Chymodiactin

Chymopapain is injected directly into a herniated ("slipped'') disk in the spine to dissolve part of the disk and relieve the pain and other problems caused by the disk pressing on a nerve. Before you receive chymopapain, you will be given an anesthetic (either a general anesthetic to put you to sleep or a local anesthetic).

Very rarely, use of chymopapain may cause serious side effects, including paralysis of the legs or death. Another dangerous side effect of chymopapain injection is a severe allergic reaction called anaphylaxis. This side effect occurs in less than 1% of the patients receiving the medicine, but it occurs more often in women than in men. Before receiving chymopapain, you should discuss its use, and the possibility of anaphylaxis or other serious side effects, with your doctor.

Chymopapain injections are given only in a hospital, usually in an operating room, by your surgeon.

This medicine was available only with your doctor's prescription.

The sale and distribution of chymopapain was discontinued in the US in January 27, 2003 .

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of chymopapain in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of chymopapain in the elderly with use in other age groups.

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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:

• Allergic reaction to papaya or
• Previous chymopapain injection—Increased risk of serious allergic reactions.

• Diseases of the back (spine), muscles, or nerves or
• High blood pressure (hypertension) or
• Stroke or bleeding in the brain (or if any member of your family has ever had these problems) or
• Surgery of the back—The chance of side effects may be increased.

Dosing

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.

Along with its needed effects, a medicine may cause some unwanted effects. Very rarely, use of chymopapain has caused serious side effects, including paralysis of the legs or death. Also, this medicine may cause dangerous allergic reactions, especially in women.

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal or stomach cramps or pain
• changes in facial skin color
• constipation (severe)
• convulsions (seizures)
• decreased or uncontrolled urination
• fast or irregular breathing
• headache (sudden, severe, and continuing)
• hot skin
• pain, tenderness, swelling and/or skin color changes of the leg or foot
• puffiness or swelling of the eyelids or around the eyes
• runny nose
• shortness of breath, troubled breathing, tightness in chest, or wheezing
• skin rash, redness, hives, or itching
• swelling of abdomen or stomach
• uncontrolled bowel movements
• vomiting
• weakness in legs (severe) or problems with moving legs

Other side effects may occur that usually do not need medical attention. Pain and muscle spasms in the lower back may last for several days after you have received this medicine. Stiffness or soreness in the back may last for several months. Other side effects may go away after a short time. However, check with your doctor if any of the following side effects continue or are bothersome:

• Back pain, stiffness, or soreness
• muscle spasms in lower back

• Cramps, pain, or mild weakness in legs
• decreased sensitivity to pain
• dizziness
• feeling of burning in lower back
• foot drop
• headache
• nausea
• numbness or tingling in legs or toes

Check with your doctor as soon as possible if any of the following side effects occur:

• Back pain or muscle weakness (sudden and severe)
• skin rash, hives, or itching

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.