Laviv

Laviv is an autologous cellular product that is used to improve the appearance of nasolabial fold wrinkles.

This medicine is only recommended for those who have completed a Fibrocell-approved training program.

This product is available in suspension.

Before using Laviv, you must know all about the risks and complications associated with it.

Tell to your doctor if you are allergic to Azficel-T or to any other medications. You should also inform your healthcare providers if you are allergic to foods, dyes, or animals.

Safety and effectiveness of this medicine have not been established in children and elderlies.

Pregnancy category C – The use of Azficel-T during pregnancy is warranted only if benefits justify risks to the fetus and only when no alternative management is appropriate.

There are no adequate studies whether Azficel-T can pass through breast milk or if it could cause harmful effects to the infant. Discuss with your doctor if you are breastfeeding a baby.

Tell your doctor if you are taking any other medication as drug interaction may occur when two or more drugs are being taken at the same time.

Some medical conditions can interact with this medication.

Tell your doctor if you have any of the following conditions:

• Achondroplasia
• Ataxia-telangiectasia
• Ehlers-Danlos syndrome
• Epidermolysisbullosa
• Hypertrophic scarring
• Keloid formation
• Marfan syndrome
• Osteogenesisimperfecta
• Allergy to certain antibiotics (e.g., gentamicin, amphotericin), dimethyl sulfoxide (DMSO), or any products of cattle (bovine) origin
• Weakened immune system
• Bleeding problems
• Herpes labialis
• Leukocytoclasticvasculitis
• Skin infections of the face—Should not be used in patients with these conditions.
• Skin cancer, history of—Use of Laviv® is not recommended in patients with these conditions.

To use Laviv properly, you must follow all instructions given by your doctor.

Azficel-T is injected through your nasolabial fold wrinkles by a nurse or other trained health care professionals in a hospital or clinic. This medicine is usually given in 3 doses with 3 to 6 weeks interval each.

Skin biopsies will be taken by your doctor behind your ears. Those skin samples will be then sent to the manufacture for culture and processing. Certain cells are grown from these samples for approximately 3 to 6 months. Thereafter, the processed cells are shipped back by the manufacturer to your doctor. Your doctor will check to see if the cells that come back from the manufacturer are yours. Afterwards, your doctor will administer your medicine into the nasolabial fold wrinkles.

After the injection, you should not rub, massage or compress the area for at least 72 hours. Apply a cold pack for 2-3 minutes. Do not place ice directly against the skin. Do not apply any cosmetic products to the treatment area for 72 hours. Discard the leftover medication and injection materials as biohazardous waste. Counsel the patient on care of the injection site.

It is very important that you receive all the dose of this medicine. If you miss a dose, your Laviv® cells will expire and must be discarded. Your doctor will work with you to schedule a new treatment session.

Before using Laviv, there are some precautions you must take.

Your doctor will be checking you regularly for the effectiveness of the medication. Blood tests may be ordered as well for undesirable effects.

This medication is made especially for you from your own skin cells. Using someone else’s skin cells may cause a serious reaction. Do not let anyone use your medicine.

Check with your doctor if you have developed any signs of allergic reaction.

Check with your doctor if you have large, flat, blue, or purplish patches in the skin; or unusual bleeding or bruising after receiving Laviv®. This medicine may increase your risk of bleeding or bruising at the injection site.

Tell your doctor if you are taking or if you are planning to take any other medications.

As with many medications, there are several potential side effects associated with Laviv.

If any of the following side effects occur, check with your doctor right away:

• Bruising, swelling, or pain at the injection site
• Redness of the skin at the injection site
• Blistering, crusting, irritation, or itching at the injection site
• 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

Less serious side effects:

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

Not all side effects are listed above. If you notice any other effects, check with your healthcare professional.