Dosing Information

Tavlesse offers the convenience of oral dosing taken twice daily with or without food or dietary restrictions1, 2

Tavlesse dosing information

*12-week evaluation period as per the product labelling.
†Clinical benefit: platelet count increase to a level sufficient to avoid clinically important bleeding. The daily dose of 300 mg should not be exceeded. Tablets not actual size.

Tavlesse is an oral medication taken twice daily with or without food1,2

Tavlesse is available as 100 mg and 150 mg tablets1,2. Tavlesse is a film-coated tablet. The 100 mg tablet is approx. 9.0 mm round, biconvex, dark orange tablet debossed with '100' on one side and 'R' on the other side. The 150 mg tablet is approx. 7.25 mm x 14.5 mm oval, biconvex, light orange tablet debossed with '150' on one side and 'R' on the other side1,2

Use the lowest dose of Tavlesse to achieve and maintain a platelet count of at least 50,000 /μL as necessary to reduce the risk of bleeding1,2

If a dose is missed, the next dose should be taken at its regularly scheduled time1,2

In addition to supportive care measures, management of some adverse reactions may require dose interruption, reduction, or discontinuation1,2

In clinical trials, stable concurrent ITP therapy was allowed and rescue therapy was permitted if needed1,2

See section 4.2 of the Summary of Product Characteristics for specific guidance on dose modifications and recommendations for treatment discontinuations regarding hypertension, hepatotoxicity, diarrhoea and neutropenia

86% of patients in the phase 3 clinical studies were maintained at the 150 mg BID dose1,2

Recommended monitoring

As part of chronic ITP care, patient monitoring is recommended with Tavlesse1,2

Complete blood counts (CBCs), including platelet counts and neutrophils

Baseline plus monthly monitoring until a stable platelet count (50,000 /μL) is achieved, then regular monitoring

Liver function tests (LFTs) (eg. ALT, AST and bilirubin)

Liver function tests (LFTs) (eg. ALT, AST and bilirubin)

Blood pressure

Baseline plus monitoring every 2 weeks until blood pressure is controlled, then monthly thereafter and adjust or initiate anti-hypertensive therapy to ensure maintenance of blood pressure control during fostamatinib therapy

Tavlesse dose modification guidance

Modifying the Tavlesse dose can help manage adverse reactions1,2

In addition to supportive care measures, management of some adverse reactions may require dose interruption, reduction or discontinuation
See section 4.2 of the Summary of Product Characteristics for specific guidance on dose modifications and recommendations for treatment discontinuations regarding hypertension, hepatotoxicity, diarrhoea and neutropenia

Starting with the current dose, gradually reduce the dose following the steps provided below, until the adverse reaction resolves

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 * - - -

Concomitant use with a strong CYP3A4 inhibitor increases exposure to the major active metabolite of Tavlesse. Monitor for toxicities of Tavlesse that may require Tavlesse dose modifications when given concurrently with a strong CYP3A4 inhibitor

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