.
- Evaluate for concomitant use of moderate or strong CYP2C9 inhibitors; contraindicated if taking them.
- Evaluate for active and latent tuberculosis (TB); not recommended with active TB. Start preventive therapy for latent TB or high-risk patients with negative test before initiating.
- Screen for viral hepatitis B or C; not recommended with active infection. Follow treatment guidelines or refer to liver specialist if infected; monitor for reactivation during treatment.
- Obtain complete blood count (CBC); not recommended if absolute lymphocyte count (ALC) < 500 cells/mm3, absolute neutrophil count (ANC) < 1,000 cells/mm3, or hemoglobin (Hg) < 8 g/dL.
- Obtain lipid panel.
- Complete necessary immunizations per guidelines, including herpes zoster vaccinations.
Monitoring Requirements
- Monitor CBC periodically during therapy and modify dosage as recommended.
- Monitor lipids periodically during therapy.
- Monitor for hepatitis B reactivation during treatment per clinical guidelines.
- Monitor blood creatine phosphokinase (CPK) due to reported increased CPK.
Treatment Interruption & Resumption Criteria
- ALC < 500 cells/mm3: Resume when count is ≥ 500 cells/mm3.
- ANC < 1,000 cells/mm3: Resume when count is ≥ 1,000 cells/mm3.
- Hg < 8 g/dL: Resume when value is ≥ 8 g/dL.
- No recommendation for low platelet (PLT) count.
Safety Considerations, Warnings & Contraindications
- Boxed warnings: Serious infections/TB, mortality, malignancy, MACE, thrombosis (consistent with JAKi class labeling).
- Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant moderate/strong CYP2C9 inhibitors.
- Risk of gastrointestinal (GI) perforations.
- Lab abnormalities: ALC, ANC, Hg, lipids.
- Avoid live vaccines during or immediately prior to therapy.
- Not recommended in severe or end-stage renal disease (eGFR < 30 mL/min/1.73 m2). No dosage adjustment needed for mild or moderate impairment.
- Not recommended in severe hepatic impairment. No dosage adjustment needed in mild or moderate impairment.
Place in Therapy Considerations
- May be used as first-line (1L) therapy for severe AA.
- Systemic JAK inhibitors provide alternatives to conventional synthetic immunomodulators (cyclosporine, methotrexate, azathioprine).
- Consider risk-benefit of increased mortality, malignancy, MACE, and thrombosis for a nonfatal but potentially psychologically devastating disease.
Document 858: Deuruxolitinib LEQSELVI in Alopecia Areata Criteria May 2026
Exclusion Criteria
- CYP2C9 poor metabolizers
- Concomitant moderate or strong CYP2C9 inhibitors (e.g., fluconazole, miconazole, voriconazole, fluvastatin, fluvoxamine, metronidazole, sulfamethoxazole, amiodarone, capecitabine)
- Uncontrolled active infection (may start/restart once treatment for the infection is initiated)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients can be treated)
- Congenital or acquired immunodeficiency
- Malignancy in the previous 5 years other than successfully treated nonmelanoma skin cancer or successfully treated cervical cancer (unless treating dermatologist and oncologist agree that risk-benefits favor using the drug)
- At increased risk of thrombosis or major adverse cardiovascular events where potential harms are expected to outweigh the anticipated benefits
- Lymphocytes < 500 cells/mm3, neutrophils < 1000 cells/mm3, or hemoglobin < 8 g/dL (may start/restart once lymphopenia, neutropenia and/or anemia resolve)
- Severe renal impairment or end-stage renal disease (eGFR < 30 mL/min)
- Severe hepatic impairment (Child-Pugh C)
- Concomitant therapy with immunosuppressive biologics or potent immunosuppressants (e.g., other Janus kinase inhibitors, biologic immunomodulators, azathioprine, cyclosporine, tacrolimus) except overlaps during treatment transition
- Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
- Breastfeeding (avoid feeding breastmilk to infants during treatment and for one day after the last dose)
- NO hair regrowth with previous use of a systemic Janus kinase inhibitor
Inclusion Criteria
- Determined patient’s CYP2C9 genotype
- Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated expert
- Diagnosis of severe alopecia areata based on ≥ 50% scalp hair loss
- Offered all age-appropriate vaccinations prior to initiating therapy
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc] and antibody to hepatitis B surface antigen [anti-HBs])
- Current or past completion of hepatitis C screening (may initiate while waiting for test results)
Additional Inclusion Criteria & Specific Populations
- If HBsAg-negative but anti-HBc-positive and consult is deemed indicated: A GI/liver or infectious diseases expert has been (e-)consulted for advice on whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation
- For females who can become pregnant: Checked pregnancy status. Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
- For females who are pregnant: Counseling provided on potential risks vs benefits of treatment and patient informed that drug may cause fetal harm
Clinical Management & Policy Notes
- Alopecia areata is NOT a cosmetic condition. The Directive 1108.08 policy on Cosmetic and Enhancement Drugs does NOT apply
- Alternative Janus kinase inhibitors (e.g., baricitinib, ritlecitinib) may be considered instead for CYP2C9 poor metabolizers or patients on concomitant moderate/strong CYP2C9 inhibitors
- Antiviral prophylaxis for HBV should use agents with high genetic barrier to resistance such as entecavir or tenofovir
- Vaccinations should be updated before initiation when possible; recombinant zoster vaccine should be completed or at least initiated by the end of the first year, preferably when drug dosage is low, disease is stable, or at other times when a robust immune response to vaccination can be expected
- Prescribed at the FDA-recommended dose for severe alopecia areata
- Routine retesting is not required for prescription renewals. Retesting in high-risk patients should be considered