Laviv
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
LAVIVTM 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.
History
There is currently no drug history available for this drug.
Other Information
LAVIV is an autologous cellular product composed of fibroblasts suspended in Dulbecco's Modified Eagle's Medium (DMEM) without phenol red. Dermal fibroblasts from post-auricular skin biopsy tissue are aseptically expanded using standard tissue-culture procedures until sufficient cells for three doses are obtained. Cells are then cryopreserved in a protein-free solution containing DMSO. When the patient administration is scheduled, cells are thawed, washed, and shipped to the clinic. A final sterility test is initiated prior to shipping, but the result will not be available for up to 14 days. A passing sterility culture result from the test performed on the cryopreserved bulk material (Drug Substance) and a negative Gram stain test result on the final LAVIV drug product are required for release of a product for shipping.
Sources
Laviv Manufacturers
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Fibrocell Technologies, Inc.
![Laviv (Azficel-t) Injection, Suspension [Fibrocell Technologies, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Laviv | Fibrocell Technologies, Inc.
For autologous intradermal injection only
Only healthcare providers who have completed a Fibrocell-approved training program should administer LAVIV.
2.1 DosageInject LAVIV at 0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions, administering up to 2 milliliters (2 vials) of LAVIV per session, at 3-6 week intervals.
2.2 Preparation Confirm that the unique patient identifier on the LAVIV vial matches the identity of the patient who will receive the LAVIV injections. Allow the LAVIV vial(s) to reach room temperature before use. Examine vial(s) for leaks and for any evidence of damage or contamination. Gently invert each vial to re-suspend the product within the media. Tap the top of the vial to release any fluid retained in the top of the vial prior to opening the vial. DO NOT DILUTE THE PRODUCT. Before the injection, prepare a minimum of four sterile syringes and needles. Small unit syringes (e.g., 0.5 milliliter insulin syringes) are recommended for better injection control. A detachable larger bore needle (e.g., 21-gauge) should be used to withdraw product from the vials to minimize cell damage. Using aseptic technique, unscrew the vial cap and withdraw up to 0.5 milliliters from the vial into each syringe, noting the total volume. After a 21-gauge needle is used to withdraw LAVIV from the vial, the needle should be replaced with a 30-gauge needle prior to injection. Short, sharp needles (e.g., 30-gauge, half-inch needles) are recommended for better injection control and minimization of inflammation. 2.3 Administration Identify the areas to be injected and make sure the injection areas are free of cosmetics, hair or facial jewelry. Evaluate the need for topical anesthesia. If a topical anesthetic is administered, remove any topical anesthetic from the face prior to injection of LAVIV. DO NOT USE injectable local anesthetics. Clean the treatment area with an aseptic solution prior to injection. Place the patient in a comfortable position (e.g., recumbent) to facilitate proper injection angle. Inject LAVIV into the superficial papillary dermis at 0.1 milliliter per linear centimeter, using a 30-gauge needle. When the needle is inserted into the correct plane of the skin (i.e., along the line of each nasolabial fold wrinkle), the needle should be visible through the epidermis. Confirm intradermal injection by the appearance of blanching and a fluid bleb at the injection site. Avoid injecting LAVIV into the blood vessels, subcutaneously, or intramuscularly. Apply multiple injections as needed to cover the entire nasolabial fold wrinkle. Overlap injection areas slightly; otherwise, the last few millimeters of each injection site may receive no product. To prevent exudation of LAVIV from the injection site, make sure that the end of the needle is inserted slightly adjacent to the tract of the previous injection. After the injection, leave the treated area undisturbed. Do not rub, massage or compress the area. Apply a cold pack for 2-3 minutes. Do not place ice directly against the skin. Discard leftover LAVIV and injection materials as biohazardous waste. Counsel the patient on care of the injection site.
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