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TAVALISSE can help you reach your treatment goals

We couldn’t find a way to get my platelets up, so my doctor and I talked through my options and decided to try TAVALISSE. —Patient being treated with TAVALISSE

TAVALISSE has helped patients increase and maintain their platelet counts

In studies that included 150 adults with chronic immune thrombocytopenia (ITP), TAVALISSE was compared to placebo (a sugar pill) to see how effective it was at raising platelet counts over 6 months. All patients in these studies had taken at least one prior treatment that did not work well enough to manage their chronic ITP, such as steroids, immunoglobulins, rituximab, thrombopoietin receptor agonists, and/or splenectomy.

It does not matter where you are in your treatment journey—patients who benefited from TAVALISSE did so regardless of the type or number of treatments they had tried in the past.

What results can I expect from taking TAVALISSE?

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INCREASED PLATELET COUNTSWITH TAVALISSE

At the start of the TAVALISSE studies, patients with chronic ITP had low platelet counts, with an average of 16,000 platelets per microliter. Some patients who responded to treatment experienced a significant increase in their platelet counts, reaching an average of

97,000

platelets per microlitera

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platelet increasesWITHIN WEEKS

Most patients who had a positive response to taking TAVALISSE saw increased platelet counts during their first weeks on treatment, while others took longer to see a response.

Your healthcare provider will monitor your platelet counts and make any dose adjustments that are right for you.

After you take TAVALISSE for 3 months, your healthcare provider should be able to tell if you are responding to treatment.

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response lasting3+ years

In an ongoing study, most patients who responded to treatment with TAVALISSE have maintained an increased platelet count beyond 3 years.b

aA subset of patients who took TAVALISSE in these studies had a stable response, which was defined as having a platelet count of over 49,999 platelets per microliter at least 4 times during the last 3 months of the study. These numbers—16,000 and 97,000 platelets per microliter—are the average platelet counts from the beginning and end of the study in these patients.

bThese are patients who achieved a response to TAVALISSE in a reasonable amount of time, defined in this study as reaching a platelet count of over 49,999 platelets per microliter within 3 months (12 weeks) of starting treatment.

Every person’s body is different, so your response to TAVALISSE may vary. Your healthcare provider will monitor your platelet counts, watch for any side effects, and make changes to your treatment to help you reach your goals.

Understanding potential side effects

What is the most important safety information I should know?

Your healthcare provider will explain the common and serious side effects that people may have while taking TAVALISSE, and give you tips on how to manage some of them. 

The most common side effects of TAVALISSE include:

  • Diarrhea
  • High blood pressure
  • Nausea
  • Rash
  • Dizziness
  • Tiredness
  • Liver problems
  • Respiratory infection
  • Chest pain
  • Stomach (abdomen) pain
  • Decrease in white blood cell count (neutropenia)

These are not all the side effects of TAVALISSE. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA, at 1-800-FDA-1088.

Your healthcare provider will want to know how you are doing on TAVALISSE. They may change your dose, temporarily stop, or permanently stop treatment with TAVALISSE if you have side effects.

If I get diarrhea, are there ways to manage it?

Your healthcare provider may recommend the following:

stay hydrated
Stay hydrated

To prevent dehydration, drink fluids throughout the day, such as water, electrolytes, decaffeinated tea, and clear broth.

diet
Make changes to your diet

Eat small meals often and limit foods that are spicy, greasy, or high in fiber (such as nuts or seeds).

take medicine
Take medicine

Some over-the-counter antidiarrheal medicines can help provide relief. Your healthcare provider can help with specific recommendations.

Patient testimonial—Raynelle’s story

For a decade, Raynelle struggled with frequent disruptions in her daily routine due to chronic ITP. Then her doctor prescribed TAVALISSE. Watch this video to hear more about her journey.

Important Safety Information

What is TAVALISSE?

TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough. It is not known if TAVALISSE is safe and effective in children.

What is the most important information I should know about TAVALISSE?

TAVALISSE can cause serious side effects including: 

  • High blood pressure (hypertension). New or worsening high blood pressure is common in people treated with TAVALISSE and can be severe. Your healthcare provider will check your blood pressure regularly during treatment with TAVALISSE. If needed, your healthcare provider may start you on blood pressure medicine or change your current medicine to treat your blood pressure. Tell your healthcare provider if you get headaches, confusion, dizziness, chest pain, or shortness of breath.
  • Liver problems. Changes in liver function blood tests are common with TAVALISSE. Liver problems may occur and can be severe. Your healthcare provider will regularly do blood tests to check how well your liver is working during treatment with TAVALISSE.
  • Diarrhea. Diarrhea is common in people treated with TAVALISSE and can be severe. Tell your healthcare provider if you get diarrhea during treatment with TAVALISSE. Your healthcare provider may recommend changes in your diet, drinking more water, or medicine to limit these symptoms.
  • Decreases in white blood cell count (neutropenia). Decreases in your white blood cell count are common with TAVALISSE and can be severe. This may increase your risk for infection, including serious infections. Your healthcare provider will regularly do blood tests to check your white blood cell counts.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAVALISSE if you have side effects.

What do I need to discuss with my healthcare provider before taking TAVALISSE?

Before you take TAVALISSE, tell your healthcare provider about all of your medical conditions, including if you: 

  • have high blood pressure
  • have liver problems
  • are pregnant or plan to become pregnant. TAVALISSE can harm your unborn baby.
    • Your healthcare provider will check if you are pregnant before starting treatment with TAVALISSE.
    • Females who can become pregnant should use effective birth control during treatment with TAVALISSE and for at least 1 month 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 TAVALISSE with certain other medicines may affect how the other medicines work or how TAVALISSE works. 

What are the possible side effects of TAVALISSE?

The most common side effects of TAVALISSE include:

  • Nausea, rash, dizziness, tiredness, respiratory infection, chest pain, and stomach (abdomen) pain.

These are not all the side effects of TAVALISSE. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA, at 1-800-FDA-1088

Back to the top

Important Safety Information

What is TAVALISSE?

TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment  for ITP has not worked well enough. It is not known if TAVALISSE is safe and effective in children.

What is the most important information I should know about TAVALISSE?

TAVALISSE can cause serious side effects including:

  • High blood pressure (hypertension). New or worsening high blood pressure is common in people treated with TAVALISSE and can be severe. Your healthcare provider will check your blood pressure regularly during treatment with TAVALISSE. If needed, your healthcare provider may start you on blood pressure medicine or change your current medicine to treat your blood pressure. Tell your healthcare provider if you get headaches, confusion, dizziness, chest pain, or shortness of breath.

September is ITP Awareness month

Join Rigel in helping to raise awareness of immune thrombocytopenia (ITP) and showing support for ITP patients, care partners, and healthcare providers

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