Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Midostaurin
Novartis Europharm Ltd
L01XE
midostaurin
Antineoplastic agents
Leukemia, Myeloid, Acute; Mastocytosis
Rydapt is indicated:in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2);as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).
Revision: 11
Authorised
2017-09-18
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rydapt 25 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 25 mg midostaurin. Excipients with known effect Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule (capsule). Pale orange, oblong capsule with red imprint “PKC NVR”. The dimensions of the capsule are approximately 25.4 x 9.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rydapt is indicated: • in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2); • as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Rydapt should be initiated by a physician experienced in the use of anti-cancer therapies. Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. Posology Rydapt should be taken orally twice daily at approximately 12-hour intervals. The capsules should be taken with food (see sections 4.5 and 5.2). Prophylactic antiemetics should be administered in accordance with local medical practice as per patient tolerance. _ _ _ _ 3 _AML _ The recommended dose of Rydapt is 50 mg orally twice daily. Rydapt is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rydapt 25 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 25 mg midostaurin. Excipients with known effect Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule (capsule). Pale orange, oblong capsule with red imprint “PKC NVR”. The dimensions of the capsule are approximately 25.4 x 9.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rydapt is indicated: • in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2); • as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Rydapt should be initiated by a physician experienced in the use of anti-cancer therapies. Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. Posology Rydapt should be taken orally twice daily at approximately 12-hour intervals. The capsules should be taken with food (see sections 4.5 and 5.2). Prophylactic antiemetics should be administered in accordance with local medical practice as per patient tolerance. _ _ _ _ 3 _AML _ The recommended dose of Rydapt is 50 mg orally twice daily. Rydapt is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days Прочетете целия документ