Rydapt 25mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Midostaurin

Disponible depuis:

Novartis Pharmaceuticals UK Ltd

Code ATC:

L01XE39

DCI (Dénomination commune internationale):

Midostaurin

Dosage:

25mg

forme pharmaceutique:

Capsule

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: ; GTIN: 5010678918212

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RYDAPT
® 25 MG SOFT CAPSULES
midostaurin
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rydapt is and what it is used for
2.
What you need to know before you take Rydapt
3.
How to take Rydapt
4.
Possible side effects
5.
How to store Rydapt
6.
Contents of the pack and other information
1.
WHAT RYDAPT IS AND WHAT IT IS USED FOR
WHAT RYDAPT IS
Rydapt contains the active substance midostaurin. It belongs to a
class of medicines called protein kinase
inhibitors.
WHAT RYDAPT IS USED FOR
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 act

Résumé des caractéristiques du produit

OBJECT 1
RYDAPT 25 MG SOFT CAPSULES
Summary of Product Characteristics Updated 08-Jun-2018 | Novartis
Pharmaceuticals UK Ltd
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 reactions. See
section 4.8 for how to report adverse reactions.
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