Tavalisse

Tavalisse is a prescription medication for adult patients with chronic ITP, a disorder in which the number of platelets circulating in the body is severely reduced, who have had an insufficient response to a previous treatment. Tavalisse belongs to a group of drugs called tyrosine kinase inhibitors. Tavalisse reduces the destruction of platelets by the body's immune system by targeting an enzyme called SYK (spleen tyrosine kinase).

This medication comes in a tablet form and is taken twice daily, with or without food. 

Common side effects include nausea, diarrhea, stomach pain, and rash. Tavalisse can also cause dizziness, and fatigue. Do not drive or operate heavy machinery until you know how Tavalisse affects you.

Tavalisse is a prescription medicine that is 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tavalisse. See the “Tavalisse Precautions” section.

Common side effects of Tavalisse include the following:

• nausea
• stomach pain
• respiratory infection
• dizziness
• rash
• tiredness
• chest pain

This is not a complete list of Tavalisse side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

This is not a complete list of Tavalisse drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tavalisse including the following:

• 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.

• Decrease in white blood cell counts (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.

Do not take Tavalisse if you are allergic to Tavalisse or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tavalisse, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tavalisse, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tavalisse or to any of its ingredients
• have hypertension
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. There are no well-done studies that have been done in humans with Tavalisse. In animal studies, pregnant rats and rabbits were given this medication, and the babies had adverse developmental outcomes directly linked to Tavalisse. 

• 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 doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Tavalisse and for at least 1 month after the last dose.

It is not known if Tavalisse crosses into human milk. In rodents, a 5- to 10-fold higher concentration of the drug was detected in the breast milk than in the blood. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Tavalisse.

Take Tavalisse exactly as prescribed.

Tavalisse comes in a tablet form and is taken twice daily.

Take Tavalisse with for without food.

If you miss a dose, take the next dose at its regularly scheduled time.

Your healthcare provider will check your platelet count during your treatment with Tavalisse and may change your dose of Tavalisse as needed.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Tavalisse is available in two dose strengths: 100 mg and 150 mg.

Tavalisse should be initiated at 100 mg twice daily for 4 weeks, and increased to 150 mg twice daily, if needed, to achieve a platelet count of at least 50 x 109/L.

Management of some adverse events may require dose interruption, reduction, or discontinuation, in addition to supportive care measures.

If you take too much Tavalisse, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Tavalisse at room temperature between 68°F and 77°F (20°C to 25°C).

• The bottle of Tavalisse contains 2 desiccant canisters that help keep your medicine dry. Do not remove the desiccant canisters from the bottle.

• Keep Tavalisse and all medicines out of the reach of children.