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How-to Guide

INDICATION
KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to
severe convexity or fullness associated with submental fat in adults.
The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental
region has not been established and is not recommended.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
KYBELLA® is contraindicated in the presence of infection at the injection sites.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Steps to Guide the Dosing
and Administration Process

Get Started: Gather Supplies


and Take Before-and-After Photos

Identify Anatomic Landmarks and


Mark the Treatment Zone

Prep the Patient and Determine the Dose

Perform the Injection

Conclude the Treatment


and Consult With the Patient

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS
Marginal Mandibular Nerve Injury
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle
weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range
1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal
mandibular branch of the facial nerve.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Get Started: Gather Supplies

PREPARATION AND INJECTION


POSTTREATMENT 1-mL syringes
Topical/injectable anesthetics A large-bore needle (eg, 21 G)
Sterile water 30-G (or smaller), 0.5-inch needles
Cotton pads/balls KYBELLA® 2-mL vials
Skin-marking pen/pencil
Ruler
Topical antiseptic
Skin-marking, 1-cm2 injection grid
Scissors
Cold compress or ice pack
Isopropyl alcohol
Gauze

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Dysphagia
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions,
eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously
(range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of
dysphagia as treatment may exacerbate the condition.
Injection-Site Hematoma/Bruising
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should
be used with caution in patients with bleeding abnormalities or who are currently being treated with
antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Get Started: Take Before-and-After
Photos in Each Patient Session
• Use patient photos to illustrate the Maximize consistency between
submental profile during consultation profile photos using the Frankfort plane
Lower orbital arch
• Help patients visually relate by
drawing a sloped chin profile line
Tragus of the ear
on their before photo
• Track patient progress throughout
their treatment series by showing
A horizontal plane from
the change in the slope of their the lower orbital arch to
profile line on each after photo the cephalic margin of
the tragus of the ear1,2

Capture photos in each view before every treatment session

FRONTAL LATERAL (right and left sides) OBLIQUE

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity
(1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Care should be taken to avoid inadvertent
injection directly into an artery or a vein as it can result in vascular injury.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Identify Anatomic Landmarks3,4

Be especially aware of the


marginal mandibular nerve
to reduce potential for injury5
Marginal Mandibular Nerve Facial Muscles

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration
may vary among individuals and may persist. Consider withholding subsequent treatments until resolution.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Mark the Treatment Zone

DELINEATE THE
NO-TREATMENT ZONE
• Use a topical antiseptic to thoroughly
cleanse the skin, removing all makeup
before marking the Treatment Zone
• Mark the inferior border of the mandible3,5
• Mark the area 1 cm to 1.5 cm below the inferior border of the mandible5

OUTLINE THE TREATMENT ZONE


• Mark the anterior, posterior, and lateral boundaries of the submental fat compartment4,5

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Injection Site Ulceration and Necrosis
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases
of injection site ulceration and necrosis have been reported with administration of KYBELLA®. Do not
administer KYBELLA® into affected area until complete resolution.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Prep the Patient:
Pretreatment Protocol
ANESTHETIZE
• Apply ice/cold packs or local anesthesia
to enhance patient comfort5

APPLY GRID
• Check placement of skin-marking grid
• Remove clear protective top sheet
• Press grid onto clean, dry skin and dampen
while maintaining even pressure
• Wait 15 seconds, then peel backing and assess
Be sure to use alcohol to remove any grid dots that fall outside the approved Treatment Zone.

CLEAN
• Use a topical antiseptic to clean the
treatment area gently so as not to remove
markings and grid dots

IMPORTANT SAFETY INFORMATION (continued)


ADVERSE REACTIONS
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/
swelling, hematoma/bruising, pain, numbness, erythema, and induration.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Treat With the Established
Dosing Standard
Determine the dose by counting the number of dots in the Treatment Zone

SPACING GUIDE
Customize and apply the spacing guide
in the patient’s Treatment Zone you
have identified and plan your injections
accordingly. Each injection must be
spaced 1 cm apart.5
No more than a total of 50 injections in Perforations
the patient’s Treatment Zone.5
Use alcohol to remove any grid dots
Translating dots to vials1
that fall outside the patient’s 0.2 mL per injection site1
Treatment Zone.
Number of dots Total dose (mL) Number of vials
a

10 2 1

20 4 2

30 6 3 Average dosing
range per
treatment session
40 8 4 in clinical trials5

50 10 5

a
Discard unused portion of vials.5

IMPORTANT SAFETY INFORMATION (continued)


CONTRAINDICATIONS
KYBELLA® is contraindicated in the presence of infection at the injection sites.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Treat With the Established
Dosing Standard (continued)

Average dosing per treatment in clinical trials5:

First treatment*:
6.4 mL (≈ 4 single-use vials)

Sixth treatment †:
4.4 mL (≈ 3 single-use vials)

*In clinical trials, subjects received an average of 3.2 vials at first treatment.5
†
Subjects who received all 6 treatments were administered an average of 2.2 vials at the sixth treatment.5
Discard unused portion of vials.

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS
Marginal Mandibular Nerve Injury
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle
weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range
1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal
mandibular branch of the facial nerve.
Dysphagia
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions,
eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously
(range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of
dysphagia as treatment may exacerbate the condition.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Perform the Injection

DRAW
Draw up all your syringes in advance using
a large-bore needle
• Draw 1 mL of KYBELLA® into a sterile 1-mL syringe5
• Expel any air bubbles in the syringe barrel5
• Continue until all syringes are filled
• Dilution or admixture of KYBELLA® with other
compounds is not recommended5

For injection, replace the large-bore needle with a 30-G (or smaller), 0.5-inch needle.5
KYBELLA® is clear, colorless, and free of particulate matter. Discard vial if solution is discolored and/or contains particulate matter.5

PINCH
• Start by having the patient tense the platysma
muscle, then pinch the preplatysmal fat
between 2 fingers5

Postplatysmal Fat

Platysma
IMPORTANT SAFETY INFORMATION (continued) Muscle

WARNINGS AND PRECAUTIONS (continued) Preplatysmal Fat

Injection-Site Hematoma/Bruising
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should
be used with caution in patients with bleeding abnormalities or who are currently being treated with
antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Perform the Injection (continued)

INJECT
• Injecting perpendicular to the skin, place 0.2 mL
of KYBELLA® adjacent to each grid dot within
the Treatment Zone5
• Inject approximately midway into the
preplatysmal fat layer5

Injection Technique Considerations

• Injections that are too superficial (into the dermis) may result
in skin ulceration and necrosis5
• If resistance is met, withdraw the needle to an appropriate
depth before injecting5
• Avoid injection into other tissues, such as the muscle, salivary
glands, and lymph nodes5
• Avoid inadvertent injection directly into an artery or vein as it
Platysma muscle can result in vascular damage5
Preplatysmal fat

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity
(1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Care should be taken to avoid inadvertent
injection directly into an artery or a vein as it can result in vascular injury.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Perform the Injection (continued)

WITHDRAW THE NEEDLE


• Take your finger off the plunger as
you withdraw the needle to avoid
inadvertent administration in structures
outside the submental fat compartment
• Apply pressure to each injection site as
necessary to minimize bleeding5
• Apply an adhesive dressing, if needed,
for bleeding5

Submental fat

Do not withdraw the needle from subcutaneous


fat during injection. This could increase the risk of
intradermal exposure and potential skin ulceration
and necrosis.5

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration
may vary among individuals and may persist. Consider withholding subsequent treatments until resolution.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Conclude the Treatment

• Consider applying ice or cold pack to the


treatment area for 5 to 15 minutes
• Remove the grid and markings using cotton
dampened with isopropyl alcohol
• Assess smiling and swallowing to screen
for dysphagia or any injury to the marginal
mandibular nerve

Remind patients about the potential for treatment-area adverse reactions5:

• Edema/swelling • Erythema • Pain


• Numbness • Induration

IMPORTANT SAFETY INFORMATION (continued)


WARNINGS AND PRECAUTIONS (continued)
Injection Site Ulceration and Necrosis
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases
of injection site ulceration and necrosis have been reported with administration of KYBELLA®. Do not
administer KYBELLA® into affected area until complete resolution.
ADVERSE REACTIONS
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/
swelling, hematoma/bruising, pain, numbness, erythema, and induration.
Please see additional Important Safety Information throughout this guide, and accompanying
full Prescribing Information.
Consult With Patients
Posttreatment
MAKE SURE PATIENTS KNOW

Swelling is an expected reaction to treatment5—it generally became


less severe and happened less often with subsequent treatment
sessions in studies6
TIP: Show patients a 1-day posttreatment photo so they can see how swelling may look.

Results are progressive—KYBELLA® permanently destroys fat cells


in the submental treatment area5

1 5
3 The recommended number of sessions in their treatment series
1-6
2
64
to achieve aesthetic goals5

Each treatment is at least 1 month apart5

Show before-and-after photos at every visit

The number of treatments is tailored* to the amount of submental fat and aesthetic goals;
59% of subjects received 6 KYBELLA® treatments in clinical trials.5
*Multiple injections under the chin per treatment; up to 6 treatments at least 1 month apart.5

References: 1. Data on file, Allergan; Integrated Summary of Efficacy: ATX-101. 2. Orbitomeatal plane. Stedman’s Medical Dictionary. 28th ed.
Baltimore, MD: Lippincott Williams & Wilkins; 2006:1504. 3. Drake RL, Vogl AW, Mitchell AWM, Tibbitts RM, Richardson PE, eds. Gray’s Atlas
of Anatomy. 2nd ed. Philadelphia, PA: Churchill Livingstone; 2015. 4. Hatef DA, Koshy JC, Sandoval SE, Echo AP, Izaddoost SA, Hollier LH. The
submental fat compartment of the neck. Semin Plast Surg. 2009;23(4):288-291. 5. KYBELLA® Prescribing Information, May 2020. 6. Data on
file, Allergan; Integrated Summary of Safety: ATX-101.

© 2020 Allergan. All rights reserved. All trademarks are the property of their respective owners.
hcp.MyKybella.com KYB130482-v2 07/20 007329

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