Generic Name and Formulations:
Fostamatinib disodium hexahydrate 100mg, 150mg; tabs.
Rigel Pharmaceuticals Inc.
Indications for TAVALISSE:
Thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had insufficient response to previous treatment.
≥18yrs: Initially 100mg twice daily. Increase to 150mg twice daily if platelet count not at ≥50x109/L after 4 weeks. Discontinue if insufficient increase in platelet count after 12 weeks. Dose modifications: see full labeling.
<18yrs: not recommended.
Monitor CBCs, including platelets, monthly until stable count (≥50 x 109/L) achieved, then periodically thereafter. Monitor LFTs monthly. Discontinue if AST/ALT >5XULN for ≥2wks or ≥3XULN and total bilirubin >2XULN. Monitor blood pressure every 2 weeks until stable dose established, then monthly thereafter. Interrupt or discontinue dose if hypertensive crisis (>180/120mmHg) occurs; discontinue if repeat BP >160/100mmHg for >4 weeks. Temporarily interrupt if severe diarrhea (Grade ≥3) occurs; resume at next lower daily dose if improved to Grade 1. Monitor ANC monthly and for infection. Temporarily interrupt if ANC <1 x 109/L occurs and remains low after 72hrs until resolved; resume at next lower daily dose. Use lowest effective dose. Embryo-fetal toxicity. Use effective contraception during and for ≥1 month after last dose. Pregnancy; confirm negative status prior to initiation. Nursing mothers: not recommended (during and for ≥1 month after last dose).
Tyrosine kinase inhibitor.
Concomitant strong CYP3A4 inducers: not recommended. Concomitant strong CYP3A4 inhibitors or substrates; monitor for toxicity. May potentiate concomitant BCRP (eg, rosuvastatin) or P-gp (eg, digoxin) substrates: monitor for toxicity.
Diarrhea, hypertension, nausea, respiratory infection, dizziness, ALT/AST increase, rash, abdominal pain, fatigue, chest pain, neutropenia.
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