ASH Clinical News ACN_4.12_SUPP_web | Page 13

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
TAVALISSE presents
an opportunity
to provide your
patients with a
targeted defense
• 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 Brief Summary of full Prescribing Information on following page or
visit TAVALISSE.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).
Reference: 1. TAVALISSE™ [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; 2018.
A novel agent that addresses an unmet
need in chronic ITP treatment 1
Clinical benefi t demonstrated in
pivotal trials 1
Convenience of an oral medication
that can be taken with or without food 1
© 2018 Rigel Pharmaceuticals, Inc. All rights reserved.
TAVA_ITP-18342 0918
TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc.
PROTECTING PLATELETS.
DEFENDING PATIENTS.