Tavalisse

What is Tavalisse used for?

• Tavalisse is used to treat immune thrombocytopenia (ITP).

Before taking Tavalisse, tell your doctor:

For all patients taking Tavalisse:

• If you are allergic to Tavalisse; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Tavalisse, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Tavalisse.
• If you are breast-feeding. Do not breast-feed while you take Tavalisse or for 1 month after you stop Tavalisse.

Children:

• If the patient is a child. Do not give Tavalisse to a child.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Tavalisse with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tavalisse?

• Tell all of your health care providers that you take Tavalisse. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood pressure has happened with Tavalisse. Have your blood pressure checked as you have been told by your doctor.
• This medicine may cause diarrhea. If you get diarrhea, talk with your doctor about ways to lower this effect. Do not stop taking Tavalisse without talking with your doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you are 65 or older, use Tavalisse with care. You could have more side effects.
• This medicine may cause fertility problems. This may affect being able to have children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Tavalisse. Talk with your doctor.
• Use birth control that you can trust to prevent pregnancy while taking Tavalisse and for 1 month after stopping Tavalisse.
• If you get pregnant while taking Tavalisse or within 1 month after your last dose, call your doctor right away.

How is Tavalisse best taken?

Use Tavalisse as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking Tavalisse as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Tavalisse that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Severe diarrhea.
• Diarrhea that will not go away.
• Feeling confused.
• Chest pain.
• Shortness of breath.
• Low white blood cell counts have happened with Tavalisse. This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

What are some other side effects of Tavalisse?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Upset stomach.
• Dizziness.
• Signs of a common cold.
• Belly pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tavalisse?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tavalisse, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Tavalisse or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tavalisse. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.