These highlights do not include all the information needed to use TAVALISSE� safely and effectively. See full prescribing information for TAVALISSE.
TAVALISSE� (fostamatinib disodium hexahydrate) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
TAVALISSE is a kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. (1)
DOSAGE AND ADMINISTRATION
Initiate TAVALISSE at 100 mg orally twice daily with or without food. After 4 weeks, increase to 150 mg twice daily, if needed, to achieve platelet counts of at least 50 � 109/L as necessary to reduce the risk of bleeding. (2.1)
Manage adverse reactions using dose reduction, interruption of treatment, or discontinuation. (2.3)
Discontinue TAVALISSE after 12 weeks of treatment if the platelet count does not increase to a level sufficient to avoid clinically important bleeding. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 150 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypertension: Monitor blood pressure every 2 weeks until stable, then monthly. Manage hypertension using standard antihypertensive treatment and, if needed, interrupt, reduce or discontinue TAVALISSE. (5.1)
Hepatotoxicity: Monitor LFTs monthly. If LFT levels are elevated, interrupt, reduce or discontinue TAVALISSE. (5.2)
Diarrhea: Manage diarrhea with supportive measures. If diarrhea becomes severe, interrupt, reduce or discontinue TAVALISSE. (5.3)
Neutropenia: Monitor ANC monthly, and for infection. If neutrophil count decreases below 1.0 � 109/L, interrupt, reduce or discontinue TAVALISSE. (5.4)
Embryo-Fetal Toxicity: TAVALISSE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.5)
ADVERSE REACTIONS
The most common adverse reactions (?5% and more than placebo) are diarrhea, hypertension, nausea, respiratory infection, dizziness, ALT/AST increased, rash, abdominal pain, fatigue, chest pain and neutropenia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Rigel Pharmaceuticals, Inc. at 1-800-983-1329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: Concomitant use with a strong CYP3A4 inhibitor increases exposure to R406 (the major active metabolite).(7)
Strong CYP3A4 Inducers: Concomitant use is not recommended. (7)
USE IN SPECIFIC POPULATIONS
Pregnancy: Advise women of the risk to a fetus. (8.1)
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2018