Orthoclone OKT 3 (Intravenous)

Muromonab-CD3 is a monoclonal antibody. It is used to lower the body's natural immunity in patients who receive organ (for example, kidney) transplants.

When a patient gets an organ transplant, the body's white blood cells will try to reject the transplanted organ. Muromonab-CD3 helps to stop the white blood cells from rejecting it.

The effect of muromonab-CD3 on the white blood cells may also lower the body's ability to fight infections. Before starting treatment, you and your doctor should discuss the benefits of this medicine as well as the risks of using it.

Muromonab-CD3 is to be given only by or under the immediate supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and to check for unwanted effects.

While you are being treated with muromonab-CD3 and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Muromonab-CD3 may lower your body's resistance. For some immunizations, there is a chance you might get the infection the immunization is meant to prevent. For other immunizations, it may be especially important to receive the immunization to prevent a disease. In addition, other people living in your house should not take the oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken the oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers your nose and mouth.

Treatment with muromonab-CD3 may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.

This medicine commonly causes chest pain, dizziness, fever and chills, shortness of breath, stomach upset, and trembling within a few hours after the first dose. These effects should be less after the second dose. However, check with your doctor or nurse immediately if you have chest pain, rapid or irregular heartbeat, shortness of breath or wheezing, or swelling of the face or throat after any dose.

In deciding to use a medicine, you need to consider the risks against the benefits. This is a choice you make with your doctor. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or packaging ingredients carefully.

Pediatric

There is no specific information comparing the use of muromonab-CD3 in children to its use in other age groups. However, children are more likely to become dehydrated from diarrhea and vomiting that may be caused by this medicine.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults or if they cause different side effects or problems in older adults. There is no specific information comparing the use of muromonab-CD3 in elderly patients to its use in other age groups.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust 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]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Angina (chest pain) or
• Circulation problems or
• Convulsions (seizures) or
• Recent heart attack or
• Other heart problems or
• Kidney problems or
• Lung problems or
• Nervous system problems—Increased risk of serious unwanted effects from muromonab-CD3

• History of blood clots—Risk of blood clots in transplanted organs or blood vessels

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Infection—Muromonab-CD3 reduces your body's ability to fight infections

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Because of how muromonab-CD3 works in the body, it could cause effects that may not show up until years after using the medicine. These delayed effects may include certain types of cancer, like lymphomas and skin cancers. Talk to your doctor about these possible effects.

Not all of the following side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if you experience any of the following side effects:

Less common

• Chest pain
• rapid or irregular heartbeat
• shortness of breath or wheezing
• swelling of face or throat

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

More common

• Diarrhea
• dizziness or faintness
• fever and chills
• general feeling of discomfort or illness
• headache
• muscle or joint pain
• nausea and vomiting

Less common or rare

• Confusion
• black, tarry stools
• blood in urine or stools
• convulsions (seizures)
• cough or hoarseness
• hallucinations (seeing, hearing, or feeling things that are not there)
• itching or tingling
• loss of hearing or vision
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• skin rash
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• swollen or painful glands
• tightness in the chest
• trembling and shaking of hands
• troubled breathing
• unusual sensitivity of eyes to light
• unusual bleeding or bruising
• unusual tiredness
• weakness

After you stop using this medicine, it may still cause some side effects that need attention. During this time, check with your doctor immediately if you notice the following side effect:

• Fever and chills

Other side effects not listed may also occur in some patients. If you notice any other effects, consult 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.

In the U.S.

• Orthoclone OKT 3

Pharmacologic Class: Monoclonal Antibody

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.

• For injection dosage form: To prevent organ transplant rejection: Adults—5 milligrams (mg) injected into a vein once a day. Children less than 12 years of age—Dose is based on body weight and must be determined by your doctor.

• What are Monoclonal Antibodies and how do they work?