Allergan Ltd

Allergan Ltd

Belkyra 10 mg/ml solution for injection

Package leaflet: Information for the user

 

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 an important 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.

 

 

  1. 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.
  • Tissue damage around the treatment area (i.e., skin erosion, ulceration, necrosis) can occur. This can result in scarring. If ulceration or necrosis occur, you should never be given treatment with Belkyra  again (see section 4 Possible side effects).

 

 

 

 

Belkyra should not be used if you are obese or if you are suffering from body dysmorphic disorder (distorted view of how you look).

 

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.

 

 

  1. How to use BELKYRA

 

How BELKYRA is administered

Belkyra will be given by a doctor, (or if national guidance permits, a healthcare professional under the supervision of a doctor), directly underneath the skin (‘subcutaneous use’). Belkyra will be injected in small amounts in several locations in your treatment area, that is 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

A doctor will decide how much Belkyra will be administered.

 

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 and will be decided by the doctor. 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.
  • Tissue damage around the treatment area (i.e., skin erosion, ulceration, necrosis) can occur. This can result in scarring.

 

If you experience any of the above 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

 

Common side effects (may affect up to 1 in 10 people):

  • Injection site reactions:
  • bleeding
  • discomfort
  • warmth
  • change of skin colour
  • Nerve injury around the jaw
  • Skin tightness
  • Difficulties in swallowing (dysphagia)
  • Feeling sick (nausea)
  • Headache

 

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)
  • scar

 

Side effects where the frequency is not known (frequency cannot be estimated from the available data):

  • Reduced or abnormal sensation in the area of the mouth (e.g. lip, tongue) (hypoaesthesia oral, paraesthesia oral)
  • Injection site reaction:
  • reduced sense of touch or altered sensation in the cheek
  • tissue damage and cell-death (necrosis) around the treatment area
  • Injury of blood vessels if injected accidentally into artery or vein

 

Most of the side effects seen got better during the 4-week period between treatments. However, some of the injection site reactions may be present for a longer period.

 

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:

 

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

 

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal.

 

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.

 

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

 

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 dissolution and pH adjustment), hydrochloric 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 Business & Technology Park,

Dublin 17, D17 E400, Ireland

 

Manufacturer

Almac Pharma Services, Ltd.

Seagoe Industrial Estate,

Portadown,

Craigavon,

County Armagh, BT63 5QD

United Kingdom

 

Allergan Pharmaceuticals International Ltd.

Clonshaugh Business & Technology Park,

Dublin 17,

D17 E400,

Ireland

 

 

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: BELKYRA

 

Czech Republic, Slovakia: BELKYRA 10 mg/ml

 

Norway: Belkyra

 

Slovenia: BELKYRA 10 mg/ml raztopina za injiciranje

 

 

This leaflet was last revised in 19 May 2021

 

Version 8