Basic Information
Grasustek
Regulatory Information
EMEA/H/C/004556
June 20, 2019
April 26, 2019
5
July 4, 2024
Company Information
Germany
Gutenbergstrasse 13 24941 Flensburg
"JUTA" Pharma GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Overview Summary
Grasustek is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections. It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection). Grasustek is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia). Grasustek is a ‘biosimilar medicine’. This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Grasustek is Neulasta. Grasustek contains the active substance pegfilgrastim.