Your first 90 days
Your first 90 days on Wayrilz for immune thrombocytopenia (ITP)
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.
Wayrilz has no REMS form and no vaccine requirement before the first fill. What the label does ask for is a liver blood test before starting, and a pregnancy check for anyone who could become pregnant. After that comes a tablet morning and evening, a few foods and heartburn medicines to work around, and a watch for infection and liver signs. This page lays out the first 3 months from the FDA label, Sanofi's HemAssist program and one insurer's written rules.
What has to happen before the first bottle ships
Wayrilz has no REMS, so the first fill waits on baseline liver tests, an insurance approval and a specialty pharmacy shipment, not on a safety program form. These are the 6 things in the way, in order.
Liver blood tests before the first dose
The label asks the hematologist to check bilirubin and liver enzymes before starting and again as needed during treatment.
- Liver injury, sometimes severe or fatal, has happened with drugs in the same BTK inhibitor family.
- In the Wayrilz trials, liver enzyme rises were mostly mild to moderate.FDA label
A pregnancy check, if you could become pregnant
The label says to confirm pregnancy status before starting, because animal studies suggest Wayrilz may harm an unborn baby.
- Birth control is advised during treatment and for 1 week after the last dose.
- Breastfeeding is not advised during treatment or for at least 1 week after.FDA label
A full medicine and food review
Many medicines change Wayrilz levels, including some antibiotics, antifungals and heartburn medicines.
- The Patient Information asks you to list every prescription, over-the-counter medicine, vitamin and herbal supplement.
- It also asks you to avoid grapefruit, starfruit and Seville oranges, which are often used in marmalade.FDA label
Liver or kidney problems, raised before day 1
The label says to avoid Wayrilz with moderate or severe liver impairment and with severe kidney impairment.
- Mild liver problems and mild to moderate kidney problems need no dose change.
- Tell the hematologist about either condition before the first fill.FDA label
HemAssist enrollment and the insurance approval
The hematologist's office enrolls you online or by faxing an enrollment form to HemAssist.
- HemAssist then checks your insurance benefits and looks for financial help you may qualify for.HemAssist
The specialty pharmacy
HemAssist can send the prescription on to your specialty pharmacy and help arrange the shipments.
- The Free Trial Program can supply the first month with an enrollment form and a valid prescription.HemAssist
The days that matter
Counted from the first dose, with the liver and pregnancy checks before it, refills every 30 days from the bottle, and the weeks when the trial saw platelets respond. 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.Liver tests and a pregnancy check
The office draws blood for bilirubin and liver enzymes, and checks pregnancy status where it applies.
- The label asks for both before the first dose.
HemAssist enrollment and the insurance request
The office enrolls you in HemAssist online or by fax.
- HemAssist checks your insurance benefits and looks for financial help while the plan reviews the request.
The specialty pharmacy ships
HemAssist routes the prescription to the specialty pharmacy and helps with the shipment.
- New patients can get the first month free through the Free Trial Program.
First dose, 1 tablet, then another that evening
One 400mg tablet twice a day at about the same times, swallowed whole with a glass of water.
- Food is optional, though the label says it may ease stomach side effects.
Refill, then about every 30 days
A 60-tablet bottle runs out here.
- A 56-tablet carton of 2 blister packs runs out on day 29, so ask the pharmacy which one you get.
When platelets first responded in the trial
In LUNA-3, the median time to a first platelet response on Wayrilz was 36 days.
- A response meant a count of at least 50,000, or 30,000 to 50,000 and double the starting count.
Refill, number 2
The trial's 12-week checkpoint
By week 12 of LUNA-3, 64% of patients on Wayrilz had a platelet response, against 32% on placebo.
- Only those who responded by then could continue the full 24-week blinded part of the trial.
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 Wayrilz 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 August 26, 2025, read from the FDA's label database today. FDA label
- August 2025
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
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, twice a day, swallowed whole
The label dose is 400mg twice daily at about the same times each day, with or without food.
- Tablets are swallowed whole with a glass of water and never cut, crushed or chewed.
- There is one strength and no dose steps.FDA label
- If you miss a dose
The Patient Information says to take the missed dose as soon as you remember on the same day.
- It should be at least 2 hours apart from the next regular dose.FDA label
- Heartburn medicines
The label says to avoid proton pump inhibitors, such as esomeprazole, because they lower Wayrilz levels.
- With an antacid or an H2 blocker such as famotidine, take Wayrilz at least 2 hours before it.
- If you take a proton pump inhibitor, the Patient Information says to talk to your healthcare provider.FDA label
- Grapefruit, starfruit and Seville oranges
These fruits and products made from them can raise Wayrilz levels and the risk of side effects.
- The Patient Information says to avoid them, including marmalade made from Seville oranges.FDA label
- Medicines that change Wayrilz levels
The label says to avoid moderate or strong CYP3A inhibitors and inducers.
- The label's examples include ritonavir, fluconazole, erythromycin, verapamil and rifampin.
- If a short course of an inhibitor cannot be avoided, such as an infection medicine for 7 days or less, the label says to pause Wayrilz.
- The hematologist decides how that is handled.FDA label
- Medicines Wayrilz can raise
Wayrilz is a moderate CYP3A inhibitor, so it can raise levels of some other medicines.
- The label also flags medicines carried by the P-gp, BCRP and OATP1B transporters.
- Ask the pharmacist to check each new prescription against it.FDA label
- Pregnancy and breastfeeding
Birth control is advised during treatment and for 1 week after the last dose for anyone who can become pregnant.
- Tell your healthcare provider about a known or suspected pregnancy.
- Breastfeeding is not advised during treatment or for at least 1 week after.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit (20 to 25 Celsius), in the original bottle or blister pack.
- The label says to protect the tablets from light and moisture and keep them 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
The label warns that BTK inhibitors raise the risk of serious bacterial, viral and fungal infections.
- One LUNA-3 patient on Wayrilz died of pneumonia.
- The Patient Information says to tell your healthcare provider right away about fever, chills or flu-like symptoms.FDA label
Signs of liver problems
Stomach-area pain or discomfort, dark or tea-colored urine, or yellowing of the skin or the whites of the eyes.
- The Patient Information says to tell your healthcare provider right away.
- The label says Wayrilz is paused if liver injury is suspected and stopped if it is confirmed.FDA label
Diarrhea, nausea and stomach pain
In LUNA-3, diarrhea occurred in 32% of patients on Wayrilz against 10% on placebo, and nausea in 20% against 6%.
- Stomach pain occurred in 14% against 1%.
- All were mild to moderate, and most settled with supportive care while treatment continued.FDA label
Headache and other common effects
Headache occurred in 18% on Wayrilz against 7% on placebo, and COVID-19 in 14% against 4%.
- Joint pain, dizziness, vomiting and cough were less common.
- Mild to moderate neutropenia, a drop in one type of white blood cell, occurred in 11%.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 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.FEP Blue policy
- 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.PA checklist
- 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.FEP Blue policy
- 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.FEP Blue policy
- 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.HemAssist
- 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
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Age 18 or older, with persistent or chronic immune thrombocytopenia (ITP)
- A poor response to at least one of corticosteroids, immunoglobulins, spleen removal or a TPO receptor agonist
- A platelet count under 50,000 per microliter before starting
- The prescriber agrees to check bilirubin and liver enzymes at baseline and as needed
- Not taken together with a TPO receptor agonist
Approval length. 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. FEP Blue policy
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 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
Details as the drugmaker publishes them. HemAssist
Five questions for the pharmacist or the support line
- Which specialty pharmacy are you, and what number will your calls come from?
- Will I get the 60-tablet bottle or the 56-tablet carton, and when should I order my refill?
- I take these medicines and supplements. Are any of them CYP3A inhibitors or inducers, or affected by Wayrilz?
- I take a heartburn medicine. Is it a proton pump inhibitor, an H2 blocker or an antacid, and how do I time it?
- If I miss a dose late in the day, is there still time to take it before the next one?
Questions people ask in the first weeks
How long does it take to get Wayrilz after it is prescribed?
There is no fixed number of days for this step. There is no REMS, so the baseline liver tests and the insurance approval are usually the slow parts. HemAssist's Free Trial Program can supply the first month while coverage is worked out.
Does Wayrilz need blood tests?
The label asks for liver tests, bilirubin and liver enzymes, before starting and as needed during treatment. It also asks for a pregnancy check before starting in anyone who can become pregnant. Your hematologist will also keep checking platelet counts to see whether it is working.
How long does Wayrilz take to work?
In the LUNA-3 trial, the median time to a first platelet response was 36 days. By week 12, 64% of patients on Wayrilz had responded, against 32% on placebo. In the last 12 weeks of the 24-week trial, 23% had a durable response against none on placebo.
What if I miss a dose of Wayrilz?
The Patient Information says to take it as soon as you remember on the same day. The missed dose should be at least 2 hours apart from the next regular dose.
Can I take heartburn medicine with Wayrilz?
The label says to avoid proton pump inhibitors, because they lower Wayrilz levels. Antacids and H2 blockers are allowed if Wayrilz is taken at least 2 hours before them. Ask your hematologist before changing any heartburn medicine.
Why was Wayrilz denied by my insurance?
The FEP policy, one example, wants proof of a poor response to an earlier ITP treatment and a platelet count under 50,000. It also will not approve Wayrilz alongside a TPO receptor agonist. HemAssist can help the office with coverage questions and an appeal.
Does Medicare cover Wayrilz?
Coverage depends on the plan, and Sanofi has not published a Medicare figure. The HemAssist copay program is closed to Medicare patients by its terms. Ask HemAssist whether the Patient Assistance Program fits your situation.
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Sources
- DailyMed - WAYRILZ- rilzabrutinib tablet, film coated (prescribing information and Patient Information, revised August 2025), Genzyme Corporation (Sanofi), via DailyMed, August 26, 2025.
- NDA 219685 approval letter, Wayrilz (rilzabrutinib) tablets, August 29, 2025, FDA, August 29, 2025.
- Access Treatment and Support for WAYRILZ | Sanofi HemAssist, Sanofi, November 7, 2026.
- Insurance and Financial aid for Rare Blood Disorder | Sanofi HemAssist, Sanofi, November 7, 2026.
- WAYRILZ Prior Authorization Checklist, Sanofi, February 1, 2026.
- Pharmacy Policy 5.85.073, Wayrilz, Blue Cross Blue Shield Federal Employee Program, July 1, 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 hematologist. Found an error? Use the report link in the footer and it will be checked against the source.