Hematology
Immune thrombocytopenia (ITP): the approved drugs compared for prescribers
Wayrilz side by side on what each 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 immune thrombocytopenia (ITP).
The immune thrombocytopenia (ITP) prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
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.
| Wayrilzrilzabrutinib | |
|---|---|
| Label dated | August 26, 2025 |
| Starting dose | 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. |
| 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 |
| Required 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 |
| 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 |
| 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 |
- Label dated
- August 26, 2025
- Starting dose
- 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.
- 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
- Required 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
- 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
- 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
FDA decisions for immune thrombocytopenia (ITP)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- August 2025Wayrilz. The FDA approved Wayrilz on August 29th for adults with persistent or chronic ITP who had an insufficient response to an earlier treatment. The approval requires a pregnancy study, a breast milk study, a transporter drug interaction study and a severe kidney impairment study. DailyMed lists this August 2025 label as the only version. FDA letter
Open trials
Questions prescribers ask about Immune thrombocytopenia (ITP)
Does Wayrilz require a REMS?
No. Wayrilz has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Wayrilz require?
Bilirubin and transaminases at baseline and as clinically indicated, more often if abnormal; withhold for suspected DILI and discontinue if confirmed; monitor for infection.
What do insurers require before covering Wayrilz?
This is one public insurer policy, an example rather than every plan. 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.
Which support program starts Wayrilz patients on therapy?
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.
A reference for licensed professionals, checked on November 7, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Immune thrombocytopenia (ITP) page and the first 90 days pages for Wayrilz.