Muromonab-cd3 (Intravenous)

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

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

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 monitor for unwanted effects.

While you are being treated with muromonab-CD3 and after you stop treatment with it, do not get 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 that the immunization is meant to prevent. For other immunizations, it may be especially important to receive the immunization to prevent a disease. Additionally, others living in your house should not take oral polio vaccine because there is a chance they could pass the polio virus to you. Also, avoid people who have recently taken 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, 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 and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

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. There is no specific information comparing the use of muromonab-CD3 in the elderly to 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 others can be used together, even if an interaction might occur. In these cases, your doctor may need to change the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, 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

• Recent exposure to chickenpox or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

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

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

Because muromonab-CD3 works in the body, there is a chance it may cause effects that do not appear until years after the medicine is used. These delayed effects may include certain types of cancer, such as lymphomas and skin cancers. Talk about these possible effects with your doctor.

Even though not all of the following side effects may occur, if they do, they may need medical attention.

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

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 any of the following side effects happen:

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 right away 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, 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.

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.