CALQUENCE CAPSULES

Pays: Afrique du Sud

Langue: anglais

Source: South African Health Products Regulatory Authority (SAHPRA)

Disponible depuis:

AstraZeneca Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

forme pharmaceutique:

CAPSULES

Composition:

EACH CAPSULE CONTAINS ACALABRUTINIB 100,0 mg

Statut de autorisation:

Registered

Notice patient

AstraZeneca Pharmaceuticals (Pty) Ltd
Approval Date:
29/03/2022
CALQUENCE 100 mg (acalabrutinib) capsules
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
CALQUENCE
100 MG CAPSULES
(
acalabrutinib
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CALQUENCE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider
•
CALQUENCE has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What CALQUENCE is and what it is used for
2.
What you need to know before you take CALQUENCE
3.
How to take CALQUENCE
4.
Possible side effects
5.
How to store CALQUENCE
6.
Contents of the pack and other information
1.
WHAT CALQUENCE IS AND WHAT IT IS USED FOR
CALQUENCE is a medicine used to treat cancer. CALQUENCE capsules
contain
acalabrutinib, an active substance belongs to the Bruton tyrosine
kinase (BTK) inhibitor class
of anti-cancer medicines.
CALQUENCE is used for the treatment of adults with:
•
mantle cell lymphoma (MCL), who have received at least one prior
treatment for their
cancer
•
chronic lymphocytic leukaemia (CLL)
AstraZeneca Pharmaceuticals (Pty) Ltd
Approval Date:
29/03/2022
CALQUENCE 100 mg (acalabrutinib) capsules
CALQUENCE blocks BTK and can reduce the number of cancer cells and
slow the
progression of the disease. CALQUENCE will only be prescribed to you
by a doctor with
experience in the use of medicines for cancer.
If you have any questions about how CALQUENCE works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALQUENCE
DO NOT TAKE CALQUENCE
•
If you are hypersensitive (allergic) to acalabrutinib or any of the
other ingredients of
CALQUENCE (listed in section 6.)
WARNINGS AND PRECAUTIONS
Special care should be taken with CALQUENCE
Talk to your doctor before taking CALQUENCE if you:
•
have recently un

Résumé des caractéristiques du produit

AstraZeneca Pharmaceuticals (Pty) Ltd
Approval Date: 29/03/2022
CALQUENCE 100 mg (acalabrutinib) capsule
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1.
NAME OF THE MEDICINE
CALQUENCE
100 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg acalabrutinib.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule
Size 1 hard gelatine 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 (MCL)
who have received at least one prior therapy.
CALQUENCE is indicated for the treatment of patients with chronic
lymphocytic leukaemia
(CLL).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with CALQUENCE should be initiated and supervised by a
medical practitioner
experienced in the use of anticancer therapies.
POSOLOGY
_MCL _
The recommended dose of CALQUENCE for the treatment of MCL is 100 mg
(1 capsule) twice
daily.
_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.
Refer to the obinutuzumab
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.
AstraZeneca Pharmaceuticals (Pty) Ltd
Approval Date: 29/03/2022
CALQUENCE 100 mg (acalabrutinib) capsule
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 ADJUSTMENT
_Adverse Reactions _
Recommended dose modifications of CALQUENCE for Grade ≥ 3 adverse
reactions
are provided in Table 1.
TABLE 1. RECOMMENDED DOSE ADJUSTMENTS FOR ADVERSE REACTIONS*
ADVERSE
REAC