Rydapt 25mg Soft Capsules

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

Midostaurin

متاح من:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

Midostaurin

الوحدات في الحزمة:

56 Capsules; 112 Capsules

المصنعة من قبل:

Catalent Germany Eberbach GmbH

نشرة المعلومات

RYDAPT® SOFT CAPSULES
Midostaurin (25mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
RYDAPT
is used for
2.
How
RYDAPT
works
3.
Before you use
RYDAPT
4.
How to use
RYDAPT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
RYDAPT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT RYDAPT IS USED FOR
Rydapt
contains
the
active
substance
midostaurin.
It
belongs
to
a
class
of
medicines
called
protein
kinase
inhibitors.
Rydapt is used to treat acute myeloid
leukaemia (AML) in adults who have a
defect
in
a
gene
called
FLT3.
Acute
myeloid leukaemia is a form of cancer of
certain white blood cells (called myeloid
cells) in which the body over-produces
an abnormal type of these cells.
Rydapt is also used in adults to treat
aggressive systemic mastocytosis (ASM),
systemic
mastocytosis
with
associated
haematological neoplasm (SM-AHN), or
mast cell leukaemia (MCL). These are
disorders in which the body produces too
many mast cells, a type of white blood
cell.
Symptoms
are
caused
when
too
many mast cells enter organs such as the
liver, bone marrow or spleen, and release
substances
such
as
histamine
into
the
blood.
HOW RYDAPT WORKS
Midostaurin blocks the action of some
enzymes (kinases) in the abnormal cells
and stops their division and growth.
At the start of treatment in AML Rydapt
is
always
used
together
with
chemotherapy
(medicines
for
treating
cancer).
If
you have
any questions about how
Rydapt works or why this medicine has
been prescribed for you, ask your doctor,
pharmacist or nurse.
BEFORE YOU USE RYDAPT
-
_When you must not use it _
•
If you are allergic to midostaurin
or any of the other ingredients of
Rydapt. If you think you may be
allergic, ask your doctor for
advice.
•
if you are already taking any of
the following medicines:
o
medicines used to treat
tuberculosis, such as rifampicin;
o
medicines used to treat epilepsy,
such as carbamazepine or
phenytoin;
o
enzalutamide, a medicine used
to treat prostate ca

خصائص المنتج

Novartis
Page 2
Malaysia Package Leaflet
14 Nov 2022
Rydapt
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.
Novartis
Page 3
Malaysia Package Leaflet
14 Nov 2022
Rydapt
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 agen