TAVALISSE® (fostamatinib disodium hexahydrate) tablets

RIGEL ONECARE provides support to patients taking TAVALISSE

Nurses at RIGEL ONECARE are fully trained to support patients prescribed TAVALISSE, whether their TAVALISSE is fulfilled through integrated, in-office dispensing or specialty pharmacies. Services provided by RIGEL ONECARE include:

Benefits investigation, prior authorization, and appeals resources
Copay assistance*
Temporary and long-term free drug supply*
Adherence support and product-education phone calls

*All Rigel programs are subject to eligibility requirements. Restrictions may apply.

Contact Rigel OneCare

833-RIGELOC (744-3562)

Monday-Friday
8 am - 8 pm ET

To learn more about RIGEL ONECARE programs and to enroll a patient:

DOWNLOAD ENROLLMENT FORM

phone

1-833-rigelOC

(1-833-744-3562) or 650-449-8646

MONDAY-FRIDAY FROM 8 am – 8 pm ET

Fax 1-833-FXrigel

(1-833-397-4435) or 650-449-8682
RigelONECARE.com

With TAVALISSE Financial Assistance, eligible patients pay as little as $15

The TAVALISSE Copay Assistance Program can help eligible patients with commercial insurance pay as little as $15 per prescription fill. Enroll your patients now by answering a few eligibility questions.

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

RIGEL ONECARE provides support to patients taking TAVALISSE

With TAVALISSE Financial Assistance, eligible patients pay as little as $15

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