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Fostamatinib(Tavalisse)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

Reference price:

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Formulation:

TABLET

Validity period:

Not specified in the document.

Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

TAVALISSE (fostamatinib) is an oral kinase inhibitor specifically designed to target spleen tyrosine kinase (SYK), a key mediator in the pathogenesis of immune thrombocytopenia. By inhibiting SYK, fostamatinib disrupts signal transduction pathways involved in antibody-mediated platelet destruction, thereby increasing platelet counts in affected individuals. The drug is administered orally, with dosing regimens tailored to patient response and tolerability.

Fostamatinib is metabolized to its active form, tamatinib, which exerts the primary pharmacological effect. Clinical studies have demonstrated its efficacy in patients with chronic ITP who have not responded adequately to previous treatments. TAVALISSE may be taken with or without food, and its use requires regular monitoring of blood pressure, liver function, and complete blood counts due to potential adverse effects such as hypertension, hepatotoxicity, diarrhea, and neutropenia. Use in populations other than adults with chronic ITP is not specified in the specification.

Generic name

Fostamatinib(Tavalisse)

English name

Fostamatinib

Alternative Names

Tavalisse

Drug prices

Indications

FDA-Approved: Treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy (e.g., corticosteroids, immunoglobulins, splenectomy).

Therapeutic Target

spleen tyrosine kinase (SYK)

Active Ingredients

Fostamatinib disodium hexahydrate.

Dosage form

TABLET

specifications

100 mg: Bottle of 60 tablets (NDC 71332-001-01). 150 mg: Bottle of 60 tablets (NDC 71332-002-01).

Description

Chemical Structure: Disodium salt prodrug converted to tamatinib in vivo.

Molecular Formula: C23H24FN6Na2O9P⋅6H2OC23H24FN6Na2O9P⋅6H2O.

Inactive Ingredients:

Core: Mannitol, sodium bicarbonate, sodium starch glycolate, povidone, magnesium stearate.

Coating: Polyvinyl alcohol, titanium dioxide, PEG 3350, talc, iron oxides.

Dosage and Administration

Initial Dosing

Starting Dose: 100 mg orally twice daily (with/without food).

Dose Escalation: Increase to 150 mg twice daily after 4 weeks if platelet count <50 × 10⁹/L.

Dose Adjustments

Adverse Reactions: Refer to Tables 1 and 2 (e.g., hypertension, hepatotoxicity):

Hypertensive Crisis: Interrupt or discontinue.

ALT/AST >3× ULN: Interrupt and reduce dose.

Severe Diarrhea: Interrupt and resume at lower dose.

Discontinuation Criteria

No Response: Discontinue after 12 weeks if platelet count remains insufficient to prevent bleeding.

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