Laviv (Intradermal)

Azficel-T is used to improve the appearance of wrinkles that are seen from the sides of the nose to the corners of the mouth (called nasolabial folds or "smile lines"). This medicine is made from your own skin cells (autologous cellular product) mixed with water and salts.

This medicine is to be given only by a doctor who has completed a Fibrocell-approved training program.

It is very important that your doctor check your progress at regular visits to make sure that azficel-T is working properly and to check for unwanted effects.

Laviv® is made especially for you from your own skin cells. Do not use someone else's skin cells because it may cause a serious reaction. Do not let anyone use your medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may increase your risk of bleeding or bruising at the injection site. Check with your doctor right away if you have large, flat, blue, or purplish patches on the skin; or unusual bleeding or bruising after receiving Laviv®. Make sure your doctor knows if you are taking aspirin, pain or arthritis medicine called NSAIDs (such as celecoxib, ibuprofen, naproxen, rofecoxib, valdecoxib, Advil®, Aleve®, Bextra®, Celebrex®, Motrin®, or Vioxx®), or a blood thinner (such as warfarin, Coumadin®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the potential benefits it may provide. For this medicine, please keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies conducted on how azficel-T affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

While appropriate studies on how azficel-T affects older adults have not been conducted, no specific problems related to age have been reported so far.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if there may be an interaction. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence how this medicine works for you. Be sure to tell your doctor about any other medical issues you have, especially:

• Achondroplasia (genetic disorder) or
• Ataxia-telangiectasia (genetic disorder) or
• Ehlers-Danlos syndrome (genetic disorder) or
• Epidermolysis bullosa (genetic disorder) or
• History of hypertrophic scarring or
• History of keloid formation or
• Marfan syndrome (genetic disorder) or
• Osteogenesis imperfecta (genetic disorder) or
• History of skin cancer—The use of Laviv® is not recommended for patients with these conditions.

• Allergy to certain antibiotics (e.g., gentamicin, amphotericin), dimethyl sulfoxide (DMSO), or any products made from cattle (bovine) or
• Skin infections of the face—Should not be used in patients with these conditions.

• Weakened immune system—Use with caution due to a higher risk of infection and healing issues.

• Bleeding problems or
• Herpes labialis (cold sores) or
• Leukocytoclastic vasculitis (blood vessel disorder)—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bruising, swelling, or pain at the injection site
• Redness of the skin at the injection site

Less common

• Blistering, crusting, irritation, or itching at the injection site

Rare

• Darkening of the skin at the injection site
• Decreased skin sensation at the injection site
• Fever
• Painful cold sores or blisters on the lips
• Sores, welting, or blisters
• Swelling or puffiness of the eyelids or face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Blemishes on the skin
• Headache
• Jaw pain
• Pimples
• Toothache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Laviv

A trained doctor will give you this medicine in a hospital or clinic. This medicine is given through a small needle placed into your nasolabial fold wrinkles.

Your doctor will take three small skin samples (called biopsies) from behind your ears and send them to the manufacturer. Certain cells are grown from these samples for 3 to 6 months.

The processed cells (Laviv®) are shipped back by the manufacturer to your doctor. Your doctor will check and confirm if it came from your own skin. Then, your doctor will inject your medicine into the nasolabial fold wrinkles.

This medicine is usually given in 3 doses, spaced 3 to 6 weeks apart.

After treatment with this medicine:

• Apply a cold compress for 2 to 3 minutes at a time if needed to ease swelling or discomfort. Do not apply ice directly to the face.
• Do not wash the injection site for at least 24 hours.
• Do not rub, scrub, or massage the injection site for at least 72 hours.
• Do not apply any cosmetic products (e.g., make-up, facial creams, or sunscreen) to the treatment area for 72 hours.

It is very important that you receive all doses of this medicine. Try to keep all scheduled appointments. If you miss a dose, your medicine will not be usable. Your doctor will work with you to schedule a new appointment for the skin collection or biopsy. You may also get a new appointment for your injection.

This medicine usually comes with a patient information leaflet. Read the information carefully and make sure you understand them before receiving this medicine. If you have any questions, ask your doctor.