Sculptra – Product Information
|Condition:||Skin Conditions (Dermatological Disorders)|
|Class:||Miscellaneous uncategorized agents|
|Ingredients:||poly-L-lactic acid, sodium carboxymethylcellulose, mannitol|
SCULPTRA is a poly-L-lactic acid implant in the form of a sterile apyrogenic suspension, which is reconstituted from a sterile dry powder by the addition of sterile water for injections (European Pharmacopoeia). This suspension contains microparticles of poly-L-lactic acid, the crystalline form of polylactic acid, carboxymethylcellulose and non-pyrogenic mannitol. Poly-L-lactic acid is the crystalline form of polylactic acid. Poly-L-lactic acid is a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family.
The SCULPTRA sterile freeze-dried powder is supplied in an elongated clear glass vial with an aluminium ring at one end, which is hermetically sealed by a rubber stopper, covered by a flip-off cap. The contents of the vial are reconstituted prior to use with 5 ml of sterile water for injections to form a sterile non-pyrogenic suspension.
Sterile: prepared aseptically
Composition of Sculptra
Each vial contains:
150 mg Poly-L-lactic acid
90 mg Sodium carboxymethylcellulose
127.5 mg Mannitol
Class III medical device containing a scheduled substance (prescription medicine)
Increase the volume of depressed areas, particularly to correct skin depressions.
Large volume restoration and/or correction of the signs of facial fat loss (lipoatrophy) including HIV patients treated with antiretroviral drugs.
SCULPTRA should not be used in any person who has hypersensitivity to any of the components of the product. Do not use in the case of acute or chronic skin disease (infection or inflammation) near the area to be treated. Treatment should be deferred until the inflammation or infection has been controlled.
SCULPTRA should only be used subcutaneously or deep intradermally. Avoid superficial injections in order to avoid the appearance of early papules or nodules at the injection site, which could be suggestive of improper injection techniques (superficial placement, excessive amount of product, incorrect reconstitution). In addition, massaging the treatment area to ensure proper distribution of the product may also minimize the appearance of papules or nodules.
Do not inject into a blood vessel, to avoid the risk of skin infarction or embolism of a blood vessel. The fluidity of SCULPTRA makes it easy to aspirate with the syringe before injection, to ensure that the needle is not in a blood vessel.
Do not over-correct a contour deficiency, because the depression should gradually improve within several weeks as the treatment effect of SCULPTRA occurs.
Caution must be taken when injecting SCULPTRA in areas of thin skin, especially in the peri-orbital and the peri-oral areas. An increased risk of papules and nodules in the periorbital area has been reported. Refer to instructions for use for information regarding injection techniques.
Do not inject into the red area of the lip (vermillion).
Always mix the powder with sterile water for injections (sterile water for injections: in compliance with European Pharmacopoeia).
For implantation of SCULPTRA, use 26 G needles with single-use sterile syringes.
Single patient and single session use only: Discard immediately after use. Do not reuse or do not resterilize the vial. Do not use if package or vial is opened or damaged.
Precautions for use
The injection site should be cleaned with an antiseptic and free from inflammation or infection.
As with all injections, patients treated with anti-coagulants may run the risk of a haematoma or localized bleeding at the injection site.
The safety of SCULPTRA for use during pregnancy, in breastfeeding women or in patients under 18 years has not been established.
No studies of interactions of SCULPTRA with drugs or other substances or implants have been made.
SCULPTRA should only be used by healthcare providers with expertise in the correction of volume defects after fully familiarizing themselves with the product, the product education materials and its complete instruction leaflet.
The safety of using SCULPTRA in patients with susceptibility to keloids formation and hypertrophic scarring has not been established. SCULPTRA should not be used in patients with known history of, or susceptibility to, keloid formation or hypertrophic scarring.
The patient should be informed that exposure of the treated area to excessive sun, UV lamp exposure until any initial swelling and redness has resolved should be minimized.
If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with SCULPTRA, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if SCULPTRA is administered before the skin has healed completely after such a procedure.
Side effects of the treatment
The adverse reactions considered to be possibly or probably related to the administration of poly-L-lactic acid have been obtained from clinical studies or detected from post-marketing surveillance and literature reports.
Injection site reactions
Injection site haemorrhage
Injection site pain
Injection site induration
Injection site swelling
Immune system disorders
Infections and infestations
Injection site infection, including cellulitis (facial), staphylococcal infection
Injection site abscess
Skin and subcutaneous tissue disorder
Injection site atrophy, skin hypertrophy Injection site erythema
Injection site urticarial
Subcutaneous papules, non visible, typically palpable, asymptomatic
Visible nodules, including periorbital nodules, with or without inflammation or discoloration. Granuloma
The 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 (refer to Warning). Delayed occurrence of subcutaneous nodules at the injection site (within 1 to 14 months post injection) with sometimes a prolonged duration of up to 2 years. In some cases, they resolved spontaneously or following treatment with intralesional corticosteroids. Surgical excision was sometimes required when the nodules were larger in size, occurring in difficult anatomical regions (e.g., lower eyelid) or persisting after other treatments.
Treatment of overcorrection
Small, invisible but palpable, or visible nodules or areas of induration have been noted in the injection area and may be due to over-correction. Nodules are occasionally associated with inflammation or discoloration. The occurrence of nodules may be minimized by adhering to proper technique (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.
Istructions for use
Reconstitution prior to use
The contents of the vial are reconstituted with 5 mL of sterile water for injections.
SCULPTRAis reconstituted in the following way:
- 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 contact sanofi-aventis (see contact information provided below).
- Attach an 18 G sterile needle to a sterile single use 5mL syringe.
- Draw 5 ml of sterile water for injections (sterile water for injections: in compliance with European Pharmacopoeia) into the 5 mL syringe.
- Introduce the 18 G needle into the stopper of the vial and slowly add all the sterile water for injection into the vial.
- Let the vial stand for at least 2 hours (do not shake during this period) to ensure that the powder is fully hydrated by the water. SCULPTRA can be stored at 2 to 8°C in the refrigerator or at room temperature up to 30oC during hydration (refer to Storage Conditions).
- 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 must be injected within 72 hours of reconstitution. If it is not used within 72 hours, it must be discarded.
- Clean the penetrable stopper of the vial with an antiseptic, and use a new 18 G needle to withdraw the appropriate amount of the suspension (typically 1 mL) into a single-use 1-3 mL sterile syringe. Do not store reconstituted product in the syringe.
- 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.
- To withdraw remaining contents of the vial, repeat steps 6 through 8.
- Discard immediately after single session/patient use
- Patient Assessment
- Patient Preparation
- The needle for injections
- The dermal plane
- Injecting: threading or tunneling
- Injecting: Depot
- Massage during the injection session
- Degree of correction
- Post treatment care
- Treat, wait, assess
A complete medical history should be taken to determine if the treatment is appropritate. Before treatment with SCULPTRA, the patient should be informed completely of the indications, contraindications, warnings, precautions for use, possible side effects and mode of administration of SCULPTRA. A complete medical history should be takem to make sure that the treatment is appropriate. Each patient should be informed that the amount of SCULPTRA and the number of injection sessions will depend on the patient’s need and the severity of the depressed area. Patients should be informed that more than one injection session is typically necessary to achieve the desired results.
As with all transcutaneous procedures, SCULPTRA injection carries a risk of infection. Standard precautions associated with injectable materials should be followed. Universal precautions must be observed when there is a potential for contact with patient body fluids. The injection site should be cleaned with an antiseptic and free from contamination or infection.
SCULPTRA should be injected using a 26 G sterile needle. Do not inject with needles smaller than 26 G and do not bend the needle. To maintain a uniform suspension throughout the procedure, intermittently agitate the product in the syringe. Before initial injection, expel a few drops SCULPTRA through the attached 26 G needle to eliminate air and to check for needle blockage. If the 26 G needle becomes occluded or dull during an injection session replacement may be 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 recheck for needle blockage.
SCULPTRA should be injected into the deep dermis or subcutaneous layer. In order to control the injection depth of SCULPTRA, stretch/pull the skin opposite to the direction of the injection to create a firm injection surface. The 26 G sterile needle, bevel up, should be introduced into the skin at an angle of approximately 30-40 degrees, until the desired skin depth is reached. A change in tissue resistance is felt when the needle crosses from the dermis into the 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 product is injected too superficially, the injected area will blanch immediately or shortly after injection. If this occurs, the needle should be removed and the treatment area gently massaged. In the event that the blanching does not disappear, the patient should not be re-injected.
When the appropriate dermal plane is reached, the needle angle should be lowered to advance the needle in that dermal plane. Prior to depositing SCULPTRA in the skin, a reflux maneuver should be performed to assure that a blood vessel has not been entered. Using the threading or tunneling technique, a thin trail of SCULPTRA should then be deposited in the tissue plane as the needle is withdrawn. To avoid deposition in the superficial skin, deposition should be stopped before the needle bevel is visible in the skin.
Volume per injection
The maximum volume of SCULPTRA per each individual injection should be limited to approximately 0.1 mL – 0.2 mL spaced at a distance of 0.5cm – 1 cm. Avoid overcorrection.
Volume per treatment area
The volume of product injected per treatment area will vary depending on the surface area to be treated.
During the initial treatment sessions with SCULPTRA, only a limited correction should be made. In contrast to other wrinkle fillers, SCULPTRA provides a gradual improvement of the depressed area over several weeks as the treatment effects occurs. Additional sessions may be needed to achieve full effect.
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.
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 deep to the temporalis muscle. Intramuscular injection should be avoided.
Volume per injection
The volume of SCULPTRA should be reduced to approximately 0.05 mL/injection. Following each injection, the area should be massaged.
The treatment areas should be periodically massaged during the injection session to evenly distribute the product.
The depressed area should never be overcorrected (overfilled) in an injection session. Limited correction of the treatment area allows for the gradual improvement of the depressed area over several weeks as the treatment effect occurs. Typically, patients will experience some degree of oedema 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 oedema typically resolves in several hours to a few days, resulting in the ‘reappearance’ of the original contour deficiency.
Immediately following an injection session with SCULPTRA, redness, swelling, and/or bruising may be noted in the treatment area (refer to Adverse Reactions). After the injection session, an ice pack (avoiding any direct contact of the ice with the skin) should be applied to the treatment area in order to reduce swelling and/or bruising. It is important to thoroughly massage the treatment area(s) to evenly distribute the product . The patient should periodically massage the treated areas for five minutes, five times per day for five days after the treatment to ensure a natural-looking correction.
SCULPTRA may be visualized with ultrasound imaging and MRI. If you are having an ultrasound or MRI performed on the area injected with SCULPTRA inform your healthcare provider that you have SCULPTRA injected in the area. SCULPTRA is not observed with CT scans and X-rays.
During the first treatment session with SCULPTRA, only a limited correction should be made. Do not overcorrect (overfill). The patient should then be evaluated at no sooner than four weeks post-treatment to determine if additional correction is needed. The original skin depression may initially reappear, but the depression should gradually improve within several weeks as the treatment effect of SCULPTRA occurs. The patient should be informed of the potential need for additional treatments at the first consultation.
Mode of actions
SCULPTRA is implanted by subcutaneous or deep intradermal injections with a 26 G needle. The tight granulometric distribution of the microparticles of poly-L-lactic acid, its slow degradation kinetics, and a viscosity which is suitable for both deep intradermal or subcutaneous injections, gives SCULPTRA its mechanical properties and prolonged resorbability, which make this implant suitable for filling areas of depressed skin.
SCULPTRA powder should be stored at room temperature away from heat (maximum 30°C). Upon reconstitution, SCULPTRA can be stored up to 72 hours at 2 to 8°C in the refrigeraton or at room temperature up to 300C.
Do not freeze.
Do not use if package or vial is opened or damaged.
IF THE VIAL, SEAL OR THE FLIP- OFF CAP ARE DAMAGED, DO NOT USE, AND CONTACT SANOFI-AVENTIS (SEE CONTACT INFORMATION PROVIDED BELOW).
After patient use, treatment syringes and needles may be potential biohazards. Handle accordingly and discard the needles and syringes in a safe disposal container.