Kryxana 200mg Film-coated Tablets

País: Malásia

Língua: inglês

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

Ingredientes ativos:

Ribociclib succinate

Disponível em:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

DCI (Denominação Comum Internacional):

Ribociclib succinate

Unidades em pacote:

21 Tablets; 42 Tablets; 63 Tablets

Fabricado por:

Novartis Pharmaceutical Manufacturing LLC

Folheto informativo - Bula

KRYXANA
®
FILM-COATED
TABLETS
Ribociclib (200 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Kryxana is used for
2.
How Kryxana works
3.
Before you use Kryxana
4.
How to use Kryxana
5.
While you are using Kryxana
6.
Side effects
7.
Storage and Disposal of Kryxana
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT KRYXANA IS USED FOR
KRYXANA is a prescription medicine
used to treat adults with hormone
receptor (HR)-positive, human epidermal
growth factor receptor 2 (HER2)-
negative breast cancer that has gotten
worse or has spread to other parts of the
body (metastatic),
in combination with:
•
an aromatase inhibitor as the first
endocrine-based therapy in
pre/perimenopausal or
postmenopausal women or in men;
or
•
fulvestrant as the first endocrine-
based therapy or following disease
progression on endocrine therapy in
postmenopausal women or in men.
It is not known if KRYXANA is safe and
effective in children.
HOW KRYXANA WORKS
KRYXANA works by blocking the
effects of enzymes called cyclin
dependent kinases (CDK) which signal
cancer cells to grow and divide to make
new cells. By blocking these enzymes,
KRYXANA can reduce cancer cell
growth, the ability to make new cancer
cells, and can kill cancer cells.
BEFORE YOU USE KRYXANA
-
_When you must not use it _
•
Avoid eating grapefruit and avoid
grapefruit juice during treatment
with KRYXANA since these may
increase the amount of KRYXANA
in your blood.
_ _
_ _
•
Do not breast-feed during your
treatment with KRYXANA and for
at least 3 weeks after the last dose of
KRYXANA.
_ _
•
Do not take if you have
hypersensitivity to the active
substance or to peanut, soya or any
of the excipients.
_ _
_ _
-
_Before you start use it _
BEFORE YOU TAKE KRYXANA, TELL YOUR
HEALTHCARE PROVIDER IF YOU:
•
have any heart problems, including
heart failure, irregular heartbeats,
and QT prolongation
•
have ever had a heart attack
•
have a slow heartbeat (bradycardia)
•
h

Características técnicas

KRYXANA
®
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
KRYXANA is indicated for the treatment of adult patients with hormone
receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
in combination with:
•
an aromatase inhibitor as initial endocrine-based therapy in
pre/perimenopausal or postmenopausal women or in
men; or
•
fulvestrant as initial endocrine-based therapy or following disease
progression on endocrine therapy in
postmenopausal women or in men.
2
DOSAGE AND ADMINISTRATION
2.1
DOSING AND ADMINISTRATION
The recommended dose of KRYXANA is 600 mg (three 200 mg film-coated
tablets) taken orally, once daily for 21
consecutive days followed by 7 days off treatment resulting in a
complete cycle of 28 days. KRYXANA can be taken with
or without food
_[see Clinical Pharmacology (12.3)]_
.
When given with KRYXANA, refer to the Full Prescribing Information for
the recommended dose of the aromatase
inhibitor being used.
When given with KRYXANA, the recommended dose of fulvestrant is 500 mg
administered on Days 1, 15, 29, and once
monthly thereafter. Please refer to the Full Prescribing Information
of fulvestrant.
Pre/perimenopausal women, or men, treated with the combination KRYXANA
plus an aromatase inhibitor should be treated
with a luteinizing hormone-releasing hormone (LHRH) agonist according
to current clinical practice standards.
Men treated with the combination of KRYXANA plus fulvestrant should be
treated with a luteinizing hormone-releasing
hormone (LHRH) agonist according to current clinical practice
standards.
Patients should take their dose of KRYXANA at approximately the same
time each day, preferably in the morning.
If the patient vomits after taking the dose, or misses a dose, no
additional dose should be taken that day. The next prescribed
dose should be taken at the usual time. KRYXANA tablets should be
swallowed whole (tablets should not be chewed,
crushed or split prior to swallowing). No tablet should be ingested if
it is