Frequently asked questions

Tavlesse is a film-coated tablet containing fostamatinib disodium hexahydrate available as 100 mg or 150 mg tablets.^{1, 2}

Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.^{1, 2}

Tavlesse is the 1^st treatment that targets spleen tyrosine kinase (SYK) in macrophages to inhibit downstream signalling in chronic ITP.^1-4 Tavlesse has a targeted mechanism of action to limit immune-mediated platelet destruction.^{1, 2}

The fostamatinib in ITP (FIT) clinical programme (FIT 1,2 and 3) was designed to assess the efficacy, safety and durability of Tavlesse in adult patients with Chronic ITP. Results from these trails have been published and are available for FIT-1 and FIT-2 as well as for the open label extension, FIT-3.^{4, 5} Please refer to the Trial Design information and the Clinical Resources above.

Tavlesse dosing should be individualised based on a patient’s platelet count. The lowest dose to achieve and maintain a platelet count of ≥ 50,000/ μL should be used. Dose adjustments are based on platelet count response and tolerability.^{1, 2}

The recommended starting dose of Tavlesse is 100 mg twice daily. This can be increased to 150 mg twice daily after 4 weeks based on platelet count and tolerability. A maximum dose of 300 mg daily must not be exceeded.^{1, 2}

Tavlesse should be prescribed and supervised by a physician experienced in the treatment of haematological diseases. Dosing should be based on patient’s platelet counts. The lowest dose of Tavlesse to achieve and maintain a platelet count of ≥ 50,000/ μL should be used. The recommended starting dose is 100 mg BID, which can be increased to 150 mg BID after 4 weeks, based on platelet count and tolerability. A daily dose of 300 mg must not be exceeded. Tavlesse can be taken with or without food.^{1, 2}

Tabulated list of adverse reactions

The adverse reactions are presented from the placebo-controlled clinical trials and organised according to primary system organ class (SOC) for each preferred term in MedDRA. The adverse reactions are ranked by frequency within each SOC, and presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10),common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

The most commonly reported adverse reactions of hypertension, liver function test abnormalities, diarrhoea, neutropenia and infections can be managed by dose reductions and dose modifications.^{1, 2}

Tavlesse can be used in elderly (≥ 65 years old) patients, and no dose adjustments are necessary.¹ In general, incidences of adverse reactions were higher in the older population.^{1, 2} (See Summary of Product Characteristics for further information)

No, Tavlesse should not be used in children and adolescents < 18 years of age because of adverse reactions on actively growing bones observed in non-clinical studies.^{1, 2}

For more information, please refer to the Tavlesse Summary of Product Characteristics.^{1, 2} or contact medinfo.uk@grifols.com.