Azficel-T (az-FYE-sel - tee)
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).
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not receive this medicine if you have had an allergic reaction to azficel-T, amphotericin, gentamicin, dimethyl sulfoxide (DMSO), or any products made from cattle (bovine). Do not use this medicine if you have skin infections of the face.
How to Use This Medicine
- 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.
- 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 (such as make-up, facial creams, or sunscreen) to the treatment area for 72 hours.
- Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
If a dose is missed:
- 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.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor 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®).
- Tell your doctor if you are also using medicines that weaken the immune system (such as medicine for cancer).
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, blood vessel disorder (such as vasculitis), cold sores (herpes labialis), genetic disorders of the skin, immune system problems, or a history of skin cancer, keloids, or excessive scarring.
- 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 using 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®.
- Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Bleeding, bruising, pain, swelling, itching, blistering, or lumps where the shot was given.
- Fever over 100 degrees F.
- Painful cold sores.
- Redness, warmth, or pain at the injection site lasting for more than 3 days.
- Swelling of the face or eyelids.
If you notice these less serious side effects, talk with your doctor:
- Acne or pimples.
- Toothache, or jaw pain.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088