Frequently asked questions

Find out more about Tavlesse through our most frequently asked questions.

What is Tavlesse?

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

What is Tavlesse indicated for?

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

What makes Tavlesse different?

Tavlesse is the 1st 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

What is the trial evidence for Tavlesse?

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.

What is the recommended dosing for Tavlesse?

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

How should Tavlesse be administered?

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

What are the common adverse reactions of Tavlesse?

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).

MedDRA SOC

Infections and infestations

Frequency

Uncommon

Adverse reactions

Pneumonia


Frequency

Common

Adverse reactions

Upper respiratory tract infection, respiratory tract infection, bronchitis, lower respiratory tract infection, viral upperrespiratory tract infection

Blood and lymphatic disorders

Frequency

Common

Adverse reactions

Neutropenia, febrile neutropenia

Nervous system disorders

Frequency

Very common

Adverse reactions

Dizziness


Frequency

Common

Adverse reactions

Dysgeusia, headache

Vascular disorders

Frequency

Very common

Adverse reactions

Hypertension


Frequency

Uncommon

Adverse reactions

Hypertensive crisis

Gastrointestinal disorders

Frequency

Very common

Adverse reactions

Diarrhoea, nausea, frequent bowel movement


Frequency

Common

Adverse reactions

Abdominal pain upper, abdominal pain

Skin and subcutaneous tissue disorders

Frequency

Common

Adverse reactions

Rash, rash erythematous, rash macular

General disorders and administration site conditions

Frequency

Common

Adverse reactions

Chest pain, fatigue, influenza like illness

Investigations

Frequency

Very common

Adverse reactions

Alanine aminotransferase increased, aspartateaminotransferase increased, blood pressure (BP) increased,BP diastolic abnormal, BP diastolic increased, BP systolicincreased, hepatic enzyme increased, liver function testabnormal


Frequency

Common

Adverse reactions

Neutrophil count decreased

MedDRA SOC Frequency Adverse reactions

Infections and infestations

Uncommon

Pneumonia

Common

Upper respiratory tract infection, respiratory tract infection, bronchitis, lower respiratory tract infection, viral upperrespiratory tract infection

Blood and lymphatic disorders

Common

Neutropenia, febrile neutropenia

Nervous system disorders

Very common

Dizziness

Common

Dysgeusia, headache

Vascular disorders

Very common

Hypertension

Uncommon

Hypertensive crisis

Gastrointestinal disorders

Very common

Diarrhoea, nausea, frequent bowel movement

Common

Abdominal pain upper, abdominal pain

Skin and subcutaneous tissue disorders

Common

Rash, rash erythematous, rash macular

General disorders and administration site conditions

Common

Chest pain, fatigue, influenza like illness

Investigations

Very common

Alanine aminotransferase increased, aspartateaminotransferase increased, blood pressure (BP) increased,BP diastolic abnormal, BP diastolic increased, BP systolicincreased, hepatic enzyme increased, liver function testabnormal

Common

Neutrophil count decreased

How should the most commonly reported adverse reactions associated with Tavlesse be managed?

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

Daily dose
300 mg/day
Administered as

AM:

PM:

200 mg/day
Administered as

AM:

PM:

150 mg/day
Administered as

AM: *

PM: - - -

100 mg/day
Administered as

AM: *

PM: - - -

Tablets not actual size
*Once daily fostamatinib should be taken in the morning. If further dose reduction below 100 mg/day is required, discontinue fostamatinib.

Daily dose Administered as
AM PM
300 mg/day
200 mg/day
150 mg/day * - - -
100 mg/day * - - -

Dose reduction schedule1, 2:

Commonly reported adverse reaction

Hypertension

Recommended action
  • Initiate or increase dose of antihypertensive medication until blood pressure (BP) is controlled
  • If target not met after 8 weeks, reduce Tavlesse dose to next lower dose
  • If BP is ≥ 160/100 mmHg for > 4 weeks, despite aggressive antihypertensive therapy, interrupt or discontinue Tavlesse

Liver function test (LFT) abnormality/hepatotoxicity

Recommended action
  • If patient symptomatic, eg. nausea, vomiting, abdominal pain, interrupt Tavlesse; if LFTs do not increase, resume Tavlesse at next lower daily dose
  • If patient asymptomatic, monitor LFTs every 72 hours and consider Tavlesse dose interruption or reduction if AST/ALT is 3 to 5x ULN and total BL is < 2x ULN; if dose interrupted, then resume Tavlesse at the next lower daily dose
  • If AST/ALT persists at ≥ 5x ULN for ≥ 2 weeks or AST/ALT is 3x ULN or higher and total BL is > 2x ULN then discontinue Tavlesse

Diarrhoea

Recommended action
  • Manage diarrhoea using supportive measures eg. dietary changes, hydration and/or anti-diarrhoeal medication)
  • If symptoms are severe temporarily interrupt Tavlesse, until diarrhoea improves, then resume Tavlesse at the next lower daily dose

Neutropenia

Recommended action
  • If ANC decreases to < 1.0 x109 /L and remains low after 72 hours, temporarily interrupt Tavlesse until resolved; resume Tavlesse at the next lower daily dose

LFT=liver function test; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BP=blood pressure; BL=bilirubin; ULN=upper limit of normal; ANC=absolute neutrophil count.
For detailed information, please refer to the Tavlesse Summary of Characteristics.

Commonly reported adverse reaction Recommended action

Hypertension

  • Initiate or increase dose of antihypertensive medication until blood pressure (BP) is controlled
  • If target not met after 8 weeks, reduce Tavlesse dose to next lower dose
  • If BP is ≥ 160/100 mmHg for > 4 weeks, despite aggressive antihypertensive therapy, interrupt or discontinue Tavlesse

Liver function test (LFT) abnormality/hepatotoxicity

  • If patient symptomatic, eg. nausea, vomiting, abdominal pain, interrupt Tavlesse; if LFTs do not increase, resume Tavlesse at next lower daily dose
  • If patient asymptomatic, monitor LFTs every 72 hours and consider Tavlesse dose interruption or reduction if AST/ALT is 3 to 5x ULN and total BL is < 2x ULN; if dose interrupted, then resume Tavlesse at the next lower daily dose
  • If AST/ALT persists at ≥ 5x ULN for ≥ 2 weeks or AST/ALT is 3x ULN or higher and total BL is > 2x ULN then discontinue Tavlesse

Diarrhoea

  • Manage diarrhoea using supportive measures eg. dietary changes, hydration and/or anti-diarrhoeal medication)
  • If symptoms are severe temporarily interrupt Tavlesse, until diarrhoea improves, then resume Tavlesse at the next lower daily dose

Neutropenia

  • If ANC decreases to < 1.0 x109 /L and remains low after 72 hours, temporarily interrupt Tavlesse until resolved; resume Tavlesse at the next lower daily dose

Can Tavlesse be used in elderly patients?

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)

Can Tavlesse be used in children and adolescents < 18 years old?

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

Where can I get more information on Tavlesse?

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

ITP: immune thrombocytopenia

References:

  1. Tavlesse Summary of Product Characteristics. Great Britain. Grifols. Date of revision: January 2021. Available at https://www.medicines.org.uk/emc/product/11479 . Accessed on 14/2/2022.

  2. Tavlesse Summary of Product Characteristics. Northern Ireland. Grifols. Date of revision: August 2021. Available at https://www.emcmedicines.com/en-gb/northernireland/medicine?id=9c2f7cf0-129d-42a3-a61c-d729ae80e50c. Accessed on 14/2/2022

  3. Newland A, Lee E, McDonald V, et al. Fostamatinib for persistent/chronic adult immune thrombocytopenia. Immunotherapy. 2018;10(1):9-25

  4. Bussel J, Arnold DM, Grossbard E, et al. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: results of two phase 3, randomized, placebo-controlled trials. Am J Hematol. 2018;93(7):921-930
  5. Bussel J, Arnold DM, Boxer MA, et al. Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program. Am J Hematol. 2019;94(5):546-553.