TAKHZYRO lanadelumab 300 mg/2 mL solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lanadelumab, Quantity: 300 mg

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride

Administration route:

Subcutaneous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

Product summary:

Visual Identification: Colourless to slightly yellow solution, appearing clear or slightly opalescent.; 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: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-06-15

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.
TAKHZYRO
®
_PRE-FILLED SYRINGE_
_lanadelumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET BEFORE YOU
START USING TAKHZYRO.
This leaflet answers some common
questions about TAKHZYRO. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
TAKHZYRO is a new medicine.
Please check with your doctor
whether there is any additional
information about this medicine that
you should know since you were last
treated with this medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using TAKHZYRO
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAKHZYRO IS
USED FOR
TAKHZYRO is a medicine used in
adults, and adolescents aged 12 years
and older to prevent angioedema
attacks in hereditary angioedema
(HAE).
You may still experience acute HAE
attacks whilst using TAKHZYRO.
You should make sure that you carry
acute attack treatment and that you
use this treatment as advised by your
doctor.
HAE is a hereditary condition which
means it can run in families. It
happens when your blood does not
have enough of a protein called 'C1
esterase inhibitor' (or 'C1 inhibitor'),
or it does not work properly. This
leads to too much 'plasma kallikrein',
which in turn produces higher levels
of 'bradykinin' in your bloodstream.
Too much bradykinin leads to
symptoms of HAE like swelling and
pain.
TAKHZYRO contains the active
substance lanadelumab. It is a type of
protein that blocks the activity of
plasma kallikrein. This helps to
reduce the amount of bradykinin in
your bloodstream and prevents
symp

Summary of Product characteristics

TAKHZYRO PI V4 (CCDS V4)
1
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.
AUSTRALIAN PRODUCT INFORMATION - TAKHZYRO
® (LANADELUMAB)
SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Lanadelumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ready-to-use solution, for subcutaneous injection only.
TAKHZYRO is a sterile, preservative-free solution supplied in a
single-dose pre-filled syringe
or a single-dose vial.
Each pre-filled syringe or vial contains 300 mg of lanadelumab in 2 mL
solution.
_Excipient with known effect: _
Each mL of solution contains 3.45 mg (0.150 mmol) of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
The solution is colourless to slightly yellow, appearing either clear
or slightly opalescent.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
TAKHZYRO is indicated for routine prevention of recurrent attacks of
hereditary angioedema
(C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12
years and older.
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
TAKHZYRO therapy should be initiated under supervision of a physician
experienced in the
care of patients with hereditary angioedema (HAE).
DOSAGE
The recommended starting dose is 300 mg lanadelumab every 2 weeks. In
patients who are
stably attack free on treatment, a dose reduction of 300 mg
lanadelumab every 4 weeks may be
considered, especially in patients with low weight.
_Elderly: _
Limited information is available on patients above 65 years of age.
Available data indicates
that no dose adjustment is required for patients above 65 years of
age.
▼
TAKHZYRO PI V4 (CCDS V4)
2
_Hepatic impairment: _
No studies have been conducted in patients with hepatic impairment.
_ _
_Renal impairment: _
No studies have been conducted in patients with renal impairment.
_ _
_Paediatric pop