Kythera Biopharmaceuticals Inc.

Kythera Biopharmaceuticals Inc. Drugs

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  2.1 Dosage

  KYBELLA is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2.

  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.

  See General Considerations for Administration (2.2) and Injection Technique (2.3) before injection.

  2.2 General Considerations for Administration

  KYBELLA should be administered by a healthcare professional.

  Screen patients for other potential causes of submental convexity/fullness (e.g., thyromegaly and cervical lymphadenopathy).

  Give careful consideration to the use of KYBELLA in patients with excessive skin laxity, prominent platysmal bands or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome.

  Use caution in patients who have had prior surgical or aesthetic treatment of the submental area. Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer KYBELLA or to obtain the desired aesthetic result.

  KYBELLA is clear, colorless and free of particulate matter. Visually inspect KYBELLA vials for particulate matter and/or discoloration, and discard the vial if the solution is discolored and/or contains particulate matter.

  After use, discard any remaining solution in the vial.

  2.3 Injection Technique

  The safe and effective use of KYBELLA depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques.

  Health care professionals administering KYBELLA must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures [see Warnings and Precautions (5)].

  Avoid injections near the area of the marginal mandibular nerve [see Warnings and Precautions (5.1)]

  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 [see Warnings and Precautions (5.1)].

  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 KYBELLA 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). The number of injections and the number of treatments should be tailored to the individual patient's submental fat distribution and treatment goals.

  Figure 2. Sagittal View of Platysma Area

  Injecting into the treatment area

  Use of ice/cold packs, topical and/or injectable local anesthesia (e.g., lidocaine) may enhance patient comfort.

  Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites (Figures 2 and 3).

  Figure 3. Treatment Area and Injection Pattern

  Do not inject KYBELLA outside the defined parameters [see Warnings and Precautions (5.1, 5.4)].

  Using a large bore needle, draw 1 mL of KYBELLA into a sterile 1 mL syringe and expel any air bubbles in the syringe barrel. Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0.5 inch needle, inject 0.2 mL of KYBELLA into the pre-platysmal fat (see Figure 2) next to each of the marked injection sites by advancing the needle perpendicular to the skin. Injections that are too superficial (into the dermis) may result in skin ulceration. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration. Avoid injecting into the post-platysmal fat by injecting KYBELLA into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer (Figure 2). If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered. Avoid injecting into other tissues such as the muscle, salivary glands and lymph nodes. Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied.

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