Your first 90 days
Your first 90 days on Lisraya for dermatomyositis
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Lisraya is the first oral treatment the FDA has approved for dermatomyositis, and it carries the strongest warning the FDA uses. Before the first dose, the prescriber checks for tuberculosis and hepatitis, runs blood tests and brings vaccines up to date. After that the routine is one tablet a day, a monthly delivery and a cholesterol test around week 12. This page lays out those first 3 months from the FDA label, Priovant's support program and what insurers have published so far.
The Lisraya label has been updated. The FDA lists a newer label dated November 5, 2026, and this page was written from the August 27, 2026 label. Trial Friend is checking what changed. Your doctor and pharmacist go by the current label.
What has to happen before the first bottle ships
Lisraya has no REMS, so the first fill waits on screening tests, updated vaccines, an enrollment form and an insurance approval. These are the 7 things in the way, in order.
A tuberculosis check
The boxed warning says to test for latent and active TB before and during treatment, and to treat TB first if the test is positive.
- The label also says to watch for active TB during treatment, even after a negative test.
- The Medication Guide asks you to say if you have had TB or close contact with someone who has it.FDA label
Hepatitis screening and blood tests
The label calls for hepatitis screening before the first dose and asks the prescriber to consider a blood count and liver and kidney tests.
- It says Lisraya is not recommended with active hepatitis B or C. It also says to avoid starting with very low white blood cell counts or a hemoglobin under 8g/dL.FDA label
Vaccines brought up to date
The label asks for vaccines to be updated under current guidelines before treatment, including a shingles (herpes zoster) vaccine.
- It says to avoid live vaccines right before and during treatment with Lisraya.
- Ask which of your planned vaccines are live before you schedule them.FDA label
A pregnancy check and a plan for birth control
For anyone who can become pregnant, the label asks the prescriber to check pregnancy status before the first dose.
- Effective birth control is needed during treatment and for 3 days after the last dose.
- Breastfeeding is not recommended during treatment or for 3 days after the last dose.FDA label
A full health history and medicine list
The Medication Guide asks you to mention infections, smoking, cancer, heart attack, stroke, blood clots, diverticulitis, stomach ulcers and diabetes.
- Each of these ties to a warning somewhere on the Lisraya label.
- It also asks for a list of every medicine, vitamin and herbal supplement you take.FDA label
The enrollment form
The prescriber's office sends a combined Lisraya prescription and My Compass Support enrollment form by fax or email.
- The patient consent page is optional for the office, because a Patient Access Liaison will follow up with you to get it.Enrollment form
The insurance approval
Many plans require an authorization, and your doctor submits that request to your insurance.
- Your Patient Access Liaison keeps you updated, and Priovant says treatment can start once the liaison confirms the approval.My Compass Support
The days that matter
Counted from the first dose, with screening and vaccines in the weeks before, a refill every 30 days and the week 12 cholesterol test. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.TB, hepatitis and blood tests
The prescriber orders the screening the label lists, including a TB check, hepatitis screening, a blood count, and liver and kidney tests.
- A positive TB test means TB treatment comes first, by the label.
Vaccines updated, including shingles
The label asks for vaccines to be brought up to date before treatment, including a shingles vaccine.
- It says to avoid live vaccines right before the first dose and during treatment.
Enrollment and the liaison's welcome
After you enroll in My Compass Support, your Patient Access Liaison calls or texts to introduce themselves.
- The liaison checks your benefits and keeps you updated on the insurance request.
Pregnancy check, where it applies
For anyone who can become pregnant, the label asks the prescriber to verify pregnancy status before the first dose.
- Effective birth control runs from the first dose until 3 days after the last one.
The specialty pharmacy calls
Orsini or PANTHERx calls to set a delivery time, and you can ask its pharmacist about allergies or interactions.
- Priovant says the first shipment also includes a Lisraya Starter Kit.
First dose, one 30mg tablet
Lisraya is one 30mg tablet taken by mouth once a day, with or without food.
- A bottle holds 30 tablets, which is a 30-day supply.
Two weeks in
Colds and sinus infections, headache, tiredness, urinary infections and nausea were among the most common side effects in the trial.
- This is a reasonable point to tell the office what has changed and to confirm the first refill.
Refill, then every 30 days
A 30-tablet bottle runs out here at one tablet a day.
- The label lists only this one bottle size, so refills come about every 30 days.
Refill, number 2
Cholesterol test
The label asks for a cholesterol test about 12 weeks after the first dose, because Lisraya raised LDL and HDL cholesterol in the trial.
- Blood counts and liver enzymes are also checked during treatment, on the schedule the prescriber sets.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Lisraya label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated November 5, 2026, read from the FDA's label database today. FDA label
- November 2026
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 2026
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
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- One tablet, once a day, with or without food
The label dose is 30mg once a day, taken by mouth with or without food.
- Each tablet is pink, capsule-shaped and stamped BT30 on one side.FDA label
- If a dose is missed
Neither the label nor the Medication Guide says what to do after a missed dose of Lisraya.
- Ask the prescriber or pharmacist for their instruction before it happens.FDA label
- Not with other JAK or TYK2 medicines
The label does not recommend Lisraya together with other JAK inhibitors, other TYK2 inhibitors or biologic DMARDs.
- Tell every prescriber that you take Lisraya, so a new medicine can be checked against this list.FDA label
- Infections, including shingles
The label says Lisraya raises the risk of serious infections, and shingles was reported in 5% of trial patients taking it.
- The Medication Guide says to call your healthcare provider right away about any sign of infection.FDA label
- Steroids, NSAIDs and the stomach
The label names corticosteroids and NSAIDs as risk factors for a tear in the stomach or intestines.
- In the trial, 76% of patients were taking oral steroids at the start.
- The Medication Guide says stomach-area pain, fever, chills, nausea or vomiting needs medical help right away.FDA label
- Sun, skin checks and smoking
The label advises limiting sun with protective clothing and a broad-spectrum sunscreen.
- It also recommends periodic skin checks for people at higher risk of skin cancer.
- Smoking lowers the level of Lisraya in the blood, and the label says it may work less well in smokers.FDA label
- Diabetes and low blood sugar
The label says Lisraya may cause low blood sugar in people with diabetes.
- The prescriber may ask for more frequent glucose checks, and the Medication Guide says to call about any problems with low blood sugar.FDA label
- Pregnancy, birth control and breastfeeding
Animal studies suggest Lisraya may harm an unborn baby, so the label calls for effective birth control during treatment and for 3 days after.
- Breastfeeding is not recommended during treatment or for 3 days after the last dose.
- Pregnancies can be reported to Priovant's pregnancy safety study at 1-800-511-9141.FDA label
- Storage
The Medication Guide says to store the tablets below 86 degrees Fahrenheit, which is 30 degrees Celsius.
- It also says to keep Lisraya and all medicines out of the reach of children.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of infection
Fever, sweating or chills, cough, shortness of breath, muscle aches, warm or painful skin, burning when you urinate, diarrhea or stomach pain.
- The Medication Guide says to call your healthcare provider right away about any of these.FDA label
Signs of a heart attack, stroke or blood clot
Chest pain or pressure, pain in the arm, back, neck or jaw, weakness on one side, slurred speech, or a swollen, painful leg.
- Sudden shortness of breath, coughing up blood or fainting also count.
- The Medication Guide says to get emergency help for heart attack or stroke signs, and medical help right away for clot signs.FDA label
Allergic reactions
Hives, trouble breathing, feeling faint or dizzy, or swelling of the lips, tongue or throat.
- The Medication Guide says to stop taking Lisraya and get emergency medical help right away if these occur.FDA label
Stomach pain
Stomach-area pain, fever, chills, nausea or vomiting are listed with the risk of a tear in the stomach or intestines.
- The Medication Guide says to get medical help right away, and the risk is higher with steroids or NSAIDs.FDA label
The most common side effects
In the trial, headache affected 15% of people on Lisraya against 3% on placebo, and tiredness 12% against 3%.
- Colds and sinus infections affected 15% against 11%, urinary infections 11% against 5%, and nausea 11% against 4%.
- Serious infections occurred in 10% of people on Lisraya and 1% on placebo.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.Priovant authorization checklist
- 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.Enrollment form
- 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.FDA label
- 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.Enrollment form
- 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.My Compass Support
- 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
Checked 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. Priovant authorization checklist
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. My Compass Support
Five questions for the pharmacist or the support line
- Are you Orsini or PANTHERx, and what number will your delivery calls come from?
- Here is my full list of medicines, vitamins and supplements. Are any of them on the Lisraya interaction list in the label?
- I take steroids and sometimes an NSAID for pain, so what should I watch for while on Lisraya?
- The label does not say what to do after a missed dose, so what should I do if one is missed?
- Which of the vaccines I am due for are live vaccines that the label says to avoid?
- What is my cost per bottle after insurance, and has the copay program been applied?
Questions people ask in the first weeks
How long does it take to get Lisraya after it is prescribed?
There is no fixed number, because the TB and blood tests, vaccines, enrollment and insurance review each take their own time. If a plan first says no and an appeal is filed, the Bridge Program may supply Lisraya at no cost while the appeal is pending.
Does Lisraya have a boxed warning?
Yes, the August 2026 label carries a boxed warning for serious infections, death, cancer, major heart events and blood clots. The higher rates of death, cancer, heart events and clots were seen with another JAK inhibitor in people with rheumatoid arthritis. The label says cancer, heart events and clots have also occurred in people taking Lisraya.
What tests are needed before starting Lisraya?
The label asks the prescriber to consider TB and hepatitis screening, a blood count, liver and kidney tests, and a pregnancy check where it applies. The boxed warning says TB testing happens before and during treatment. A cholesterol test follows about 12 weeks after the first dose.
Can I get vaccines while taking Lisraya?
The label says to avoid live vaccines right before and during treatment, and to update vaccines, including the shingles vaccine, before starting. It also asks patients to tell their healthcare provider they take Lisraya before any vaccination.
Was Lisraya studied in people taking steroids?
Yes, 76% of trial patients took oral steroids at the start, at an average of 11.4mg a day of prednisone or the equivalent. Among those taking 7.5mg or more, 45% on Lisraya used no steroids at weeks 48 and 52, against 29% on placebo. Any change to a steroid dose is a decision for the prescriber.
What if I miss a dose of Lisraya?
The label and the Medication Guide do not give any missed-dose instruction for Lisraya. Ask the prescriber or pharmacist what to do before it happens.
Can I pick up Lisraya at my regular pharmacy?
Priovant says Lisraya is filled by a specialty pharmacy, either Orsini or PANTHERx. The pharmacy calls to set a delivery time and ships it to your home each month.
Why was Lisraya denied by my insurance?
We found no public insurer policy for Lisraya as of November 9, 2026, so each plan sets its own rules. Priovant's checklist suggests documenting the diagnosis in detail along with past treatments and how they worked. Your liaison can help, and the Bridge Program may cover the wait during an appeal.
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Sources
- LISRAYA (brepocitinib) tablets, for oral use, prescribing information and Medication Guide, Revised 8/2026, Priovant Therapeutics, via DailyMed, August 27, 2026.
- NDA 220106 approval letter, Lisraya (brepocitinib) tablets, FDA, August 27, 2026.
- FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults, FDA, August 27, 2026.
- LISRAYA Patient Support & Cost Assistance, Priovant Therapeutics, November 9, 2026.
- Your Dedicated Partner for Treatment: My Compass Support for LISRAYA, patient brochure LIS-138 08/26, Priovant Therapeutics, November 9, 2026.
- My Compass Support Program & Resources | LISRAYA, Priovant Therapeutics, November 9, 2026.
- Here for You, Your Patients, and Your Team: My Compass Support for LISRAYA, HCP brochure LIS-139 08/26, Priovant Therapeutics, November 9, 2026.
- LISRAYA (brepocitinib) Prescription and My Compass Support Enrollment Form, LIS-378 10/26, Priovant Therapeutics, November 9, 2026.
- LISRAYA (brepocitinib) Authorization Checklist for Dermatomyositis, LIS-142 09/26, Priovant Therapeutics, November 9, 2026.
- A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR), NCT05437263, ClinicalTrials.gov, record verified September 2026, November 9, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing rheumatologist or dermatologist. Found an error? Use the report link in the footer and it will be checked against the source.