SCULPTRA® Prescribing Information
(injectable poly-L-lactic acid) Rx only

DEVICE DESCRIPTION |  INTENDED USE / INDICATIONS
CONTRAINDICATIONS |  WARNINGS
PRECAUTIONS |  ADVERSE EVENTS
CLINICAL STUDIES |  INDIVIDUALIZATION OF TREATMENT
HOW SUPPLIED |  STORAGE |  STERILITY |  INSTRUCTIONS FOR USE
PATIENT INSTRUCTIONS

The Sculptra implant package (i.e., lyophilized vials and syringe) are provided sterile.

Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner.

Information for the use of SCULPTRA® is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING SCULPTRA® PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY. Please direct any questions to sanofi-aventis U.S. LLC Bridgewater, NJ 08807; 1-800-633-1610.

 

DEVICE DESCRIPTION
SCULPTRA® is an injectable implant containing microparticles of poly-L-lactic acid (PLLA), a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family, carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP). SCULPTRA is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 5 mL of Sterile Water for Injection, USP (SWFI) to form a sterile non-pyrogenic suspension.

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

 

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE EVENTS
Adverse event data from four clinical studies that included 277 patients are summarized in Tables 1 & 2 below.

TABLE 1:
NUMBER OF PATIENTS WITH TREATMENT-RELATED ADVERSE EVENTS OBSERVED IN
CLINICAL STUDIES WITH TWO-YEAR FOLLOW-UP
  VEGA STUDY

50 Patients		 C&W
STUDY***
29 Patients		 AVERAGE
DURATION
(DAYS)
INJECTION PROCEDURE RELATED
ADVERSE EVENTS
Bruising 3 (6%) 11(38%) 6
Edema 2 (4%) 2 (7%) 3
Discomfort 0 3 (10%) 3
Hematoma 14 (28%) 0 17
Inflammation 0 3 (10%) 3
Erythema 0 3 (10%) 3

DEVICE-RELATED ADVERSE EVENTS
 		 AVERAGE
ONSET**
(Months)
Injection site subcutaneous papule* 26 (52%) 9 (31%) 7
*Subcutaneous papules refer to lesions of 5 mm or less, typically palpable, asymptomatic and non-visible.
**Onset data available from VEGA study only. Duration not noted for subcutaneous papules because most were ongoing at study completion.
*** Safety data were collected post hoc for 27 of the patients at approximately two years from study start.
TABLE 2:
NUMBER OF PATIENTS WITH TREATMENT-RELATED ADVERSE EVENTS OBSERVED IN
CLINICAL STUDIES WITH ONE-YEAR FOLLOW-UP
APEX 002
STUDY

99 Patients		 BLUE PACIFIC
STUDY

99 patients
INJECTION PROCEDURE RELATED ADVERSE
EVENTS
Bruising 1 (1%) 30 (30%)
Edema 3 (3%) 17 (17%)
Discomfort 19 (19%) 15 (15%)
Erythema 0 3 (3%)

DEVICE-RELATED ADVERSE EVENTS
Injection site subcutaneous papule 6 (6%) 13 (13%)

The duration of adverse events in Table 2 was not collected. The most common device related effect was the delayed occurrence of subcutaneous papules which were confined to the injection site and were typically palpable, asymptomatic, and non-visible. The study protocols did not include evaluation of treatment for subcutaneous papules, therefore, no information is available on how the papules were treated. In the VEGA study, the average onset of subcutaneous papules was 7 months after initial injection (range 0.3 – 25 months). Subcutaneous papules resolved spontaneously in 6/26 patients (24%) during the study. No information of onset and duration of papules is available from the Chelsea & Westminster study.
Treatment related adverse events, not included in Table 1 & 2, observed in clinical studies with a frequency of less than 5% were: injection site tenderness, injection site lesion, injection site bleeding, injection site induration, injection site infection and fever.

 

Post Marketing Surveillance

The following adverse events were received from post-marketing surveillance for SCULPTRA and SCULPTRA Aesthetic in the US and outside the US, that were not observed in the clinical trials with SCULPTRA:
allergic reaction, angioedema (Quincke's edema), application site discharge, fatigue, hypersensitivity reaction, hypertrophy of skin, injection site abscess, injection site atrophy, injection site fat atrophy, injection site granuloma (including ectropion), injection site induration, lack of effectiveness, malaise, periorbital nodules, photosensitive reaction, scar and skin discoloration, skin infection (including cellulitis (facial) and staphylococcal infection), skin rash, skin roughness, skin sarcoidosis, telangiectasias, urticaria, visible nodules with or without inflammation or discoloration, injection site reaction, hair breakage, colitis not otherwise specified, brittle nails, aching joints.
Scarring, mostly a non-serious event, has been reported in association with skin discoloration, nodules, lumps, indurations, granulomas, hyperpigmentation, hypertrophic scars, and suspicion of keloid formation. Time to onset ranged from 1 month to 24 months post-Sculptra injection and outcome ranged from ‘improved’ to ‘on-going’ at last contact.

Skin discoloration has been reported as a non-serious event, typically reported in association with lumps and nodules. It has also been reported with blanching and telangiectasias. Time to onset usually ranged from 1 month to 12 months post-injection. Outcome ranged from 'improved' to 'on-going' at last contact.

Serious adverse events have infrequently been reported. The most commonly reported serious adverse events (by MedDRA Preferred Term) were injection site nodule, granuloma, nodule, erythema, pain, inflammation, edema, hypersensitivity and pruritus. Regarding these infrequently reported adverse events the following describes serious adverse events with a frequency greater than 5 reported events:


CLINICAL STUDIES
Clinical data including skin thickness measurements and serial photographs were collected in four clinical studies.
Vega Study
This was a 96-week, open-label, uncontrolled, single-center study to determine the treatment effects of SCULPTRA on the signs of lipoatrophy of the face in 50 patients infected with human immunodeficiency virus. Patients had a mean age of 45 years (range 33-58), 84% were Caucasian and 98% were male. All patients had little or no adipose tissue in cheek area at baseline, indicating severe facial lipoatrophy (mean adipose thickness of 0.5±0.7 mm, ranging from 0.0 to 2.1 mm).

Treatment
Injection sessions were conducted at approximately two-week intervals, and the majority (86%) of the patients received four to five injection sessions. Generally, one vial of product was injected intradermally into multiple points of each cheek at each injection session. The quantity of injected product and number of injection sessions depended upon the severity of the facial depression.
Results
The mean increases from baseline in skin thickness are presented in Figure 1 below.

FIGURE 1
MEAN INCREASES ABOVE BASELINE IN SKIN THICKNESS (MM) OBSERVED IN THE
VEGA STUDY

Chemical Structure

All patients experienced increases in skin thickness in the treatment area (minimum increase of 2.2 mm noted at Week 8 visit). Statistically significant increases above baseline values of mean skin thickness were noted at all time points (Weeks 8, 24, 48, 72 and 96) during the study. Increases in mean skin thickness changes above baseline persisted for up to 2 years.

Chelsea & Westminster (C&W) Study
This was a 24-week, open-label, single-center, uncontrolled study in 30 human immunodeficiency virus positive patients with facial lipoatrophy. Patients were placed into groups of 12 or 24 weeks of follow-up. Patients had a mean age of 41 (range 32-60), 72% were Caucasian and 93% were male.

Treatment
All patients received a fixed treatment regimen of three injection sessions conducted at two-week intervals. Each vial of SCULPTRA was reconstituted with 2 mLs of SWFI and 1 mL of 2% lidocaine to give a total volume of 3 mL. Up to 3 mL of the reconstituted product was injected bilaterally into multiple points into the cheek and nasolabial areas.

Results
Baseline skin thickness in the treatment areas ranged from 2.1 to 2.7 mm and are presented in the Table 3 below.

TABLE 3:
RANGE OF MEAN INCREASES IN SKIN THICKNESS FROM BASELINE
12 WEEKS AFTER
1ST TREATMENT

N=27*		 24 WEEKS AFTER
1ST TREATMENT

N=14*
Cheek Areas 3.9 – 5.7 mm 4.9 mm
Nasolabial Areas 3.9 – 6.0 mm 4.9 – 5.3 mm
Baselines ranged from 2.1 to 2.7 mm; all changes were significant (p<0.001).
* Number of patients varies dependent upon which group they were placed.

 

Significant changes from Baseline (p<0.001) in mean skin thickness were observed in the areas treated (left and right nasolabial and cheeks) with SCULPTRA in all patients. A mean increase in skin thickness of approximately 4-6 mm was observed twelve weeks after the initiation of treatment for all treated patients.

APEX 002 and Blue Pacific Studies
Data were obtained from two, single-center, open-label, 12-month investigator-initiated studies in human immunodeficiency virus positive patients with facial lipoatrophy. Ninety-nine patients between 31 and 65 years of age were enrolled in each study. The majority of patients were Caucasian males.

Treatment
Patients were treated with SCULPTRA injections at an interval of approximately 3 to 6 weeks and received up to 6 injection sessions.

Results
The results from these studies are shown in Table 2 and were provided for safety information only.

INDIVIDUALIZATION OF TREATMENT (see also Patient Treatment)
The quantity of SCULPTRA and the number of injection sessions will vary by patient. Treatment for severe facial fat loss typically requires the injection of one vial of SCULPTRA per cheek area per injection session. A typical treatment course for severe facial fat loss involves 3-6 injection sessions, with the sessions separated by two or more weeks. Full effects of the treatment course are evident within weeks to months. The patient should be reevaluated no sooner than two weeks after each injection session to determine if additional correction is needed. Patients should be advised that supplemental injection sessions may be required to maintain an optimal treatment effect.

HOW SUPPLIED
SCULPTRA is supplied as a sterile freeze-dried preparation for injection in a clear glass vial, which is sealed by a penetrable stopper, covered by an aluminum seal with a flip-off cap. Each carton of SCULPTRA contains two vials of poly-L-lactic acid, sodium carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) NHRIC 8313-1106-02.

STORAGE
SCULPTRA can be stored at room temperature, up to 30°C (86°F). DO NOT FREEZE.
Refrigeration is not required.

STERILITY
Each vial of SCULPTRA is packaged for single-use only. Do not resterilize.

IF THE VIAL, SEAL, OR THE FLIP-OFF CAP ARE DAMAGED, DO NOT USE AND CONTACT SANOFI-AVENTIS U.S. LLC AT 1-800-633-1610.

 

INSTRUCTIONS FOR USE
The following supplies are used with SCULPTRA but are to be provided by the end-user:

Reconstitution

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 are damaged, do not use, and call sanofi-aventis U.S. LLC at 1-800-633-1610.
2. Attach an 18 G sterile needle to a sterile single-use 5 mL syringe.
3. Draw 5 mLs of SWFI into the 5mL syringe.
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. SCULPTRA can be stored at room temperature up to 30°C (86°F) during and after hydration. Refrigeration is not required.
6. Product should be gently agitated immediately prior to use. Agitate the vial until a uniform translucent suspension is obtained. 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. 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 1-3 mL sterile syringe. 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 or subcutaneous layer. Do not inject SCULPTRA using needles of an internal diameter smaller than 26 G.
9. To withdraw remaining contents of the vial, repeat steps 6 through 8.

 

Patient Treatment

 

1.  Patient Counseling.
     It is necessary to counsel the patient and discuss the appropriate indication, risks,      benefits and expected responses to the SCULPTRA treatment. Advise the patient      of the necessary precautions before commencing the procedure.


2.  Patient Assessment.

3. Patient Preparation. Each injection session is to be conducted with aseptic      technique and universal precautions due to the potential for contact with patient body      fluids: blood from the injection site. Before injecting SCULPTRA, a treatment plan      is determined and the face mapped. The mapping is done using a water soluble      pencil. See Section 6 and 7 - Injecting: Threading or Tunneling Technique, Depot      Technique.

 

4.  The needle for injections. SCULPTRA should be injected using a 26 G sterile      needle. Do not inject with needles with a diameter smaller than 26 G and/or needles      that have been bent. To maintain a uniform suspension throughout the procedure,      intermittently agitate the product in the syringe. Before initial injection, expel a few      drops of SCULPTRA through the attached 26 G needle to eliminate air and to      check for needle blockage. If the needle becomes occluded or dull during an      injection session replacement is necessary. If clogging occurs, remove the needle,      expel a small amount of product, attach a new sterile 26G needle, then expel a few      drops of SCULPTRA to eliminate the air and re-check for needle blockage.

 

5. The depth of injection. SCULPTRA should be injected into the deep dermis or      subcutaneous layer. To guide the needle, create a firm needle insertion plane by      stretching the skin. Introduce a straight, sterile, bevel-up 26 G needle into the skin at      an approximately 30-40 degree angle to the skin and then advance the needle until      the desired skin depth is reached. A change in tissue resistance is felt when the      needle crosses from the dermis into subcutaneous layer. If the needle is inserted at      too shallow (small) an angle or if the needle tip is not sufficiently advanced, then the      needle tip may be in the mid or superficial (papillary) dermis, the needle bevel may      be visible through the skin. If SCULPTRA is injected too superficially, the injected      area will blanch immediately or slightly after injection. If the injected area blanches,      remove the needle and massage the area in a circular fashion. In the event that the      blanching does not disappear, the patient should not be re-injected.

 

6. Injecting: Threading or Tunneling
             a.  Technique. When the needle tip is in the deep dermal or subcutaneous                   plane, the needle angle should be lowered to 10-20 degrees and the needle                  should be advanced parallel to the surface of the skin. Before injecting                   SCULPTRA, always perform a reflux maneuver to avoid intravascular                   injection. If blood returns to the syringe, the needle is in a blood vessel and                   should be withdrawn, pressure should be applied to the injected area until                   bleeding stops and a new syringe should be prepared. If no blood is pulled                   back into thesyringe, use the threading or tunneling technique, to deposit a                   thin trail of SCULPTRA by doing a retrograde injection when slowly                   withdrawing the needle. To avoid deposition in the superficial skin,                   deposition should be stopped before the needle bevel is visible in the skin.

 

            b.  Volume per injection. The maximum volume of SCULPTRA per each                  individual injection should be limited to 0.1 mL – 0.2 mL, spaced at a                  distance of 0.5 -1 cm. Note that in areas such as the cheek, approximately                  20 injections may be required to cover the targeted area. Avoid                  overcorrection.

 

            c.  Volume per treatment area. The volume of product injected per                  treatment area will vary depending on the surface area to be treated.                  Treatment of an entire cheek typically requires injection of one vial of                  SCULPTRA per cheek per injection session. Multiple injections (typically                  administered in a grid or cross-hatched pattern) may be required to cover                  the targeted area. The total number of injections and thus total volume of                  SCULPTRA injected will vary based on the surface area to be corrected,                  not on the depth or severity of the deficiency to be corrected. During the                  initial treatment sessions only a limited correction should be made. In                  contrast to other dermal fillers, SCULPTRA provides a gradual                  improvement of the depressed area over several weeks as the treatment                  effects occur.

 

7.   Injecting: Depot
           a.  Technique. The depot technique is most appropriate for injections into                 areas of thin skin at the level of the temples. When using this technique,                 SCULPTRA is injected as a small bolus. It is injected in the temporal                 fascia.

           b.  Volume per injection. The volume of SCULPTRA should be reduced to                 approximately 0.05 mL/injection. Following each injection, the area should                 be massaged.

 

8.   Massage during the injection session. The treatment areas should be       periodically massaged in a circular fashion after every 3-4 injections to evenly       distribute the product.

9.   Degree of correction. The depressed area should be under-corrected, never fully       corrected or overcorrected (overfilled) during an injection session. Under-      correction of the treatment area allows for gradual improvement of the contour       deficiency as the SCULPTRA effect occurs over several weeks between       assessment and possible next injection session. Typically, patients will experience       some degree of edema associated with the injection procedure itself, which will give       the appearance of a full correction by the end of the injection session (within about       30 minutes). The patient should be informed that the injection-related edema       typically resolves in several hours to a few days, resulting in the ‘reappearance’ of       the original contour deficiency.

10. Post-treatment care. Immediately following an injection session with       SCULPTRA, redness, swelling, and/or bruising may appear in the treatment area.       Refer to ADVERSE EVENTS for details of the incidence and severity of       adverse event observed immediately post-injection during the clinical trial. After the       injection session, an ice pack (avoiding any direct contact of the ice with the       skin) should be applied to the treated areas in order to reduce edema and/or       bruising. To help SCULPTRA distribute evenly in the contour deficiency, it is       important to manually massage in a circular fashion the treatment area for a minimum       of 2 minutes. A facial moisturizer should be used to perform the massage. The       patient should periodically massage the treatment areas for five minutes, five times       per day for five days after the injection session to promote a natural-looking       correction.
      Early occurrence of subcutaneous nodules at the injection site (within 3 to 6 weeks       after the treatment) may be minimized by adhering to proper dilution and injection       techniques (e.g., avoiding superficial injections or over-correction). In addition,       massaging the treatment area to ensure proper distribution of the product may also       minimize the appearance of nodules. Nodules usually resolve spontaneously.       However, as reported in published literature, some nodules may require medical       treatment such as subcision (break-up of nodules with sterile saline solution), and       delayed occurrence of subcutaneous nodules at the injection site (usually will       manifest within 3 to 4 months after the treatment) may require treatment such as       intralesional injections of corticosteroids, subcision and/or excision.

 

11. Treat, Wait, Assess. During the first injection session with SCULPTRA, only a       limited correction should be made. The contour deficiency should be under-      corrected, never fully corrected or overcorrected (overfilled) during any       injection session. Re-evaluate the patient no sooner than two weeks after the       injection session to determine if additional correction is needed. The patient should       be advised before and after an injection, that typically at the end of the injection       session, it is expected to experience some degree of swelling associated with the       injection procedure itself. This will give the appearance of a full correction by the       end of the injection session and this injection-related swelling typically resolves in       several hours to a few days. For this reason, the original contour deficiency may       initially reappear, but the deficiency is expected to gradually improve within several       weeks of SCULPTRA injection as the effect occurs. The patient should be advised       of the potential need for additional injection sessions at the first consultation.

 

PATIENT INSTRUCTIONS
It is recommended that the following information be shared with patients by the healthcare provider:


ANY SIDE EFFECTS OR PRODUCT COMPLAINTS SHOULD BE REPORTED TO:
sanofi-aventis U.S. LLC
Bridgewater, NJ USA
1-800-633-1610

Prescribing Information as of September 2009.

 

Dermik Laboratories
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

1-800-633-1610

 

©2009 sanofi-aventis U.S. LLC

 

Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner.

A PATIENT'S GUIDE TO TREATMENT WITH SCULPTRA®


SCULPTRA®
(injectable poly-L-lactic acid)

Please review this information carefully before beginning your SCULPTRA Treatment.

This guide is intended to help you become familiar with SCULPTRA use, as well as the expected correction, method of injection, post-injection skin care and possible side effects. You may request additional information such as the product label that further describes SCULPTRA and its clinical data from your physician. This information is also available on www.sculptra.com.
This information is not meant to replace information provided by your healthcare provider. You should always ask your healthcare provider about your treatment and care.
GLOSSARY
Anesthetic:  A substance that causes loss of feeling or awareness. A topical or local anesthetic is a drug that causes temporary loss of feeling in a part of the body.
Antiseptic:  An agent that kills bacteria or prevents or slows growth of germs.
Biocompatible:  A material that does not harm the body.
Biodegradable:  A material that can be broken down by the body.
Collagen:  The most common protein found in the body. Collagen is used to form a framework to support cell and tissue.
Hypersensitivity:  undesirable, discomfort producing reaction; or an allergic reaction.
Injection:  Product delivery at the location of a hollow needle tip beneath the surface of the skin.
Induration:  Any hardening or thickening of tissue or skin.
Keloid formation/Hypertrophic scarring:  An overgrowth of scar tissue at the site of a skin injury. Keloids/hypertrophic scarring may occur around surgical cuts, traumatic wounds, vaccination sites, burns, or minor scratches. Hypertrophic scarring commonly resolves during the first year after injury; keloid formation most commonly does not resolve.
Lipoatrophy:  The loss of body fat that is normally under the skin.
Nodule:  Lump under the surface of the skin that is less than 5 mm and not visible, but can be felt when pressed.
Palpable:  Able to be touched and felt.
Papule:  Lump under the surface of the skin that is less than 5 mm and not visible, but can be felt when pressed.
Patient label:  Product information for patients
Peri-orbital:  Around the eye.
Poly-L-lactic acid:  A man-made lactic acid polymer that is biocompatible and biodegradable and has been used for over 25 years in dissolvable stitches, soft tissue implants and other implants.
Side effect:  An unwanted event caused by use of the product.
Synthetic:  "man-made."

 

WHAT IS SCULPTRA?
SCULPTRA is a sterile, injectable, biocompatible, biodegradable material that is made of very small particles of a synthetic polymer known as "poly-L-lactic acid" (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (US) and sterile water for injection (USP). While the time needed for SCULPTRA to resorb in humans is not known, in rabbits, particles were visible at over one year after injection.

WHO MIGHT BENEFIT FROM TREATMENT WITH SCULPTRA?
SCULPTRA is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Your healthcare provider can help you determine if you might benefit from SCULPTRA and the optimal correction expected for you.

WHO SHOULD NOT USE SCULPTRA?
You should not use SCULPTRA if you:

WHAT SHOULD I BE AWARE OF BEFORE RECEIVING SCULPTRA INJECTIONS?
In addition to the other information contained in this guide, you should be aware of the following:


 

HOW DOES SCULPTRA WORK?
SCULPTRA is injected below the surface of the skin in the area of fat loss. SCULPTRA provides an increase in skin thickness. SCULPTRA will not correct the underlying cause of the facial fat loss, but will help improve the appearance by increasing skin thickness in the treated area. SCULPTRA works by initially filling with small particles of poly-L-lactic acid (PLLA) beads. As the particles are broken down by the body, beads biodegrade the body and may produce new collagen where SCULPTRA is injected. Visible results appear within the first few treatment sessions.

WHAT WERE THE RESULTS OF THE CLINICAL STUDIES CONDUCTED ON SCULPTRA?
Four clinical studies were conducted to evaluate Sculptra in patients with HIV associated facial lipoatrophy. The studies varied in the number of treatment sessions (3 to 6 injection sessions), the time between treatment sessions (2 to 6 week intervals), the quantity of Sculptra injected (3 mL to 1 vial, depending on the study design and the severity of the facial depression) and the length of time patients were followed in the study (96 weeks, 24 weeks, 12 months). A total of 278 patients received treatment with Sculptra across the 4 studies. In two of the studies, increases in skin thickness from baseline was provided. In the first study, in patients with severe facial lipoatrophy, an increase in skin thickness was observed starting at week 8 (average of 5.2 mm) through to Week 96 (average of 7.0 mm). In the second study, an increase in skin thickness was observed in 27 patients at 12 weeks (ranging from 3.9 to 6.0 mm in the cheek area and nasolabial areas) and in 14 patients at 24 weeks (ranging from 4.9 to 5.3 mm in the cheek area and nasolabial areas). Safety from the 4 studies was evaluated by comparing the number and severity of side effects observed during the studies. Side effects are summarized in the table 1 below.

 

TABLE 1:
NUMBER OF PATIENTS WITH TREATMENT-RELATED SIDE EFFECTS OBSERVED
IN CLINICAL STUDIES WITH ONE TO TWO YEARS OF FOLLOW-UP
 

277 Patients
INJECTION PROCEDURE RELATED
SIDE EFFECTS
Bruising 59 (21%)
Swelling* 27 (10%)
Pain 37 (13%)
Redness 6 (2%)
 
DEVICE-RELATED SIDE EFFECTS
Small lumps under the skin 54 (19%)
* Occasionally accompanied with redness

The most common side effects with the use of SCULPTRA include injection-related side effects at the site of the injection, such as bleeding, tenderness or pain, redness, bruising, or swelling. These side effects generally last, on average, 3 to 17 days.

One possible delayed side effect with SCULPTRA can be small lumps under the skin in the treated area. These small lumps may not be visible, and you may notice them only when you press on the treated skin. These lumps tend to happen within the first six to twelve months after the first treatment. Occasionally, these lumps go away on their own. Visible lumps, sometimes with redness or color change to the treated area, have also been reported. As with all procedures that involve an injection through the skin, there is a risk of infection.

Report any side effects to your health care provider.

WHAT ADVERSE EVENTS HAVE BEEN REPORTED THROUGH VOLUNTARY POST-MARKETING SURVEILLANCE OF SCULPTRA AND SCULPTRA AESTHETIC USE IN AND OUTSIDE OF THE US?
The most commonly reported serious adverse events were lumps or nodules at the injection site, delayed swollen lumps (granulomas), redness, pain, inflammation, swelling, hypersensitivity and itching. The following events were reported more than 5 times:


Other events that were reported included: application site discharge, fatigue, hypertrophy of skin, injection site atrophy, injection site hardness (induration), lack of effectiveness, malaise, photosensitive reaction, scar, skin discoloration, skin rash, skin roughness, skin disease inflammation (skin sarcoidosis), skin whitening at the injection site, dilated small blood vessels (telangiectasias), hives (urticaria), visible lumps with or without inflammation or discoloration, injection site reaction, hair breakage, colitis, brittle nails and aching joints.

ARE SKIN TESTS NEEDED BEFORE TREATMENT WITH SCULPTRA?
No skin testing is required prior to use in patients with skin that heals normally.

HOW OFTEN ARE SCULPTRA TREATMENTS GIVEN AND HOW MANY TREATMENTS ARE REQUIRED?
Your health care provider will decide with you the number of treatment sessions and the amount of SCULPTRA you will need at each treatment session. Patients with severe facial fat loss may require three to six treatment sessions. Touch-up treatments may be needed to maintain the desired effect. Your health care provider should see you two or more weeks after each treatment to assess whether you need additional treatment.

HOW LONG DO TREATMENT EFFECTS LAST?
Treatment effects will differ for each person. In a clinical study the treatment results lasted for up to 2 years after the first treatment session, in most patients. Touch-up treatments may be needed to maintain the desired effect. A post approval study is being conducted to determine the long-term effects beyond two years.

DO INJECTIONS OF SCULPTRA HURT?
As with any injection, to decrease pain during injection, a topical or local anesthetic may be applied to the injection area before injecting SCULPTRA. In the clinical studies, 13% of treated patients reported pain.

WHAT CAN I EXPECT TO HAPPEN AT A TREATMENT SESSION?
Your health care provider will answer all of your questions and ask about your medical history to determine if SCULPTRA injection is appropriate for you. Tell your healthcare provider about all the medicines you are taking, even over the counter medicines or treatments. You and your healthcare provider will determine if a topical or local anesthetic is needed. 


WHAT CAN I EXPECT AFTER TREATMENT?
Immediately following a treatment session with SCULPTRA, redness, swelling, pain, bruising or all of these signs can happen in the treatment area. These signs usually go away in a few hours to a few days. Some have been known to last up to 17 days. Your health care provider will give you specific post-treatment care instructions. Some specific instructions you should follow after treatment are:
 

HOW QUICKLY CAN I GET BACK TO MY DAILY ACTIVITIES?
Most patients are able to get back to their activities immediately following treatment.

WHEN WILL I BE ABLE TO APPLY MAKE-UP AFTER TREATMENT?
Make-up may be applied a few hours after treatment if there are no complications such as open wounds or bleeding.

WHAT ARE MY OTHER OPTIONS FOR TREATMENT?
Consult with your physician to determine the options available to you for treatment.
FOR FURTHER QUESTIONS AND INFORMATION, OR TO REPORT ANY SIDE EFFECTS, PLEASE CALL SANOFI-AVENTIS AT 1-800-633-1610

Patient Prescribing Information as of September 2009.
Dermik Laboratories
A business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
Telephone: 1-800-633-1610


POL-WFSPLW-WEBW-SEP09

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