Azficel-T

Azficel-T is used as aesthetic cell therapy indicated to improve the appearance of moderate to severe nasolabial fold wrinkles in adults.

Azficel-T is available under the following different brand names: laViv.

Dosages of Azficel-T:

Dosage Forms and Strengths

Injectable Suspension

• Approximately 18 million autologous fibroblasts/1.2mL

Dosage Considerations – Should be Given as Follows:

Nasolabial Fold Wrinkles

• Autologous aesthetic cell therapy indicated to improve the appearance of moderate to severe nasolabial fold wrinkles in adults
• The manufacturing process 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 intradermally (ID) per linear centimeter into the nasolabial fold wrinkles
• Not indicated for use in pediatric patients

Storage and handling

• Employ universal precautions when handling; not routinely tested for adventitious viruses
• Do not freeze, sterilize, or incubate; this may result in the 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 the expiration date

Common side effects of Azficel-T include:

• Injection-site redness, bruising, swelling, pain, hemorrhage, swelling, nodules, papules, irritation, dermatitis, and itching

Less common side effects of azficel-T include:

• Acne
• Facial or eyelid swelling
• 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

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Azficel-T has no listed severe interactions with other drugs.

Azficel-T has no listed serious interactions with other drugs.

Azficel-T has moderate interactions with at least 46 different drugs.

Azficel-T has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains Azficel-T. Do not take laViv if you are allergic to azficel-T or any ingredients contained in this drug.

Contraindications

• Allogeneic use
• Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin
• Active infection in the facial area

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Azficel-T?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Azficel-T?"

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 the 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, nonsteroidal anti-inflammatory drugs (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

Pregnancy and Lactation

Use Azficel-T with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

It is unknown whether azficel-T is distributed in breast milk. Consult your doctor before breastfeeding.