Calquence

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Acalabrutinib 100mg

Available from:

AstraZeneca Limited

Dosage:

100 mg

Pharmaceutical form:

Capsule

Composition:

Active: Acalabrutinib 100mg Excipient: Black ink (Calquence) Gelatin Indigo carmine Iron oxide yellow Magnesium stearate Silicified microcrystalline cellulose Sodium starch glycolate Starch Titanium dioxide

Prescription type:

Prescription

Therapeutic indications:

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).

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu/PVC, alu, polyamide blister with heat sealed alu lid - 56 capsules - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2020-04-01

Patient Information leaflet

CALQUENCE
®
CMI 120821
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CALQUENCE

ACALABRUTINIB 100 MG CAPSULES
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
CALQUENCE. It does not contain all the
information that is known about CALQUENCE.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have 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
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 may slow the spread
of the cancer.
ASK YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU. Your doctor may have prescribed it for another
reason.
It is available only with a doctor's prescription.
There is not enough information to recommend the use of this medicine
for children or adolescents under the age of
18 years.
BEFORE YOU USE CALQUENCE
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE CALQUENCE IF YOU HAVE AN ALLERGY TO ANY MEDICINE
CONTAINING ACALABRUTINIB OR OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms of an allergic reaction may inclu

Summary of Product characteristics

CALQUENCE Data Sheet 120821
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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CALQUENCE
®
100 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg acalabrutinib.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
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.
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
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.
CALQUENCE Data Sheet 120821
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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 capsules 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 or greater
adverse reactions
are provided in Table 1.
TABLE 1
RECOMMENDED DOSE ADJUSTMENTS FOR AD