Dosing & Uses
Dosage Forms & Strengths
- ~18 million autologous fibroblasts/1.2mL
Nasolabial Fold Wrinkles
Autologous aesthetic cell therapy indicated to improve the appearance of moderate to severe nasolabial fold wrinkles in adults
Manufacturing process for takes approximately 11-22 weeks after receipt of the patient’s biopsy samples by the manufacturer
Recommended regimen consists of a series of 3 intradermal injection sessions administered 3-6 weeks apart
Inject 0.1 mL ID per linear centimeter into the nasolabial fold wrinkles
Storage & handling
- Employ universal precautions when handling; not routinely tested for adventitious viruses
- Do not freeze, sterilize, or incubate; this may result in inactivity of the product
- Protect from exposure to sunlight
- Store refrigerated each vial on its side at 2-8°C (36-46°F) to minimize viscosity
- Remove vials from refrigerator 15-30 minutes before administration to allow product to reach room temperature
- Do not administer beyond expiration date
Serious - Use Alternative
Significant - Monitor Closely
Injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus
Facial or eyelid edema
Hypersensitivity or decreased skin sensation at the injection site
Post-procedural discomfort (headache, toothache, and jaw pain)
Hyperpigmentation at the injection site
Basal cell carcinoma
Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin
Active infection in the facial area
For autologous intradermal injection only
Intradermal administration only by healthcare providers who have completed a Fibrocell-approved training program
May cause bleeding and bruising at treatment site; patients taking aspirin, NSAIDS, or anticoagulants, as well as patients with coagulopathies, have a greater risk of severe bleeding or bruising
Although no drug interaction studies have been performed, concomitant use of aspirin, NSAIDs, or anticoagulants is not recommended; decisions regarding continued use or cessation of anticoagulants should be made in consultation with the health care provider
Vasculitis, Herpes labialis, and basal cell carcinoma have been observed treatment
Keloid and hypertrophic scarring may occur following postauricular skin biopsies or injections
Patients with genetic disorders affecting dermal fibroblasts or formation of normal collagen matrices may have an abnormal response
Immunosuppressed patients, or those who undergo chemotherapy for malignancies or receive immunomodulatory therapies for autoimmune diseases, may have an increased susceptibility to infection and difficulty healing
Chemotherapeutic drugs may interfere with the function of azficel-T; patients with malignancies requiring ongoing therapy should not use
Sterility tests are not completed when azficel-T is shipped to the clinic
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Unknown whether distributed in breast milk
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Cultured fibroblast cells obtained autologously are confirmed to contain collagen and suspended to form injectable biological as dermal filler
Following injection, the cultured fibroblasts are thought to synthesize new extracellular matrix and/or to stimulate remodeling of existing tissue components, thereby altering the structure, texture and appearance of the skin at injection site
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|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
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|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
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