Prescribing guide
Wayrilz (rilzabrutinib)Dosing, liver monitoring, CYP3A and acid-reducer interactions, and prior authorization criteria for ITPFor prescribers and their offices treating immune thrombocytopenia (ITP): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS; baseline bilirubin, transaminases and pregnancy status before the first dose; HemAssist enrollment online or by fax to 1-855-398-7634; prior authorization; HemAssist triages the prescription to the patient's specialty pharmacy.
Example PA threshold
FEP Blue example: age 18 or older, persistent or chronic ITP, inadequate response to corticosteroids, immunoglobulins, splenectomy or a TPO-RA, baseline platelets under 50,000/mcL, liver test monitoring, no concurrent TPO-RA.
Monitoring
Bilirubin and transaminases at baseline and as clinically indicated, more often if abnormal; withhold for suspected DILI and discontinue if confirmed; monitor for infection.
Support line
HemAssist Sanofi Support, 1-833-723-5463 (option 3 for PA help), Monday to Friday 8 AM to 7 PM ET, copay as little as $0 per fill for commercial plans, a first-month Free Trial, and a Patient Assistance Program.
Give your patient their plan
A one-page handout for starting Wayrilz, 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/wayrilzBefore 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 |
|---|---|---|
| Baseline labs | Bilirubin and transaminases before the first dose. Verify pregnancy status in females of reproductive potential and counsel on effective contraception during treatment and for 1 week after the last dose. | FDA label |
| Medication reconciliation | Avoid moderate or strong CYP3A inhibitors and inducers and proton pump inhibitors. Review CYP3A substrates and P-gp, BCRP or OATP1B substrates with a narrow margin. Counsel on grapefruit, starfruit and Seville oranges. | FDA label |
| Check hepatic and renal function | Avoid in moderate or severe hepatic impairment (Child-Pugh B or C) and in severe renal impairment. No adjustment for Child-Pugh A or mild to moderate renal impairment. | FDA label |
| Enroll in HemAssist | Enroll online or fax the enrollment form to 1-855-398-7634. HemAssist runs a benefits investigation, checks eligibility for financial programs, triages the prescription to the patient's specialty pharmacy and helps with shipments and claims. | HemAssist |
| Submit the prior authorization | Sanofi's checklist suggests a letter of intent and a letter of medical necessity with the first request. The LMN carries ICD-10-CM D69.3, the dosing regimen and NDC, and prior treatments with dates and responses. | PA checklist |
| Bridge a slow approval | Free Trial: the first month's supply with an enrollment form and a valid prescription, once per patient per product for their lifetime, not valid in Vermont. Free product may not be billed to any payer. | HemAssist |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, July 1, 2026. Approval a year at a time, up to 800mg a day, renewed if the platelet count has risen to 50,000 or higher. This policy took effect on July 1, 2026, after the current August 2025 label, and cites that label. Its rule against combining Wayrilz with a TPO receptor agonist is the plan's own, since the label does not forbid it. Other plans set their own rules, too. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age and diagnosis | 18 or older, with persistent or chronic ITP | Diagnosis note, onset date and ICD-10-CM code | FEP Blue policy |
| Prior therapy | Inadequate response to at least one of corticosteroids, immunoglobulins, splenectomy or a thrombopoietin receptor agonist | Agents, doses, dates and platelet response to each | FEP Blue policy |
| Baseline platelets | Platelet count under 50,000/mcL (50 x 10^9/L) before initiation | Dated CBC | FEP Blue policy |
| Liver monitoring | Prescriber agrees to monitor bilirubin and transaminases at baseline and as clinically indicated | Baseline liver panel and the monitoring plan | FEP Blue policy |
| Monotherapy against TPO-RAs | No dual therapy with a thrombopoietin receptor agonist | Current medication list; a stop date if switching | FEP Blue policy |
| Renewal | Platelet count improved to 50,000/mcL or greater, continued liver monitoring, no TPO-RA | Recent platelet counts | FEP Blue policy |
Wayrilz dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 onward | 400mg orally twice daily at about the same times, with or without food; swallow whole with water, do not cut, crush or chew. No titration and no other strength. | FDA label |
| Missed dose | Take as soon as possible on the same day, at least 2 hours apart from the next scheduled dose. | FDA label |
| Acid reducers | Give Wayrilz at least 2 hours before an antacid or H2 receptor antagonist; avoid proton pump inhibitors. | FDA label |
| Short CYP3A inhibitor course | If a moderate or strong CYP3A inhibitor cannot be avoided and is short term, such as an anti-infective for 7 days or less, interrupt Wayrilz. | FDA label |
| Supply | Bottle of 60 tablets (NDC 58468-0251-6), a 30-day supply; carton of 2 blister packs of 28 (NDC 58468-0251-5), a 28-day supply. Store at 20 to 25C in the original package, protected from light and moisture. | FDA label |
| Specific populations | Avoid in Child-Pugh B or C and severe renal impairment; no adjustment for age 65 or older; not established in pediatric patients. | FDA label |
| Quantity limit | The FEP Blue policy approves up to 800mg daily for 12 months at a time. | FEP Blue policy |
Monitoring the Wayrilz label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Bilirubin and transaminases; pregnancy status where applicable | Required before initiation by sections 2.1 and 2.3 | FDA label |
| As clinically indicated | Bilirubin and transaminases | More frequent testing if abnormal; withhold for suspected DILI, discontinue if confirmed | FDA label |
| Throughout | Signs and symptoms of infection | Evaluate promptly and treat; fatal pneumonia in 1 LUNA-3 patient, other serious infections 0.8% each | FDA label |
| Throughout | Diarrhea, nausea, abdominal pain | 32%, 20% and 14% against 10%, 6% and 1% on placebo, all grade 1 or 2; most resolved with supportive care while continuing | FDA label |
| Throughout | Neutrophil count | Grade 1 or 2 neutropenia in 11%; discontinuation for any adverse reaction 4.5% | FDA label |
| Response | Platelet count | Median 36 days to first response in LUNA-3; 63.9% against 31.9% responded in the first 12 weeks; durable response 23.3% against 0% | FDA label |
Wayrilz drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Avoid | Moderate or strong CYP3A inhibitors (ritonavir raised AUC 8-fold; fluconazole, erythromycin and verapamil predicted about 3-fold), and grapefruit, starfruit and Seville oranges | FDA label |
| Avoid | Moderate or strong CYP3A inducers (rifampin lowered AUC about 80%; efavirenz and rifabutin predicted up to 70%) | FDA label |
| Avoid | Proton pump inhibitors (esomeprazole lowered AUC 51%); separate antacids and H2 blockers by dosing Wayrilz at least 2 hours before | FDA label |
| Monitor | CYP3A substrates; rilzabrutinib is a moderate CYP3A inhibitor (midazolam AUC up to 3-fold predicted); consider substrate dose adjustment | FDA label |
| Monitor | P-gp, BCRP and OATP1B substrates where small concentration changes cause serious toxicity; a postmarketing transporter study is required | FDA letter |
| Pharmacokinetics | Half-life 1.6 to 4.5 hours; steady state within 3 days; high-fat meal lowered AUC 20% and Cmax 31% | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedThe FEP policy below wants chronic or persistent ITP, a poor response to an earlier treatment, and platelets under 50,000 before starting. The hematologist's records of past treatments and platelet counts usually answer these.
- The request was missing paperworkSanofi's prior authorization checklist suggests sending a letter of medical necessity with the first request. It lists the ITP diagnosis code, past treatments with dates and how each worked. HemAssist helps offices with prior authorizations at 1-833-723-5463, option 3.
- You also take a TPO receptor agonistThe FEP policy will not approve Wayrilz together with a TPO receptor agonist. The label does not forbid it, and the LUNA-3 trial allowed stable doses alongside Wayrilz. The hematologist decides, and the request then shows the plan.
- The renewal after a yearThe FEP policy renews only if the platelet count improved to 50,000 or higher. The office sends recent platelet results with the renewal request.
- Coverage is taking a whileThe Free Trial Program can supply the first month with an enrollment form and a valid prescription. It is a one-time offer for a first prescription and is not valid in Vermont.
- A copay you cannot payWith commercial insurance, the Copay Assistance Program offers as little as $0 per fill. Medicare, Medicaid, Medigap, VA, DoD, TRICARE and state programs are excluded by its terms. The Patient Assistance Program may help people who are uninsured, underinsured or between plans.
HemAssist Sanofi Support
- A benefits check after enrollment, and help finding the financial programs you may qualify for
- A Copay Assistance Program for commercial insurance, as little as $0 per fill, not valid with Medicare, Medicaid, Medigap, VA, DoD, TRICARE or state programs
- A Free Trial Program that supplies the first month, once per lifetime, not valid in Vermont
- A Patient Assistance Program that may help people who are uninsured, underinsured or have a temporary loss of coverage
- Clinical Educators who explain ITP and Wayrilz, and help routing the prescription to a specialty pharmacy and arranging shipments
Questions prescribers' offices ask about Wayrilz
What is the Wayrilz dose?
The August 2025 label gives 400mg orally twice daily, at about the same times each day, with or without food, swallowed whole with water. There is one strength and no titration; food may improve GI tolerability.
What testing does the label require before Wayrilz?
The August 2025 label asks for bilirubin and transaminases at baseline and as clinically indicated, and verification of pregnancy status in females of reproductive potential. There is no REMS, no boxed warning and no contraindication.
Which drugs interact with Wayrilz?
The August 2025 label says to avoid moderate or strong CYP3A inhibitors and inducers, and proton pump inhibitors. Wayrilz is dosed at least 2 hours before an antacid or H2 blocker; it is a moderate CYP3A inhibitor and inhibits P-gp, BCRP and OATP1B in vitro.
What does the label say to do about liver injury?
The August 2025 label says to monitor more often if liver tests become abnormal, withhold Wayrilz if DILI is suspected and discontinue it if DILI is confirmed. Avoid use in moderate or severe hepatic impairment (Child-Pugh B or C).
What do insurers ask for to approve Wayrilz?
The FEP Blue policy on this page, effective July 1, 2026, asks for age 18 or older and persistent or chronic ITP. It needs an inadequate response to corticosteroids, immunoglobulins, splenectomy or a TPO-RA, and a baseline platelet count under 50,000/mcL. It also requires agreement to monitor liver tests and excludes dual therapy with a TPO-RA; renewal needs platelets of 50,000/mcL or higher.
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Sources
- DailyMed - WAYRILZ- rilzabrutinib tablet, film coated (prescribing information and Patient Information, revised August 2025), Genzyme Corporation (Sanofi), via DailyMed, 2025-08-26.
- NDA 219685 approval letter, Wayrilz (rilzabrutinib) tablets, August 29, 2025, FDA, 2025-08-29.
- Access Treatment and Support for WAYRILZ | Sanofi HemAssist, Sanofi, 2026-11-07.
- Insurance and Financial aid for Rare Blood Disorder | Sanofi HemAssist, Sanofi, 2026-11-07.
- WAYRILZ Prior Authorization Checklist, Sanofi, 2026-02-01.
- Pharmacy Policy 5.85.073, Wayrilz, Blue Cross Blue Shield Federal Employee Program, 2026-07-01.
A reference drawn from the August 26, 2025 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 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.