Label: information for the user

BELKYRA 10mg/ml injectable solution

deoxycholic acid

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is BELKYRA and how it is used

2. What you need to know before starting to use BELKYRA

3. How to use BELKYRA

4. Possible adverse effects

5. Storage of BELKYRA

6. Contents of the package and additional information

BELKYRA contains the active ingredient called deoxycholic acid. The body naturally produces deoxycholic acid to help digest fats.

This medication is used in adults for the treatment of submental fat (unwanted fat below the chin) when its presence has a significant psychological impact on the patient.

BELKYRA contains a non-human and non-animal version of deoxycholic acid, which is identical to naturally produced deoxycholic acid. BELKYRA is an injectable medication administered by your doctor.

Do not use BELKYRA:

• If you are allergic to deoxycholic acid or any of the other components of this medication (listed in section 6).
• If you have an infection in the area of the chin or neck where the medication is to be injected.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Belkyra. Your doctor or nurse will check your health status before each treatment. Inform your doctor or nurse of any illness you suffer from before each treatment.

Your doctor or nurse will pay special attention to the area around your neck, as precautions must be taken in the presence of any disease or previous surgery (e.g., scars, liposuction, difficulty swallowing, thyroid gland enlargement, or lymph node enlargement).

• A temporary nerve damage of the mandibular nerve may occur, which may lead to an asymmetric smile or facial muscle weakness.

• Damage to the tissues around the treated area (i.e., skin erosion, ulceration, necrosis) may occur. This may cause scarring.If ulceration or necrosis appears, you should never receive another treatment with Belkyra again (see section 4).
• Infection around the treatment area may occur and may require additional medical treatment. If redness or pain appears, consult your doctor, pharmacist, or nurse.

Belkyra should not be used if you have obesity or a body dysmorphic disorder (distorted perception of your own image).

Children and adolescents

This medication is not indicated for use in children and adolescents.

Other medications and BELKYRA

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

The effects of this medication on pregnant women or breastfeeding women are unknown. As a precaution, the use of Belkyra is not recommended during pregnancy.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or nurse before using this medication.

Driving and operating machines

Belkyra is not expected to affect the patient's ability to drive or operate machines.

BELKYRA contains sodium

This medication contains 4.23 mg of sodium (main component of cooking salt/table salt) in each ml. This is equivalent to 0.2% of the maximum daily sodium intake recommended for an adult.

How BELKYRA is administered

BELKYRA is administered directly under the skin (“subcutaneously”) by a doctor, or in countries where regulations permit, by a healthcare professional under the supervision of a doctor. BELKYRA will be injected in small amounts at multiple points in the treatment area, which is the fatty tissue directly under the skin in the area located under the chin.

Your doctor may take some measures to alleviate pain before and after the injection.

Dose

Your doctor will decide the amount of BELKYRA administered.

You will receive multiple injections per treatment session. The total number of injections and the number of treatment sessions needed to achieve a satisfactory response will depend on your individual needs and will be decided by your doctor. The treatment may be repeated several times, but no more than 6 treatment sessions should be exceeded, with 2 to 4 sessions usually being sufficient. The time interval between treatment sessions should be at least 4 weeks.

If you have been administered more BELKYRA than you should have

If you have been administered more BELKYRA than recommended, local adverse effects may increase (see section 4). In this case, consult your doctor or nurse.

At the end of this prospectus, further information on use and handling by the doctor or healthcare professional is provided.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

• A temporary nerve injury in the jaw may occur, which may lead to an asymmetric smile or facial muscle weakness.
• Tissue damage around the treated area (such as skin erosion, ulceration, necrosis) may occur, causing scarring.

Inform your doctor or nurse immediately if you experience any of the aforementioned adverse effects.

A list of adverse effects observed with the following frequencies is included below:

Very common(may affect more than 1 in 10 people):

• Reactions at the injection site:
• • Pain
  • Liquid retention in the tissue (edema) and swelling
  • Sensory symptoms (paresthesia): loss of sensation, decreased sensation, numbness, tingling, unusual sensitivity
  • A small, localized area of hardness (nodule)
  • Haematomas
  • Tissue rigidity or thickening (induration)
  • Redness of the skin (erythema)
  • Itching

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

• Reactions at the injection site:
• Haemorrhage
• Discomfort
• Heat
• Change in skin color
• Jaw nerve injury
• Skin tension
• Dysphagia (difficulty swallowing)
• Nausea
• Headache

Uncommon(may affect up to 1 in 100 people):

• Strange taste in the mouth (dysgeusia)
• Dysphonia (difficulty speaking)
• Reactions at the injection site:
• Hair loss (alopecia)
• Urticaria
• Skin lesions (ulcers)
• Allergic reaction (hypersensitivity)
• Scarring

Frequency not known(cannot be estimated from available data)

• Reduced or abnormal sensation in the mouth area (e.g. lip, tongue) (oral hypoesthesia, oral paresthesia).

• Reaction at the injection site (see “Warnings and precautions”):
• • Decreased sensitivity to touch or altered sensation in the cheek.
  • Tissue damage and cell death (necrosis) around the treated area.
  • Infection, including redness, swelling, or pain (cellulitis) or pus accumulation (abscess)
  • Vascular injury if accidentally injected into an artery or vein.

Most observed adverse effects improved within the 4-week period between treatments. However, some of these reactions at the injection site may persist for a longer time.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after “CAD/EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. It is recommended to use the injectable solution immediately after opening.

Do not use this medication if you observe visible particles.

Composition of BELKYRA

• The active ingredient is deoxycholic acid.

1 ml of injectable solution contains 10 mg of deoxycholic acid. 1 vial with 2 ml contains 20 mg of deoxycholic acid.

• The other components are water for injection, sodium chloride, sodium hydroxide (for dissolution and pH adjustment), hydrochloric acid (for pH adjustment) and anhydrous disodium hydrogen phosphate.

Appearance of BELKYRA and packaging contents

BELKYRA is a transparent, colorless and sterile injection solution.

Package size:

A box with 4 vials (Type I glass vials with a chlorobutyl rubber stopper, aluminum seal and a polypropylene flip-off cap).

Each vial contains 2 ml of injectable solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid

Spain

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

Last review date of this leaflet:

April 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for medical professionals or healthcare professionals:

The injectable solution should be visually inspected before use. Only transparent, colorless and particle-free solutions should be used.

Dosage

The total volume injected and the number of treatment sessions should be adapted to the treatment goals and the distribution of submental fat in each individual patient.

Inject 0.2 ml (2 mg) per injection point, with 1 cm distance. The maximum dose of 10 ml (100 mg, equivalent to 50 injections) should not be exceeded in a single treatment session.

A maximum of 6 treatment sessions may be performed, although most patients will show improvement between sessions 2 and 4 of the treatment. The interval between treatment sessions should be at least 4 weeks.

For patient comfort during injections, oral analgesics or NSAIDs, local anesthetic topical and/or injectable (e.g., lidocaine) and/or cold gel packs may be administered at the discretion of the healthcare professional.

Administration form

The product is only indicated for subcutaneous administration.

BELKYRA is supplied in single-use vials ready for use. Invert the vial slowly several times before use and do not dilute.

BELKYRA should be prepared for injection as follows:

1. Remove the pressure cap from the vial and clean the perforable stopper of the vial with an antiseptic. Do not use if the vial, seal or cap are damaged.
2. Place a sterile large-caliber needle in a sterile disposable 1 ml syringe.
3. Insert the sterile large-caliber needle into the vial stopper and withdraw 1 ml of BELKYRA in the 1 ml syringe.
4. Replace the large-caliber needle with a 30 G (or smaller) 12-13 mm needle. Expel air bubbles from the syringe before injecting the product into the subcutaneous fat.
5. To extract the remaining contents of the vial, repeat steps 3 and 4.

Only trained medical professionals with experience in treatment and knowledge of submental anatomy should administer BELKYRA. In countries where regulations permit, healthcare professionals with adequate training may administer BELKYRA under the supervision of a medical professional. The safe and effective use of BELKYRA depends on the selection of suitable patients, which includes knowing the patient's history of previous interventions and the possibility that these may have altered the superficial cervical anatomy. Special caution should be exercised when using BELKYRA in patients with excessive skin laxity, prominent platysmal bands or other conditions in which a reduction in submental fat may produce undesirable results.

Insert the needle perpendicular to the skin to inject BELKYRA.

The placement of the needle with respect to the mandible is very important, as it reduces the risk of injury to the marginal mandibular nerve, a motor branch of the facial nerve. This nerve injury presents as an asymmetric smile due to paresis of the depressor muscles of the lip.

To avoid injury to the marginal mandibular nerve:

• Do not inject above the lower border of the mandible.
• Do not inject in a region defined by a line 1-1.5 cm below the lower border (from the angle of the mandible to the chin).
• Inject BELKYRA only within the treatment area with the target submental fat (see Figures 1 and 3).

Figure1. Avoid the marginal mandibular nerve area

Do not inject into the platysma muscle. Before each treatment session, palpate the submental area to ensure the presence of sufficient submental fat and to identify the subcutaneous fat between the dermis and the platysma muscle (preplatysmal fat) in the target treatment area (Figure 2).

Figure 2. Sagittal view of the platysma area

Mark the planned treatment area with a surgical marker and use a 1 cm2marking template to mark the injection points (Figures 2 and 3).

Figure 3. Treatment area and injection pattern

Do not inject BELKYRA outside the defined parameters.

Each vial is for a single patient. After use, discard the unused medication.