WAYRILZ

Frequently Asked Questions

ABOUT ITP

What is ITP?

ITP is a rare autoimmune disorder in which your body mistakenly attacks its own platelets. Platelets are vital blood cells that help your blood clot. When platelets are destroyed or reduced, it leads to a lower-than-normal platelet count, raising the risk of bleeding.



Learn about ITP

How does ITP impact the immune system?

A healthy immune system is designed to stay in balance, responding when needed and settling down when the threat is gone.


In ITP, parts of the immune system become overactive and start attacking platelets by mistake.


This disruption in immune balance is one of the key reasons ITP is considered an autoimmune condition, not just a platelet disorder.

What are the common symptoms of ITP?

Common symptoms of ITP include:

  • Easy bruising or bruises without a clear cause
  • Red or purple pinpoint spots on arms and legs (petechiae)
  • Frequent or prolonged bleeding (like heavy periods in women, bleeding gums or nosebleeds)
  • ITP may also impact aspects of your daily life, such as your energy levels, fatigue, and mood


See how ITP can affect daily life

How does ITP impact quality of life?

ITP can affect how you feel, both physically and emotionally. Fatigue, brain fog, anxiety about platelet counts, and a limited ability to complete daily tasks are common for many people living with ITP.


Learn more about the impact of ITP on daily life

How do I know if it’s time to consider a new ITP treatment?

It may be time to consider a new treatment if your current treatment isn’t working well enough, your platelet levels are difficult to maintain, or you’re still experiencing ITP symptoms.


Talk to your doctor about your symptoms, treatment goals, and whether WAYRILZ may be right for you.

ABOUT WAYRILZ

What is a multi-immune modulator in ITP?

A multi-immune modulator is a type of medicine used to treat ITP.


WAYRILZ, a Bruton's tyrosine kinase (BTK) inhibitor, is a multi-immune modulator.


It works by selectively targeting key sources of ITP in multiple ways to help restore immune balance, which may allow your body to better protect and raise platelet counts.

What is WAYRILZ?

WAYRILZ is a twice-daily pill for adults with persistent or chronic ITP. It can be prescribed by your doctor as early as after your first treatment for ITP (such as steroids or intravenous immunoglobulin, IVIg) if that treatment didn't work well enough.

How is WAYRILZ different from other ITP treatments?

Some treatments for ITP broadly suppress the immune system (such as steroids or immunosuppressants). Others focus primarily on increasing platelet production (such as thrombopoietin receptor agonists, TPO-RAs).


WAYRILZ is designed to target key sources of ITP—helping to restore immune balance—which may allow your body to better protect and raise platelet counts.


Explore how WAYRILZ works

How does WAYRILZ work?

In ITP, the immune system is out of balance and mistakenly attacks your platelets. A protein called Bruton's tyrosine kinase (BTK) plays a key role in sending signals that drive this imbalance. WAYRILZ is a BTK inhibitor—it works by targeting and modulating those harmful signals at the source.

Is WAYRILZ a steroid or an immunosuppressant?

WAYRILZ is not a steroid or an immunosuppressant.


Steroids and other immunosuppressants work in ways that broadly suppress the immune system.


WAYRILZ is a BTK inhibitor designed to target and modulate specific overactive immune signals without broadly suppressing the immune system.


Learn more about how WAYRILZ works

Can WAYRILZ help to improve platelet counts?

By month 6 in the clinical study, 23% of people taking WAYRILZ reached and maintained target platelet counts (at least 50,000) compared to 0% of people not taking WAYRILZ.


During the last 12 weeks of the study, people reached a platelet level of 50,000 or higher more than 5 times when measured weekly, without rescue therapy, including at least twice in the final 6 weeks.


Many reached target platelet counts quickly—within the first few weeks—and people taking WAYRILZ were able to keep platelet counts up longer.*


Also, fewer people taking WAYRILZ needed additional emergency treatment to raise platelet counts.†


See the clinical study results


*Platelet counts reached 50,000 or higher, or between 30,000 and <50,000 and at least doubled from where they started, without emergency treatment.
†During the study, 58% of people who did not take WAYRILZ needed additional treatment compared to only 33% of people taking WAYRILZ. Medicines like IVIg, or intravenous immunoglobulin, were given only if needed.

How did the WAYRILZ study consider impact of ITP on daily life?

People taking WAYRILZ reported the impact it had on their quality of life.


Prior to the start of the study, patients completed a survey called the ITP-PAQ that looked at how ITP affected different parts of their lives. At month 6, patients took the ITP-PAQ survey again. Each measurement was reported with a score ranging from 0 to 100, with a higher score indicating improving and lower score indicating worsening.


For example, people taking WAYRILZ saw an improvement in overall quality of life by 10.6 points vs 2.3 points for those not taking WAYRILZ.


The results of these analyses are descriptive and not statistically tested to determine a difference between treatment groups.


ITP can affect more than just platelet counts. When talking with your doctor about treatment goals, it’s important to consider how the impact of ITP shows up in your day-to-day life.

How long will I take WAYRILZ?

If WAYRILZ is right for you, it may be used as an ongoing treatment to help maintain consistent platelet counts over time. Your doctor will decide how long you should take WAYRILZ based on how you respond.

Do I need to try several treatments before taking WAYRILZ?

WAYRILZ is FDA approved for adults with persistent or chronic ITP who received a prior treatment that did not work well enough.


You don't have to try multiple different treatments before your doctor can prescribe WAYRILZ.


If your first treatment (like steroids or IVIg) isn't working as well as you and your doctor had hoped—or if you've tried multiple treatments—WAYRILZ could be an option for you.

TAKING WAYRILZ

How is WAYRILZ taken?

WAYRILZ is a pill taken twice a day. It can conveniently fit into your schedule because there are no infusions and no injections.


You can take WAYRILZ with food, or without food. Swallow pills whole with water. Do not chew, cut, or crush.


Taking WAYRILZ with food may help if you experience stomach-related side effects.


Take WAYRILZ exactly as your doctor tells you to take it. Do not change your dose or stop taking WAYRILZ unless your doctor tells you to.


Learn how to take WAYRILZ

What should I expect when starting WAYRILZ?

Take WAYRILZ exactly as your doctor tells you to take it. Do not change your dose or stop taking WAYRILZ unless your doctor tells you to.


WAYRILZ is one pill taken twice a day. You can take WAYRILZ with food, or without food. If you experience diarrhea, nausea, or stomach area (abdominal) pain during treatment with WAYRILZ, taking it with food may reduce these side effects.


Swallow pills whole with water. Do not cut, crush, or chew.


Tell your doctor if you are taking medications for heartburn, acid reflux, or ulcers, such as antacids, H2 (histamine-2) blockers, or proton pump inhibitors (PPIs), as these may require additional instructions.


If you miss a dose, take the missed dose as soon as you remember on the same day and at least 2 hours apart from the next regularly scheduled dose.


Learn what to expect when starting WAYRILZ

How quickly can WAYRILZ start working?

WAYRILZ can help raise platelet counts relatively quickly, though how fast it works varies from person to person.


In the clinical study, people taking WAYRILZ who responded to treatment in the first 3 months reached target platelet counts typically around week 2,* with the overall group reaching target counts around week 5.†


Your doctor will monitor your platelet counts regularly to track your response, and it's important to continue taking WAYRILZ as prescribed even if you don't see immediate changes.


The most important thing is to maintain regular follow-up appointments so your healthcare provider can determine if WAYRILZ is providing the expected benefits for your ITP management.


*Within the first 3 months of the study, platelet counts reached ≥50,000 or between 30,000 and <50,000 and at least doubled from where they started, without needing emergency treatment.

†Platelet counts reached 50,000 or higher, or between 30,000 and <50,000 and at least doubled from where they started, without emergency treatment.

What are the most common side effects of WAYRILZ?

The most common side effects of WAYRILZ include:

  • Diarrhea
  • Nausea
  • Headache
  • Stomach area (abdominal) pain
  • COVID-19*


Taking WAYRILZ with food may help reduce or prevent some stomach-related symptoms, such as diarrhea and nausea.


These are not all of the possible side effects of WAYRILZ.


Call your doctor for medical advice, including tips on managing potential side effects. You may report side effects to the FDA at 1-800-FDA-1088.


*The WAYRILZ study was conducted during the COVID-19 pandemic. COVID-19 cases that occurred during the study were reported as part of the safety data.


Read more about safety

Why is COVID-19 listed as a side effect of WAYRILZ?

The WAYRILZ study took place during the COVID-19 pandemic. Because COVID-19 infections occurred during the study, they were reported as part of the safety results.


Read more about safety

Are there any foods or medicines I should avoid while taking WAYRILZ?

You should avoid grapefruit, starfruit and products that have these fruits, and Seville oranges (often used in marmalades) while taking WAYRILZ. These products may increase the amount of WAYRILZ in your blood, which increases the risk of side effects of WAYRILZ.


Tell your doctor about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements.


Taking WAYRILZ with certain other medicines may affect how WAYRILZ works and can cause side effects. WAYRILZ may also affect how other medicines work.


Please tell your doctor if you are taking medications for heartburn, acid reflux, or ulcers, such as antacids, H2 (histamine-2) blockers, or proton pump inhibitors (PPls), as these may require additional instructions.

What if I miss a dose of WAYRILZ?

If you miss a dose, take it as soon as possible on the same day and return to your regular schedule the following day. The missed dose and next regular scheduled dose must be taken more than 2 hours apart. Do not take an extra dose to make up for a missed dose.


Take WAYRILZ exactly as your doctor tells you to take it. Do not change your dose or stop taking WAYRILZ unless your doctor tells you to.


Learn how to take WAYRILZ

STARTING WAYRILZ

How do I talk to my doctor about WAYRILZ?

You can start by getting your own personalized guide on this website. Answer a few questions about how ITP affects you, as well as your treatment goals. This may help you have a more productive conversation with your doctor when discussing if WAYRILZ could be a good option for you.


Start your personalized guide

Can I travel with WAYRILZ?

Absolutely!


Because it’s an oral treatment, WAYRILZ is easy to take with you—no refrigeration or special handling needed.


WAYRILZ should be kept at room temperature in the original packaging. Protect WAYRILZ from light and moisture.


Learn how to take WAYRILZ

What support is available for WAYRILZ?

Living with ITP can be a complex path to follow. But you’re not alone. Our dedicated HemAssist team is here to help. We’ll work with you one-to-one to help you start and stay with treatment as prescribed.


This includes:

  • Assistance navigating insurance coverage and helping you understand your out-of-pocket costs
  • Identifying the financial assistance programs for which you may be eligible
  • Providing education about your condition and treatment
  • Supplemental training on taking your treatment
  • Offering tools and tips to help build a treatment routine
  • Helping you navigate life changes and transitions


Learn more about support along the way with HemAssist

Can I afford WAYRILZ?

Every person’s situation is different, which is why we work directly with you to help identify the financial assistance programs for which you may be eligible.


Explore what financial options may be available for you

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WHAT IS WAYRILZ?
WHAT IS WAYRILZ?
IMPORTANT SAFETY INFORMATION
WHAT IS WAYRILZ?

WAYRILZ is a prescription medicine that is used to treat adults with persistent or chronic immune thrombocytopenia (ITP) who received a prior treatment that did not work well enough.

It is not known if WAYRILZ is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking WAYRILZ?


Tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • have kidney problems
  • 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 with WAYRILZ. Females who are able to become pregnant should use an effective birth control during treatment with WAYRILZ and for 1 week after the last dose.
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with WAYRILZ and for at least 1 week after the last dose.


Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. Taking WAYRILZ with certain other medicines may affect how WAYRILZ works and can cause side effects. WAYRILZ may also affect how other medicines work.


What should I avoid while taking WAYRILZ?


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 WAYRILZ in your blood, which increases the risk of side effects of WAYRILZ.


What are the possible side effects of WAYRILZ?


WAYRILZ may cause serious side effects, including:

  • Serious infections. WAYRILZ 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 WAYRILZ. 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.


The most common side effects of WAYRILZ include diarrhea, nausea, headache, stomach area (abdominal) pain, and COVID-19.


These are not all of the possible side effects of WAYRILZ.

Please see full Prescribing Information, including Patient Information.

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