CALQUENCE acalabrutinib 100 mg capsule blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

acalabrutinib, Quantity: 100 mg

Disponible desde:

AstraZeneca Pty Ltd

formulario farmacéutico:

Capsule, hard

Composición:

Excipient Ingredients: iron oxide yellow; indigo carmine aluminium lake; pregelatinised starch; sodium starch glycollate type A; Gelatin; Shellac; silicified microcrystalline cellulose; propylene glycol; titanium dioxide; iron oxide black; magnesium stearate

Vía de administración:

Oral

Unidades en paquete:

56 capsules

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. CALQUENCE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.,CALQUENCE is indicated for the treatment of patients with chronic lymphocytic leukaemia(CLL)/small lymphocytic lymphoma (SLL).

Resumen del producto:

Visual Identification: Size 1 hard gelatin capsule with a yellow body and blue cap, marked in black ink with ACA 100 mg; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered (with Provisional Indication/s)

Fecha de autorización:

2019-11-21

Información para el usuario

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. You can report side
effects to your doctor, or directly at www.tga.gov.au/
reporting-problems .
CALQUENCE
®
_Acalabrutinib_
THIS MEDICINE HAS PROVISIONAL REGISTRATION IN AUSTRALIA FOR (CALQUENCE
IS INDICATED FOR THE TREATMENT OF PATIENTS
WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR
THERAPY.). THE DECISION TO PROVISIONALLY REGISTER THIS
NEW USE OF THE MEDICINE HAS BEEN MADE ON THE BASIS OF PROMISING
RESULTS FROM PRELIMINARY STUDIES. MORE EVIDENCE IS
REQUIRED TO BE SUBMITTED WHEN AVAILABLE TO SUBSTANTIATE THE BENEFIT OF
THE MEDICINE FOR THIS USE.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CALQUENCE. It
does not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
CALQUENCE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CALQUENCE IS
USED FOR
CALQUENCE is an anticancer
medicine used in adults to treat:
•
Mantle Cell Lymphoma (MCL), a
type of blood cancer that affects
the lymph nodes (lymph glands).
It is used in patients who have
had at least one other treatment
for their cancer.
•
Chronic Lymphocytic Leukaemia
(CLL)/Small Lymphocytic
Lymphoma (SLL), a type of
blood cancer that affects
lymphocytes (a certain type of
white blood cell) and the lymph
nodes.
CALQUENCE contains the active
ingredient acalabrutinib which
belongs to a group of anti-cancer
medicines called Bruton tyrosine
kinase (BTK) inhibitors. BTK is a
protein in the body that helps cancer
cells to grow.
CALQUENCE works by blocking
BTK which may help to reduce the
number of cancer cells and ma

Ficha técnica

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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) CAPSULES
1
NAME OF THE MEDICINE
acalabrutinib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg acalabrutinib.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Capsule, hard.
Size 1 hard gelatin capsule with a yellow body and blue cap, marked in
black ink with
‘ACA 100 mg’
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 capsule) twice
daily.
_CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) _
The recommended dose of CALQUENCE for the treatment of CLL is 100 mg
(1 capsule) twice
daily, either as monotherapy or in combination with obinutuzumab.
Administer CALQUENCE
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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 regimen, see
section 5.1 Pharmacodynamic properties).
Doses should be separated by approximately 12 hours.
Treatment with CALQUENCE should c