CALQUENCE FILM-COATED TABLET 100MG

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

acalabrutinib maleate eqv acalabrutinib

から入手可能:

ASTRAZENECA SINGAPORE PTE LTD

ATCコード:

L01EL02

医薬品形態:

TABLET, FILM COATED

構図:

acalabrutinib maleate eqv acalabrutinib 100mg

投与経路:

ORAL

処方タイプ:

Prescription Only

製:

AstraZeneca AB

認証ステータス:

ACTIVE

承認日:

2023-09-29

製品の特徴

1
CALQUENCE
®
(ACALABRUTINIB)
1.
NAME OF THE MEDICINAL PRODUCT
CALQUENCE
(acalabrutinib) 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains acalabrutinib maleate equivalent to
100 mg of acalabrutinib.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The Calquence 100 mg tablet is an orange, 7.5 x 13 mm, oval, biconvex
tablet, debossed with
‘ACA 100’ on one side and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CALQUENCE is indicated
:
•
in combination with obinutuzumab or as monotherapy for the treatment
of patients with
previously untreated chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma
(SLL).
•
as monotherapy for the treatment of patients with CLL/SLL who have
received at least one
prior therapy.
•
for the treatment of patients with mantle cell lymphoma (MCL) who have
received at least
one prior therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with CALQUENCE should be initiated and supervised by a
physician experienced in
the use of anticancer therapies.
POSOLOGY
_MCL _
The recommended dose of CALQUENCE for the treatment of MCL is 100 mg
(1 tablet) twice
daily.
_CLL/SLL _
The recommended dose of CALQUENCE for the treatment of CLL/SLL is 100
mg (1 tablet) twice
daily, either as monotherapy or in combination with obinutuzumab.
Refer to the obinutuzumab
2
prescribing information for recommended obinutuzumab dosing
information. (For details of the
combination regimen, see section 5.1).
Doses should be separated by approximately 12 hours.
Treatment with CALQUENCE should continue until disease progression or
unacceptable toxicity.
MISSED DOSE
If a patient misses a dose of CALQUENCE by more than 3 hours, instruct
the patient to take the
next dose at its regularly scheduled time. Extra tablets of CALQUENCE
should not be taken to
make up for a missed dose.
DOSE ADJUSTMENTS
_ADVERSE REACTIONS _
Recommended dose modifications of CALQUENCE for Grade ≥ 3 adverse