Orthoclone OKT 3

Generic Name: Muromonab-CD3 (MUE-roe-MOE-nab-CD 3)Brand Name: Orthoclone OKT 3

Orthoclone OKT 3 may cause serious allergic reactions. These may occur at any time while you use Orthoclone OKT 3 . It may also cause other serious and sometimes fatal effects, including heart and nervous system problems. Tell your doctor right away if you experience shortness of breath; chest pain; numbness of an arm or leg; sudden severe dizziness, headache, nausea, or vomiting; fainting; severe stomach pain; trouble speaking; vision changes (eg, light sensitivity or blindness); one-sided weakness; seizures; or paralysis after you receive Orthoclone OKT 3 .

You should only receive Orthoclone OKT 3 in a health care facility where you can receive proper treatment in case you have a severe allergic reaction or other severe side effects.

Your doctor may give you another medicine (methylprednisolone) to help lower the risk of certain severe side effects from Orthoclone OKT 3 .

Orthoclone OKT 3 is used for:

Treating organ rejection after a kidney transplant. It is also used to treat organ rejection in patients with a heart or liver transplant if corticosteroids do not work well. It may also be used for other conditions as determined by your doctor.

Orthoclone OKT 3 is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.

Do NOT use Orthoclone OKT 3 if:

  • you are allergic to any ingredient in Orthoclone OKT 3 or to products made with mouse protein
  • you have certain levels (greater than or equal to 1:1000) of antimouse antibody titers
  • if you are pregnant, suspect that you may be pregnant, or are breast-feeding
  • you have uncompensated heart failure, fluid overload, uncontrolled high blood pressure, or a history of seizures, or you are at risk for seizures
  • you have a fever higher than 100 degrees F (37.8 degrees C), chickenpox, or shingles

Contact your doctor or health care provider immediately if any of these apply to you.

Before using Orthoclone OKT 3 :

Some medical conditions may interact with Orthoclone OKT 3 . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart problems (eg, angina, heart failure), lung problems (eg, fluid buildup, chronic obstructive pulmonary disease), nervous system problems, or shock due to a severe infection (sepsis)
  • if you have a fever or infection, swelling, high or low blood electrolyte levels (eg, potassium, sodium), or conditions that may increase or decrease the amount of fluid in the body (eg, dialysis, dehydration, blood loss)
  • if you have history of seizures, blood clots or blood clotting problems, blood vessel problems, stroke, or recent heart attack or head injury

Some MEDICINES MAY INTERACT with Orthoclone OKT 3 . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, furosemide, hydrochlorothiazide) because they may increase the risk of Orthoclone OKT 3 s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Orthoclone OKT 3 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Orthoclone OKT 3 :

Use Orthoclone OKT 3 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Orthoclone OKT 3 will be given as an injection at your doctor's office, hospital, or clinic.
  • If you miss a dose of Orthoclone OKT 3 , contact your doctor right away.

Ask your health care provider any questions you may have about the proper use of Orthoclone OKT 3 .

Important safety information:

  • Orthoclone OKT 3 may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Orthoclone OKT 3 with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Orthoclone OKT 3 may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Orthoclone OKT 3 may increase your risk of developing certain cancers (eg, lymphoma). Contact your doctor if you experience any unusual lumps or skin thickening, growths, or color changes. Discuss any questions or concerns with your doctor.
  • Lab tests, including kidney and liver function, blood pressure, blood counts, blood electrolytes, weight checks, and chest x-rays, may be performed while you use Orthoclone OKT 3 . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Orthoclone OKT 3 with caution in the ELDERLY; they may be more sensitive to its effects.
  • Orthoclone OKT 3 should be used with extreme caution in CHILDREN; they may be more sensitive to its effects, including bleeding or swelling in the brain, seizures, meningitis, certain infections, blood clots, dehydration, and the development of certain cancers (eg, lymphoma).
  • PREGNANCY and BREAST-FEEDING: It is not known if Orthoclone OKT 3 can cause harm to the fetus. Do not use Orthoclone OKT 3 if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Orthoclone OKT 3 is found in breast milk. Do not breast-feed while taking Orthoclone OKT 3 .

Possible side effects of Orthoclone OKT 3 :

Every medicine can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite; diarrhea; dizziness; fatigue; flushing; headache; increased sweating; nausea; nervousness; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or tarry stools; calf pain/tenderness; chest pain; confusion; decreased hearing/deafness; decreased urination; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; hoarseness; mental or mood changes; muscle or joint aches or pain; neck soreness or stiffness; numbness of an arm or leg; one-sided weakness; paralysis; seizures; severe or persistent tiredness, weakness, nausea, vomiting, or diarrhea; shortness of breath; signs of infection (eg, chills, fever, sore throat); skin thickening, growths, or color change; speech changes; stomach pain; sudden severe dizziness or headache; swelling of the arms, legs, hands, or feet; tremor; trouble swallowing; uncontrolled muscle movements; unusual bruising or bleeding; unusual lumps; vision changes (eg, blindness, sensitivity to light); wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination; diarrhea; fever; muscle pain; severe chills; shortness of breath; swelling; or vomiting.

Proper storage of Orthoclone OKT 3 :

Orthoclone OKT 3 is usually handled and stored by a health care provider. If you are using Orthoclone OKT 3 at home, store Orthoclone OKT 3 as directed by your pharmacist or health care provider. Keep Orthoclone OKT 3 out of the reach of children and away from pets

General information:

  • If you have any questions about Orthoclone OKT 3 , please talk with your doctor, pharmacist, or other health care provider.
  • Orthoclone OKT 3 is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Orthoclone OKT 3 . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.