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INDICATION

LAVIV™ (azficel-T) is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV™ for areas other than the nasolabial folds have not been established. The efficacy of LAVIV™ beyond six months has not been established.

Please see full Prescribing Information for LAVIV.

IMPORTANT SAFETY INFORMATION

LAVIV™ (azficel-T) is made especially for you from your own skin cells. Using someone else’s cells can cause a serious reaction. Do not let anyone else use your LAVIV. Prior to injection, confirm with your physician that your information on the LAVIV vial is correct. Your health care provider will help you to decide whether you are a candidate for LAVIV and may help you avoid some of the adverse reactions from LAVIV. Before getting LAVIV, tell your healthcare provider if you have any medical problems including allergic reactions to any drugs or food, bleeding disorders or take blood-thinning medicines like aspirin, ibuprofen, or COUMADIN® (warfarin sodium), keloids or excessive scarring, skin cancer or any malignancy, genetic disorders affecting your skin, immune problems or take medicines that affect your immune system, or any other illness or medical problem. Tell your healthcare provider if you are allergic to the antibiotics amphotericin or gentamicin, bovine materials (products made from cattle), or dimethyl sulfoxide (DMSO). Do not use LAVIV if you have a skin infection on your face because LAVIV treatment can make the infection worse.

The most common side effects of LAVIV are at the injection-site, including redness, bruising, swelling, pain, bleeding, lumps, irritation, and itchiness. In clinical trials with LAVIV, most injection-site adverse reactions resolved within one week and most required no treatment. There are additional adverse reactions that occurred in less than 1% of patients following LAVIV treatment in clinical trials. Talk to your healthcare provider about these adverse reactions. For more information about LAVIV, please see full Prescribing Information.

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Last modified: March 28, 2012

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