Set your patients up for success with the TAVALISSE Onboarding Kitprotecting platelets. defending patients.

Downloadable resources to help patients start and stay on track with TAVALISSE

These tools are designed to help educate patients on chronic immune thrombocytopenia (ITP) and what to expect from TAVALISSE treatment. They also provide tips for a successful start to therapy, information on copay assistance, and other useful guidance.

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.

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The TAVALISSE Treatment Journal

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

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Explore the clinical benefits of TAVALISSE explore

RIGEL ONECARE and Copay Assistance

This information sheet explains how RIGEL ONECARE can help patients with access and support and explains the benefits and eligibility requirements for the TAVALISSE Copay Assistance 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 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.

TAVALISSE Prescribing Information

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

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.

ITP Patient Education Poster

This poster explains the symptoms of ITP, how ITP is diagnosed, and next steps after diagnosis.

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

Set your patients up for success with the TAVALISSE Onboarding Kitprotecting platelets. defending patients.

Downloadable resources to help patients start and stay on track with TAVALISSE

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