CALQUENCE FILM-COATED TABLET 100MG

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

acalabrutinib maleate eqv acalabrutinib

Saadav alates:

ASTRAZENECA SINGAPORE PTE LTD

ATC kood:

L01EL02

Ravimvorm:

TABLET, FILM COATED

Koostis:

acalabrutinib maleate eqv acalabrutinib 100mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

AstraZeneca AB

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2023-09-29

Toote omadused

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