azficel-T

Action and Spectrum

Actions and Spectrum:

azficel-T is a sterile, non-pyrogenic, off-white, lyophilized powder containing a purified population of autologous fibroblast cells. It is used in the treatment of moderate to severe nasolabial fold wrinkles in adults.

azficel-T works by injecting fibroblast cells into the skin, they stimulate the production of collagen and other extracellular matrix components, resulting in the improvement of skin elasticity and appearance. Fibroblast cells are responsible for producing elastin, collagen and other extracellular matrix components, which are essential for maintaining the structural integrity of the skin.

The spectrum of azficel-T is limited to the treatment of moderate to severe nasolabial folds. It is not intended for use in other areas of the face or body, nor is it intended for the treatment of other skin conditions.

Drug Interaction

Adverse Reaction

Frequency defined

1-10%

Injection-site redness

Swelling

Bruising

Pain

Edema

Hemorrhage

Nodules

Irritation

Papules

Pruritus

dermatitis

<1%

Injection-site ischemia

Facial or eyelid edema

Leukocytoclastic vasculitis

Hypersensitivity or decreased skin sensation at the injection site

Herpes labialis

Acne

Hyperpigmentation at the injection site

Basal cell carcinoma

Post-procedural discomfort (toothache, headache and jaw pain)

Black Box Warning

Black Box Warning:

azficel-T does have a black box warning associated with its use. The warning states that the product should only be administered by a healthcare physician who has received training in the use of azficel-T. Additionally, the warning highlights the potential risks associated with the use of azficel-T, including the risk of infection, allergic reactions, and the formation of granulomas (small lumps of inflamed tissue).

The warning also advises that patients should be monitored for any signs of infection or adverse reactions, and that appropriate medical treatment should be administered promptly if necessary. Patients who have a history of autoimmune disease or who are immunosuppressed may be at increased risk for adverse reactions and should be closely monitored.

Contraindication / Caution

Contraindication/Caution:

Contraindication

• Hypersensitivity: azficel-T is contraindicated in patients who have a known hypersensitivity to any of its components.
• Active Infections: azficel-T should not be used in patients with active infections, including local or systemic infections, until the infection has resolved.
• Bleeding disorders: azficel-T should be used with caution in patients with bleeding disorders, as the injection process may cause bleeding at the injection site.
• Immunodeficiency: azficel-T should not be used in patients with an active autoimmune disease or who are immunodeficient, as they may be at an increased risk of developing infections or other adverse reactions.
• Pregnancy and lactation: azficel-T should not be used during pregnancy or lactation, as the safety of the product has not been established in these populations.

Caution

• Age: azficel-T is intended for use in adults aged 22 and older. In pediatric populations, safety and effectiveness have not been established.
• Injection site reactions: Injection site reactions such as swelling, redness and bruising may occur after treatment with azficel-T. Patients should be informed of these potential side effects and advised on how to manage them.
• Granulomas: azficel-T may cause the formation of small lumps of inflamed tissue called granulomas. These may appear at or around the injection site and can be either temporary or long-lasting. Patients are need to be monitored for the development of granulomas after treatment with azficel-T.
• Use in conjunction with other cosmetic treatments: The safety and effectiveness of azficel-T when used in conjunction with other cosmetic treatments have not been established. Therefore, caution should be exercised when using azficel-T in combination with other cosmetic treatments.

Interaction with other medications: There is no information available on the interaction of azficel-T with other medications. Patients should inform their healthcare professional of all drugs they are currently taking before undergoing treatment with azficel-T.

Pregnancy / Lactation

Pregnancy consideration:

US FDA pregnancy category: C

Lactation:  

Excreted into human milk is Not known.

Pregnancy category:

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/later trimester.      
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
• Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:

azficel-T is an autologous cellular product that is made up of fibroblast cells obtained from a small skin biopsy taken from behind the patient’s ear. Fibroblast cells are responsible for producing collagen and other extracellular matrix proteins that provide support and structure to the skin.

When injected into the treatment area, azficel-T stimulates production of the collagen and other extracellular matrix proteins, which helps to improve the appearance of wrinkles. Collagen is a major component of the skin’s connective tissue, and its production decreases with age, leading to the formation of sagging and wrinkles skin.

azficel-T is thought to work by increasing the number of fibroblast cells in the treatment area, which in turn increases the production of collagen and other extracellular matrix proteins. This leads to improved skin texture, increased elasticity, and a decreased appearance of wrinkles.

Pharmacodynamics:

The mechanism of action of this substance is currently unknown. However, it is known that cultured fibroblast cells obtained autologously are confirmed to contain collagen and are suspended to form an injectable biological dermal filler. After injection, these fibroblasts are believed to synthesize new extracellular matrix and/or stimulate the remodeling of existing tissue components. This process may alter the structure, texture, and appearance of the skin at the injection site.

Pharmacokinetics:

Absorption

azficel-T is an autologous cellular product that is not intended to be systemically absorbed, and therefore, its pharmacokinetics have not been studied extensively.

Distribution

After a small skin biopsy is taken from behind the patient’s ear, the fibroblast cells are isolated and cultured in the laboratory to produce a suspension of autologous fibroblast cells. This suspension is then reconstituted with sterile water for injection and administered by injection into the treatment area.

Instead, the product acts locally in the treatment area, where the injected fibroblast cells stimulate the production of collagen and other extracellular matrix proteins.

Metabolism

It is composed of living fibroblast cells, which are not expected to be metabolized in the traditional sense. The cells are expected to integrate with the recipient’s skin cells and function as they would naturally.

Elimination and excretion

It is not expected to be eliminated from the body as a whole, as the fibroblast cells are intended to remain in the skin and promote collagen production over time. Any breakdown or degradation of the fibroblast cells would be expected to occur locally in the skin, rather than systemically.

Adminstartion

Administration:

Intradermal administration

azficel-T is a sterile, non-pyrogenic, lyophilized powder for injection, and it must be administered by a licensed healthcare professional who has received training in the use of azficel-T. The administration process typically involves the following steps:

• Pre-treatment evaluation: The healthcare professional will evaluate the patient’s prior medical history, perform a physical examination, and assess the patient’s suitability for treatment with azficel-T.
• Preparation of the injection site: The healthcare professional will clean and disinfect the injection site.
• Reconstitution of azficel-T: The lyophilized powder is reconstituted with sterile water for injection to create a suspension of autologous fibroblast cells.
• Injection of azficel-T: The healthcare professional will use a sterile needle to inject azficel-T into the treatment area. The number and location of injections will depend on the extent of the wrinkles being treated.

Post-treatment evaluation: The healthcare professional will evaluate the patient’s response to treatment and provide instructions for post-treatment care, such as avoiding excessive sun exposure, refraining from vigorous exercise, and avoiding the use of certain medications.

Patient Information Leaflet

Patient information leaflet

Generic Name:  azficel-T

Pronounced: [az-FYE-sel – tee]

Why do we use azficel-T?

azficel-T is an autologous cellular product that is used for the correction of moderate to severe nasolabial fold wrinkles in adults aged 22 and older. Nasolabial folds are the lines that run from the corners of the nose to the corners of the mouth, and they become more prominent with age due to the loss of volume and elasticity in the skin.

azficel-T is intended for use in patients who have previously undergone facial dermal filler treatment and who have achieved an optimal correction. It is designed to be used as a maintenance therapy to help prolong the effects of the initial treatment.

The product contains autologous fibroblast cells that are obtained from a small skin biopsy taken from behind the patient’s ear. These cells are then cultured, expanded in the laboratory before being injected into the treatment area to stimulate collagen production and improvement in the appearance of wrinkles.

It is important to note that azficel-T is not a permanent solution for wrinkles and that its effects are temporary. Patients should discuss the expected duration of treatment and potential risks and benefits with their healthcare provider before undergoing treatment with azficel-T.