Rydapt

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Midostaurin

Saadav alates:

Novartis Europharm Ltd

ATC kood:

L01XE

INN (Rahvusvaheline Nimetus):

midostaurin

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Leukemia, Myeloid, Acute; Mastocytosis

Näidustused:

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).

Toote kokkuvõte:

Revision: 11

Volitamisolek:

Authorised

Loa andmise kuupäev:

2017-09-18

Infovoldik

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

Toote omadused

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