IMBRUVICA ibrutinib 280 mg film-coated tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ibrutinib, Quantity: 280 mg

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

IMBRUVICA is indicated for the treatment of patients with MCL who have received at least one prior therapy.,IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenstr?m?s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with Waldenstrom?s macroglobulinaemia (WM).,IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).,IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one prior therapy.

Product summary:

Visual Identification: Purple oblong film-coated tablet debossed with "ibr" on one side and "280" on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-08-04

Patient Information leaflet

IMBRUVICA® (220601) CMI
1
IMBRUVICA
® CAPSULES
AND TABLETS
_ibrutinib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IMBRUVICA
capsules and tablets. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
IMBRUVICA against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN IMBRUVICA ASK YOUR
DOCTOR OR HEALTHCARE PROFESSIONAL.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING IMBRUVICA.
You may need to read it again.
WHAT IMBRUVICA IS
USED FOR
IMBRUVICA is an anticancer
medicine that contains the active
substance ibrutinib.
IMBRUVICA is used to treat the
following blood cancers in adults:
•
Mantle Cell Lymphoma (MCL), a
type of cancer affecting the
lymph nodes;
•
Chronic Lymphocytic Leukaemia
(CLL), including Small
Lymphocytic Lymphoma (SLL),
a type of cancer affecting a type
of white blood cell called
lymphocytes that also involve the
lymph nodes.
•
Waldenström's
macroglobulinemia (WM), a very
rare cancer affecting the
lymphocytes
IMBRUVICA works by blocking a
protein in the body that helps cancer
cells live and grow. This protein is
called Bruton's tyrosine kinase. By
blocking this protein, IMBRUVICA
may help kill and reduce the number
of cancer cells and may also slow the
spread of the cancer.
ASK YOUR DOCTOR OR HEALTHCARE
PROFESSIONAL IF YOU HAVE ANY
QUESTIONS ABOUT WHY IMBRUVICA
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
IMBRUVICA
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE IMBRUVICA:
•
if you are allergic
(hypersensitive) to ibrutinib, or
other ingredients of
IMBRUVICA. See Product
Description at the end of this
leaflet for a list of ingredients.
DO NOT TAKE IMBRUVICA:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the pack has
pas

Summary of Product characteristics

32.211106
1
IMBRUVICA (220531) API
A
USTRALIAN
P
RODUCT
I
NFORMATION
IMBRUVICA
®
IBRUTINIB
CAPSULES AND TABLETS
1. NAME OF THE MEDICINE
Ibrutinib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPSULES
_140 MG CAPSULES _
IMBRUVICA capsules contain 140 mg ibrutinib as the active ingredient.
FILM-
COATED TABLETS
IMBRUVICA tablets contain 140 mg, 280 mg, 420 mg or 560 mg of
ibrutinib.
Excipients with known effect: sugars as lactose
The characterization data demonstrate that ibrutinib at pH 1.2 is
considered slightly soluble and at
pH
3
to
8
ibrutinib
is
considered
practically
insoluble
as
defined
by
USP
and
European
Pharmacopoeia nomenclature. Ibrutinib is non-hygroscopic and the
melting onset temperature is
149-158 ˚C. The drug substance has one ionizable group, the
protonated pyrimidine moiety, with a
pKa of 3.74 in an aqueous solution with methanol as a co-solvent.
For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
CAPSULES
_140 MG CAPSULES_
White opaque, size 0, hard gelatin capsule is marked with “ibr 140
mg” in black ink.
FILM-COATED TABLETS
_140 MG TABLETS _
Yellow-green to green round film-coated tablet debossed with “ibr”
on one side and “140” on the
other.
_280 MG TABLETS _
Purple oblong film-coated tablet debossed with “ibr” on one side
and “280” on the other.
_420 MG TABLETS _
Yellow-green to green oblong film-coated tablet debossed with
“ibr” on one side and “420” on the
other.
_560 MG TABLETS _
Yellow to orange oblong film-coated tablet debossed with “ibr” on
one side and “560” on the other.
Product Information - Australia
32.211106
2
IMBRUVICA (220531) API
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IMBRUVICA is indicated for the treatment of patients with MCL who have
received at least one prior
therapy.
IMBRUVICA as a single agent is indicated for the treatment of adult
patients with Waldenström’s
macroglobulinaemia (WM) who have received at least one prior therapy,
or in first line treatment for
patients unsuitable