Usual Adult Dose for Submental Fat Reduction

Area-adjusted dose of 2 mg/cm2 injected subcutaneously into fat tissue in the submental area.

Comments:

• A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1-cm apart.
• Up to 6 single treatments may be administered at intervals no less than 1 month apart.
• The number of injections and the number of treatments should be tailored to the individual patient's submental fat distribution and treatment goals.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years; this drug is not intended for use in children or adolescents.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• Consult the manufacturer product information for proper injection technique.
• Avoid injections near the marginal mandibular nerve area and into the platysma.
• The drug should not be injected into or in close proximity (1 to 1.5 cm) to salivary glands, lymph nodes, and muscles to avoid potential tissue damage.
• Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer this drug and the ability to obtain the desired aesthetic result in patients with prior surgical or aesthetic treatment of the submental area.
• Use of ice/cold packs, topical and/or injectable local anesthesia (e.g., lidocaine) may enhance patient comfort.
• Injection of excessive doses/volumes may increase the risk of adverse reactions.
• Administration of this drug should be performed by a healthcare professional.
• Each vial is for single patient use and should not be diluted; unused portion should be discarded.

• Screen patients for other potential causes of submental convexity/fullness (e.g., thyromegaly and cervical lymphadenopathy).
• The safe and effective use of this drug for subcutaneous fat outside the submental region has not been established and is not recommended.
• This drug has a unique hologram on the vial label; health care providers are advised to not use the drug and to call 1-844-KYTHERA (1-844-598-4372) if they do not see a hologram on the vial.