SIMULECT

Drug Name: SIMULECT

SIMULECT DESCRIPTION:
BASILIXIMAB - INJECTION (bass-ih-LICKS-ih-mab)

COMMON SIMULECT BRAND NAME(S):
Simulect

SIMULECT SIDE EFFECTS:
Nausea, stomach pain, diarrhea, constipation, headache, or mild dizziness may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: fever, cough, weakness, sores around the mouth or genitals, unusual bleeding or bruising, vision problems, mental/mood changes, pain with urination, change in the amount of urine, chest pain, irregular pulse. Tell your doctor immediately if any of these serious but very unlikely side effects occur: unusual lumps, swollen glands, night sweats, unexplained weight loss. An allergic reaction to SIMULECT is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, unusually fast or slow heartbeat, sneezing, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE SIMULECT:
SIMULECT: Give SIMULECT directly into a vein (IV); or use as directed by your doctor. SIMULECT is usually given in two doses: the first dose is given within two hours prior to transplant surgery and the second dose is given four days after surgery. SIMULECT is used in addition to other medications (e.g., cyclosporine, corticosteroids) to prevent rejection of transplanted organs. Take all medications exactly as prescribed by your doctor. If you have any questions, ask your doctor or pharmacist. Follow all instructions for proper mixing and dilution with correct IV fluids. When mixing the diluted solution, gently invert the bag to avoid foaming; do not shake. Ask your pharmacist if you have questions regarding the use of this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

SIMULECT USES:
Basiliximab is a monoclonal antibody. It is used to prevent rejection of transplanted organs (e.g., kidney).

SIMULECT PRECAUTIONS:
Tell your doctor your medical history, especially of any allergies you may have. SIMULECT may make you dizzy; use caution when engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages because they can intensify the dizziness effect of SIMULECT. If you must stop using SIMULECT due to an allergic reaction, never use the drug again. Consult your doctor or pharmacist for more details. If you must restart basiliximab, you have a chance of developing an allergic reaction. Know the symptoms of this allergic reaction (see side effects section). Consult your doctor or pharmacist before restarting basiliximab, and be sure you have easy access to medical care if you are restarting treatment. The use of medications that affect the immune system may lead to increased risk of infection or certain types of cancer. Notify your doctor promptly if you experience fever, weakness, swollen glands, night sweats, unusual lumps, or any new symptoms. SIMULECT should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Women of childbearing potential should use effective birth control before beginning therapy with SIMULECT, during the use of this drug, and for two months after finishing therapy with SIMULECT. Consult your doctor or pharmacist for more information. It is not known if SIMULECT passes into breast milk. Because of the potential risk to the infant, breast-feeding while using SIMULECT is not recommended. Consult your doctor before breast-feeding.

SIMULECT DRUG INTERACTIONS:
Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use. Do not start or stop any medicine without doctor or pharmacist approval.

SIMULECT OVERDOSE:
If overdose is suspected contact your local poison control center or emergency room immediately.

SIMULECT NOTES:
Do not share SIMULECT with others. Laboratory and/or medical tests may be performed to monitor for side effects and response to treatment.

MISSED SIMULECT DOSE:
If you miss a dose, contact your doctor or pharmacist immediately (see Precautions section for more details).

SIMULECT STORAGE:
Refrigerate vials between 36 and 46 degrees F (2 and 8 degrees C) away from light and moisture. Do not freeze. After mixing and dilution in correct IV fluids (consult your pharmacist for details), the drug is stable at refrigerator temperature for 24 hours or at room temperature for 4 hours. Discard any unused liquid. Your condition can cause complications in a medical emergency. For information on enrollment call Medic Alert(TM) at 1-800-854- 1166. In Canada call 1-800-668-1507.