Azficel-T, Injection az-fih-cell T

What are other names for this medicine?

Type of medicine: antiwrinkle treatment

Generic and brand names: azficel-T; laViv

What is this medicine used for?

This medicine is given by injections (shots) to smooth wrinkles that go from the sides of your nose to the corners of your mouth. This medicine is made from your own skin cells.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine, to dimethyl sulfoxide (DMSO), or to cows or beef
• a bleeding disorder or blood clotting problem
• a weakened immune system from diseases such as HIV/AIDS or cancer, or from taking chemotherapy, medicines to prevent organ transplant rejection, or steroid medicines to treat arthritis
• any genetic disorder, for example osteogenesis imperfecta or Marfan syndrome
• skin cancer, any skin disease, or a tendency to form scars

Tell your provider if you take aspirin, nonsteroidal anti-inflammatory medicines such as ibuprofen (Advil), or warfarin (Coumadin). These medicines may increase your risk of bleeding.

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant while receiving these shots. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving these shots without your healthcare provider's approval.

How do I use it?

Your healthcare provider will first remove 3 small skin samples from behind your ear. The skin samples are sent to the lab, where a type of cell called fibroblasts are isolated and grown. This takes 3 to 6 months. The cells are then sent back to your healthcare provider, who will inject the cell therapy medicine into your face.

You will usually have 3 treatments, with 3 to 6 weeks between each treatment.

• Do not put ice on your face after the injection. You can use a cold washcloth for 2 or 3 minutes at a time to ease swelling or discomfort.
• Do not wash the injection site for at least 24 hours.
• Do not scrub or rub the area around the injection site for at least 72 hours.
• Do not use products such as make-up, facial creams, sunscreen, or other skin products on the face for at least 72 hours.
• What if I miss a dose?
• Do not miss an appointment for a treatment. The cells will expire if you miss a treatment and must be thrown out. If you miss an appointment for a treatment, contact your healthcare provider to reschedule your appointment.

What should I watch out for?

If you have a fever over 100°F, redness, warmth, or pain at the injection or biopsy sites lasting for more than 3 days, contact your healthcare provider. These may be signs of serious infection.

There is a chance that your skin samples will not make enough cells to use. Talk with your healthcare provider about this.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are receiving this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away). If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): itchy sores or sores that bleed; skin bumps or scars without having injured the area; fever over 100°F, redness, warmth, or pain at the injection or biopsy sites that lasts more than 3 days.

Other: Pain, swelling, redness, bruising, or itching at the injection site; headache; dark skin at the injection site; cold sores.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.