Galderma - Sculptra, 5ml Vial - Box 10 Vials

INTENDED USE / INDICATIONS
Sculptra is indicated for correction of shallow to deep nasolabial fold contour deficiencies and other
facial wrinkles for use in immune-competent subjects *.

Sculptra is indicated for correction of fine lines and wrinkles in the cheek region for use in immunecompetent subjects *.

Sculptra is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in
people with human immunodeficiency virus**.

INSTRUCTIONS FOR USE
Sculptra has been evaluated in immune-competent people as a single regimen for correction of
shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
Sculptra has been evaluated for correction of fine lines and wrinkles in the cheek region for use in
immune-competent subjects
Sculptra use should be limited to use in a single regimen of up to four sequential sessions each
spaced three to four-weeks apart.
Educational resources are available through myGAINtraining.com, which provides training on the
anatomy of the treatment area, effective patient assessment, and appropriate injection techniques.
Health care professionals may contact Galderma for educational and training resources specific to the
correction of fine lines and wrinkles in the cheek region.
Completion of device-specific use training is required and will be verified prior to purchase of
Sculptra for the correction of fine lines and wrinkles in the cheek region for use in immunecompetent subjects.
The following supplies are used with Sculptra but are to be provided by the end-user:
• Sterile Water for Injection (SWFI), USP
• Single-use 5 mL sterile syringe
• Single-use 1 or 3 mL (depending on healthcare professional preference) sterile syringes (at least
2)
• 18 G sterile needles (at least 2)
• 26 G (5 mL reconstitution volume) or 25 G (8 mL reconstitution volume) sterile needles (several
should be available). It is recommended to use a thin wall needle to reduce the risk of clogging.
• Antiseptic (such as alcohol)
• 2% sterile lidocaine solution (8 mL reconstitution volume)

Reconstitution
Sculptra may be reconstituted with either 5 mL of SWFI and stored for up to 72 hours or
reconstituted with 8 mL of SWFI for immediate use according to the instructions below.
5 mL Reconstitution
(for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles)
Sculptra is reconstituted in the following way:
1. Remove the flip-off cap from the vial and clean the penetrable stopper of the vial with an
antiseptic. If the vial, seal, or flip-off cap is damaged, do not use, and call Galderma
Laboratories, L.P. at 1-855-425-8722.
2. Attach an 18 G sterile needle to a sterile single-use 5 mL syringe.
3. Draw 5 mL of SWFI into the 5 mL syringe.
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4. Introduce the 18 G sterile needle into the stopper of the vial and slowly add all SWFI into the
vial.
5. Let the vial stand for at least 2 hours to ensure complete hydration; do not shake during this
period. Upon reconstitution, Sculptra can be stored for up to 72 hours at temperatures between
5-30ºC. Refrigeration is not required.
6. Product should be gently agitated immediately prior to use. Agitate the vial until a uniform
translucent suspension is obtained that will have some foam on the top, see Figure 3. A single
vial swirling agitator may be used. The reconstituted product is usable within 72 hours of
reconstitution. As it is a single use vial, discard any material remaining after use or after 72 hours
following reconstitution.

7. Reconstituted Sculptra is a suspension with particles that will sediment at standing. To maintain a
uniform suspension throughout the procedure, intermittently agitate the Sculptra vial between the
withdrawals to syringes. Clean the penetrable stopper of the vial with an antiseptic and use a new
18 G sterile needle to withdraw an appropriate amount of the suspension (typically 1 mL) into a
single–use 1 or 3 mL sterile syringe. Tilt the vial horizontally and withdraw suspension from the
lower lateral of the vial to avoid withdrawing foam. Do not store the reconstituted product in the
syringe.
8. Replace the 18 G needle with a 26 G sterile needle before injecting the product into the deep
dermis. Do not inject Sculptra using needles of an internal diameter smaller than 26 G. If
clogging of the needle occurs, remove the needle, attach a new sterile needle, then expel a few
drops of Sculptra to eliminate the air and re-check for needle blockage.
9. To withdraw remaining contents of the vial, repeat steps 7 through 8. Do not inject the foam.
10. Discard any remaining product immediately after single session/patient use