Tavalisse is a brand-name oral tablet prescribed for low platelet levels due to chronic immune thrombocytopenia. Tavalisse contains the active drug fostamatinib.
Tavalisse is FDA-approved to treat low platelet levels in certain adults with chronic (long-term) immune thrombocytopenia (ITP). It’s prescribed for people who’ve tried other ITP treatments that weren’t effective.
You’ll find key information about Tavalisse below.
- Drug class: Kinase inhibitor
- Drug form: Oral tablet
- Generic available? No
- Prescription required? Yes
- Controlled substance? No
- Year of FDA approval: 2018
Tavalisse can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Tavalisse. These lists do not include all possible side effects.
For more information about the possible side effects of Tavalisse, talk with your doctor or pharmacist. They can give you tips on managing any side effects that may concern or bother you.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Tavalisse, you can do so through MedWatch.
Mild side effects
Mild side effects* of Tavalisse can include:
Most of these side effects may go away within a few days to a couple of weeks. If they become more severe or don’t go away, talk with your doctor or pharmacist.
* This is a partial list of mild side effects from Tavalisse. To learn about other mild side effects, talk with your doctor or pharmacist, or see the Tavalisse prescribing information.
† For more information about this side effect, see “Side effect details” below.
Serious side effects
Serious side effects from Tavalisse aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Elevated liver enzymes, which may be a sign of liver problems. Symptoms can include:
- abdominal pain
- High blood pressure.*
- Low level of certain white blood cells.*
- Allergic reaction.*
* For more information about this side effect, see “Side effect details” below.
Side effect details
Here are some details about certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Tavalisse.
High blood pressure
What you can do
Your doctor will likely have you monitor your blood pressure at home while you take Tavalisse. In most cases, they’ll want to check your blood pressure in their office every 2 weeks until you’re on a stable dose.* Your doctor will then usually monitor your blood pressure once every month to see if it’s still at a safe level.
If your blood pressure increases, your doctor may prescribe medication to lower it. After you start taking the blood pressure drug, your blood pressure could remain high. In this situation, your doctor may decrease your dose of Tavalisse. If you have very high blood pressure that may become dangerous, your doctor may pause or stop treatment with Tavalisse.
* Your doctor may need to adjust your dose of Tavalisse to find the amount that works best for you.
Diarrhea may occur with Tavalisse. This was one of the most common side effects of people who took Tavalisse in clinical trials. Most cases of diarrhea in the trials were mild. However, there were some severe cases of diarrhea reported.
What you can do
If you have diarrhea during your treatment with Tavalisse, talk with your doctor. They may recommend drinking more water and changing your diet. The goal is to ease the diarrhea and help prevent dehydration. In addition, your doctor may recommend a diarrhea medication.
If you have severe diarrhea, your doctor may decrease your dose of Tavalisse. Or they could pause or stop your treatment with the drug.
Low level of certain white blood cells
Tavalisse may decrease the level of neutrophils in your body. These are white blood cells that help your immune system fight infection. With a low level of neutrophils, your immune system may weaken. This can increase your risk of infection. A low neutrophil level (called neutropenia) does not usually cause symptoms. However, an infection due to neutropenia may cause symptoms such as a fever, sore throat, or cough.
What you can do
If you develop symptoms of infection while taking Tavalisse, talk with your doctor. An infection may mean that your neutrophil level is low. Your doctor will monitor your neutrophil level throughout your treatment.
If you develop a low white blood cell level with Tavalisse, your doctor may pause your treatment. In some cases, they may decrease your dose. If your level is very low, your doctor may recommend a medication other than Tavalisse.
As with most drugs, some people can have an allergic reaction after taking Tavalisse.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
Call your doctor right away if you have an allergic reaction to Tavalisse, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
As with all medications, the cost of Tavalisse can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Keep in mind that you may be able to get a 90-day supply of Tavalisse. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.
It’s important to note that you may have to get Tavalisse at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.
Before approving coverage for Tavalisse, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.
If you’re not sure whether you’ll need to get prior authorization for Tavalisse, contact your insurance company.
Financial and insurance assistance
If you need financial support to pay for Tavalisse, or if you need help understanding your insurance coverage, help is available.
Rigel Pharmaceuticals, Inc., the distributor of Tavalisse, offers a program called Rigel OneCare as well as Tavalisse copay assistance. For more information and to find out if you’re eligible for support, call 833-rigelOC (833-744-3562) or visit the drug website.
To learn more about saving money on prescriptions, check out this article.
Tavalisse may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.
If recommended by your doctor, you may be able to receive a 90-day supply of Tavalisse, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.
If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.
Tavalisse is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.
Tavalisse is used to treat low platelet levels due to a condition called chronic immune thrombocytopenia (ITP). With ITP, your immune system mistakenly attacks your platelets (cells that help your blood clot). In addition, ITP can cause your body to make platelets more slowly than usual. With fewer platelets, you may bruise or bleed more easily.
What’s the mechanism of action of Tavalisse?
The way the drug works is known as its mechanism of action. The mechanism of action of Tavalisse is to block the action of a protein in your body called spleen tyrosine kinase (SYK). This protein causes a series of immune system events that eventually leads your body to destroy platelets.
By blocking the activity of SYK, Tavalisse helps prevent platelets from being destroyed. With an increased level of platelets, ITP symptoms ease.
How long does it take to work?
Tavalisse may begin to work as soon as you take your first dose. However, it can take time before you notice a change in your symptoms. Talk with your doctor about what to expect.
Here are answers to some frequently asked questions about Tavalisse.
How does Tavalisse compare with the drugs Promacta and Nplate?
Tavalisse, Promacta (eltrombopag), and Nplate (romiplostim) are all medications approved to treat chronic immune thrombocytopenia. Tavalisse is approved for use only in adults. Promacta and Nplate are prescribed for adults and children of certain ages. Promacta is also approved to treat low platelet levels in people with hepatitis C or certain types of anemia.
Both Tavalisse and Promacta come as oral tablets. Promacta is also available as an oral liquid suspension. Nplate is given only as a subcutaneous injection.
Although these three medications are all used to increase your platelet levels, they work in different ways. This means that the dosing and side effects of the medications are also different.
Your doctor may recommend one medication over the others based on what medical conditions you have and what medications you’re taking. Talk with your doctor about the best treatment plan for you.
What tests will I need during Tavalisse treatment?
Your doctor will recommend certain tests throughout your treatment with Tavalisse. These can include blood tests, such as complete blood counts and liver function tests. You’ll likely have these blood tests every month, especially at the beginning of your treatment.
Your doctor will also probably recommend monitoring your blood pressure. When you first start Tavalisse treatment, you’ll usually check your blood pressure every 2 weeks. Your doctor may need to adjust your dose of Tavalisse to find the amount that works best for you. When your doctor no longer needs to adjust your Tavalisse dose, you’ll likely check your blood pressure monthly.
If you have additional questions about what tests you’ll need throughout your treatment with Tavalisse, talk with your doctor.
Is Tavalisse a biologic?
Tavalisse is not a biologic drug. Biologics are specialized medications that are made from living cells.
If you have additional questions about the use of biologics for chronic ITP, talk with your doctor.
* Some of these drugs are used off-label to treat ITP. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.
Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Tavalisse, talk with your doctor. They can tell you about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.
Alternatives for chronic immune thrombocytopenia
Examples of other drugs that doctors may prescribe to treat chronic immune thrombocytopenia include:
The Tavalisse dosage your doctor prescribes will depend on several factors. These include:
- how well Tavalisse is working for you
- side effects that you experience with Tavalisse
Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Tavalisse comes as an oral tablet. It comes in strengths of 100 milligrams (mg) and 150 mg.
Dosage for chronic immune thrombocytopenia
The recommended dosage of Tavalisse for chronic immune thrombocytopenia is 100 mg twice per day. After you have taken Tavalisse for 1 month, your doctor will check your platelet levels. If they’re still low, your doctor may increase the dosage to 150 mg twice per day.
If you develop side effects from Tavalisse, your doctor may decrease your Tavalisse dose.
If your platelet level does not rise after taking Tavalisse for 12 weeks, your doctor might switch you to a different medication.
What if I miss a dose?
If you miss a dose of Tavalisse, skip the dose that you missed. Then take your next dose as scheduled.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Will I need to take this drug long term?
Tavalisse is meant to be used as a long-term treatment. If you and your doctor determine that Tavalisse is safe and effective for you, you’ll likely take it long term.
The Food and Drug Administration (FDA) approves prescription drugs such as Tavalisse to treat certain conditions.
Tavalisse for chronic immune thrombocytopenia
Tavalisse is FDA-approved to treat low platelet levels in adults with a condition called chronic immune thrombocytopenia (ITP). Before your doctor prescribes Tavalisse, you must have tried another ITP medication, such as prednisone (Rayos) or eltrombopag (Promacta), but it didn’t work.
Chronic immune thrombocytopenia explained
With ITP, your immune system mistakenly attacks platelets in your body. (Platelets are a type of blood cell that helps your blood clot.) ITP can also cause your body to make platelets more slowly than usual.
Low platelet counts due to ITP may cause symptoms such as:
ITP is considered chronic if it lasts long term.
Effectiveness for chronic immune thrombocytopenia
Tavalisse is an effective treatment option for people with chronic ITP who have already tried another ITP medication that did not work. The American Society of Hematology’s guidelines for ITP mention Tavalisse as an approved treatment option for chronic ITP. The guidelines specify that Tavalisse use is typically after two other treatments for ITP have been tried, but they were not successful.
For information about how Tavalisse performed in clinical trials, see the drug’s prescribing information.
Tavalisse and children
Tavalisse is not approved for use in children with ITP at this time. It’s unknown whether this drug is a safe or effective treatment option for children.
If your child has ITP, talk with their doctor about possible treatments.
Tavalisse is not known to interact with alcohol. However, alcohol can worsen some of the side effects of the medication. For example, Tavalisse may cause nausea or dizziness. Alcohol can also cause these conditions, so drinking while taking Tavalisse may increase your risk of these side effects.
Tavalisse can also cause more serious side effects, such as elevated liver enzymes, which may be a sign of liver problems. Drinking alcohol may increase the risk of liver problems as well. If you consume alcohol during Tavalisse treatment, you may have a higher risk of liver problems than usual.
If you have questions about drinking alcohol while taking Tavalisse, talk with your doctor or pharmacist.
Tavalisse can interact with several other medications. It can also interact with certain supplements and foods.
Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
Tavalisse and other medications
Below is a list of medications that can interact with Tavalisse. This list does not contain all drugs that may interact with Tavalisse.
Before taking Tavalisse, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Types of drugs that can interact with Tavalisse include:
- CYP3A4 inhibitors. These are drugs that block the action of a protein called CYP3A4. These medications may be used for a variety of conditions, including infections and heart problems. Taking Tavalisse with a CYP3A4 inhibitor may increase your risk of side effects from Tavalisse. Examples of CYP3A4 inhibitors include:
- CYP3A4 inducers. These are drugs that make a protein called CYP3A4 work faster than usual. CYP3A4 inducers may be used for a variety of conditions, including infections and seizures. Taking Tavalisse with these medications may make Tavalisse less effective than usual. Examples of CYP3A4 inducers include:
- rifampin (Rimactane)
- phenytoin (Dilantin)
- Certain cholesterol medications. Taking Tavalisse with certain cholesterol medications may increase the risk of side effects from the cholesterol drugs. Examples of these cholesterol medications include:
- Digoxin. This medication is used to treat certain heart conditions, such as congestive heart failure. Taking Tavalisse and digoxin (Lanoxin) can increase your risk of side effects from digoxin.
Tavalisse and herbs and supplements
Taking Tavalisse with a supplement called St. John’s wort may make Tavalisse less effective than usual.
St. John’s wort is sometimes used to treat depression. It’s a known CYP3A4 inducer. (For more information about CYP3A4 inducers, see “Tavalisse and other medications” above.)
If you’re currently taking St. John’s wort, talk with your doctor before starting Tavalisse treatment. They may be able to suggest an alternative to St. John’s wort.
Tavalisse and foods
Drinking grapefruit juice or eating grapefruit during your treatment with Tavalisse may increase your risk of side effects from the drug. Your doctor may recommend that you avoid consuming grapefruit and grapefruit juice while you take Tavalisse.
You should take Tavalisse according to the instructions your doctor gives you.
Take your dose of Tavalisse twice daily by mouth as directed by your doctor.
When to take
Your doctor will likely recommend that you take Tavalisse twice per day. You should take the medication at about the same time each day to keep a steady level of the drug in your body. This helps Tavalisse work effectively.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Accessible labels and containers
Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.
If you have trouble opening medication bottles, ask your pharmacist if they can put Tavalisse in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.
Taking Tavalisse with food
You can take Tavalisse with or without food.
Can Tavalisse be crushed, split, or chewed?
The manufacturer of Tavalisse has not provided any recommendations about crushing, splitting, or chewing the tablets. If you have difficulty swallowing Tavalisse, talk with your doctor or pharmacist. They can help you determine if you may be able to crush, split or chew the tablets.
Your doctor will likely recommend that you do not take Tavalisse while you’re pregnant. The drug may cause harm to a fetus. This is based on animal studies* and how Tavalisse works.
Due to this possible risk, if you can become pregnant, your doctor will order a pregnancy test for you before you start taking Tavalisse. This is to confirm that you’re not pregnant. In addition, you should use birth control during Tavalisse treatment and after for a time. For details, see the “Tavalisse and birth control” section below.
There have not been any clinical trials about whether Tavalisse affects fertility in humans. In animal studies,* female animals given Tavalisse had fewer pregnancies. Based on this information, Tavalisse may affect human fertility.
If you’re pregnant or planning to become pregnant, talk with your doctor before taking Tavalisse. They can advise you on the pros and cons of the medication.
* Animal studies do not always indicate what may happen in humans.
Your doctor will likely recommend that you do not take Tavalisse while you’re pregnant. If you’re planning a pregnancy or you or your partner can become pregnant, talk with your doctor about your birth control needs while taking Tavalisse.
For more information about taking Tavalisse during pregnancy, see the “Tavalisse and pregnancy” section above.
For females taking Tavalisse. If you’re a female* and can become pregnant, you should use an effective form of birth control while taking Tavalisse. You should continue to use it for at least 1 month after your final dose.
For males taking Tavalisse. The manufacturer of Tavalisse has not provided birth control recommendations for males* taking the drug. If you’re a male taking Tavalisse and your sexual partner can become pregnant, talk with your doctor about your birth control needs.
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
Breastfeeding during treatment with Tavalisse and for at least 1 month after your final dose is not recommended. This is due to the possibility of serious side effects in a child who is breastfed.
It’s not known if Tavalisse is safe to take while breastfeeding or how the drug may affect a breastfed child. In animal studies, Tavalisse passed into breast milk. Animal studies do not always indicate what may happen in humans. However, because the drug was present in animal breast milk, Tavalisse will likely be present in human breast milk as well.
If you’re breastfeeding or considering it, talk with your doctor. They can advise you on healthy feeding options for your child and other medications.
This drug comes with several precautions. Before taking Tavalisse, talk with your doctor about your health history. Tavalisse may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- High blood pressure. Tavalisse may cause high blood pressure. If your blood pressure is already high, the drug may raise it further, which could be dangerous. Before you start taking Tavalisse, tell your doctor if you have high blood pressure. They may monitor your blood pressure more often than usual and adjust the dose of any blood pressure medication you take.
- Liver problems. Before you start taking Tavalisse, tell your doctor about any liver problems you have, such as hepatitis or liver failure. This medication may make liver problems worse. Your doctor may monitor your liver function with blood tests more often than usual throughout treatment. In some cases, they may recommend a different treatment option for you.
- Allergic reaction. If you’ve had an allergic reaction to Tavalisse or any of its ingredients, your doctor will likely not prescribe Tavalisse. Ask your doctor what other medications may be better options for you.
- Pregnancy. Your doctor will likely recommend that you do not take Tavalisse while you’re pregnant. For more information, see the “Tavalisse and pregnancy” section above.
- Breastfeeding. Breastfeeding during treatment with Tavalisse and for at least 1 month after your final dose is not recommended. For more information, see the “Tavalisse and breastfeeding” section above.
Note: For more information about the potential negative effects of Tavalisse, see the “Tavalisse side effects” section above.
Do not take more Tavalisse than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.
What to do in case you take too much Tavalisse
If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. If your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
When you get Tavalisse from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The
How long a medication remains good to use can depend on many factors, including how and where you store the medication.
You should store Tavalisse tablets at room temperature from 68°F to 77°F (20°C to 25°C). If necessary, you can store the tablets from 59°F to 86°F (15°C to 30°C).
Each bottle of Tavalisse contains two canisters of desiccants, which are substances that help absorb moisture. Be sure to keep the desiccant canisters in the bottle with your Tavalisse tablets.
If you no longer need to take Tavalisse and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.