Azficel-T (Intradermal)

As an autologous cellular product, Azficel-T is approved by the FDA to treat moderate-severe nasio-labial fold wrinkles in adults.

Overview

Azficel-T is injected intradermally in order to improve the appearance of wrinkles which are seen from the corners of the mouth to the sides of the nose, often referred to as 'œsmile lines'. The product is typically manufactured from the patient's own skin cells and placed in a mixture of salts and water, which is then reapplied to the face.

Although it can potentially be used 'œoff-label' to treat other conditions, the efficacy and safety of Azficel-T use elsewhere on the body has not yet been established, and it should therefore only be used as directed by a physician.

Azficel-T is generally used as a short-term treatment, and the efficacy of it in fighting the signs of ageing in the nasio-labial folds in a period exceeding six months is currently unknown.

Conditions treated:

  • Nasiolabial wrinkles

Type of medicine:

  • Autologous cellular product

Side effects:

Along with its desired effects, this medication may also cause some unwanted side effects. Not all of these side effects may occur, and not all of them will require medical attention if they do, although it is important to check with a doctor in the event of side effects becoming uncomfortable or unbearable. The most common side effects associated with the use of Azficel-T include the following: bruising, swelling and pain at the site of injection, redness at the site of injection, blistering or itching at the site of injection, darkening of the skin at the site of injection, swelling or puffing of the eyelids or face, fever and/or cold sores on the lips.

As the patient continues to undergo treatment with the medicine as directed by a physician, many (if not all) of these symptoms should subside. If they continue to persist or get worse over time, the patient is advised to consult their doctor immediately.

Most patients will only experience minimal side effects during treatment with Azficel-T. However, other side effects have been reported rarely, albeit regularly enough to mention. These include: skin blemishes, pain in the jaw, pimples, headaches and/or toothaches. Patients who experience these side effects and find them to be particularly bothersome should contact their healthcare provider who may be able to answer any questions or advise on how to alleviate symptoms.

In rare instances, patients may experience side effects which are unlisted. Because Azficel-T is a relatively new medicine, some side effects may, as of yet, be undetected. Patients who experienced side effects which are not yet listed are advised to contact the FDA with as much information as possible regarding their experiences with the medication.

Dosage:

As with all medicines, it is important that patients only use Azficel-T as directed by a skincare expert or qualified doctor. This means that patients should avoid injecting any more of the medication than advised, and to stick to the frequency of treatment laid out by their healthcare professional. In addition to this, patients should cease using Azficel-T if and when advised to do so by their doctor, even if they have a supply of the medicine remaining.

Azficel-T should only be administered by healthcare providers who have successfully completed a Fibrocell-approved training program. It should not be self-administered by the patient unless they possess the revelant qualifications, and should only be administered in a clinical setting.

The medication should be injected at 0.1mm per linear centimetre, directly into the wrinkle folds in the nasolabial area. The recommended regimen of treatment is currently three treatments, administering up to 2ml of Azficel-T per session, at intervals of three to six weeks.

A single vial of Azficel-T contains somewhere in the region of 18 million autologous fibroblasts in a 1.2ml suspension, which is sufficient enough to administer 1ml of product in the patient.

When preparing the injection, healthcare providers should confirm a unique patient identifier on the vial of the drug matches the identity of the patient set to receive the injection. The vial should be allowed to reach room temperature before use and should be examined for evidence of contamination, leaks or damage. The vial should then be gently inverted to resuspend the product and tapped to release and fluid retained at the top of the vial before opening.

The patient's healthcare provider should prepare a minimum of four sterile syringes, preferably small unit (0.5mg or less) ones in order to gain greater injection control. Areas of the face which are due to be injected should be inspected to ensure that they are free of hair, cosmetics, facial jewelry or any other potential contaminants.

Some patients may require a topical anesthetic either before or after a dose of Azficel-T is administered. If anesthetic is applied prior to treatment, the healthcare professional should ensure any remnants are removed from the face prior to injection.

Interactions:

Many drugs interact with other medicines and chemicals in the body, and these interactions can potentially cause one or more of the medicines involved to be rendered ineffective. In some instances, interactions can cause potentially harmful side effects. For these reasons, it is important that patients keep a detailed list of every drug they are currently taking. This extends beyond prescription medicines to include over the counter medications, herbal supplements and vitamins.

The following medications are thought to cause increased bruising at biopsy and/or injection sites of patients being treated with Azficel-T:

  • Aspirin
  • Non-Steroidal Anti-Inflammatory Drugs
  • Anticoagulants

Continued use of any of these medicines is not recommended in conjunction with Azficel-T treatment. Patients undergoing treatment with any of these drugs are advised to discuss the use of Azficel-T with a qualified healthcare practitioner as they are at increased risk of moderate to severe bleeding on top of bruising or redness.

Azficel-T should only be administered to the patient whose skin has been used to produce the medicine, as severe immunological reactions can occur otherwise. Each vial has a unique patient identifier to prevent this from occurring.

Warnings:

In addition to advising their doctor of any medications currently being taken, patients are also advised to discuss their medical history, including any allergies.

The use of Azficel-T requires multiple injections into the nasiolabial folds, and three post-auricular skin biopsies. These procedures can have a tendency to cause trauma to the skin, and over time may lead to keloid scar formation in individuals who are particularly susceptible. Although neither keloid nor hypertrophic scar formation was observed during clinical trials, it is worth noting that the study group included just four subjects of African-American origin, and Fitzpatrick skin types were not represented at all. Each of these groups may be more susceptible to scarring. Patients with a history of keloids and/or hypertrophic scarring are advised to consult with their doctor prior to undergoing treatment with Azficel-T.

It is possible for hypersensitivity reactions, such as anaphylaxis, to occur during treatment with Azficel-T. With this in mind, patients should be assured that healthcare professionals are required to keep treatments for anaphylactic shock (epi-pen) nearby for immediate administration in such instances.

Patients with genetic disorders that the formation of collagen matrices, dermal fibroblasts or other skin components could potentially experience an abnormal response to Azficel-T. This medicine is therefore not recommended for patients with conditions such as achondroplasia, Ehlers-Danlos syndrome, osteogenesis imperfecta, Marfan syndrome, ataxia-telangiectasia or epidermolysis bullosa.

In very rare cases, Basal cell cancer is known to have occurred followed treatment with Azficel-T. Patients with a history of skin cancers should discuss with their doctor as to whether treatment with this medicine is appropriate, and whether the benefits outweigh the risks.

Autoimmune disease sufferers could be more prone to infection and may have greater difficulty healing following the use of Azficel-T. As this product is an autologous cell product, its safety and efficacy in patients with autoimmune disorders is not guaranteed. Immunosuppressed patients, such as those currently undergoing chemotherapy, could potentially have an increased susceptibility to infection and subsequently find it more difficult recovering from treatment with Azficel-T.

Patients with infectious diseases have not been studied with regard to Azficel-T use, and the generation of autologous cell products from those with infections is therefore not recommended. Patients who wish to undergo costmetic treatment whilst suffering from an infectious condition should discuss the risks and benefits with a qualified healthcare professional.

In some instances, cases of leukocytoclastic vasculitis and herpes labialis have been known to occur following treatment with Azficel-T.

No information is currently available regarding the clinical use of Azficel-T by patients who are currently breastfeeding. However, as the medicine is a cellular material manufactured from the patient's own cells, it is not expected to cause any unwanted or adverse effects in nursing infants.

Storage:

Azficel-T should be protected from exposure to direct sunlight, and kept refrigerated (at a temperature between 2C-8C) in a dark, dry medical fridge. This medication must not be frozen, sterilized or incubated ' these processes could result in the inactivation of the product.

Vials of Azficel-T should be stored on their side to minimize viscosity, and should be removed from the refrigerator at least 15-30 minutes prior to use to allow them to reach room temperature. Vials should be used prior to the expiration date and time as printed on the product, as should be disposed of by a heathcare professional as a biohazardous material when expired.

Summary:

Azficel-T is an effective cosmetic treatment which is routinely used to reduce the appearance of facial wrinkles. It may also have some allogeneic uses but it is typically used to treat patients who wish to alter the prominence of nasiolabial wrinkles.

The substance is generated from the patient's own skin cells, a process which can take between 11 to 22 weeks. In some instances, the manufacturing process may not yield sufficient enough quantities of fibroblasts from the patient's skin biopsies, therefore rendering the treatment ineffective.

However, the majority of patients report little or no side effects, and are ultimately happy with the results that regular intradermal injections with Azficel-T provide; any side effects (bruising or redness following injection) are deemed to be inconsequential in comparison to the benefits of undergoing treatment with the drug.

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