Document: Belkyra solution for injection ENG PL change

• Belkyra solution for injection PL
• Belkyra solution for injection ENG PL

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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

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.

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).

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.

How BELKYRA is administered

Belkyra will be given by a healthcare professional directely 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 administeredmore 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):

• 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 color

• 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)

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 the national reporting system listed in Appendix V. 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

1 ml of solution for injection (injection) contains 10 mg deoxycholic acid. 1 vial with 2 ml contains 20 mg deoxycholic acid.

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

<To be completed nationally>

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:

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in 29 June 2016.

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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.

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.

Method of administration

The product is indicated for subcutaneous administration only.

Belkyra is supplied in ready-to-use, single-use 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.

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

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

Do not inject Belkyra outside the defined parameters.

Each vial is for single patient use only. After use, discard any unused product.