azficel-T (Rx)

Brand and Other Names:laViv
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and azficel-T

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (44)

                • 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.

                • warfarin

                  azficel-T, warfarin. 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.

                Minor (0)

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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

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.