azficel-T

azficel-T

(az-fi-sell tee) ,

LaViv

(trade name)

Classification

Therapeutic: cosmetic agents
Pharmacologic: temporary class
Pregnancy Category: C

Indications

To improve the appearance of moderate to severe wrinkles in the nasolabial fold.

Action

Cells are obtained from patient's post-auricular skin. These dernmal fibroblasts are then prepared and injected into nasolabial folds.

Therapeutic effects

Decreased nasolabial fold wrinkles.

Pharmacokinetics

Absorption: Unknown.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (improvement in appearance)

ROUTEONSETPEAKDURATION
Intradermal4–5 mounknownunknown

Contraindications/Precautions

Contraindicated in: Previous hypersensitivity to azficel-T; Hypersensitivity to amphotericin, dimethyl sulfoxide (DMSO), gentamicin or materials of bovine origin; Known history of keloid or excessive scar formation; Acute local skin infection ( may cause spread).
Use Cautiously in: Genetic disorders affecting dermal fibroblasts or formation of normal collagen matrices (abnormal responses may occur);Concurrent immunosuppressants, radiation, chemotherapy or immunomodulatory therapy (↑ risk of infection with ↓ healing);Concurrent use of anticoagulants (↑ risk of bleeding); Obstetric: Use in pregnancy only if clearly needed; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Local

  • erythema (most frequent)
  • bruising (most frequent)
  • edema (most frequent)
  • bleeding
  • dermatitis
  • irritation
  • nodules
  • papules
  • pruritus
  • redness
  • keloid/hypertrophic scarring

Miscellaneous

  • hypersensitivity reactions including analphyaxis (life-threatening)
  • basal cell cancer
  • herpes labialis
  • vasculitis

Interactions

Drug-Drug interaction

Concurrent use of antineoplastices, immunosuppressants and immunomodulators ↑ risk of infection and poor healing.Concurrent use of anticoagulants ↑ risk of bleeding.

Route/Dosage

Intradermal (Adults) 0.1 mL/linear centimeter into nasolabial fold wrinkles. Course is three treatment sessions (up to 2 mL/session) at 3–6 wk intervals.

Availability

Suspension for autologous intradermal injection: 18 million autologous fibroblasts/1.2 mL sufficient to deliver 1 mL of product

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of allergic reactions (difficulty breathing, trouble swallowing, rash, hives, severe redness, swelling) during and following injections. Stop injections and treat symptomatically.

Potential Nursing Diagnoses

Disturbed body image (Indications)

Implementation

  • Only health care professional completing a Fibrocell-approved training program should administer azficel-T.
  • Intradermal: Azficel-T is made when 3 small skin biopsies are taken from behind patient ears and sent to manufacturer. Certain cells, called fibroblasts, are grown from samples taking 3–6 mo. Once grown and returned, health care professional matches patient to azficel-T vial to patient unique identifier and cells are injected into nasolabial fold in 3 sessions, 3–6 mo apart.
  • Allow vial to reach room temperature 15–30 min. Gently invert to re-suspend; tap vial to release fluid retained in top. Do not dilute. Prepare 4 sterile 0.5 mL syringes with 21-gauge needles; replace with 30-gauge needle for injections.
    • Make sure injection areas are free from hair, cosmetics, or facial jewelry.
    • Evaluate need for topical anesthesia; do not use injectable local anesthetics.
    • After injection, leave treated area undisturbed. Do not rub, massage or compress area. Apply a cold pack for 2–3 minutes. Do not place ice directly against skin.

Patient/Family Teaching

  • Explain purpose and procedure for azficel-T. Inform patient of importance of treatment schedule. If a treatment session is missed, cells will expire and must be thrown out, so new treatment sessions must be scheduled. Also, there is a chance that skin samples will not make enough cells to use. If this occurs, new biopsies may need to be taken.
  • Advise patient on post-treatment care. Do not apply ice to face; cold compress may be applied for 2–3 minutes at a time, if needed to ease swelling or discomfort. For at least 24 hours, do not wash site of injections. Do not scrub, rub or manipulate treatment area for at least 72 hours. Do not apply any products (make-up, facial creams, sunscreen) to treatment area for 72 hr.
  • Inform patient of what to expect post-procedure. Expect mild to moderate redness, swelling, puffiness, or bruising following injections. Advise patient to call doctor or emergency department for any persistent or unexpected side effects.
  • Instruct patient to notify health care provider if fever over 100°F, redness, warmth, or pain at injection or biopsy sites lasts more than 3 days.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.

Evaluation/Desired Outcomes

  • Decreased nasolabial fold wrinkles. Effects are not immediate, but may appear over course of the three-treatment regimen.
References in periodicals archive ?
"In June, we expect to report primary endpoint results from our Phase II clinical trial of azficel-T for the treatment of vocal cord scarring and also initiate a Phase I clinical trial of FCX-007, our orphan gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa."
This RDEB programme will integrate Fibrocell's Azficel-T Autologous Fibroblast technology with Intrexon's UltraVector technology, representing the first of several drug development programmes from the collaboration to create genetically-modified personalized biologics for rare skin and connective tissue diseases.
Fibrocell's technology led to the FDA-approved cell based autologous fibroblast product, azficel-T (T.AVTV).
The company's LAVIV (azficel-T) is the first and only Food and Drug Administration (FDA)-approved personalised cell therapy for aesthetic use.
Net proceeds from the planned offering are expected to be used by the company to fund Phase III clinical trials for additional azficel-T indications, to progress its collaboration programmes with Intrexon Corporation, working capital and general corporate and administrative expenses.
Initially, this patented, proprietary technology was applied for use via the company's first product on the market, LAVIV(TM) (azficel-T).
4 November 2011 - US cell therapy company Fibrocell Science Inc (OTCBB:FCSC) on Thursday announced encouraging study results for LAVIV (azficel-T) in the treatment of moderate to severe depressed acne scars.
4 October 2011 - US cell therapy firm Fibrocell Science Inc (OTCBB:FCSC.OB) said on Monday its mouth-wrinkle smoothing product Laviv (azficel-T) is being sold in major urban territories across the USA.
Fibrocell Science's lead therapy, azficel-T, is an investigational autologous (personalized) cell therapy.
Cell therapy company Fibrocell Science Inc (OTCBB:FCSC.OB.ob) said on Monday that it has introduced LAVIV (azficel-T) in major metropolitan areas throughout the US.
23 December 2009 - US-based biotechnology company Fibrocell Science Inc (OTC: FCSC) announced Monday it has received a Complete Response letter from the US Food and Drug Administration (FDA) related to the Biologics License Application (BLA) for azficel-T.
Cell therapy company Fibrocell Science Inc (OTCBB:FCSC.OB.ob) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for its Biologics License Application for its lead product, laViv (azficel-T).