TAVALISSE RESOURCES

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PATIENT ONBOARDING

Use these materials to familiarize yourself with information to confidently prescribe TAVALISSE.

Prescribing Information

Information such as indication, dosing, safety, and efficacy as approved by the FDA.

Learn more about the convenience of oral dosing

Dosing and Administration Guide

Learn about the convenience of oral dosing without food restrictions, dosing modifications, and management of certain adverse reactions.

TAVALISSE placebo-controlled trials (FIT-1 + FIT-2) in the American Journal of Hematology

Review the published results of FIT-1 and FIT-2 in: Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930.

TAVALISSE open-label extension study (FIT-3) in the American Journal of Hematology

Review the published results of FIT-3 in: Bussel JB, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546-553.

Post hoc analysis of the TAVALISSE trial population by line of therapy in the British Journal of Haematology

Review the published post hoc analysis of the FIT studies in: Boccia R, Cooper N, Ghanima W, et al. Fostamatinib is an effective second-line therapy in patients with immune thrombocytopenia. Br J Haematol. 2020;190(6):933-938.

Post hoc long-term thrombotic risk and efficacy analysis in Therapeutic Advances in Hematology

Review the published post hoc analysis of the FIT studies in: Cooper N, Altomare I, Thomas MR, et al. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021;12:e20406207211010875. doi:10.1177/20406207211010875

Take a closer look at TAVALISSE—learn more about ITP pathogenesis, SYK inhibition, and a patient's experience with treatment.

Videos on the complex pathogenesis of ITP and how SYK inhibition limits immune-mediated platelet destruction as a novel way to treat ITP

Hear from Dr Craig Kessler

Professor of Medicine and Pathology with the Division of Hematology-Oncology, Director of the Division of Coagulation in the Department of Laboratory Medicine at the Georgetown University Medical Center

Learn more about:

Hear from ITP experts and a patient living with chronic ITP

Mohit Narang, MD: Director, Maryland Oncology Hematology

Adam Schmuckler, PA-C, MMSC: Maryland Oncology Hematology

Connie: a patient living with chronic ITP

Learn about Connie's treatment journey in an in‑depth conversation with her healthcare team:

Mechanism of Action

See how TAVALISSE is believed to inhibit downstream signaling that leads to platelet destruction in chronic ITP.

These resources are designed to provide key points of support to patients all the way through their TAVALISSE treatment journey.

Patient Resources

TAVALISSE Brochure

This brochure provides information on ITP, how TAVALISSE is different from other therapies, and how TAVALISSE can help patients reach their treatment goals.

English

Spanish

The TAVALISSE Treatment Journal

This journal offers suggestions to help incorporate TAVALISSE into patients' lifestyles, stay on track with treatment, and monitor progress.

English

Spanish

TAVALISSE Patient Information

Reviews important information for patients about TAVALISSE, including for whom TAVALISSE is intended, how to take TAVALISSE, and what to expect while on treatment.

Access Materials

TAVALISSE Enrollment and Patient Assistance Program Form

Use the TAVALISSE Enrollment and Patient Assistance Program Form as a prescription and to enroll a patient into RIGEL ONECARE and the Patient Assistance Program, if eligible.

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Spanish

PATIENT VIDEO LIBRARY

A Different Approach to Treatment

In this overview of treatment for chronic ITP, advanced nurse practitioner Charina Toste discusses how TAVALISSE works differently than other chronic ITP treatments. She explains that chronic ITP can be a serious condition when left untreated, but can be effectively managed with the right treatment.

What to Expect with TAVALISSE

Advanced nurse practitioner Charina Toste gives patients an overview of treatment with TAVALISSE and shares what to expect from their medication, which can help patients more clearly recognize progress toward their treatment goals.

Fitting TAVALISSE into Your Lifestyle

TAVALISSE is a medication with dosing flexibility, making it convenient for patients to fit it into their lifestyle. Advanced nurse practitioner Charina Toste provides tips to help patients get the benefits of treatment by taking their medication regularly as prescribed.

Setting Your Treatment Goals

Identifying personal goals—like getting back to activities they enjoy—and discussing them with their healthcare provider can help patients stay on track with treatment. Advanced nurse practitioner Charina Toste demonstrates how to set treatment goals and track progress.

Important Safety Information

Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

Important Safety Information

Warnings and Precautions

TAVALISSE RESOURCES

Patient Resources

Access Materials

PATIENT VIDEO LIBRARY

Indication and Important Safety Information

Indication

Important Safety Information

Warnings and Precautions

Drug Interactions

Adverse Reactions

Indication and Important Safety Information

Indication

Important Safety Information

Warnings and Precautions

September is ITP Awareness month