CALQUENCE acalabrutinib (as maleate) 100 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

acalabrutinib maleate monohydrate, Quantity: 129 mg

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; microcrystalline cellulose; hyprolose; sodium stearylfumarate; hypromellose; copovidone; titanium dioxide; macrogol 3350; medium chain triglycerides; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.,This indication is approved via the provisional approval pathway, based on overall response rate. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. CALQUENCE is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).

Product summary:

Visual Identification: The CALQUENCE 100 mg film-coated tablet is an orange, 7.5 x 13 mm, oval, biconvex tablet, debossed with 'ACA 100' on one side and plain on the reverse; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered (with Provisional Indication/s)

Authorization date:

2022-10-13

Patient Information leaflet

CALQUENCE
® TABLETS
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING CALQUENCE TABLETS?
CALQUENCE tablets contains the active ingredient acalabrutinib maleate
monohydrate. CALQUENCE tablets is used to treat
Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukaemia
(CLL)/Small Lymphocytic Lymphoma (SLL).
For more information, see Section 1. Why am I using CALQUENCE tablets?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CALQUENCE TABLETS?
Do not use if you have ever had an allergic reaction to CALQUENCE or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CALQUENCE tablets? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CALQUENCE tablets and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CALQUENCE TABLETS?
•
The usual dose is one 100 mg tablet twice a day. Doses should be taken
about 12 hours apart.
•
Swallow the tablet whole with water. Do not chew, crush, dissolve, or
divide the tablets.
More instructions can be found in Section 4. How do I use CALQUENCE
tablets? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CALQUENCE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, nurse, surgeon or pharmacist you visit
that you are using CALQUENCE
tablets.
•
You should be careful to protect yourself from the sun.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dose without checking
with your doctor.
•
Do not give this medicine to anyone else, even

Summary of Product characteristics

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This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
CALQUENCE
®
ACALABRUTINIB (AS MALEATE MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
acalabrutinib maleate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains acalabrutinib maleate monohydrate
equivalent to 100 mg of
acalabrutinib
.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The CALQUENCE 100 mg film-coated 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 for the treatment of patients with mantle cell
lymphoma who have
received at least one prior therapy.
This indication is approved via the
PROVISIONAL APPROVAL
pathway, based on overall response rate.
Full registration for this indication depends on verification and
description of clinical benefit in
confirmatory trials.
CALQUENCE is indicated for the treatment of patients with chronic
lymphocytic leukaemia
(CLL)/small lymphocytic lymphoma (SLL).
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with CALQUENCE should be initiated and supervised by a
physician experienced in the
use of anticancer therapies.
RECOMMENDED DOSAGE (18 YEARS AND ABOVE)
_MANTLE CELL LYMPHOMA (MCL) _
The recommended dose of CALQUENCE for the treatment of MCL is 100 mg
(1 tablet) twice
daily.
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_CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) _
The recommended dose of CALQUENCE for the treatment of CLL is 100 mg
(1 tablet) twice daily,
either as monotherapy or in combination with obinutuzumab. Administer
CALQUENCE prior to
obinutuzumab when given on the same day. Refer to the obinutuzumab
product information for
recommended obinutuzumab dosing information (for details of the
combination