Description
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) placed in a mixture of water and salts.
This medicine is to be given only by a doctor who has completed a Fibrocell-approved training program.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of azficel-T in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of azficel-T have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Achondroplasia (genetic disorder) or
- Ataxia-telangiectasia (genetic disorder) or
- Ehlers-Danlos syndrome (genetic disorder) or
- Epidermolysis bullosa (genetic disorder) or
- Hypertrophic scarring, history of or
- Keloid formation, history of or
- Marfan syndrome (genetic disorder) or
- Osteogenesis imperfecta (genetic disorder) or
- Skin cancer, history of—Use of Laviv® is not recommended in patients with these conditions.
- Allergy to certain antibiotics (e.g., gentamicin, amphotericin), dimethyl sulfoxide (DMSO), or any products of cattle (bovine) origin or
- Skin infections of the face—Should not be used in patients with these conditions.
- Weakened immune system—Use with caution due to an increased risk for infection and healing problems.
- Bleeding problems or
- Herpes labialis (cold sores) or
- Leukocytoclastic vasculitis (blood vessel disorder)—Use with caution. May make these conditions worse.
Proper Use
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.
Precautions
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 reaction, 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 with breathing; trouble with 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 in 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.
Side Effects
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.
DRG-20074992
