Pronunciation:

mue-roe-MOE-nab-CD3

Brand Names:

• Orthoclone OKT 3

Warnings:

Anaphylactic and anaphylactoid reactions may occur following administration of any dose. Serious, occasionally life-threatening or lethal, systemic, cardiovascular, and central nervous system reactions have been reported. These have included: pulmonary edema, especially in patients with volume overload; shock; cardiovascular collapse; cardiac or respiratory arrest; seizures; coma; cerebral edema; cerebral herniation; blindness; and paralysis. Monitor fluid status prior to and during treatment and premedicate with methylprednisolone to minimize symptoms of Cytokine Release Syndrome .

Classifications:

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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 this medicine 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.

Before Using This Medicine:

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.

Children—

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 this medicine.

Older adults—

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.

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 this medicine.

Other 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.

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:

• 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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 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.

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.

Side Effects of This Medicine:

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.

Because of the way that muromonab-CD3 acts on the body, there is a chance that it may cause effects that may not occur until years after the medicine is used. These delayed effects may include certain types of cancer, such as lymphomas and skin cancers. Discuss these possible effects with your doctor.

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

Check with your doctor immediately if any of the following side effects occur:

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 occur:

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 produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

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.