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BELKYRA 10 MG/ML SOLUTION FOR INJECTION

Active substance(s): DEOXYCHOLIC ACID / DEOXYCHOLIC ACID

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Package leaflet:
Information for the user
BELKYRA 10 mg/ml
solution for injection
Deoxycholic acid

solution for injection
Deoxycholic acid

BELKYRA® 10 mg/ml
BELKYRA® 10 mg/ml
solution for injection
Deoxycholic acid

Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read
it again.
- If you have any further questions, ask your
doctor, pharmacist or nurse.
- If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What BELKYRA is and what it is used for
2. What you need to know before you
use BELKYRA
3. How to use BELKYRA
4. Possible side effects
5. How to store BELKYRA
6. Contents of the pack and other information
1. What BELKYRA is and what it is
used for
Belkyra contains the active substance
deoxycholic acid. Deoxycholic acid is
produced naturally in your body to aid in the
digestion of fats.
The medicine is used in adults for the
treatment of submental fat (unwanted fat
under the chin) when its presence has
a psychological impact for the patient.
Belkyra contains a non-human, non-animal
version of deoxycholic acid which is
identical to naturally-occuring deoxycholic
acid. Belkyra is an injectable medicine given
by your doctor or nurse.

2. What you need to know before you
use BELKYRA
Do not use BELKYRA:
• if you are allergic to deoxycholic acid
or any of the other ingredients of this
medicine (listed in section 6).
• if you have an infection in your chin
or neck area where the product will be
injected.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Belkyra. Your doctor or nurse
will check how well you are before each

treatment. Make sure you tell your doctor or
nurse about any illness you have before each
treatment.
Your doctor or nurse will pay particular
attention to the area around your neck
because caution is necessary in the case
of any diseases or previous surgery (e.g.
scarring, liposuction, difficulty swallowing,
enlargement of the thyroid gland or lymph
glands).
• Temporary nerve injury in the jaw, leading
to an uneven smile or facial muscle
weakness, can occur.
• Temporary tissue damage (i.e., skin
erosion) can occur if Belkyra is injected
into structures other than subcutaneous fat.
Therefore Belkyra has to be administered
only subcutaneously.
These side effects have all fully resolved
without permanent effects and without
treatment.

Children and adolescents
This medicine is not indicated for use in
children and adolescents.
Other medicines and BELKYRA
Tell your doctor or nurse if you are taking,
have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
The effects of this medicine in pregnant
and breast-feeding women are not known.
As a precaution the use of Belkyra during
pregnancy is not recommended.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or nurse for advice
before taking this medicine.

Driving and using machines
Belkyra is not expected to affect your ability
to drive a car or operate machinery.
BELKYRA contains sodium
This medicinal product contains
4.23 mg sodium per mL, to be taken into
consideration by patients on a controlled
sodium diet.
3. How to use BELKYRA
How BELKYRA is administered
Belkyra will be given by a healthcare
professional directly underneath the
skin (‘subcutaneous use’). A healthcare
professional will administer injections of
Belkyra into the fat tissue directly below the
skin in the area under your chin.

Your doctor or nurse may take some
measures for the relief of pain before and
after the injection.

Dose
Your doctor or nurse will determine the dose
you will receive and supervise the injection.
Your doctor or nurse will inject small
amounts of Belkyra in several locations in
your treatment area. Your doctor or nurse
will decide how much Belkyra will be
administered and how many treatments you
will need based upon the amount of fat under
your chin.
You will receive multiple injections per
treatment session. The total number of
injections and treatment sessions needed
to achieve a satisfactory response depends
upon your individual needs. Treatment can
be repeated multiple times but should not
exceed 6 treatment sessions; 2 to 4 treatment
sessions are usually sufficient. The time
between each treatment session should be at
least 4 weeks.

If you have been administered more
BELKYRA than you should
If more Belkyra is given to you than
recommended, this can lead to a possible
increase of local side effects (see section 4).
If this does happen, talk to your doctor
or nurse.
Additional information regarding the use
and handling by the medical or healthcare
professional is given at the end of this
leaflet.
If you have any further questions on the use
of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not everybody
gets them.
• Temporary nerve injury in the jaw,
leading to an uneven smile or facial
muscle weakness, can occur.
• Temporary tissue damage (i.e., skin
erosion) can occur if Belkyra is injected
into structures other than subcutaneous
fat. Therefore Belkyra has to be
administered only subcutaneously.
If you experience these side effects, contact
your doctor or nurse immediately.
Following is a list of the side effects,
which have been observed according to the
following frequencies:

Very common side effects (may affect
more than 1 in 10 people):
• Injection site reactions:
• pain
• water retention in the tissue (oedema)
and swelling
• sensitivity symptoms (paraesthesia):
loss of sensitivity, reduced sensitivity,
numbness, tingling, unusual sensitivity
• small round area of localized hardness
(nodule)
• bruising
• firmness or thickening of tissue
(induration)
• redness of the skin (erythema)
• itching

Malta
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal

Common side effects (may affect up to
1 in 10 people):
• Injection site reactions:
• bleeding
• discomfort
• warmth
• change of skin color
• Nerve injury around the jaw
• Skin tightness
• Difficulties in swallowing (dysphagia)
• Feeling sick (nausea)
• Headache

This medicinal product does not require any
special storage conditions. After opening, an
immediate use of the solution for injection is
recommended.

Uncommon side effects (may affect up to
1 in 100 people):
• Unusual taste in the mouth (dysgeusia)
• Difficulties in speaking (dysphonia)
• Injection site reactions:
• hair loss (alopecia)
• hives (urticaria)
• skin sores (ulcer)
• allergic reaction (hypersensitivity)
Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via:
UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store BELKYRA
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry
date which is stated on the label and the
carton after “EXP”. The expiry date refers to
the last day of that month.

Do not use this medicine if you notice any
visible particles.

6. Contents of the pack and other
information
What BELKYRA contains
• The active substance is deoxycholic acid.
1 ml of solution for injection (injection)
contains 10 mg deoxycholic acid.
1 vial with 2 ml contains 20 mg
deoxycholic acid.
• The other ingredients are water for
injection, sodium chloride, sodium
hydroxide (for pH adjustment),
hydrocholoric acid (for pH adjustment)
and disodium phosphate anhydrous.
What BELKYRA looks like and
contents of the pack
Belkyra is a clear, colourless and sterile
solution for injection.
Pack size:
One carton with 4 vials (Type I glass with
a chlorobutyl rubber stopper, aluminium seal
and polypropylene flip-top lid).
Each vial contains 2 ml solution for
injection.

Marketing Authorisation Holder
Allergan Pharmaceuticals
International Limited
Clonshaugh Industrial Estate
Coolock
Dublin 17
Ireland

Manufacturer
Almac Pharma Services, Ltd.
Seagoe Industrial Estate,
Portadown,
Craigavon,
County Armagh, BT63 5QD
United Kingdom
This medicinal product is authorised in
the Member States of the EEA under
the following names:
Austria, Bulgaria,
Estonia, Finland,
Greece, Hungary,
Iceland, Italy, Latvia,
Lithuania, Luxembourg,
Malta, Poland,
Portugal, Romania,
Spain, Sweden
Czech Republic,
Slovakia
Norway
Slovenia

BELKYRA

BELKYRA
10 mg/ml
Belkyra
BELKYRA
10 mg/ml raztopina
za injiciranje

This leaflet was last revised in April 2017.

The following information is intended
for healthcare professionals only:
The solution for injection should be
inspected visually prior to use. Only clear,
colourless solutions free of visible particles
should be used.

Posology
The total volume injected and the
number of treatments should be tailored
to the individual patient’s submental fat
distribution and treatment goals.
Inject 0.2 ml (2 mg) per injection site, 1 cm
apart. The maximum dose of 10 ml (100 mg
equivalent to 50 injections) should not be
exceeded in one treatment session.
Up to a maximum of 6 treatment sessions
can be performed. Most patients experience
improvement in 2 to 4 treatment sessions.
The time interval between treatment
sessions should be at least 4 weeks.

Method of administration
The product is indicated for subcutaneous
administration only.
Belkyra is supplied in ready-to-use, singleuse vials. Gently invert the vial several
times prior to use. Do not dilute.
Belkyra should only be administered by
healthcare professionals with appropriate
qualifications, expertise and knowledge of
the submental anatomy. Safe and effective
use of Belkyra depends on appropriate
patient selection, which includes knowledge
of patient history of prior interventions
and their potential to alter the superficial
cervical anatomy. Careful consideration
should be given to the use of Belkyra
in patients with excessive skin laxity,
prominent platysmal bands or other
conditions for which reduction of submental
fat may result in an undesirable outcome.
Insert the needle perpendicular to the skin
for injections with Belkyra.
Needle placement with respect to the mandible
is very important as it reduces the potential
for injury to the marginal mandibular nerve,
a motor branch of the facial nerve. Injury to the
nerve presents as an asymmetrical smile due to
paresis of lip depressor muscles.

Avoid injection into the platysma. Prior
to each treatment session, palpate the
submental area to ensure sufficient
submental fat and to identify subcutaneous
fat between the dermis and platysma
(pre‑platysmal fat) within the target
treatment area (Figure 2).

Figure 2. Sagittal View of
Platysma Area

Outline the planned treatment area with
a surgical pen and apply a 1 cm2 injection grid
to mark the injection sites (Figures 2 and 3).

Figure 3. Treatment Area and
Injection Pattern

To avoid injury to the marginal
mandibular nerve:
• Do not inject above the inferior border
of the mandible.
• Do not inject within a region defined
by a 1-1.5 cm line below the inferior
border (from the angle of the mandible
to the mentum).
• Inject Belkyra only within the target
submental fat treatment area (see
Figures 1 and 3).

Figure 1. Avoid the Marginal
Mandibular Nerve Area

Do not inject Belkyra outside the defined
parameters.
Each vial is for single patient use only.
After use, discard any unused product.

To improve patient comfort during
injection, oral analgesics or NSAIDs,
topical and/or injectable local anaesthesia
(e.g., lidocaine) and/or cooling using ice
gel packs may be applied to the area of
injection at the discretion of the healthcare
professional.

73179MD057J

Leaflet Belkyra 2 mL (10mg/mL) GB/IRE/Malta 73179MD057J MoH Submission

73179MD057J

2 of 2

3

BLACK

Perigord AS
03/May/2017

Times New Roman, Helvetica Neue LT Pro

pl-belkyra-UK+IE+MT.docx

10.5pt.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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