Has the new Sculptra mixing time changed?

Question

Has the new sculptra changed in how long you have to mix it before use? My doctor says it only needs to be mixed that day before use now because they reformulated it. Is this true?

Michael A. Persky, MD · Answer

Hi SB,
Yes, Sculptra can now be mixed immediately prior to use when the proper protocol is used.  Many practices still mix their Sculptra days before usage, but in a pinch I can mix it just prior to use.  Make sure to choose an expert Sculptra injector should you choose this great treatment.  Good luck and be well.
Michael Persky, MD

Mahmood Siddique, DO · Answer

Short answer: Yes. The current U.S. label allows immediate-use reconstitution: you can mix a vial with 8 mL sterile water (SWFI) for immediate use (optionally add 1 mL of 2% lidocaine just before injection). The label also still permits a 5 mL SWFI reconstitution that must hydrate ≥2 hours and can be stored up to 72 hours before use. FDA Access Data
This change came with an FDA label update that approved higher dilution and immediate-use reconstitution; it wasn’t a fundamental reformulation of the PLLA itself. Practical Dermatology
Bottom line: Your doctor’s “mix the day of treatment” approach is consistent with the updated instructions for use

Michael I. Echavez, MD · Answer

The formulation for Sculptra has not changed, but the mixing time can vary, depending on the treating physician.  I do normally mix my Sculptra the day before I use it but some physicians will mix it just before treating the patient.  As long as the vial is well mixed, the result should be the same, no matter when it is reconstituted.

Jeffrey H. Spiegel, MD · Answer

Sculptra is less of a mixture than a suspension.  The molecules stimulate your body to produce more tissue, so getting the molecules into the body is key.  Once they are suspended in the liquid they are ready to go.  It never made sense to wait so long after combining with water, and it still doesn't.  The company has now realized that and adjusted their recommendations.

Victoria Falcone, DO · Answer

Yes, it is safe to mix Sculptra the day before the procedure. The product is hydrated with sterile water. This can be done one day to several weeks prior to injection.

Lisa Vuich, MD · Answer

Thanks for your question. It used to be required to reconstitute Sculptra well in advance of a planned injection. Fortunately, we now know that it can be mixed even on the same day as the injection. The directions are as follows: Sculptra may be reconstituted with either 5 mL of sterile water and stored for up to 72 hours, or reconstituted with 8 mL of sterile water for immediate use. I hope that helps!

Anshul Gambhir, MD · Answer

Hi there! Our office will mix our sculptra 3 days before use. There are other ways to dilute it if you need to use it immediately that same day, but it is mixed differently than our typical sculptra. Hope this helps!

Marianna Blyumin-Karasik, MD · Answer

That is correct, more recent clinical studies indicated that reconstituting sculptra on the day of the procedure is just as safe as preparing the mix prior.

Darryl J. Blinski, MD · Answer

Not really, the concept is to attain an emulsion of the powered product in sterile water. Personally, I use a rolling machine after combining the powder with the sterile water allowing to run over night to assure complete emulsification. I ALWAYS self examine the mixture prior to use to see if any granules are present. The better the mixture the better the amount of the product becomes in use. Good Luck out there.....

Reuel Aspacio, MD, FAAD - Account Suspended · Answer

Hi there,

Yes, this is true it can actually be the same day as injection.  As long as it is mixed properly, and your massaging is done as it is supposed to you should have great results.

Has the new Sculptra mixing time changed?

Answers (10)

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