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Overview: Tavalisse is commonly used to treat low platelet levels in people with a condition called immune thrombocytopenia, where the body attacks and destroys its own platelets. Tavalisse helps to stop the body from destroying platelets by blocking a substance called spleen tyrosine kinase (SYK). Common side effects include diarrhea, high blood pressure, nausea or stomach pain, dizziness, tiredness, and infections in the nose, throat, or lungs. Tell your health care provider right away if you have severe diarrhea (more than seven stools in one day) or have symptoms of very high blood pressure such as a sudden headache, confusion, chest pain, or trouble breathing.

Uses

What is Tavalisse used for?

Tavalisse (fostamatinib) is commonly used to treat low platelet levels in people with a chronic (long-term) condition called immune thrombocytopenia (ITP).

Tavalisse may also be used for other conditions as determined by your health care provider.

How does Tavalisse work (mechanism of action)?

In people with immune thrombocytopenia (ITP), the immune system attacks and destroys its own platelets. Some of the signals that tell the immune system to destroy its own platelets are sent through a substance called spleen tyrosine kinase (SYK). Tavalisse blocks SYK, which helps to stop the immune system from destroying platelets.

How is Tavalisse supplied (dosage forms)?

Brands and other names

  • Tavalisse

Dosage forms and strengths

  • 100 mg oral tablets
  • 150 mg oral tablets

How should I store Tavalisse?

Tavalisse should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in the original bottle. Do not remove the moisture-absorbing canisters (desiccants) from the bottle.

Side Effects

What are the most common side effects of Tavalisse?

The most common side effects of Tavalisse are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea (see below)
  • High blood pressure (see below)
  • Nausea
  • Infections in the nose, throat, or lungs
  • Dizziness
  • Liver damage (see below)
  • Rash
  • Stomach pain
  • Tiredness
  • Chest pain
  • Low neutrophil levels (neutropenia) (see below)

There may be other side effects of Tavalisse that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tavalisse?

While less common, the most serious side effects of Tavalisse are described below, along with what to do if they happen.

Severe Allergic Reactions. Tavalisse may cause allergic reactions, which can be serious. Stop taking Tavalisse and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Diarrhea. Diarrhea is common with Tavalisse. Tell your health care provider if you develop diarrhea. If you are given medicine to prevent or treat diarrhea, take it exactly as your health care provider tells you. Your health care provider may also recommend changes to your diet or lifestyle to help prevent diarrhea. Call your health care provider right away if you have any of the following.

  • Severe diarrhea, such as seven or more loose stools in one day
  • Diarrhea with weakness, dizziness, or fever

Increased Blood Pressure (Hypertension). Tavalisse may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Tavalisse. Your health care provider may monitor your liver function while you are taking this medicine. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Low Neutrophil Levels (Neutropenia). Tavalisse may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Tell your health care provider right away if you have any of the following symptoms of infection or low neutrophil levels.

  • Fever, chills, or sweats
  • Cough or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Warnings & Precautions

Who should not use Tavalisse?

Allergies to Ingredients. People who are allergic to any of the following should not take Tavalisse.

  • Fostamatinib
  • Tavalisse
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific Tavalisse products they stock.

What should I know about Tavalisse before using it?

Do not take Tavalisse unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Tavalisse with other people, even if they have the same condition as you. It may harm them.

Keep Tavalisse out of the reach of children.

Tavalisse can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how this medicine affects you.

Keep all follow-up appointments. Your health care provider may need to monitor your blood tests and blood pressure to help prevent side effects and determine the best dose of Tavalisse for you.

What should I tell my health care provider before using Tavalisse?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Tavalisse is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • High blood pressure
  • Liver problems

Other Medicines and Supplements. Tavalisse may interact with other medicines and supplements. Before or after using Tavalisse, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Tavalisse may cause harm to your fetus. You must not be pregnant before starting Tavalisse. Tell your health care provider if you are pregnant or plan to become pregnant. If you can become pregnant, you should use effective birth control during treatment with Tavalisse and for at least one month after your last dose.

Breastfeeding. It is not known if Tavalisse passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Tavalisse or for at least one month after your last dose. Your health care provider will let you know if you should stop breastfeeding or stop Tavalisse.

How can I get more information about Tavalisse?

For more information about Tavalisse, you can visit the drugmaker’s website at www.tavalisse.com or call them at 800-983-1329.

Interactions

Does Tavalisse interact with foods or drinks?

There are no known interactions between Tavalisse and foods or drinks.

It is unknown if drinking alcohol will affect Tavalisse.

Does Tavalisse interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Many medicines may alter the blood levels of Tavalisse, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Tavalisse. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Tavalisse?

If you or someone else has used too much Tavalisse, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Tavalisse?

If you miss a dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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