Description
Autologous cultured chondrocytes are used, as part of an overall program (that includes knee surgery and special exercises), to help repair damaged knee cartilage caused by acute or repetitive trauma in patients who had not responded to a prior arthroscopic or other surgical repair procedure. 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 medicine is to be given only by or under the direct supervision of a trained doctor.
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 Carticel® in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of Carticel® have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Carticel® in the elderly.
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:
- Allergy to gentamicin or aminoglycoside antibiotics or
- Allergy to products made from cow—Should not be used in patients with these conditions.
- 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.
Proper Use
This medicine is to be given only by a doctor who have completed Vericel's Surgeon Training Program. Carticel® will be injected into your knee joint with a needle during surgery.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it and to check for unwanted effects.
Use crutches to help you walk for the first 6 to 8 weeks after receiving the implant.
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.
Check with your doctor right away if sharp pain occurs in the knee that received the implant, or if “locking” of the knee occurs.
Autologous cultured chondrocytes are the patient's own cartilage cells. Patients undergoing surgical procedures using Carticel® are not routinely tested for transmissible infectious diseases and may increase risk to have them. Talk with your doctor about this risk if you are concerned.
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
- Sharp pain or "locking" when you try to move your knee joint
Less common
- Bruising (severe)
- difficulty with moving
- heat, redness, swelling, or oozing at the site of surgery
- muscle pain or stiffness
- pain, swelling, or redness in the joints
Less common or rare
- Inability to bend the knee
- swelling of the knee
Rare
- Fever and pain (occurring together)
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:
More common
- “Crackling” sound or pain when moving the knee
- increased growth of scar over your knee joint
- stiffness or “catching” of the knee
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.
CON-XXXXXXXX
