These highlights do not include all the information needed to use LAVIVTM (azficel-T) safely and effectively. See full prescribing information for LAVIV TM .
LAVIV TM . (azficel-T)
Suspension for Intradermal Injection.
Initial U.S. Approval: 2011
INDICATIONS AND USAGE
LAVIV
TM (azficel-T) is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. (
1)
The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. (
1)
The efficacy of LAVIV beyond six months has not been established. (
1)
DOSAGE AND ADMINISTRATION
For autologous intradermal injection only
Only healthcare providers who have completed a Fibrocell-approved training program should administer LAVIV. (2)
Inject LAVIV at 0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions at 3-6 week intervals. (2)
DOSAGE FORMS AND STRENGTHS
A single vial of LAVIV contains approximately 18 million autologous fibroblasts in a 1.2 milliliters suspension, sufficient to administer 1 milliliter of product. (3)
CONTRAINDICATIONS
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Allogeneic use of LAVIV
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Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin
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Active infection in the facial area
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions can occur with LAVIV. (5.1)
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LAVIV can cause bleeding and bruising at the treatment site. (5.2)
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Vasculitis has occurred following treatment with LAVIV. (5.3)
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Herpes labialis has occurred f
