Subject:

•	ITP Awareness Month: Your efforts do not go unnoticed
•	Rigel stands with the ITP community
•	We appreciate your commitment to patients with ITP
•	Partnering with you this ITP Awareness Month
•	September is ITP Awareness Month

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•	Grateful for your efforts, every day
•	Thank you for all you do for your patients with chronic ITP

Varying clinical markers, such as fluctuating platelet counts and risk of bleeding and bruising, may suggest your patient is not responding to treatment and may need an individualized approach based on their treatment goals.¹

TAVALISSE^® (fostamatinib disodium hexahydrate) tablets is the first spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.^2,3

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.

Please see additional Important Safety Information below.

	ROBUST RESPONSE 70% of patients (n=101) demonstrated sustained clinical benefit (≥30 x 10⁹/L) over time⁴
	MAINTAINED DURABLE AND STABLE BENEFIT Response, once achieved, was maintained for the majority of the time on treatment^2,4
	MOST ADVERSE REACTIONS WERE MILD TO MODERATE No new or more frequent toxicities were observed with long-term use⁵
	ORAL DOSING WITH NO FOOD RESTRICTIONS The convenience of oral dosing, with or without food²

TAVALISSE may be an option for your patients with chronic ITP.

Explore efficacy data

Find support for every step of treatment, including how to access TAVALISSE, copay assistance, patient support services, and downloadable resources for you and your patients.

Learn more about RIGEL ONECARE	Download the enrollment form
Download the enrollment form

Download the Dosing and Administration Guide

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

Download the Patient Brochure

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

TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

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

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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%).

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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.

Please see TAVALISSEhcp.com for full Prescribing Information.

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).

References: 1. González-Porras JR, Godeau B, Carpenedo M. Switching thrombopoietin receptor agonist treatments in patients with primary immune thrombocytopenia. Ther Adv Hematol. 2019;10:2040620719837906. doi:10.1177/2040620719837906 2. TAVALISSE^®. Package Insert. Rigel Pharmaceuticals, Inc. 3. 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. doi:10.1002/ajh.25125
4. 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;12:12;20406207211010875. doi:10.v1177/20406207211010875 5. 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. doi:10.1002/ajh.25444

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