Azficel-T

Azficel-T
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Azficel-T is a autologous cellular product that is FDA approved for the treatment of improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. Common adverse reactions include injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

LAVIVTM is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established.

The efficacy of LAVIV beyond six months has not been established.

Dosage

For autologous intradermal injection only

Only healthcare providers who have completed a Fibrocell-approved training program should administer LAVIV.

2.1 Dosage Inject LAVIV at 0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions, administering up to 2 milliliters (2 vials) of LAVIV per session, at 3-6 week intervals.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Azficel-T in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Azficel-T in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Azficel-T in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Azficel-T in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Azficel-T in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Azficel-T in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Azficel-T in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Azficel-T in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Azficel-T during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Azficel-T with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Azficel-T with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Azficel-T with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Azficel-T with respect to specific gender populations.

Race

There is no FDA guidance on the use of Azficel-T with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Azficel-T in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Azficel-T in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Azficel-T in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Azficel-T in patients who are immunocompromised.

Administration and Monitoring

Administration

Preparation Confirm that the unique patient identifier on the LAVIV vial matches the identity of the patient who will receive the LAVIV injections. Allow the LAVIV vial(s) to reach room temperature before use. Examine vial(s) for leaks and for any evidence of damage or contamination. Gently invert each vial to re-suspend the product within the media. Tap the top of the vial to release any fluid retained in the top of the vial prior to opening the vial. DO NOT DILUTE THE PRODUCT. Before the injection, prepare a minimum of four sterile syringes and needles. Small unit syringes (e.g., 0.5 milliliter insulin syringes) are recommended for better injection control. A detachable larger bore needle (e.g., 21-gauge) should be used to withdraw product from the vials to minimize cell damage. Using aseptic technique, unscrew the vial cap and withdraw up to 0.5 milliliters from the vial into each syringe, noting the total volume. After a 21-gauge needle is used to withdraw LAVIV from the vial, the needle should be replaced with a 30-gauge needle prior to injection. Short, sharp needles (e.g., 30-gauge, half-inch needles) are recommended for better injection control and minimization of inflammation. 2.3 Administration Identify the areas to be injected and make sure the injection areas are free of cosmetics, hair or facial jewelry. Evaluate the need for topical anesthesia. If a topical anesthetic is administered, remove any topical anesthetic from the face prior to injection of LAVIV. DO NOT USE injectable local anesthetics. Clean the treatment area with an aseptic solution prior to injection. Place the patient in a comfortable position (e.g., recumbent) to facilitate proper injection angle. Inject LAVIV into the superficial papillary dermis at 0.1 milliliter per linear centimeter, using a 30-gauge needle. When the needle is inserted into the correct plane of the skin (i.e., along the line of each nasolabial fold wrinkle), the needle should be visible through the epidermis. Confirm intradermal injection by the appearance of blanching and a fluid bleb at the injection site. Avoid injecting LAVIV into the blood vessels, subcutaneously, or intramuscularly. Apply multiple injections as needed to cover the entire nasolabial fold wrinkle. Overlap injection areas slightly; otherwise, the last few millimeters of each injection site may receive no product. To prevent exudation of LAVIV from the injection site, make sure that the end of the needle is inserted slightly adjacent to the tract of the previous injection. After the injection, leave the treated area undisturbed. Do not rub, massage or compress the area. Apply a cold pack for 2-3 minutes. Do not place ice directly against the skin. Discard leftover LAVIV and injection materials as biohazardous waste. Counsel the patient on care of the injection site.

Monitoring

There is limited information regarding Monitoring of Azficel-T in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Azficel-T in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Azficel-T in the drug label.

Pharmacology

There is limited information regarding Azficel-T Pharmacology in the drug label.

Mechanism of Action

Structure

File:Azficel-T01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Azficel-T in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Azficel-T in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Azficel-T in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Azficel-T in the drug label.

How Supplied

Storage

There is limited information regarding Azficel-T Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Azficel-T in the drug label.

Precautions with Alcohol

• Alcohol-Azficel-T interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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