RITLECITINIB CAP,ORAL
Clinical Criteria Summary
Document 553
Indication & Patient Selection
- Treatment of severe alopecia areata (AA) in adults and adolescents 12 years of age and older.
Contraindications & Limitations of Use
- Known hypersensitivity to ritlecitinib or its excipients.
- Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Pretreatment Evaluations & Immunizations
- Tuberculosis screening; initiate preventive therapy for latent tuberculosis.
- Viral hepatitis screening (hepatitis B and C viruses).
- Lymphocyte and platelet counts; do not initiate treatment if absolute lymphocyte count is < 500/mm3 or platelet count is < 100,000/mm3.
- Liver function tests; do not recommend treatment in patients with severe (Child-Pugh C) hepatic impairment.
- Update immunizations according to current guidelines.
Dosing Regimen
- 50 mg orally once daily with or without food.
Monitoring & Laboratory Evaluations
- Lymphocyte and platelet counts 4 weeks after starting treatment, then per routine patient management.
Dosage Modifications & Management of Adverse Events
- Platelet count < 50,000/mm3: Discontinue treatment.
- Lymphocyte count < 500/mm3: Interrupt therapy.
- Treatment interruptions for < 6 weeks are not expected to result in significant loss of regrown scalp hair.
Safety Warnings & Precautions
- Boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
- Avoid use of live vaccines during or shortly before treatment.
Document 554
Indication & Diagnosis
- Severe alopecia areata based on ≥ 50% scalp hair loss
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated expert
- Prescribed at the FDA-recommended dose for severe alopecia areata
- Exclusion Criteria (Patient will NOT meet criteria if ANY of the following apply)
- Active, serious, systemic or localized infection, including undrained abscess (may start/restart once controlled)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting prophylaxis)
- 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 risk-benefits favor use)
- At increased risk of thrombosis or major adverse cardiovascular events where potential harms are expected to outweigh anticipated benefits
- Platelets < 100,000/mcL or lymphocytes < 500 cells/mcL (may start/restart once values exceeded)
- Severe hepatic impairment (Child-Pugh class C)
- Concomitant therapy with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants (except overlaps during treatment transition)
- Concomitant therapy with strong CYP3A inducers (e.g., rifampin)
- Pregnancy
- Lactating
- Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
Required Screening & Testing
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (at minimum: 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)
Monitoring & Follow-up
- Routine retesting for TB, hepatitis B, and hepatitis C is not required for prescription renewals; retesting in high-risk patients should be considered
- Anti-HBs titers ≥ 10 IU/L are generally considered protective and may help identify need for initial or booster vaccination or occult HBV identification
- For HBsAg-negative but anti-HBc-positive patients, anti-HBs does not guarantee protection against HBV reactivation; management depends on patient’s risk of HBV reactivation
Special Populations & Counseling
- If HBsAg-negative but anti-HBc-positive: GI/liver or infectious diseases expert must be consulted for advice on starting antiviral prophylaxis vs preemptive monitoring for HBV reactivation
- Patients who can become pregnant or have partners who can become pregnant: Counseling provided on potential risks vs benefits and use of effective contraception
- Lactating patients: Advised to avoid giving breastmilk during therapy and for at least 14 hours after the last dose
- Vaccinations should be updated before initiation when possible; recombinant zoster (SHINGRIX) vaccine should be completed or initiated by end of first year, preferably when dosage is low, disease is stable, or immune response can be expected