10 mg / ml injection solution
deoxycholic
1. What Belkyra is and what it is used for
Belkyra contains the active substance deoxycholic acid. Deoxycholic acid is produced naturally in the body to facilitate the breakdown of fat.
The drug is used in adult patients for the treatment of submental fat (unwanted fat under the chin – so-called double chin) as this has a significant psychological impact on the patient.
Belkyra contains a non-human , non-animal form (not of human or animal origin) of deoxycholic acid that is identical to naturally occurring deoxycholic acid. Belkyra is an injectable medicine given by a doctor or nurse.
2. What you need to know before using 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 the part of the chin or throat where the product is to be injected.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Belkyra. Your doctor or nurse will examine how you feel before each treatment. Tell your doctor or nurse about any illnesses you have before each treatment.
The doctor or nurse will pay special attention to the area around the neck as caution is necessary in case of any disease or previous surgery (eg scarring, liposuction, difficulty swallowing, enlarged thyroid gland, or enlarged lymph nodes ).
- Temporary nerve damage in the jaw that results in an uneven smile or weakness in the facial muscles may occur.
- Tissue damage around the treatment area (eg superficial skin wounds, ulceration, necrosis (tissue death)) may occur. If ulceration or necrosis occurs, never be treated with Belkyra again (see section 4 Possible side effects ).
All these side effects have completely disappeared without lasting effects and without treatment.
Belkyra should not be used if you are overweight or if you suffer from a body perception disorder (distorted vision of your appearance).
Children and young people
This medicine is not intended for use in children or 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 breastfeeding
The effects of this medicine on pregnant and lactating women are not known. The use of Belkyra during pregnancy is not recommended as a precautionary measure.
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 or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Belkyra contains sodium
This medicine contains 4.23 mg of sodium per ml. This should be considered by patients on a low-salt diet.
How to use Belkyra
How Belkyra is used
Belkyra is given by a doctor (or, if national guidelines allow, by other medical personnel under the supervision of a doctor) directly under the skin (“subcutaneous use”). Belkyra will be injected in small amounts in several different places in the area to be treated, which is in the adipose tissue directly under the skin in the area under the chin.
Your doctor or nurse may take certain measures to relieve pain before and after the injection.
Dosage
A doctor will decide how much Belkyra you should get.
You will receive several injections each time you receive treatment. The total number of injections and treatment sessions needed to achieve a satisfactory result depends on your individual needs and will be decided by your doctor. The treatment can be repeated several times but should not exceed 6 treatment sessions; 2 to 4 treatment sessions are usually sufficient. The time interval between each treatment session should be at least 4 weeks.
If you take more Belkyra than you should
If you have received more Belkyra than the recommended dose, this may lead to a possible increase in side effects at the injection site (see section 4). If this happens, talk to your doctor or nurse.
Further information for healthcare professionals on the use and handling of the medicine can be found at the end of this leaflet.
If you have any further questions on the use of this product, 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 damage in the jaw that results in an uneven smile or weakness in the facial muscles may occur.
- Tissue damage around the treatment area (eg superficial skin wounds, ulceration, necrosis ) may occur.
If you experience any of these side effects, contact your doctor or nurse immediately.
Here is a list of the side effects are observed divided by how common they are:
A very common side effect is (can occur in more than 1 in 10):
- Injection site reactions:
- pain
- fluid accumulation in tissue one ( edema ) and swelling
- symptoms related to sensation ( paresthesia ): loss of sensation, decreased sensitivity, numbness, tingling sensation, unusual sensitivity
- small round areas with local knots
- bruises
- stiffness or thickening of tissue ( calluses )
- reddening of the skin
- itching
Common side effects are (may affect up to 1 in 10):
- Injection site reactions:
- bleeding
- discomfort
- feeling of warmth
- discoloration of the skin
- Nerve damage around the jaw
- Tightening skin
- Difficulty swallowing
- Nausea
- Headache
Less common side effects are (may affect up to 1 in 100):
- Taste changes
- Speech difficulties
- Injection site reactions:
- hair loss
- hives
- skin ulcers
- allergic reaction ( hypersensitivity )
Has been reported (occurs in an unknown number of users):
- Impaired or abnormal sensation in the mouth area (an eg lip, tongue) ( oral hypoesthesia, oral paresthesia )
- Injection site reaction:
- decreased sensation or altered sensation in the cheek
- tissue damage and cell death ( necrosis ) around the treatment area
- Vascular damage due to an accidental injection into an artery or vein
Most of the side effects observed have improved during the 4-week period between treatments. However, some of the reactions that may occur at the injection site may persist for a longer period.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions. After opening, it is recommended that the injection solution be used immediately.
Do not use this medicine if you notice visible particles.
6. Contents of the packaging and other information
Table of Contents
- The active substance is deoxycholic acid.1 ml solution for injection contains 10 mg deoxycholic acid. 1 bottle of 2 ml contains 20 mg of deoxycholic acid.
- The other ingredients are water for injections, sodium chloride, sodium hydroxide (for the solution and pH adjustment), hydrochloric acid (for pH adjustment), and anhydrous disodium phosphate.
What the medicine looks like and the contents of the pack
Belkyra is a clear, colorless, and sterile solution for injection.
Pack size:
A carton with 4 bottles (type I glass with chlorobutyl rubber stopper, flange cap of aluminum, and snap cap of polypropylene).
One vial contains 2 ml solution for injection.
Marketing Authorisation Holder
Allergan Pharmaceuticals International Ltd
Clonshaugh Business & Technology Park,
Dublin 17, D17 E400
Ireland
Manufacturer
Almac Pharma Services, Ltd.
Seagoe Industrial Estate,
Portadown,
Craigavon,
County Armagh, BT63 5QD
UK
Allergan Pharmaceuticals International Ltd.
Clonshaugh Business & Technology Park,
Dublin 17,
D17 E400,
Ireland