Prescribing guide
Lisraya (brepocitinib)Pre-treatment screening, laboratory interruptions, immunizations, interactions and prior authorization for dermatomyositisFor prescribers and their offices treating dermatomyositis: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Label updated. The FDA's label database lists a Lisraya label dated November 5, 2026, newer than the August 27, 2026 label this guide is built from. Trial Friend is rechecking this guide; until then the current label governs: current label on DailyMed.
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.
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.
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.
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.
Give your patient their plan
A one-page handout for starting Lisraya, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/lisrayaBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Confirm the indication | Adults with dermatomyositis. Not recommended in combination with other JAK inhibitors, other TYK2 inhibitors or biologic DMARDs. Safety and effectiveness in pediatric patients are not established. | FDA label |
| Screen for TB | Evaluate and test for latent and active TB before and during treatment, and treat a positive result before starting. Consider anti-TB therapy when an adequate course for past latent or active TB cannot be confirmed, with input from a TB specialist. | FDA label |
| Hepatitis, CBC and organ function | Viral hepatitis screening per clinical guidelines; not recommended with active hepatitis B or C, and trials excluded HBsAg or HBV DNA positive and HCV antibody with HCV RNA positive patients. CBC, hepatic and renal function; not recommended in severe hepatic (Child-Pugh C) or severe renal impairment (eGFR below 30mL/min). | FDA label |
| Immunize | Update immunizations per current guidelines, including prophylactic varicella zoster or herpes zoster vaccination. Avoid live vaccines immediately prior to and during treatment. | FDA label |
| Pregnancy | Verify pregnancy status in females of reproductive potential; effective contraception during treatment and for 3 days after the final dose. | FDA label |
| Prescribe and enroll | Combined Prescription and My Compass Support Enrollment Form (LIS-378 10/26): Lisraya 30mg tablets, 1 tablet by mouth once daily, dispense 30, refills 12 or other; ICD-10 M33.1 or M33.9. Fax 1-844-341-0485 or email mcs@priovant.com. Optional pharmacy preference, Orsini Specialty Pharmacy or PantheRx RARE Pharmacy; one is selected if left blank. The patient consent page can be left for the PAL to collect. | Enrollment form |
| Online or e-prescribe | Enrollment can also be submitted online at MyCompassSupport.com. Priovant says an office can instead e-prescribe, and the specialty pharmacy then contacts the patient to enroll in My Compass Support. | Prescriber brochure |
| Bridge attestation | Tick the Bridge box on the form to request free drug during the insurance appeal once all appeal information is submitted. Open to insured patients 18 or older who are US residents with a confirmed dermatomyositis diagnosis, subject to program terms. | Enrollment form |
| Authorization support | The PAL provides an Access Toolkit with a benefits summary, payer forms and authorization requirements, and a customizable Statement of Medical Necessity template, and tracks the request. Specialty pharmacy clinical teams can help prepare the submission. | Prescriber brochure |
| Pharmacy-submitted authorization | The form authorizes the specialty pharmacy to submit the authorization if the plan allows and the prescriber reviews and approves, using only clinical information provided by the office. | Enrollment form |
Prior authorization criteria and what to document
No public payer policy with Lisraya criteria was found as of November 9, 2026. We searched public policies on November 9, 2026, including Express Scripts, FEP Blue, Aetna, Cigna, Optum and Blue Cross Blue Shield of Michigan. None of them had published criteria for Lisraya by that date. Until plans publish their own, Priovant's authorization checklist lists what an office may document, such as skin findings, muscle enzymes and antibody results. That checklist is a drugmaker's guide, not an insurer's rule.
| Element | What the checklist lists | In the chart | Source |
|---|---|---|---|
| Diagnosis code | ICD-10 M33.1 other dermatomyositis, or M33.9 dermatopolymyositis | On the request and the enrollment form | Priovant authorization checklist |
| Skin findings | Heliotrope rash, Gottron papules or sign, shawl, V or holster sign, inverse palmar papules, calcinosis, mechanic's hands, flagellate erythema, poikiloderma, scalp erythema | Exam note with date and location; photo in the chart | Priovant authorization checklist |
| Muscle | Symmetric proximal weakness | Strength grades by muscle group, and dysphagia if present | Priovant authorization checklist |
| Muscle enzymes | Elevated CK, aldolase, AST or ALT, or LDH | Values with dates | Priovant authorization checklist |
| EMG and MRI | Myopathic EMG pattern; symmetric muscle edema on T2 or STIR imaging | Report summaries or images | Priovant authorization checklist |
| Antibodies | Positive myositis-specific autoantibody, such as Mi-2, TIF1-γ, MDA5, NXP2, SAE, Jo-1, PL-7, PL-12, EJ or OJ | Panel result with clinical correlation | Priovant authorization checklist |
| Biopsy and capillaroscopy | Muscle biopsy with perifascicular atrophy or perivascular inflammation; skin biopsy with interface dermatitis; nailfold capillary changes | Pathology reports and exam findings | Priovant authorization checklist |
| Systemic features | Raynaud phenomenon, interstitial lung disease, polyarthritis, myocarditis, dysphagia, vasculopathy | HRCT and PFTs with FVC and DLCO where ILD is present | Priovant authorization checklist |
| Exclusions | Thyroid-induced, statin-induced and genetic muscle disease ruled out | Negative tests, such as a normal TSH and no statin exposure | Priovant authorization checklist |
| Medication history | Prior medicines with dose and frequency, duration of use and response; any contraindications with the reason | Medication list and notes | Priovant authorization checklist |
| Label limits | Not recommended with other JAK or TYK2 inhibitors or biologic DMARDs | Medication list showing none of these, or their stop dates | FDA label |
Lisraya dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 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. | FDA label |
| One dose | No titration. Brepocitinib 15mg was studied in Trial DM but is not an approved dosage. No adjustment in mild or moderate renal or hepatic impairment. | FDA label |
| Serious infection | Interrupt until the infection resolves or is adequately treated; consider interrupting for herpes zoster until the episode resolves. | FDA label |
| Laboratory interruptions | ANC below 1,000 or ALC below 500 cells/mm3, or Hb below 8g/dL, means interruption, with restart once the value returns above the threshold. Suspected drug-induced liver injury means interruption until it is excluded. | FDA label |
| Discontinue | After a myocardial infarction or stroke, on symptoms of thrombosis (then evaluate and treat), or after a clinically significant hypersensitivity reaction. | FDA label |
| Missed dose | The label and Medication Guide give no missed-dose instruction. | FDA label |
| Food | A high-fat meal lowered AUC 18% and Cmax 36%; the label allows dosing with or without food. | FDA label |
| Storage | Below 30°C (86°F). | FDA label |
| Dating period | 30 months from manufacture when stored at 30°C. | FDA letter |
Monitoring the Lisraya label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | TB, viral hepatitis, CBC, hepatic panel including GGT, renal function, pregnancy status, immunization history | Section 2.1; avoid initiation with ANC below 1,000, ALC below 500, Hb below 8g/dL or active hepatitis B or C | FDA label |
| Ongoing | Neutrophils, lymphocytes, hemoglobin, AST, ALT and GGT | Per routine patient management, with no fixed interval in the label; in dermatomyositis AST and ALT may reflect disease activity, which is why the label specifies GGT | FDA label |
| About week 12 | Total, LDL and HDL cholesterol | Manage under hyperlipidemia guidelines; in Trial DM the LDL and HDL rises peaked by week 8 and then stayed stable | FDA label |
| Throughout | Active TB, including after a negative latent TB test; viral hepatitis reactivation | If HBV DNA is detected during treatment, consult a liver specialist | FDA label |
| Any time | Infection | Over 52 weeks, serious infections in 10% against 1% on placebo, most often pneumonia and sepsis (2 patients each); any infection 69% against 57%; herpes zoster 5% | FDA label |
| Age 65 and older | Serious adverse events and viral reactivation | SAEs 21% (3 patients) against 15% (2) on placebo; viral reactivation 15 per 100 patient-years against 3 in patients under 65 | FDA label |
| Diabetes | Blood glucose | Consider increased monitoring; hypoglycemia, including severe cases, has been reported after JAK inhibitor initiation | FDA label |
| Malignancy and skin | Periodic skin examination for patients at increased skin cancer risk | Advise UV protection; weigh benefits and risks in known malignancy other than successfully treated NMSC, and in current or past smokers | FDA label |
| GI | New abdominal pain | Evaluate promptly for perforation, especially with diverticulitis, NSAIDs or corticosteroids | FDA label |
| MACE in Trial DM | Adjudicated MACE in 3 Lisraya patients, 1.1 per 100 patient-years, including open-label treatment | 65% of the trial had at least 1 cardiovascular risk factor or ASCVD history at baseline | FDA label |
| Discontinuations | Adverse reactions led to discontinuation in 6% on Lisraya 30mg against 11% on placebo | Per the FDA's approval announcement | FDA announcement |
| Efficacy reference | LS mean TIS at week 52 | 47.5 against 33.3 on placebo, difference 14.2 (95% CI 5.5 to 22.9); TIS 40 or higher with prednisone-equivalent 2.5mg/day or less, 55% against 30% | FDA label |
| Trial record | Trial DM in the label is VALOR, NCT05437263 | ClinicalTrials.gov lists it as completed, with an actual completion date of September 9, 2026 | ClinicalTrials.gov |
Lisraya drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Other JAK or TYK2 inhibitors, biologic DMARDs | Not recommended in combination | FDA label |
| Smoking | Induces CYP1A1 and CYP1A2; steady-state AUC an estimated 45% and Cmax 33% lower in current smokers; effectiveness may be reduced | FDA label |
| CYP3A and P-gp inhibitors | Itraconazole 200mg once daily had no clinically significant effect on brepocitinib pharmacokinetics | FDA label |
| Oral P-gp and BCRP substrates | Brepocitinib inhibits both and may increase substrate exposure; the effect has not been studied clinically | FDA label |
| Pending data | Required postmarketing trial 5033-2 will test repeat-dose brepocitinib with P-gp and BCRP substrates; final report due February 2028 | FDA letter |
| OCT2 and MATE substrates | May raise substrate concentrations; monitor closely where small changes can cause serious adverse reactions. Serum creatinine rises are likely from inhibition of tubular secretion via OCT2, MATE1 and MATE2-K | FDA label |
| Oral contraceptives | 60mg once daily had no clinically significant effect on ethinylestradiol with levonorgestrel | FDA label |
| NSAIDs and corticosteroids | Raise the risk of GI perforation; 76% of Trial DM patients took oral corticosteroids at baseline, mean 11.4mg/day prednisone equivalent | FDA label |
| Live vaccines | Avoid immediately prior to and during treatment | FDA label |
| Pregnancy and lactation | May cause fetal harm based on animal data; no breastfeeding during treatment and for 3 days (about 5 half-lives) after the last dose; report exposures to the pregnancy safety study at 1-800-511-9141 or contactcenter@priovant.com | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedWe found no public insurer policy for Lisraya as of November 9, 2026. Priovant's authorization checklist lists what an office may document, such as the rash, muscle weakness, muscle enzymes, antibodies and biopsy results. It also asks for past medicines with the dose, duration and response.
- The plan said no at firstIf a plan first denies the authorization and an appeal is submitted, the Bridge Program may supply Lisraya free while the appeal is pending. The enrollment form says it is open to insured adults in the US with a confirmed dermatomyositis diagnosis.
- A screening result holds the startThe label says to avoid starting Lisraya with active hepatitis B or C, an active serious infection, or very low blood counts. By the label, a positive TB test means the TB is treated before Lisraya starts. The prescriber decides when the start can go ahead after a result like this.
- The prescription went to another pharmacyPriovant's enrollment form names 2 specialty pharmacies, Orsini and PANTHERx, and picks one when the office leaves the choice blank. Your liaison coordinates with the specialty pharmacy, so the liaison can say where the prescription went.
- A copay you cannot payEligible patients with private insurance may pay as little as $0 a month through the My Compass Support Copay Savings Program. The program requires a US resident with commercial coverage and an out-of-pocket cost for Lisraya.
- Medicare, Medicaid, VA or TRICARE coverageThe copay program is not valid when Medicare, Medicaid, VA, TRICARE or a similar government program pays any part of the prescription. For people with Medicare or Medicaid, the liaison can help identify independent charities that may help with costs.
My Compass Support
- A dedicated Patient Access Liaison, reachable by text, phone call, email or in person, who explains your coverage and out-of-pocket costs
- The Copay Savings Program for private insurance, as little as $0 a month, not valid when Medicare, Medicaid, VA, TRICARE or a similar government program pays any part
- Help identifying independent charities for people with Medicare or Medicaid
- A Bridge Program that may supply Lisraya at no cost while an appeal of a first denial is pending My Compass Support for prescribers
- Coordination with the specialty pharmacy, which ships Lisraya to your home each month
- A Lisraya Starter Kit in the first shipment Patient brochure
- Enrollment online, by texting LISRAYA to 37538 or by email at mcs@priovant.com, with questions to 1-888-736-9788
Questions prescribers' offices ask about Lisraya
What screening does the Lisraya label call for before initiation?
Six evaluations to consider under section 2.1 of the August 2026 label: active and latent TB, viral hepatitis per guidelines, CBC, baseline hepatic and renal function, pregnancy status, and updated immunizations. The boxed warning is firmer on TB: evaluate and test for latent and active infection before and during treatment, and treat a positive result before starting.
Which laboratory values hold Lisraya?
ANC below 1,000 cells/mm3, ALC below 500 cells/mm3 or hemoglobin below 8g/dL, per Table 1 of the August 2026 label; avoid initiation, interrupt treatment, and restart once the value returns above the threshold. Interrupt for suspected drug-induced liver injury until it is excluded, and obtain GGT, since AST and ALT can reflect dermatomyositis activity.
When are lipids checked on Lisraya?
About 12 weeks after initiation, per the August 2026 label, then managed under hyperlipidemia guidelines. In Trial DM, mean LDL rose 3.8mg/dL and HDL 4.5mg/dL over 52 weeks, peaking by week 8, with a stable LDL/HDL ratio.
Does Lisraya have a REMS or dose adjustments for interactions?
No REMS is required in the August 27, 2026 approval letter, and the label has 1 dose, 30mg once daily, with no interaction-based adjustment. Smoking lowers steady-state AUC by an estimated 45%; brepocitinib inhibits P-gp, BCRP, OCT2 and MATEs; combination with other JAK or TYK2 inhibitors or biologic DMARDs is not recommended.
What do insurers ask for to approve Lisraya?
As of November 9, 2026 we found 0 public payer policies with Lisraya criteria; the August 2026 label indication, adults with dermatomyositis, names no prior-therapy requirement. Priovant's authorization checklist (LIS-142 09/26) asks for documented diagnostic features, prior DM medications with dose, duration and response, and contraindications.
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Sources
- LISRAYA (brepocitinib) tablets, for oral use, prescribing information and Medication Guide, Revised 8/2026, Priovant Therapeutics, via DailyMed, 2026-08-27.
- NDA 220106 approval letter, Lisraya (brepocitinib) tablets, FDA, 2026-08-27.
- FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults, FDA, 2026-08-27.
- LISRAYA Patient Support & Cost Assistance, Priovant Therapeutics, 2026-11-09.
- Your Dedicated Partner for Treatment: My Compass Support for LISRAYA, patient brochure LIS-138 08/26, Priovant Therapeutics, 2026-11-09.
- My Compass Support Program & Resources | LISRAYA, Priovant Therapeutics, 2026-11-09.
- Here for You, Your Patients, and Your Team: My Compass Support for LISRAYA, HCP brochure LIS-139 08/26, Priovant Therapeutics, 2026-11-09.
- LISRAYA (brepocitinib) Prescription and My Compass Support Enrollment Form, LIS-378 10/26, Priovant Therapeutics, 2026-11-09.
- LISRAYA (brepocitinib) Authorization Checklist for Dermatomyositis, LIS-142 09/26, Priovant Therapeutics, 2026-11-09.
- A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR), NCT05437263, ClinicalTrials.gov, record verified September 2026, 2026-11-09.
A reference drawn from the August 27, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 9, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.