TALTZ ixekizumab 80 mg/mL solution for injection prefilled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ixekizumab, Quantity: 80 mg/mL

Available from:

Eli Lilly Australia Pty Ltd

INN (International Name):

ixekizumab

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; citric acid; sodium citrate dihydrate; polysorbate 80; sodium chloride

Administration route:

Subcutaneous

Units in package:

3, 2, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Plaque psoriasis,TALTZ is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,Psoriatic arthritis,TALTZ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately, or who are intolerant, to previous DMARD therapy.,TALTZ may be used as monotherapy or in combination with a conventional DMARD (e.g. methotrexate).,Axial spondyloarthritis - Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis),TALTZ is indicated for the treatment of active ankylosing spondylitis in adult patients.,Axial spondyloarthritis - Non-radiographic axial spondyloarthritis,TALTZ is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI evidence, who have responded inadequately to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs).

Product summary:

Visual Identification: Clear to opalescent, colourless to slightly yellow to slightly brown solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-09-06

Patient Information leaflet

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at www.tga.gov.au/
reporting-problems.
TALTZ
®
_PREFILLED AUTOINJECTOR AND PREFILLED SYRINGE_
_Ixekizumab (rch) (pronounced ixe-kiz-u-mab)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TALTZ IS USED
FOR
TALTZ is used to treat plaque
psoriasis and psoriatic arthritis.
Plaque psoriasis is a skin condition
caused by inflammation affecting the
skin. TALTZ reduces inflammation
and other symptoms of the disease,
such as scaling, itching and pain.
TALTZ is used in adult patients with
moderate-to-severe plaque psoriasis
who are candidates for systemic
therapy or phototherapy.
Psoriatic arthritis is an inflammatory
disease of the joints, often
accompanied by psoriasis. You will
first be given other medicines to treat
psoriatic arthritis but may be given
TALTZ if you do not respond well to
these medicines. TALTZ can be used
alone or with other medicines, such
as methotrexate.
TALTZ contains the active
ingredient ixekizumab. Ixekizumab is
a monoclonal antibody. Monoclonal
antibodies are proteins that recognise
and bind specifically to certain
proteins in the body.
TALTZ belongs to a group of
medicines called interleukin (IL)
inhibitors. TALTZ works by
neutralising the activity of the protein
called IL-17A, which is present in
high levels in psoriasis.
TALTZ has not been studied in
patients under 18 years of age.
TALTZ may be used in elderly
patients aged 65 years and over.
TALTZ is available only with a
doctor's

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
▼

This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
TALTZ (IXEKIZUMAB (RCH)) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Ixekizumab (rch)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled pen (autoinjector) or prefilled syringe contains
ixekizumab 80 mg/mL.
TALTZ (ixekizumab (rch)) is a humanised immunoglobulin G subclass 4
(IgG4) monoclonal
antibody (mAb) with neutralising activity against interleukin-17A
(IL-17A). TALTZ is
produced by recombinant DNA technology in a recombinant mammalian cell
line and
purified using standard technology for bioprocessing. Ixekizumab is
comprised of two
identical light chain polypeptides of 219 amino acids each and two
identical heavy chain
polypeptides of 445 amino acids each.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
TALTZ is supplied as a solution for injection.
The TALTZ solution is sterile, preservative free, clear and colourless
to slightly yellow. The
TALTZ solution has a pH of 5.3 to 6.1. TALTZ is administered as a
subcutaneous (SC)
injection. TALTZ is for single use, therefore contains no
antimicrobial preservative.
TALTZ is available as a 1 mL single-dose prefilled pen (autoinjector)
or a 1 mL single dose
prefilled syringe. Each autoinjector or prefilled syringe is composed
of ixekizumab (80
mg/mL).
The autoinjector and prefilled syringe each contain a 1 mL glass
syringe with a fixed needle.
The TALTZ autoinjector and prefilled syringe are manufactured to
deliver 80 mg of
ixekizumab. TALTZ is latex-free.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_PLAQUE PSORIASIS _
TALTZ is indicated for the treatment of adult patients with
moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or phototherapy.
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_PSORIA