Belotero

BELOTERO BALANCE® Dermal Filler Patient Information Guide
BELOTERO BALANCE®
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or other
licensed healthcare practitioner.
PATIENT INFORMATION SHEET
BEFORE USING BELOTERO BALANCE, PLEASE READ THE FOLLOWING INFORMATION
THOROUGHLY. Please direct any questions to Merz North America, Inc, Franksville, WI
53126; (866) 862-1211.
DESCRIPTION OF DEVICE
BELOTERO BALANCE is a hyaluronic acid gel. It has no color.
INDICATIONS/INTENDED USE
BELOTERO BALANCE is used to smooth out and fill in the fold or wrinkle that goes from the side of
the nose to the corner of the mouth (nasolabial fold) as shown in figure 1 below.

Figure 1. Facial Nasolabial Fold

HOW IS BELOTERO BALANCE ADMINISTERED?
Your doctor will inject a small amount of BELOTERO BALANCE into the skin using a small needle.
The doctor may first inject a local anesthetic such as lidocaine to numb the area.
A “touch up” injection is often given 2 weeks after the first injection to get the optimal smoothing and
rounding of skin or to make the effect last longer. You and your doctor will decide whether a second
“touch up” injection is needed later on. In one study, 67 out of 93 subjects had a second injection
of BELOTERO BALANCE. In another study, 103 out of 118 subjects were given a second injection.
CONTRAINDICATIONS
You should not use BELOTERO BALANCE if you have severe allergies or a history of allergic reactions
to hyaluronic acid, local anesthetics such as lidocaine, or to small amounts of protein from bacteria.
Injections in such patients could result in allergic reactions, anaphylactic shock, or death.
If you are unsure about this, talk about the details of your medical history with your doctor and
the risks versus the benefits of using BELOTERO BALANCE.
WARNINGS
• BELOTERO BALANCE should not be injected into blood vessels. Injection into blood vessels
will block and destroy the vessel.
• If you easily develop big scars or keloids on your skin do not use BELOTERO BALANCE because
you will most likely get a scar where BELOTERO BALANCE is injected.
PRECAUTIONS
• Injection site reactions to BELOTERO BALANCE injection include the following: swelling, bruising,
redness, pain, rash, development of small bumps, inflammation, itching, and discomfort. One out
of two subjects had at least one of these reactions after injection of BELOTERO BALANCE. In 9
out of 10 people these reactions are not serious and go away within 1 to 2 weeks. There is a small
chance that they will last longer than 2 weeks in some people.
• Do not use BELOTERO BALANCE if you have a skin infection or inflammation such as a pimple, cyst,
cold sore, or rash at the injection site. Skin infections or inflammations increase the risk of infection
from an injection. Wait until the infection is cleared up before using BELOTERO BALANCE.

• Until any initial swelling and redness have gone away and puncture sites have healed you
should minimize exposure of the treated area to excessive sun, UV lamp exposure, and
extreme cold weather.
• BELOTERO BALANCE should only be used by a physician trained in the correct procedure to inject
dermal fillers and who completely understands the entire package insert and physician label.
• BELOTERO BALANCE has not been evaluated in pregnant women, lactating women who are
breast feeding, or in subjects less than 21 years of age.
• Patients who bleed easily or are taking aspirin or other drugs which prevent blood clotting
(blood thinners) may have a greater risk for bleeding and/or bruising at the site where
BELOTERO BALANCE is injected.

• Radiation therapy or drugs which decrease your immunity or resistance to infections, such as anti-
cancer drugs, may increase your risk of infection from an injection of BELOTERO BALANCE.

• Laser treatments, chemical peels, or other procedures performed on your skin after treatment with
BELOTERO BALANCE, may increase the risk that you will have a reaction at the injection site.
• Discuss with your doctor all questions you may have about the risks from using BELOTERO
BALANCE in relation to any of the above precautions and/or warnings concerning the
use of BELOTERO BALANCE.
RISKS OF USING BELOTERO BALANCE
Injection Site Reactions
Injection site reactions to BELOTERO BALANCE are common. In three US clinical studies, more
than half of all subjects injected with BELOTERO BALANCE had one or more injection site reactions.
All subjects were asked to keep a daily diary to record any injection site reaction, how severe the
reaction was, how long it lasted and how fast it improved. Table 1 below lists the reactions that were
reported by patients during the studies, the number of patients who had them, and the maximal
severity of the reactions.
Table 1. Number of Subjects with Injection Site Reactions to BELOTERO BALANCE and Maximal
Severity of Reactions*

Swelling (145 out of 211 subjects), bruising (115 out of 211 subjects), redness (109 out of 211 subjects),
and induration or hardening of the tissue (107 out of 211 subjects) were the four most commonly
reported skin reactions to BELOTERO BALANCE. These occurred in more than half of all subjects.
Number of Subjects who had Reactions and the Maximum Severity of the
Reactions (out of 211 subjects total)

Injection Site Response TOTAL MILD MODERATE SEVERE
Swelling 145 (68.7%) 60 (28.4%) 65 (30.8%) 20 (9.5%)
Nodule (Solid Raised Area) 92 (43.6%) 46 (21.8%) 37 (17.5%) 9 (4.3%)
Bruising 115 (54.5%) 46 (21.8%) 51 (24.2%) 18 (8.5%)
Induration (Hardening of the Tissue) 107 (50.7%) 52 (24.6%) 45 (21.3%) 10 (4.7%)
Erythema (Redness) 109 (51.7%) 55 (26.1%) 48 (22.7%) 6 (2.8%)
Pain 103 (48.8%) 68 (32.2%) 26 (12.3%) 9 (4.3%)
Discoloration 61 (28.9%) 32 (15.2%) 25 (11.8%) 4 (1.9%)
Pruritus (Itching) 46 (21.8%) 37 (17.5%) 9 (4.3%) 0 (0%)
*Reported by patients

0 – Absent 1 – Mild 2 – Moderate 3 – Severe 4 – Extreme

Table 2 shows how long each skin reaction lasted after injection of BELOTERO BALANCE and for
how many patients, as reported in the patient diaries.
Table 2. Duration of Injection Site Skin Reactions

The results showed that:
• The majority of skin reactions are gone within one week
• Injection site reactions in 9 out of 10 subjects lasted less than 2 weeks.
• Swelling, pain, and redness lasted less than 3 days in 1 out of 3 subjects
• Skin discoloration, “dent” in the skin, bruising, swelling, and nodules may last longer than 2
weeks in approximately 1 out of 10 people.
During the clinical studies for BELOTERO BALANCE, the physicians recorded reactions to BELOTERO
BALANCE that were seen at each visit during the study. Table 3 presents the reactions that were
recorded by the physician during the study.
Table 3. Reactions Recorded by the Physician

In the main clinical study, 3/118 (2.5%) subjects had at least one non-injection site adverse event.
The non-injection site AEs included moderate hives-like reaction, mild herpes simplex, and mild
headache. Since each patient received BELOTERO BALANCE and Collagen Control, the cause of
these events could not be determined. In the Fitzpatrick IV, V, VI (individuals with darker skin) study
4/93 (4.3%) subjects experienced 5 non-injection site AEs. These were moderate headache, moderate
swelling on the side of the nose, moderate cold sore, moderate lip numbness, and mild lip dryness.
BELOTERO BALANCE is a prescription medical device and should only be administered by a trained
physician. BELOTERO BALANCE has not been evaluated in pregnant women, lactating women who
are breastfeeding, or in subjects less than 21 years of age.

BENEFITS OF BELOTERO BALANCE?
Hyaluronic acid is a naturally occurring substance in the body. One of the natural functions of
hyaluronic acid is to help provide structural form and shape to the external features of the body. This
property of hyaluronic acid is the basis for BELOTERO BALANCE’s effectiveness as a dermal filler.
BELOTERO BALANCE smoothes, adds volume, and fills out folds in the skin such as the nasolabial
fold. The photos below in Figure 2 show variations in the appearance of the facial nasolabial folds
from extremely deep (#4) on the far right to absent (#0) on the far left. You and your doctor will decide
how much smoothing is right for you to get the desired effect.
Figure 2. Gradation of Facial Nasolabial Fold Appearance from Absent, #0 (Far Left) to Extreme,
#4 on the Far Right

HOW LONG DOES BELOTERO BALANCE LAST?
The filling effect of BELOTERO BALANCE lasts about 6 months and then slowly goes away. The
photographs in Figure 2 show the rating scale used during the studies to rate the appearance of
nasolabial folds. In clinical trials, 170 out of 211 subjects still demonstrated an effect of at least 2
points on the rating scale 6 months after an initial BELOTERO BALANCE treatment and one touch-up
treatment. For example, a subject that started the study with a wrinkle rating of 3 (severe) would be rated
either 0 (absent) or 1 (mild). The appearance of the folds over time as the filling and smoothing effect of
BELOTERO BALANCE wears off is illustrated in Figure 2 generally moving from left to right on the scale.
CLINICAL TRIALS WITH BELOTERO BALANCE
Three clinical trials were conducted in the United States which evaluated the safety and effectiveness
of BELOTERO BALANCE for a period of 24 weeks, in a total of 211 adult subjects, 18 to 75 years of
age. The subjects consisted of both light and dark skin types and approximately 9 out of 10 subjects
were female. In these studies an optional “touch-up” injection of a lesser volume of BELOTERO
BALANCE was given to almost all subjects about 2 weeks after the first treatment.
The results indicated that BELOTERO BALANCE when injected into the skin, was clinically effective for
filling and smoothing the nasolabial folds on the face. The smoothing and filling effects of BELOTERO
BALANCE on the nasolabial fold were similar in light skin and dark skin type subjects.
The only adverse events or side effects that were related to injection of BELOTERO BALANCE were
skin reactions at the injection site. These occurred in one-third to one-half of all subjects. None was
serious and most were gone in 1 to 2 weeks (see RISKS above).
HOW DO I DECIDE ABOUT USING BELOTERO BALANCE?
Ask your doctor if you will benefit from treatment with BELOTERO BALANCE. If you and your doctor
decide that BELOTERO BALANCE is for you, you will then talk about your complete medical history
with your doctor. It is important to tell your doctor everything in your medical history, about all
medicines that you are taking, any past and present allergies and their seriousness, and all current or
past medical conditions you have had. Your doctor will discuss what your chances are for getting any
of the side effects from injection of BELOTERO BALANCE and how serious they may be.
WHERE DO I GET MORE INFORMATION?
For further information please call Merz North America at (866) 862-1211.
Copyright © 2014 Merz North America, Inc. All rights reserved. BELOTERO and BELOTERO BALANCE are registered
trademarks of MERZ PHARMA GmbH & Co. KGaA. EM00495-02/JAN 2014