Calquence Hard Capsules 100mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

Acalabrutinib

Tillgänglig från:

ASTRAZENECA SDN. BHD.

INN (International namn):

Acalabrutinib

Enheter i paketet:

60 Capsules

Tillverkad av:

ASTRAZENECA AB

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CALQUENCE
® CAPSULE _ _
ACALABRUTINIB (100MG) _ _
1
WHAT IS IN THIS LEAFLET
1.
What CALQUENCE is used
for
2.
How CALQUENCE works
3.
Before you use
CALQUENCE
4.
How to use CALQUENCE
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
CALQUENCE
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of Revision
WHAT CALQUENCE IS USED FOR
CALQUENCE is used to treat
adults with chronic lymphocytic
leukaemia (CLL).
CLL is a cancer of white blood
cells called B-lymphocytes (or B-
cells). These cells are part of the
immune system (the body’s
defences).
HOW CALQUENCE WORKS
CALQUENCE works by blocking
BTK, a protein in the body that
helps these cancer cells grow and
survive. By blocking BTK,
CALQUENCE helps to kill and
can reduce the number of cancer
cells which can slow down the
worsening of the disease.
If you have any questions about
how CALQUENCE works or why
this medicine has been prescribed
for you, ask your doctor,
pharmacist or nurse.
BEFORE YOU USE CALQUENCE
_When you must not use it _
DO NOT TAKE CALQUENCE IF:
•
you are allergic to
acalabrutinib or any of the
other ingredients of this
medicine.
If you are not sure, talk to your
doctor, pharmacist or nurse before
taking CALQUENCE.
_Children and adolescents _
Do not give this medicine to
children or adolescents aged less
than 18 years. This is because it
has not been studied in this age
group.
_Before you start to take it _
Talk to your doctor, pharmacist or
nurse before taking
CALQUENCE if you:
•
have ever had unusual
bruising or bleeding or are on
any medicine that increase
your risk of bleeding
•
have an infection
•
have recently had an
operation or are about to have
one. Your doctor may stop
treatment with CALQUENCE
before and after a medical,
surgical or dental procedure
•
have ever had hepatitis B (a
liver infection) – this is
because Calquence could
cause hepatitis B to become
active again and so that your
doctor will look out for signs
of this infection co

Produktens egenskaper

CALQUENCE
®
Acalabrutinib 100mg Hard Capsules
1.
NAME OF THE MEDICINAL PRODUCT
Calquence 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of acalabrutinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Yellow body, blue cap, size 1 (20 mm) hard capsule, marked with “ACA
100 mg” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Calquence as monotherapy or in combination with obinutuzumab is
indicated for the treatment of
adult patients with previously untreated chronic lymphocytic leukaemia
(CLL).
Calquence as monotherapy is indicated for the treatment of adult
patients with chronic lymphocytic
leukaemia (CLL) who have received at least one prior therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with this medicinal product should be initiated and
supervised by a physician experienced
in the use of anticancer medicinal products.
Posology
The recommended dose is 100 mg acalabrutinib twice daily (equivalent
to a total daily dose of
200 mg). Refer to obinutuzumab prescribing information for recommended
obinutuzumab dosing
information.
The dose interval is approximately 12 hours.
Treatment with Calquence should be continued until disease progression
or unacceptable toxicity.
Dose adjustments
_Adverse reactions_
Recommended dose modifications of Calquence for Grade ≥ 3 adverse
reactions are provided in
Table 1.
TABLE 1. RECOMMENDED DOSE ADJUSTMENTS FOR ADVERSE REACTIONS*
ADVERSE REACTION
ADVERSE
REACTION
OCCURRENCE
DOSE MODIFICATION
(Starting dose = 100mg approximately every
12 hours)
Grade 3 thrombocytopenia
with bleeding,
Grade 4 thrombocytopenia
Or
Grade 4 neutropenia lasting
longer than 7 days
Grade 3 or greater non-
hematological toxicities
First and second
Interrupt Calquence
Once toxicity has resolved to Grade 1 or
baseline, Calquence may be resumed at 100mg
approximately every 12 hours
Third
Interrupt Calquence
Once toxicity has resolved to Grade 1 or
baseline, Calquence may be r