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 ?
a biotechnology company at the forefront of research into the potential medical and aesthetic use of fibroblasts, plans to initiate a Phase II clinical trial to assess the potential of azficel-T for treating restrictive burn scars in first quarter, 2013.
Forward-looking statements include, without limitation, the Company's ability to initiate a Phase II clinical trial to assess the potential of azficel-T for treating restrictive burn scars in the first quarter of 2013.
Fibrocell's technology led to the FDA-approved cell based autologous fibroblast product, azficel-T (LAVIV).
Based on its proprietary autologous fibroblast technology, Fibrocell is pursuing breakthrough medical applications of azficel-T for restrictive burn scarring and vocal cord scarring.
OTC Bulletin Board: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted a clinical study report for its Phase II/III study of azficel-T for the treatment of moderate to severe acne scars to the U.
An autologous cell therapy, azficel-T is currently under review by the U.
The study has a target enrollment of approximately 20 participants from the completed and statistically significant pivotal Phase III studies of azficel-T (IT-R-005 and IT-R-006).
The letter also requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling.
Food & Drug Administration (FDA) the company's Phase II clinical study protocol to evaluate the safety and efficacy of Fibrocell's lead therapy, azficel-T, in improving the range of motion, function and flexibility, in patients with existing restrictive burn scars.
Jun 22, 2011: Fibrocell Receives FDA Approval For Azficel-T
Food & Drug Administration (FDA) for a completed, six-month histological study examining skin after injections of azficel-T.
Forward-looking statements include, without limitation, the future approval of azficel-T and the Company ability to conduct studies on applying its autologous fibroblast technology in additional areas, including further aesthetic applications, and for the treatment of restrictive burn scars, acne scars, and periodontal disease.