Muromonab-CD3 (Systemic)

Brand Names : Orthoclone OKT3

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 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 to rodents (such as mice or rats). Muromonab-CD3 is grown in a mouse cell culture. Also tell your health care professional if you are allergic to any other substance, such as preservatives.

Pregnancy - Studies have not been done in either humans or animals. Muromonab-CD3 may cross the placenta, but it is not known whether it causes harmful effects on the fetus. Before receiving this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding - It is not known whether muromonab-CD3 passes into breast milk. Muromonab-CD3 has not been reported to cause problems in nursing babies. However, it may be necessary for you to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

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.

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. When you are receiving muromonab-CD3, it is especially important that your health care professional know if you are taking any of the following:

• Azathioprine (e.g., Imuran) or
• Chlorambucil (e.g., Leukeran) or
• Corticosteroids (cortisone-like medicine) or
• Cyclophosphamide (e.g., Cytoxan) or
• Cyclosporine (e.g., Sandimmune) or
• Cytarabine (e.g., Cytosar-U) or
• Mercaptopurine (e.g., Purinethol) or
• Tacrolimus (e.g., Prograf) - There may be an increased risk of infection and development of cancer because muromonab-CD3 reduces the body's ability to fight them

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