Dosing & Uses
Dosage Forms & Strengths
injectable suspension
- ~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
Not indicated
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (43)
- abciximab
azficel-T, abciximab. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- alteplase
azficel-T, alteplase. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- anagrelide
azficel-T, anagrelide. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- antithrombin III
azficel-T, antithrombin III. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- argatroban
azficel-T, argatroban. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- aspirin
azficel-T, aspirin. Other (see comment). Use Caution/Monitor. Comment: Patients taking aspirin may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of aspirin is not recommended. .
- aspirin/citric acid/sodium bicarbonate
azficel-T, aspirin/citric acid/sodium bicarbonate. Other (see comment). Use Caution/Monitor. Comment: Patients taking aspirin may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of aspirin is not recommended. .
- bivalirudin
azficel-T, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- celecoxib
azficel-T, celecoxib. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- cilostazol
azficel-T, cilostazol. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- clopidogrel
azficel-T, clopidogrel. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- dabigatran
azficel-T, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- dalteparin
azficel-T, dalteparin. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- desirudin
azficel-T, desirudin. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- diclofenac
azficel-T, diclofenac. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- dipyridamole
azficel-T, dipyridamole. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- enoxaparin
azficel-T, enoxaparin. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- eptifibatide
azficel-T, eptifibatide. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- etodolac
azficel-T, etodolac. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- fenoprofen
azficel-T, fenoprofen. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- flurbiprofen
azficel-T, flurbiprofen. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- fondaparinux
azficel-T, fondaparinux. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- heparin
azficel-T, heparin. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- ibuprofen
azficel-T, ibuprofen. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- ibuprofen IV
azficel-T, ibuprofen IV. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- indomethacin
azficel-T, indomethacin. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- ketoprofen
azficel-T, ketoprofen. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- ketorolac
azficel-T, ketorolac. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- meclofenamate
azficel-T, meclofenamate. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- mefenamic acid
azficel-T, mefenamic acid. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- meloxicam
azficel-T, meloxicam. Other (see comment). Use Caution/Monitor. Comment: Patients taking anticoagulants may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of anticoagulants is not recommended. Decisions regarding continued use or cessation of anticoagulants should be made by a physician.
- nabumetone
azficel-T, nabumetone. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- oxaprozin
azficel-T, oxaprozin. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- piroxicam
azficel-T, piroxicam. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- prasugrel
azficel-T, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- protein C concentrate
azficel-T, protein C concentrate. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- reteplase
azficel-T, reteplase. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- rivaroxaban
azficel-T, rivaroxaban. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- sulindac
azficel-T, sulindac. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
- tenecteplase
azficel-T, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- ticlopidine
azficel-T, ticlopidine. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- tirofiban
azficel-T, tirofiban. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.
- tolmetin
azficel-T, tolmetin. Other (see comment). Use Caution/Monitor. Comment: Patients taking NSAIDS may experience increased bruising or bleeding at biopsy and/or injection sites. Concomitant use of NSAIDs is not recommended.
Minor (0)
Adverse Effects
1-10%
Injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus
<1%
Acne
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
Herpes labialis
Basal cell carcinoma
Injection-site ischemia
Leukocytoclastic vasculitis
Warnings
Contraindications
Allogeneic use
Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin
Active infection in the facial area
Cautions
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
Pregnancy Categories
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.Pharmacology
Mechanism of Action
Unknown
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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