Wayrilz

Wayrilz (rilzabrutinib) is a prescription oral medicine used to treat persistent or chronic immune thrombocytopenia (ITP) in adults who have not responded sufficiently to previous treatments.

Wayrilz is an oral reversible Bruton’s tyrosine kinase inhibitor (BTK inhibitor).

Wayrilz works by blocking Bruton’s tyrosine kinase, a protein involved in immune cell signaling that contributes to the immune system's destruction of platelets. By inhibiting BTK, Wayrilz reduces the immune system's attack on platelets, which increases and stabilizes platelet counts to improve ITP symptoms.

Common Wayrilz side effects are diarrhea, nausea, headache, stomach pain, and COVID-19.

Wayrilz is an oral tablet taken twice daily.

Wayrilz (rilzabrutinib) was approved by the FDA on August 29, 2025, following positive results from the Phase 3 LUNA-3 trial, which showed sustained platelet improvements in adults with immune thrombocytopenia (ITP).

Wayrilz has demonstrated clinically meaningful effectiveness in adults with persistent or chronic immune thrombocytopenia (ITP) who did not respond adequately to prior treatments.

Wayrilz Effectiveness Results (LUNA-3 Trial)

• Durable platelet response: In the Phase 3 LUNA-3 clinical trial (NCT04562766), 23% of patients treated with Wayrilz achieved and maintained target platelet counts (≥50,000/µL), compared with 0% in the placebo group.
• Time to platelet response: Among patients who responded, the median time to reach target platelet levels was 36 days, indicating that many patients experienced improvement within the first month of treatment.

Take Wayrilz exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking these tablets unless your healthcare provider tells you to.

• Take Wayrilz 2 times a day at about the same time each day.
• Take tablets with or without food.
• Swallow Wayrilz tablets whole with a glass of water. Do not cut, crush, or chew the tablets.
• If you experience diarrhea, nausea, or stomach area (abdominal) pain during treatment with this medicine, taking it with food may reduce these side effects.
• If you take an antacid or H2 blocker medicine, take your dose of Wayrilz at least 2 hours before taking an antacid or H2 blocker medicine. If you take a Proton Pump Inhibitor (PPI) medicine, talk to your healthcare provider.

Before taking Wayrilz, tell your healthcare provider about all of your medical conditions, including if you:

• liver problems
• kidney problems

Pregnancy

Tell you healthcare providers if you are pregnant or plan to become pregnant. Wayrilz may harm your unborn baby. If you are able to have a baby, your healthcare provider will do a pregnancy test before starting treatment withthis medicine.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with this medicine and for 1 week after the last dose.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if WAYRILZ passes into your breast milk. Do not breastfeed during treatment with Wayrilz and for at least 1 week after the last dose.

The most common Wayrilz side effects are diarrhea, nausea, headache, stomach area (abdominal) pain and COVID-19

Serious side effects and warnings

Wayrilz may cause serious side effects, including:

• Serious infections. This medicine can increase the risk of infections, including serious infections that can lead to death. Your healthcare provider will check you for signs and symptoms of infection during your treatment with Wayrilz. Tell your healthcare provider right away if you get any signs or symptoms of infection, including fever, chills, or flu-like symptoms.
• Liver problems, including Drug-Induced Liver Injury (DILI). Liver problems, which may be severe, life-threatening, or lead to death, have happened in people treated with Bruton’s tyrosine kinase (BTK) inhibitors. Your healthcare provider will do blood tests to check your liver before and as necessary during treatment with this medicine. Tell your healthcare provider right away if you have any signs or symptoms of liver problems, including stomach-area (abdominal) pain or discomfort, dark or “tea-colored” urine, or yellowing of the skin or the white part of your eyes.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Recommended dose: 400 mg twice daily with or without food Dose modification due to hepatotoxicity

Assess liver function tests (including bilirubin and transaminases) at baseline and as clinically indicated during treatment with Wayrilz (rilzabrutinib).

For patients who develop abnormal liver test results while receiving Wayrilz:

• Increase the frequency of monitoring for liver enzyme abnormalities.
• Monitor for clinical signs and symptoms of hepatic toxicity.

If drug-induced liver injury (DILI) is suspected:

• Withhold Wayrilz pending further evaluation.

If drug-induced liver injury is confirmed:

• Permanently discontinue Wayrilz.

If you miss a dose of Wayrilz, take the missed dose as soon as you remember on the same day and at least 2 hours apart from the next regular scheduled dose. If you take too much WAYRILZ, call your healthcare provider or Poison Help Line at 1-800-222-1222.

You should avoid grapefruit, starfruit, and products that have these fruits, and Seville oranges (often used in marmalades) during treatment with Wayrilz. These products may increase the amount of the active ingredient rilzabrutinib in your blood, which increases the risk of side effects of Wayrilz.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Wayrilz with certain other medicines may affect how it works and can cause side effects. Wayrilz may also affect how other medicines work. Know the medicines you take and keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Avoid using Wayrilz with:

• Moderate or strong CYP3A inhibitors
• Moderate or strong CYP3A inducers: Avoid using Wayrilz with moderate or strong CYP3A inducers.
• Gastric acid-reducing agents called proton pump inhibitors (PPIs).

Wayrilz should be administered at least 2 hours before taking an antacid or H2 receptor antagonist.

This is not a complete list of interactions. See the Wayrilz Prescribing Information for a complete list.

Store at room temperature between 20°C to 25°C (68°F to 77°F) in the original packaging.

Protect from light and moisture.

Active ingredients: rilzabrutinib

Inactive ingredients:

• Tablet core: crospovidone (Type A), microcrystalline cellulose, and sodium stearyl fumarate;
• Tablet coating: FD&C yellow #6/Sunset yellow FCF aluminum lake, macrogol/polyethylene glycol (PEG), polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.

Genzyme Corporation Cambridge, MA 02141 A SANOFI COMPANY