About LAVIV™ (azficel-T)

A novel, biologic approach to treating nasolabial fold wrinkles1

Imagine using your patients’ own injected skin cells to improve the appearance of nasolabial fold wrinkles. Imagine, too, offering your patients a therapy that has been clinically proven to be safe and effective.1 LAVIV™ is a breakthrough treatment that contains a patient’s own fibroblast cells, which have been grown from his or her skin samples.1 In fact, LAVIV™ is made up of at least 98% pure fibroblasts.2

Interest in LAVIV™ in the aesthetic skin care community is steadily growing . . . and with good reason:

LAVIV™ is decidedly unique. LAVIV™ is the first and only FDA-approved autologous cellular therapy to improve the appearance of moderate to severe nasolabial fold wrinkles.1,2 In order to be approved by the FDA, LAVIV™ was held to high efficacy standards. In clinical trials, LAVIV™ demonstrated a statistically significant improvement as measured by both a physician and patient assessment scale, where improvement was defined as a 2-point improvement on the scales. These trials were designed to be vehicle-controlled and demonstrate superiority to vehicle. Each dose of LAVIV™ is also held to strict testing standards to ensure product performance and safety.2

LAVIV™ delivers customized treatment. A custom aesthetic product, LAVIV™ contains a patient’s own fibroblast cells that have been grown from his or her post-auricular skin biopsy tissue. These skin samples are sent to the Fibrocell Science lab where they are aseptically expanded and then cryopreserved. Cells are later thawed, washed, and then shipped back to your office for injection.1 As a result, each dose of LAVIV™ is as unique as the patient receiving it.

Patients and physicians reported a noticeable improvement in the appearance of nasolabial fold wrinkles with LAVIV™. These results were observed in 2 clinical studies totaling more than 400 patients.1 Improvement was observed at 6 months following the final injection.

Next: Manufacturing/Mechanism of Action

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Clinically Proven Safe and Effective

Patients treated with LAVIV™ reported a noticeable improvement in the appearance of nasolabial fold wrinkles.

See the results

 
 

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 the Prescribing Information.

IMPORTANT SAFETY INFORMATION

LAVIV™ is made especially for you from your own skin cells. Using someone else’s cells can cause a serious reaction. Prior to injection, confirm with your physician that your information on the LAVIV™ vial is correct.

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.

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 health care 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, 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. The full Prescribing Information for LAVIV™ includes additional warnings about adverse reactions that occurred in less than 1% of patients following LAVIV™ treatment in clinical trials. Talk to your health care provider about these warnings.

Please tell your health care 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.

For more information about LAVIV™ please see the Full Prescribing Information.

REFERENCES
  1. LAVIV™ Prescribing Information. Fibrocell Science, Inc. June 2011.
  2. Data on file. Fibrocell Science, Inc. June 2011.

©2011 Fibrocell Science, Inc. All rights reserved. 11/11