BELKYRA deoxycholic acid 10 mg/mL injection glass vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

deoxycholic acid, Quantity: 10 mg/mL

Available from:

Abbvie Pty Ltd

INN (International Name):

Deoxycholic acid

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; hydrochloric acid

Administration route:

Subcutaneous

Units in package:

2 mL per vial. Four vials per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BELKYRA (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults

Product summary:

Visual Identification: solution for injection in a 2 mL type I glass vial with stopper and flip-top lid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-07-21

Patient Information leaflet

BELKYRA
®
CMI v5 PI v8
1
BELKYRA
®
_ _
10 mg/mL_ _(Bel-ky-ra)_ _
_deoxycholic acid solution for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
BELKYRA
®
injection.
It does not contain all the
available information. It does
not take the place of talking to
your doctor.
All medicines have risks and
benefits. Make sure you
understand the risks and benefits
of BELKYRA
®
injection.
If you have any concerns about
using this medicine, ask your
doctor.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BELKYRA
®
INJECTION IS USED
FOR
BELKYRA
®
is an injectable
prescription medicine that
contains deoxycholic acid as the
active ingredient.
BELKYRA
®
injection non-
surgically reduces fat under the
chin, resulting in a more
contoured neck profile and
jawline.
Ask your doctor if you have any
questions about the benefits and
risks of this medicine.
This medicine is available only
with a doctor’s prescription.
BELKYRA
®
injection is not
indicated for use in children or
adolescents, younger than 18
years.
BEFORE YOU ARE
GIVEN BELKYRA
®
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN BELKYRA_
_®_
_ INJECTION _
This medicine must not be
administered if you have an
allergy to:
•
The active ingredient
deoxycholic acid or to any of
the other ingredients listed at
the end of this leaflet under
Product Description
•
any other similar medicines
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
_ _
THIS MEDICINE MUST NOT BE
ADMINISTERED IF YOU HAVE AN
INFECTION IN YOUR CHIN OR NECK
AREA WHERE THE PRODUCT WILL BE
INJECTED.
If you are not sure whether this
medicine is right for you, talk to
your doctor.
_BEFORE YOU BEGIN TREATMENT _
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have had any of the following
medi

Summary of Product characteristics

BELKYRA
PIv8; CCDSv6.0
1
AUSTRALIAN PRODUCT INFORMATION
BELKYRA
® (DEOXYCHOLIC ACID)
1
NAME OF MEDICINE
Deoxycholic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BELKYRA
®
solution for injection contains deoxycholic acid 10 mg/mL
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BELKYRA
®
(deoxycholic acid) injection is a formulation of synthetically derived
deoxycholic acid in a sterile solution for subcutaneous injection. No
human or animal-derived
materials are used in the manufacture of synthetic deoxycholic acid.
Deoxycholic acid is a white to off-white crystalline powder and is
freely soluble in alkaline
solutions. The pKa and logP of deoxycholic acid have been determined
at 25°C to be 6.0 and
4.1, respectively.
BELKYRA
®
injection is a clear, colourless liquid essentially free of visible
particulates. Each
single-use 2 mL vial contains 20 mg (10 mg/mL) of deoxycholic acid
formulated in a sterile
solution of sodium hydroxide, dibasic sodium phosphate, sodium
chloride and water for
injections. The formulation is adjusted to pH 8.3 with hydrochloric
acid or sodium hydroxide
and has a tonicity compatible with that of biological tissues and
fluids.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BELKYRA
®
(deoxycholic acid) injection is indicated for improvement in the
appearance of
moderate to severe convexity or fullness associated with submental fat
in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSING CONSIDERATIONS
BELKYRA
®
injection should be administered by a medical practitioner, who
understands the
relevant submental anatomy and associated neuromuscular structures and
any alterations to
the anatomy in a particular individual patient (e.g. due to prior
surgical or aesthetic
procedures)
_(see Section 4.4 Special warnings and precautions for use)._
Screen patients for other potential causes of submental
convexity/fullness (e.g. thyromegaly
and cervical lymphadenopathy).
Use caution in patients who have had prior surgical or aesthetic
treatment of the