Medical Editor: John P. Cunha, DO, FACOEP
Laviv (azficel-T) Suspension for Intradermal Injection is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. Common side effects of Laviv include:
- injection site reactions
- dermatitis, and
The dose of Laviv is 0.1 milliliter per linear centimeter injected into the nasolabial fold wrinkles. The recommended treatment regimen of Laviv is three treatment sessions at 3-6 week intervals. Laviv may interact with aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before receiving Laviv. It is unknown if Laviv would harm a fetus. Consult your doctor before breastfeeding.
Our Laviv (azficel-T) Suspension for Intradermal Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The most common adverse reactions, occurring in ≥1% of subjects in clinical trials, were injection-site reactions, including redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus.
Adverse reactions occurring in less than 1% of trial subjects were acne, facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, post-procedural discomfort (headache, toothache, and jaw pain), herpes labialis, hyperpigmentation at the injection site, injection-site ischemia, basal cell cancer, and leukocytoclastic vasculitis.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice.
The overall clinical trial safety database for LAVIV includes 508 subjects who received at least one treatment of LAVIV and 354 subjects who received a vehicle-control in seven clinical trials for treatment of facial wrinkles (a skin biopsy study is described separately). This total safety population included patients aged 20 to 79 years, of whom 92% were female and 92% were White. The average duration of observation in the safety population was approximately 12 months.
An integrated summary of the adverse reactions from the seven clinical trials is presented in Table 1. More than 80% of all adverse reactions were local and required no treatment. Eighty-six percent of all injection-site adverse reactions resolved within one week.
The adverse reactions to the vehicle (Table 1) should not be viewed as adverse reactions to a placebo but rather as reactions to a non-cellular component of LAVIV, or to the injection procedure, or to both.
Table 1: Adverse Reactions in ≥ 1% of the Study
Population Who Received LAVIV or Vehicle
|LAVIV (508 Subjects)
|Vehicle (354 Subjects)
|Any Injection-Site Reaction||343 (67)||144 (40)|
|Erythema||81 (16)||33 (9)|
|Swelling||69 (14)||15 (4)|
|Pain||31 (6)||6 (2)|
|Hemorrhage||13 (3)||16 (5)|
|Nodules||20 (4)||3 ( < 1)|
|Papules||8 (2)||3 ( < 1)|
|Irritation||6 (1)||1 ( < 1)|
|Dermatitis||5 (1)||2 ( < 1)|
|Pruritus||5 (1)||3 ( < 1)|
|* Number and percent of subjects with injection-site reactions|
Adverse reactions occurring in fewer than 1% of trial subjects were acne, facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, post-procedural discomfort (headache, toothache, and jaw pain), herpes labialis, hyperpigmentation at the injection site, injection-site ischemia, basal cell cancer, and leukocytoclastic vasculitis. In the skin biopsy study (described below), one subject was hospitalized for leukocytoclastic vasculitis, with lesions on his legs and trunk appearing nine days after product administration in his upper arm. These lesions resolved within 35 days after onset.
Skin Biopsy Study
A skin biopsy study was conducted to observe tissue responses and adverse reactions to LAVIV at the histological level. Twenty-nine subjects who had participated in a prior clinical trial of LAVIV, and who had sufficient quantities of autologous fibroblasts remaining, received up to three treatments of LAVIV in their upper arms at five-week intervals. Seven subjects received three treatments; 21 received two treatments; and one received only one treatment. Saline injections and non-treated areas in the contralateral arm were used as controls. The dose of LAVIV used in the skin biopsy study was the same as in the clinical trials (0.1 milliliter per linear centimeter of skin). The subjects and the two independent histopathology evaluators were blinded to treatment at each skin area.
Biopsies were taken from LAVIV- and saline-treated sites at 3 and 6 months after the last injection. Biopsies from untreated sites were taken only at 3 months. Histological evaluation was performed for all 29 subjects. At 3 months, histological examination showed inflammatory cell infiltration in 50% of LAVIV-treated sites as compared with 7% of placebo-treated or untreated sites. At 6 months, inflammatory cell infiltration was seen in 27% of the LAVIV-treated sites compared with 12% of placebo-treated sites. In all 29 subjects, there was no histological evidence of abnormal fibroblasts, significant scar formation, or abnormal organization of the extracellular matrix. There were no observed differences in epidermal/dermal thickness or cellularity between LAVIV-injected and placebo-injected skin samples.
Read the entire FDA prescribing information for Laviv (Autologous Cellular Product for Intradermal Injection)