Calquence

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Acalabrutinib

זמין מ:

AstraZeneca AB

קוד ATC:

L01EL02

INN (שם בינלאומי):

acalabrutinib

קבוצה תרפויטית:

Antineoplastic agents, protein kinase inhibitors,

איזור תרפויטי:

Leukemia, Lymphocytic, Chronic, B-Cell

סממני תרפויטית:

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.

leaflet_short:

Revision: 7

מצב אישור:

Authorised

תאריך אישור:

2020-11-05

עלון מידע

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CALQUENCE 100 MG HARD CAPSULES
acalabrutinib
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, please 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 symptoms 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 Calquence is and what it is used for
2.
What you need to know before you take Calquence
3.
How to take Calquence
4.
Possible side effects
5.
How to store Calquence
6.
Contents of the pack and other information
1.
WHAT CALQUENCE IS AND WHAT IT IS USED FOR
WHAT CALQUENCE IS
Calquence is a medicine used to treat cancer.

Calquence contains the active substance acalabrutinib.

It belongs to a group of medicines called Bruton tyrosine kinase (BTK)
inhibitors.
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.
68

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
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.
3
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-
haematological