Sculptra: CONTRAINDICATIONS

4 May
2010

CONTRAINDICATIONSThe available evidence indicates that Sculptra™ is relatively safe. It is contra-indicated only for individuals with a known hypersensitivity to any of the components of the product.

WARNINGS AND PRECAUTIONS

Health care providers should consider the following facts before administering Sculptra™:
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1. The product’s long-term safety and effectiveness for more than two years have not been established. The manufacturer is conducting a post-approval

study to evaluate the product’s safety and efficacy beyond two years.

2. Sculptra™ should be used only in the deep dermis and subcutaneous layers of the skin. Superficial skin injections should be avoided.

3. Health care providers must take special care when injecting Sculptra™ into areas of thin skin.

4. The safety and efficacy of Sculptra™ in the periorbital area have not been confirmed.

5. As with all transcutaneous procedures, there is a risk of infection with injections. Standard precautions for injection should always be followed.

6. Health care providers should be aware of the risk of hematoma or localized injection-site bleeding if patients are receiving anticoagulant therapy.

7. Because there is a potential for contact with a patient’s body fluids, universal precautions are warranted. The use of aseptic technique is a necessity.

8. The product’s safety for use in pregnant women, in breast-feeding women, and in patients younger than 18 years of age has not been established.

9. Data are limited in terms of the use of Sculptra™ in women, in non-whites, and in patients with increased susceptibility to keloid formation and hypertrophic scarring. Dermik plans to conduct a post-approval study in these patients, who have not been not adequately represented in previous studies.

PATIENT COUNSELING

Following injection sessions with Sculptra™, patients should be given the following guidance:

1.  An ice pack can be applied to the treatment area within the first 24 hours in order to reduce swelling. The ice should not be applied directly to the skin.

2.  Patients should massage the treatment area daily for several days after an injection session to ensure more even distribution of the product.

3.  Redness, swelling, or bruising may occur, but these effects usually resolve within hours to one week. Hematoma formation, if any, might take up to two weeks to resolve. Most small papules that develop in the treated area are usu­ally invisible and asymptomatic. If any of these effects last longer than expected or if they appear to worsen, patients should be advised to report these findings to their health care providers immediately.

4.  If there are no complications, such as open wounds, bleeding, redness, or swelling, patients may apply makeup a few hours after the injection session.

5.  Patients should minimize their exposure to the excessive sun or ultraviolet lamps until any resulting swelling or redness has resolved.

6.  Patients should be informed that it takes a few weeks for Sculptra™ to demonstrate its effects.

7.  Patients may experience an initial facial swelling. When the swelling subsides and the original depressions reappear, they might think that the injections are not working. Patients should be advised that this effect is normal and that it will take a few weeks before the results of Sculptra™ become apparent.
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PHARMACOECONOMICS

As with any pharmaceutical product, cost may be a concern for many patients and health care professionals who will be considering this device. Unfortunately, cost information regarding Sculp-tra™ is available only to health care providers who are registered with Der-mik Laboratories to administer the injections. Therefore, we cannot make a cost comparison between this treatment option and others at this time.

OTHER TREATMENT OPTIONS

Alternative treatment options for patients with facial lipoatrophy are presented in Table 4 on page 213. Because some of the procedures listed are highly individualized, patients and their health care providers should be encouraged to discuss those strategies that would be most appropriate.

Table 4   Alternative Treatment Options for Patients with Facial Lipoatrophy

Type of ProcedureDescriptionAdvantagesDisadvantages
Fat graftingRemoval of fat via lipo-• Fat can be frozen and usedSome patients may not have sufficient
suction from one areafor subsequent visits.fat for transfer.
of the body to be injected• The patient’s own fat isFat seems to be absorbed relatively
into depressed areas ofused, thereby avoidingquickly (in approximately nine months),
the face.antigenic problems.thereby requiring additional sessions.
• Fat grafting is less invasiveGeneral anesthesia and an overnight
than other procedures.hospital stay are necessary.
FaceliftSurgical lifting and tighten-• Dramatic and durableA longer period of healing is required.
ing of the skin on the face.results (lasting for years)The surgical procedure is complex and
can be achieved.painful.
General anesthesia and a hospital stay
are required.
Dermal graft, fat graftRemoving a piece of the• Results can be long-lastingThe fat graft may disappear after a few
person’s own skin withand natural-looking.months.
the attached underlyingGeneral anesthesia and a hospital stay
fat and placing it over theare necessary.
area of facial concavity.
Artificial fillingInjections into the skin• These materials have beenThe material is absorbed within one
materials, such asthat replace the patient’sused for cosmetic purposesto three months.
collagen, injectableown fat. The material isfor many years.Allergic (antigenic) reactions have been
human tissue matrixusually of bovine origin.• The technique is less inva-reported.
implant (Dermalo-sive than other procedures.
gen™ ), and others
Synthetic,Material that is injected or• Results can be permanent (ifForeign-body reactions and rejection
nonbiodegradableimplanted under the skin.there are no complications).of the implant may occur.
implants, such as• Silicone can add volume.Nodularity can result if the implant is
siliconeplaced improperly.
The long-term effects are uncertain.
Silicone is banned in many countries.

CONCLUSION

Although HIV infection is becoming more manageable for many patients and clinicians, the complications from anti-retroviral therapy have become more difficult to manage. Unfortunately, facial lipoatrophy is the most difficult manifestation to correct. It remains a major concern among HIV-infected patients, because it can be psychologically and socially stigmatizing. Consequently, patients frequently request available treatments to correct this disorder.
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It is vital that these patients not discontinue HAART. Discussing the problem with a health care professional is essential, because sometimes other factors contribute to the development of lipoatrophy.

Sculptra™ appears to be a safe, effective, and viable alternative for patients with HIV-associated facial lipoatrophy, especially for those who cannot switch their antiretroviral treatment regimens or who do not wish to undergo painful reconstructive procedures. Because the cost of many of the alternative procedures can be quite high, patients who are considering Sculptra™ injections should be encouraged to discuss all of the available choices with their physicians.

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