azficel-T (Rx)Brand and Other Names:laViv

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable suspension

  • ~18 million autologous fibroblasts/1.2mL
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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

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Interactions

Interaction Checker

azficel-T and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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

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            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.

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            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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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            6 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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