BELKYRA™ (Portuguese)

BELKYRA™ (Portuguese) is an injectable treatment containing deoxycholic acid designed to reduce submental fat (double chin) in adults. Deoxycholic acid is a naturally occurring substance in the body that helps break down fat cells. This non-surgical procedure is performed by a healthcare professional and provides a gradual reduction in chin fat over multiple sessions. BELKYRA™ (Portuguese) is ideal for patients with moderate to severe submental fullness and can significantly improve facial contours.

Key Features:

• Contains 10 mg/mL of deoxycholic acid, a fat-dissolving agent.
• Non-surgical, minimally invasive treatment for submental fat reduction.
• Clinically tested with results visible after 2 to 4 sessions, with a maximum of 6 sessions.

BELKYRA™ (Portuguese) is supplied in a clear, sterile solution for injection. Each carton contains 4 vials, each sealed with a chlorobutyl rubber stopper, an aluminum seal, and a polypropylene flip-top lid.

Ingredients:

• 10 mg/mL of deoxycholic acid: Breaks down fat cells for gradual elimination.
• Water for injection: Ensures sterility and safety of the solution.
• Sodium chloride and sodium hydroxide: Help maintain pH balance and isotonicity.

Disodium phosphate anhydrous and hydrochloric acid: Assist in pH adjustment.

BELKYRA™ (Portuguese) is used for the reduction of submental fat in adults when it causes psychological distress. It is injected into the fat tissue under the chin to permanently destroy fat cells, preventing them from storing fat again.

Indications:

• Treatment of moderate to severe submental fullness (double chin).
• Patients with good skin elasticity to avoid post-treatment sagging.
• Alternative to liposuction for patients seeking a non-surgical option.

Contraindications:

• Patients allergic to deoxycholic acid or any ingredients in BELKYRA™ (Portuguese).
• Active infection in the chin or neck area.
• Pregnant or breastfeeding women, as safety is not established.

Side Effects:

• Very common (1 in 10 people): Swelling, pain, bruising, numbness, firmness, and redness at the injection site.
• Common (1 in 10 to 1 in 100 people): Bleeding, discomfort, warmth, skin discoloration, nausea, headaches.
• Uncommon (1 in 100 people): Changes in taste, difficulty speaking or swallowing, localized hair loss.
• Rare but serious: Nerve injury in the jaw leading to an uneven smile or muscle weakness, tissue necrosis, or severe allergic reactions.

BELKYRA™ (Portuguese) is administered by a doctor or trained healthcare professional via subcutaneous injection. The treatment area is marked before injection, ensuring precise targeting of fat deposits. The procedure is performed over multiple sessions, spaced at least 4 weeks apart.

Administration Technique:

1. Clean and mark the treatment area using a surgical pen.
2. Inject 0.2 mL (2 mg) per injection site, with sites spaced 1 cm apart.
3. Maximum of 50 injections per session, totaling up to 10 mL per treatment.
4. Use a 30G needle to minimize discomfort and ensure precise delivery.
5. Patients require 2 to 4 treatment sessions, with a maximum of 6 sessions.

Storage Guidelines:

• Store at room temperature (below 25°C).
• Do not freeze or expose to excessive heat.
• Use immediately after opening; discard any unused product.

BELKYRA™ (Portuguese) provides a safe, effective, and permanent fat-reduction solution when administered correctly. The treatment gradually improves chin contours, offering a non-surgical alternative to fat removal procedures.