This leaflet is designed to help you understand LAVIV®.
This leaflet does not take the place of talking with your healthcare provider
about LAVIV. If you have questions about LAVIV, talk to your healthcare
What is the most important information I should know
LAVIV is made especially for you from your own skin
cells. Your healthcare provider will check to see that the cells that come back
from the manufacturer are yours. Using someone else's cells can cause a serious
reaction. Do not let anyone else use your LAVIV.
The process for making LAVIV uses antibiotics
(amphotericin and gentamicin), bovine serum (from cattle), and dimethyl
sulfoxide (DMSO). If you are allergic to any of these, tell your healthcare
Do not use LAVIV if you have a skin infection on your
face because LAVIV treatment can make the infection worse. Talk to your
healthcare provider if you have any other infection.
What is LAVIV?
LAVIV is made from your own skin cells, which are used to
improve the appearance of wrinkles that go from the sides of your nose to the
corners of your mouth (called nasolabial folds). LAVIV is injected into your
face using a small needle.
Who should not get LAVIV?
You should NOT get LAVIV if you have any of the following
problems or conditions:
- Allergy to the antibiotics gentamicin or amphotericin,
DMSO, or to things made from cattle (bovine).
- Skin infections in the face.
What should I tell my healthcare provider before
Your health care provider will help you to decide whether
you are a candidate for LAVIV and may help you avoid some of the adverse
reactions from LAVIV. Before getting LAVIV, tell your healthcare provider if
you have any of the following medical problems:
- Allergic reactions to any drugs or food
- Bleeding disorders or take blood-thinning medicines like
aspirin, ibuprofen, or coumadin
- Keloids or excessive scarring
- Skin cancer or any malignancy
- Genetic disorders affecting your skin
- Immune problems or take medicines that affect your immune
- Any other illness or medical problem
How will I get LAVIV?
Your healthcare provider will take three small skin
samples (called biopsies) from behind your ears and send them to the
manufacturer. Certain cells, called fibroblasts, are grown from the samples.
This takes about three to six months.
The cells (LAVIV) are sent back to your healthcare
provider, who will inject them into your nasolabial fold wrinkles using a small
You usually get LAVIV in three treatment sessions about
3-6 weeks apart.
It is very important that you arrive on time for your
treatment sessions. If you miss a treatment session, your LAVIV cells will
expire and must be thrown out. Your healthcare provider will work with you to
schedule a new treatment session.
There is a chance that your skin samples will not make
enough cells to use. In this case, your doctor may ask you if you wish to try
What should I avoid while I am getting LAVIV
Tell your healthcare provider about all the medicines you
take, including prescription and nonprescription drugs (like aspirin, vitamins,
and dietary supplements). Your healthcare provider will advise you about the
use of these medicines during LAVIV treatment.
- People who have bleeding disorders or who take blood
thinning medicines may have more bleeding with LAVIV treatment.
- People with immune problems or who take medicines that
affect the immune system can get infection or have healing problems with LAVIV
Expect some redness, swelling, puffiness, pain or
bruising following LAVIV treatments. You can help yourself by doing the
- Do not rub, scrub, or massage the injection site for at
least 72 hours.
- Apply a cold compress for 2-3 minutes at a time. DO NOT
apply ice to the face.
- Do not wash the site of injections for at least 24 hours.
- Do not use make-up, facial creams, sunscreen, or other
skin products on the face for 72 hours.
What are the possible or reasonably likely side
effects of LAVIV?
The most common side effects are at the injection-site,
Tell your healthcare provider or call the emergency
department right away if you have
- Difficulty breathing, trouble swallowing, rash, hives, or
severe redness and swelling, because these may be signs of a serious allergic
- Fever over 100°F, redness, warmth, or pain at the
injection or biopsy sites lasting for more than three days, because these may
be signs of serious infection.
These are not all the possible side effects of LAVIV.
Tell your health provider about any side effects that concern you. You may
report side effects to FDA at 1-800-FDA-1088.
What are the ingredients in LAVIV?
LAVIV is made from your own skin cells placed in a
mixture of water and salts.
Antibiotics (amphotericin and gentamicin), bovine serum
(from cattle) and dimethyl sulfoxide (DMSO) are used during processing. Trace
amounts of these ingredients may be present in LAVIV.