CALQUENCE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACALABRUTINIB

Available from:

ASTRAZENECA (ISRAEL) LTD

Pharmaceutical form:

CAPSULES

Composition:

ACALABRUTINIB 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTRA ZENECA AB, SWEDEN

Therapeutic indications:

Mantle Cell LymphomaCALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaCALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)or small lymphocytic lymphoma (SLL).

Authorization date:

2019-12-04

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Calquence
®
Capsules
Composition:
Each capsule contains:
Acalabrutinib 100 mg
For inactive and allergenic ingredients, please refer to section 2
"Important
information about some of the ingredients in this medicine" and
section 6 - "Further
Information".
Read this leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Calquence is indicated for the treatment of:
•
adult patients with MCL (mantle cell lymphoma) who have received at
least
one prior therapy.
•
adult patients with Chronic Lymphocytic Leukemia (CLL) or Small
Lymphocytic Lymphoma (SLL).
Therapeutic group
BTK (Bruton tyrosine kinase) inhibitors.
2.
BEFORE USING THE MEDICINE
X Do not use this medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients contained in the medicine (please refer to section 6 -
"Further
Information").
Special warnings regarding the use of Calquence:
! Before treatment with Calquence tell your doctor, pharmacist or
nurse if you:
•
recently had surgery or plan to have surgery. Your doctor may stop
treatment
with Calquence for any planned surgical, medical, or dental procedure.
•
have bleeding problems.
•
have or had heart rhythm problems.
•
have an infection or are at risk group for developing infections.
•
have or had liver problems, including hepatitis B virus (HBV)
infection.
•
are pregnant or plan to become pregnant.
•
are breastfeeding or plan to breastfeed.
! Children and adolescents
There is no data regarding safety and efficacy of use of this medicine
in children and
adolescents.
! T

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
CALQUENCE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Acalabrutinib 100 mg
3.
PHARMACEUTICAL FORM
Capsules.
A size 1 hard gelatin capsule, with a blue cap and yellow body,
printed with ‘ACA 100mg’ in
black ink.
4.
INDICATIONS AND USAGE
4.1 Mantle Cell Lymphoma
CALQUENCE is indicated for the treatment of adult patients with mantle
cell lymphoma
(MCL) who have received at least one prior therapy.
4.2 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
CALQUENCE is indicated for the treatment of adult patients with
chronic lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL).
5.
DOSAGE AND ADMINISTRATION
5.1
Recommended Dosage
CALQUENCE as Monotherapy
For patients with MCL, CLL, or SLL, the recommended dose of CALQUENCE
is 100 mg taken
orally approximately every twelve hours until disease progression or
unacceptable toxicity.
CALQUENCE in Combination with Obinutuzumab
For patients with previously untreated CLL or SLL, the recommended
dose of CALQUENCE is
100 mg taken orally approximately every 12 hours until disease
progression or unacceptable
toxicity. Start CALQUENCE at Cycle 1 (each cycle is 28 days). Start
obinutuzumab at Cycle 2 for
a total of 6 cycles and refer to the obinutuzumab prescribing
information for recommended
dosing. Administer CALQUENCE prior to obinutuzumab when given on the
same day.
Advise patients to swallow capsule whole with water. Advise patients
not to open, break or chew
the capsules. CALQUENCE may be taken with or without food. If a dose
of CALQUENCE is
missed by more than 3 hours, it should be skipped and the next dose
should be taken at its
regularly scheduled time. Extra capsules of CALQUENCE should not be
taken to make up for a
missed dose.
5.2
Recommended Dosage for Hepatic Impairment
Avoid administration of CALQUENCE in patients with severe hepatic
impairment.
Dose modifications are not required for patients with mild or moderate
hepatic impairment [see
Use in Specific Populations (11.6) and Clinical Pharmacology (13.3)].
5.3
Rec