RUXOLITINIB CREAM,TOP

Clinical Criteria Summary

Topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Recommended for short-term (up to 8 weeks) and chronic non-continuous (PRN) therapy.
Considered second-line therapy following intolerance or inadequate response to trials of topical corticosteroids (TCSs) and a topical calcineurin inhibitor (CNI), unless medically inadvisable.

Apply a thin layer twice daily to affected areas.
Maximum application area: up to 20% of body surface area (BSA).
Maximum dose: 60 grams per week.
Discontinue use when signs and symptoms (e.g., itch, rash, redness) resolve.
Re-examine by a health care provider if signs and symptoms do not improve within 8 weeks.

Exclude patients with active, serious infections (including localized infections).
Screen for tuberculosis (TB); avoid therapy in untreated latent or active TB infection (may initiate after starting anti-TB therapy).
Screen for hepatitis B (at minimum: HBsAg, total anti-HBc, and anti-HBs); if HBsAg-positive, initiate antiviral prophylaxis first; if HBsAg-negative but anti-HBc-positive, consult a hepatologist or infectious diseases expert regarding prophylaxis.
Ensure current or past hepatitis C virus (HCV) screening.
Update vaccinations, including for herpes zoster.

Boxed warnings apply for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis.
Interrupt therapy if patient develops a serious or opportunistic infection until controlled.
Monitor patients for signs and symptoms of TB; regular re-testing is not recommended.
Consider interrupting therapy for herpes zoster until condition resolves.
Avoid initiation in patients with active HBV or HCV infection.
Weigh risk-benefits for malignancy, MACE, and thrombosis, particularly in current or past smokers and patients with cardiovascular risk factors.
Examine skin periodically to monitor for non-melanoma skin cancers (NMSC).
Monitor complete blood count (CBC) as clinically indicated; discontinue topical ruxolitinib if clinically significant thrombocytopenia, anemia, or neutropenia occurs.

Combination therapy with therapeutic biologics, other JAK inhibitors (JAKIs), or potent immunosuppressants (e.g., azathioprine, cyclosporine) is not recommended.
No specific contraindications are listed in the document.

Diagnosis of nonsegmental vitiligo with depigmented areas involving ≤ 10% total BSA, including ≥ 0.5% facial BSA and ≥ 3% non-facial BSA
F-VASI scores ≥ 0.5 and total VASI scores ≥ 3
Age ≥ 12 years
Exclusions: Complete leukotrichia within any facial lesions; prior JAKI therapy; prior biologic or investigational drug within 12 weeks or 5 half-lives; phototherapy within 8 weeks or during treatment; immunomodulators within 4 weeks; topical therapies within 1 week

FDA indication requires no prior therapies, indicating first-line therapy status for nonsegmental vitiligo
VHA use: Topical ruxolitinib monotherapy may be used in patients with stable, nonsegmental vitiligo who have tried topical corticosteroids, topical calcineurin inhibitors, and phototherapy unless these therapies are medically inadvisable, not available, or not feasible
Application must be limited to ≤ 10% BSA
Concurrent use with all other vitiligo therapies was not evaluated
Combination with phototherapy, therapeutic biologics, other JAKIs, or potent immunosuppressants (e.g., azathioprine, cyclosporine) is not recommended

Hematopoietic adverse events reported in < 1% of patients
Nonmelanoma skin cancers (basal cell and squamous cell carcinoma) occurred in 0.15% of patients; periodic skin assessments during and after treatment are recommended

Active, serious, systemic or localized infection, including undrained abscess (may be started/restarted once infection is controlled)
Untreated latent or active tuberculosis infection
Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis
HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral prophylaxis
Active hepatitis C
Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
Malignancy within 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 anticipated benefits
Concomitant use with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine
Concomitant use with strong CYP3A4 inhibitors
Breastfeeding (during treatment and for about 4 weeks after the last dose)

Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated expert
Diagnosis of nonsegmental vitiligo
Application intended for ≤ 10% of total body surface area
Tried and had an inadequate response or intolerance to topical corticosteroids and topical calcineurin inhibitors (unless medically inadvisable); requires ≥ 6 months adherence to prescribed regimens
Tried and had an inadequate response or intolerance to phototherapy (unless medically inadvisable, not available, or not feasible)
Vitiligo is NOT a cosmetic condition; Directive 1108.08 on Cosmetic and Enhancement Drugs does NOT apply

Immunizations must be updated prior to initiation, particularly for herpes zoster
For patients who can become pregnant or have partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception during therapy