Fostamatinib (Tavlesse) for the treatment of chronic immune thrombocytopenia

Introduction

Fostamatinib (trade name: Tavlesse) has been approved in Germany since January 2020 for the treatment of chronic immune thrombocytopenia in adults. It is an option if other treatments have not helped.

Immune thrombocytopenia, also called immune thrombocytopenic purpura, is an autoimmune disorder in which the body’s own antibodies attack the platelets in the blood (thrombocytes). This leads to a deficiency.

The lack of thrombocytes in the blood causes the blood to clot more slowly, which increases the risk of bleeding. A typical symptom of immune thrombocytopenia is small, dot-shaped spots on the skin and mucous membranes, caused by bleeding into the skin and membranes. Severe and life-threatening bleeding is also possible, but rare.

Immune thrombocytopenia is considered to be chronic if the deficiency lasts for longer than one year. The chronic form mostly affects adults.

Fostamatinib is supposed to reduce the breakdown of thrombocytes in the spleen.

Application

Fostamatinib is available in tablet form (100 and 150 mg).

The recommended starting dose is 100 mg fostamatinib twice daily. Depending on the side effects and the count, after four weeks the dose can be increased to 150 mg fostamatinib twice daily.

The maximum daily dose is 300 mg.

Other treatments

Eltrombopag or romiplostim is used to treat chronic immune thrombocytopenia if other treatments have not helped.

Assessment

In 2020 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into whether fostamatinib has any advantages compared to eltrombopag or romiplostim for the treatment of chronic immune thrombocytopenia.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of fostamatinib (Tavlesse).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Fostamatinib (chronic immune thrombocytopenia) – Benefit assessment according to § 35a SGB V. Dossier assessment; Commission A20-53. September 29, 2020. (IQWiG reports; Volume 975).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on October 22, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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