Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
GILTERITINIB AS FUMARATE
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
L01XE54
FILM COATED TABLETS
GILTERITINIB AS FUMARATE 40 MG
PER OS
Required
ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS
GILTERITINIB
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation
2020-09-07
XOSPATA ™ (GILTERITINIB) HCP EDUCATIONAL INFORMATION BROCHURE This HCP Educational Information Brochure is an Additional Risk Minimisation Measure of the XOSPATA TM Risk Management Plan provided by Astellas Pharma International B.V. Israel HCP – healthcare professional This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reaction. For prescribing information, please refer to the XOSPATA TM physician leaflet provided with this brochure or please refer to the physician leaflet available in MOH site Date of preparation: January 2021 XOS_2020_0021_IL v.02: This Prescriber Brochure format and content have been updated and approved by the Ministry of Health on Feb 2021. 3 2 XOSPATA TM ............................................................................................... 4 Indication Adverse reactions Important information on Differentiation Syndrome associated with XOSPATA TM DIFFERENTIATION SYNDROME .............................................................. 5 Incidence of Differentiation Syndrome in AML patients treated with XOSPATA TM Aetiology and pathogenesis Signs and symptoms Diagnosis Differential diagnosis Treatment PATIENT ALERT CARD.............................................................................. 7 REPORTING OF SUSPECTED ADVERSE REACTIONS .............................. 7 CONTACT DETAILS .................................................................................. 7 REFERENCES ........................................................................................... 8 This HCP Educational Information Brochure aims to provide information about Differentiation Syndrome related to XOSPATA TM , to minimise the risk associated with this safety concern. Every healthcare professional must read and understand this HCP Educational tool before prescribing XOSPATA TM . Please refer to this brochure to support the health and safety of your patient Đọc toàn bộ tài liệu
1. NAME OF THE MEDICINAL PRODUCT Xospata 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg gilteritinib (as fumarate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Round, light yellow film-coated tablet, debossed with the company logo and ‘235’ on the same side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Xospata should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Before taking gilteritinib, relapsed or refractory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. Xospata may be re-initiated in patients following haematopoietic stem cell transplantation (HSCT) (see Table 1). PATIENT GUIDE The marketing of Xospata is subject to a risk management plan (RMP) including a Patient guide. The Patient guide, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. PRESCRIBER GUIDE This product is marketed with prescriber providing important safety information. Please ensure you are familiar with this material as it contains important safety information. Posology The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily. Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on day 15 and monthly for the duration of treatment. An electrocardiogram (ECG) should be performed before initiation of gilteritinib treatment, on day 8 and 15 of cycle 1 and prior to the start of the next three subsequent months of tr Đọc toàn bộ tài liệu