Muromonab-cd3 Intravenous

In the U.S.

• Orthoclone OKT 3

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

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

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Muromonab-CD3 works by preventing the white blood cells from doing this.

The effect of muromonab-CD3 on the white blood cells may also reduce the body's ability to fight infections. Before you begin treatment, you and your doctor should talk about the good muromonab-cd3 will do as well as the risks of using it.

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

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 muromonab-cd3, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to muromonab-cd3 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

There is no specific information comparing use of muromonab-CD3 in children with use in other age groups. However, children are more likely to get dehydrated from the diarrhea and vomiting that may be caused by muromonab-cd3.

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 muromonab-CD3 in the elderly with use in other age groups.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using muromonab-cd3.

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 muromonab-cd3. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Circulation problems or
• Convulsions (seizures) or
• Heart attack (recent) or
• Heart problems, other, or
• Kidney problems or
• Lung problems or
• Nervous system problems—Increased risk of serious unwanted effects from muromonab-CD3

• Blood clots (history of)—Risk of blood clots in transplanted organ or blood vessels

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

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

Dosing

The dose of muromonab-cd3 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 muromonab-cd3. 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.

It is very important that your doctor check your progress at regular visits to make sure that muromonab-cd3 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 persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons 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, you should consider wearing a protective face mask that covers the 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.

muromonab-cd3 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.

There are no data on the excretion of muromonab CD3 into human milk. The manufacturer considers the use of muromonab CD3 during lactation to be contraindicated.