GENCALQ CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Cipla Medpro (Pty) Ltd

Dosage:

100,0 mg

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS ACALABRUTINIB 100,0 mg

Authorization status:

Registered

Patient Information leaflet

CIPLA MEDPRO (PTY) LTD ACALABRUTINIB 100 MG CAPSULES
January 2023
Version 02
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MS
PATIENT INFORMATION LEAFLET
GENCALQ CAPSULES
SCHEDULING STATUS
GENCALQ (100 mg hard gelatin capsules)
Acalabrutinib
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING GENCALQ
•
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
•
GENCALQ 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 GENCALQ is and what it is used for.
2.
What you need to know before you take GENCALQ.
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January 2023
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3.
How to take GENCALQ.
4.
Possible side effects.
5.
How to store GENCALQ.
6.
Contents of the pack and other information.
1.
WHAT GENCALQ IS AND WHAT IT IS USED FOR
WHAT GENCALQ IS
GENCALQ is a medicine used to treat cancer.
•
GENCALQ contains the active substance: acalabrutinib.
•
GENCALQ belongs to a class of anti-cancer medicines called Bruton
tyrosine kinase
(BTK) inhibitors.
WHAT GENCALQ IS USED FOR
GENCALQ is used to treat adults with a type of cancer called:
•
Mantle cell lymphoma (MCL), who have received at least one prior
treatment for
their cancer
•
Chronic lymphocytic leukaemia (CLL), which is a cancer of white blood
cells called
B-lymphocytes (or B-cells). These cells are part of the immune system
(the body’s
defences)
•
GENCALQ works by blocking BTK, a protein in the body that helps these
cancer
cells grow and survive. By blocking BTK, GENCALQ helps to kill and can
reduce the
number of cancer cells which can slow down the worsening of the
disease.
CIPLA MEDPRO (PTY) LTD ACALABRUTINIB 100 MG CAPSULES
January 2023
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2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GENCALQ
DO NOT TAKE GENCALQ:
•
if you are allergic (hypersensitive) to acalabrutinib or

Summary of Product characteristics

CIPLA MEDPRO (PTY) LTD ACALABRUTINIB 100 mg Capsules
Page 1 of 17
PROFESSIONAL INFORMATION FOR:
GENCALQ Capsules
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
GENCALQ (100 mg hard gelatin capsules)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 100 mg of acalabrutinib.
Sugar free
For the full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules.
GENCALQ capsules: White to off white to light yellow blend, filled in
size “1” Opaque, hard gelatin
capsules, with pink cap and white body, printed with black ink
“Cipla” on the cap and “100 mg” on
the body.
4.
CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS
GENCALQ is indicated for the treatment of patients with mantle cell
lymphoma (MCL) who have
received at least one prior therapy.
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GENCALQ is indicated for the treatment of patients with chronic
lymphocytic leukaemia (CLL).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with GENCALQ should be initiated and supervised by a medical
practitioner
experienced in the use of anticancer therapies.
_ _
_POSOLOGY _
MCL
The recommended dose of GENCALQ for the treatment of MCL is 100 mg (1
capsule) twice a day.
CLL
The recommended dose of GENCALQ for the treatment of MCL is 100 mg (1
capsule) twice a day,
either as monotherapy or in combination with Obinutuzumab. Refer to
the Obinutuzumab prescribing
information for recommended Obinutuzumab dosing information. Doses
should be separated by
approximately 12 hours.
Treatment with GENCALQ should continue until disease progression or
unacceptable toxicity.
MISSED DOSE
If a patient misses a dose of GENCALQ by more than 3 hours, instruct
the patient to take the next
dose at its regularly scheduled time. Extra capsules of GENCALQ should
not be taken to make up
for a missed dose.
DOSE ADJUSTMENT
_Adverse Reactions _
Recommended dose modifications of GENCALQ for Grade ≥ 3 adverse
reactions are provided in
Table 1_._
_ _
CIPLA MEDPRO (PTY) LTD ACAL