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Molecule

Fostamatinib

Available on requestOrphanHaematology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Fostamatinib is a prescription medicine indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. It is available as tablets for oral use. MedsAcross supplies Fostamatinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
B02BX09 Fostamatinib · Medicines that stop bleeding, subgroup B02B, subgroup B02BX
US FDA first approval
17 April 2018
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII SQ8A3S5101CAS 901119-35-5DrugBank DB12010Q5473550

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. 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.

Source: US FDA prescribing information

How it works

Fostamatinib is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). The major metabolite of fostamatinib, R406, inhibits signal transduction of Fc-activating receptors and B-cell receptor. The fostamatinib metabolite R406 reduces antibody-mediated destruction of platelets.

Source: US FDA prescribing information

Dosing overview

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 × 10 9 /L as necessary to reduce the risk of bleeding. Manage adverse reactions using dose reduction, interruption of treatment, or discontinuation. Discontinue TAVALISSE after 12 weeks of treatment if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.

Source: US FDA prescribing information

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. Hepatotoxicity: Monitor LFTs monthly. If LFT levels are elevated, interrupt, reduce or discontinue TAVALISSE. Diarrhea: Manage diarrhea with supportive measures. If diarrhea becomes severe, interrupt, reduce or discontinue TAVALISSE. Neutropenia: Monitor ANC monthly, and for infection. If neutrophil count decreases below 1.0 × 10 9 /L, interrupt, reduce or discontinue TAVALISSE. Embryo-Fetal Toxicity: TAVALISSE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Source: US FDA prescribing information

Side effects

The following clinically important adverse reactions, that can become serious are described elsewhere in the labeling: Hypertension Hepatotoxicity Diarrhea Neutropenia 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.

Source: US FDA prescribing information

Interactions

Strong CYP3A4 Inhibitors: Concomitant use with a strong CYP3A4 inhibitor increases exposure to R406 (the major active metabolite). Strong CYP3A4 Inducers: Concomitant use is not recommended.

Source: US FDA prescribing information

Storage

Store at room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Fostamatinib, sorted by availability.

MedicineManufacturerRegisterAvailability
Tavalisse 100 mg tabletOralRigel PharmaceuticalsUS FDAAvailable on request
Tavalisse 150 mg tabletOralRigel PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 17 April 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Fostamatinib in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Fostamatinib available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Fostamatinib and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Fostamatinib have?

The catalogue lists 1 brand names for Fostamatinib, including Tavalisse.

Is Fostamatinib approved by the US FDA?

Yes. The US FDA first approved Fostamatinib on 17 April 2018, according to Drugs@FDA.

Is Fostamatinib authorised in the European Union?

Yes. Fostamatinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Fostamatinib need cold chain shipping?

No listed presentation of Fostamatinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Fostamatinib in?

Fostamatinib is classified under ATC code B02BX09 (Fostamatinib).

References

  1. TAVALISSE prescribing information (Rigel Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 5 November 2025
  2. Tavlesse: European public assessment report (EPAR). European Medicines Agency. Retrieved 2 December 2024

Request Fostamatinib for export supply

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