TAVALISSE logo

TAVALISSE resources

Clinical resources

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

Thumbnail of Prescribing Information
Prescribing Information

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

Dosing and Administration Guide
Dosing and Administration Guide

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

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

Revew 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
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
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.

Patient resources

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

TAVALISSE Brochure thumbnail
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. 

The TAVALISSE Treatment Journal thumbnail
The TAVALISSE Treatment Journal

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

TAVALISSE TOGETHER Patient Support Program
TAVALISSE TOGETHER Patient Support Program

Provides an overview of the TAVALISSE TOGETHER program and how to enroll. This program partners with patients throughout their treatment journey, helping them to become successful with their ITP treatment and achieve their goals.

TAVALISSE Patient Information
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
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.

Videos

Dr Kessler Video Thumbnail
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

Mechanism of Action
Mechanism of Action

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

TAVA_ITP-21067 0621

Indication

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.

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.

 

Please see 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).

Back to the top

Rigel Pharmaceuticals logo

© 2021 Rigel Pharmaceuticals, Inc. All rights reserved.  TAVA_ITP-20037 0121

TAVALISSE is a registered trademark and RIGEL ONECARE is a trademark of Rigel Pharmaceuticals, Inc.

RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc.

1180 Veterans Blvd, South San Francisco, CA 94080

This site is intended for US healthcare professionals only.

Indication

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.

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.
TAVALISSE logo