Carticel

Autologous cultured chondrocytes are used, as part of an overall program that includes knee surgery and special exercises, to help repair damaged knee cartilage. Cartilage is a type of tissue that joins together and helps support parts of the body.

Autologous cultured chondrocytes are the patient's own cartilage cells. The cells are removed from the patient and sent to a laboratory, where they are processed to increase their number. The cells are then implanted (placed) in the damaged part of the knee. After implantation, the chondrocytes help form new, healthy cartilage.

This product is available in the following dosage forms:

• Implant

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:

1. 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.
2. Pediatric Population:Implantation of autologous cultured chondrocytes has been done only in adults, and there is no information about the effects of this procedure in children.
3. Geriatric Population:Implantation of autologous cultured chondrocytes has not been studied specifically in older people. There is no information comparing use of this procedure in the elderly with use in other age groups.
4. 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.
5. 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.
6. 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.
7. 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:

• • Cancer near the injured knee—It is not known whether removing and implanting the chondrocyte cells can affect the growth or spread of a nearby cancer.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Use crutches to help you walk for the first 6 or 7 weeks after receiving the implant. Walk as normally as possible with the crutches. However, place no more than 25% of your weight on the leg that received the implant. Let the crutches and your other leg hold the rest of your weight.

After the first 3 weeks, or when directed by your doctor, you may gradually increase the amount of weight placed on the knee.

Check with your doctor right away if sharp pain occurs in the knee that received the implant, or if “locking” of the knee occurs.

After the implant surgery, your doctor will direct you to start a rehabilitation program that includes exercise. This program is a very important part of your treatment. You will be instructed to start out slowly and to increase gradually the number of times that you do each exercise.

To get the most help from this program, it is very important that you follow the instructions as closely as possible. Do not do different exercises, and do not increase the number of times you do each exercise faster than directed.

If pain or swelling occurs when you increase the amount of exercise you are doing, go back to the last level of exercise until the pain and swelling are gone, then try again. Use ice packs to help reduce the swelling.

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 as soon as possible if any of the following side effects occur:
Less common

• Bruising (severe)
• Signs of an infection, such as heat, redness, swelling, and/or oozing at the place of surgery
• Rare
• Fever and pain (occurring together)

Other side effects may not occur until weeks, months, or even years after the implantation. Check with your doctor if any of the following delayed side effects occur.

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.