Rheumatology
Dermatomyositis: Lisraya, for prescribers
Lisraya on what its first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for dermatomyositis. 3 other FDA-approved medicines for dermatomyositis have no prescribing guide here yet and are listed below.
The dermatomyositis prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drug with a prescribing guide
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Lisrayabrepocitinib | |
|---|---|
| Label dated | August 27, 2026 |
| Starting dose | 30mg orally once daily with or without food. Pink, capsule-shaped, film-coated tablets debossed BT30; bottles of 30 (NDC 87211-030-30), a 30-day supply. |
| Dispensing gate | No REMS; consider TB evaluation (the boxed warning says test before and during), hepatitis screening, CBC, hepatic and renal function, pregnancy status and immunization update including zoster before day 1; avoid initiation with ANC below 1,000, ALC below 500, Hb below 8g/dL, active hepatitis B or C or an active serious infection; prescription and My Compass Support enrollment routed to Orsini or PANTHERx |
| Required monitoring | Active TB signs throughout, including after a negative baseline test; neutrophils, lymphocytes, hemoglobin and liver enzymes including GGT per routine management; lipids about week 12; glucose in diabetes; periodic skin exams for those at higher skin cancer risk |
| Example PA threshold | No public payer policy found as of November 9, 2026; Priovant's checklist: documented skin findings, proximal weakness, muscle enzymes, EMG, MRI, myositis-specific antibodies, biopsy, capillaroscopy, systemic features, exclusion of other causes, and prior DM medicines with dose, duration and response |
| Support line | My Compass Support, 1-888-736-9788, fax 1-844-341-0485, mcs@priovant.com, a Patient Access Liaison, as little as $0 a month for eligible private insurance, a Bridge Program during appeal of an initial denial, home delivery from Orsini or PANTHERx |
- Label dated
- August 27, 2026
- Starting dose
- 30mg orally once daily with or without food. Pink, capsule-shaped, film-coated tablets debossed BT30; bottles of 30 (NDC 87211-030-30), a 30-day supply.
- Dispensing gate
- No REMS; consider TB evaluation (the boxed warning says test before and during), hepatitis screening, CBC, hepatic and renal function, pregnancy status and immunization update including zoster before day 1; avoid initiation with ANC below 1,000, ALC below 500, Hb below 8g/dL, active hepatitis B or C or an active serious infection; prescription and My Compass Support enrollment routed to Orsini or PANTHERx
- Required monitoring
- Active TB signs throughout, including after a negative baseline test; neutrophils, lymphocytes, hemoglobin and liver enzymes including GGT per routine management; lipids about week 12; glucose in diabetes; periodic skin exams for those at higher skin cancer risk
- Example PA threshold
- No public payer policy found as of November 9, 2026; Priovant's checklist: documented skin findings, proximal weakness, muscle enzymes, EMG, MRI, myositis-specific antibodies, biopsy, capillaroscopy, systemic features, exclusion of other causes, and prior DM medicines with dose, duration and response
- Support line
- My Compass Support, 1-888-736-9788, fax 1-844-341-0485, mcs@priovant.com, a Patient Access Liaison, as little as $0 a month for eligible private insurance, a Bridge Program during appeal of an initial denial, home delivery from Orsini or PANTHERx
Other FDA-approved medicines for dermatomyositis
These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.
- Acthar Gelrepository corticotropin injection
- Corticosteroidsprednisone, prednisolone, methylprednisolone, dexamethasone, hydrocortisone, betamethasone, triamcinolone
- Immune globulinimmune globulin (human)
FDA decisions for dermatomyositis
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- August 27, 2026Lisraya (brepocitinib), NDA, Priovant TherapeuticsApproved
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- November 2026Lisraya. DailyMed posted an updated version of the label on November 5, 2026, which still carries the August 2026 revision date. As the first Lisraya label, it has no recent major changes section in its highlights. FDA label
- August 2026Lisraya. The FDA called Lisraya the first FDA-approved oral treatment option for dermatomyositis. It said Lisraya received Orphan Drug and Priority Review designations. FDA announcement
- August 2026Lisraya. The FDA approved Lisraya on August 27, 2026, for adults with dermatomyositis. The approval letter requires a pregnancy outcomes study and a drug interaction study with P-gp and BCRP substrates. FDA letter
Open trials
Questions prescribers ask about Dermatomyositis
Does Lisraya require a REMS?
No. Lisraya has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Lisraya require?
Active TB signs throughout, including after a negative baseline test; neutrophils, lymphocytes, hemoglobin and liver enzymes including GGT per routine management; lipids about week 12; glucose in diabetes; periodic skin exams for those at higher skin cancer risk.
What do insurers require before covering Lisraya?
This is one public insurer policy, an example rather than every plan. No public payer policy found as of November 9, 2026; Priovant's checklist: documented skin findings, proximal weakness, muscle enzymes, EMG, MRI, myositis-specific antibodies, biopsy, capillaroscopy, systemic features, exclusion of other causes, and prior DM medicines with dose, duration and response.
Which support program starts Lisraya patients on therapy?
My Compass Support, 1-888-736-9788, fax 1-844-341-0485, mcs@priovant.com, a Patient Access Liaison, as little as $0 a month for eligible private insurance, a Bridge Program during appeal of an initial denial, home delivery from Orsini or PANTHERx.
A reference for licensed professionals, checked on November 9, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Dermatomyositis page and the first 90 days pages for Lisraya.