BUSULFEX

Drug Name: BUSULFEX

BUSULFEX DESCRIPTION:
BUSULFAN - INJECTION (byou-SULL-fan)

COMMON BUSULFEX BRAND NAME(S):
Busulfex

BUSULFEX SIDE EFFECTS:
Nausea, diarrhea or constipation, headache, skin darkening, flushing, trouble sleeping, pain or swelling at the injection site, or dry mouth 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: unusual tiredness; fast or irregular heartbeat; fever, persistent sore throat, easy bruising/bleeding, mental/mood changes, vomiting, increased thirst, blurred vision; muscle cramps or weakness; chest pain, seizures, sudden weight gain; stomach pain or swelling; change in amount or color of urine; or mouth sores. Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness or fainting. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing eyes/skin, coughing up blood, or vision problems. An allergic reaction to BUSULFEX is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. Rare, possibly fatal, lung problems may occur months to years after using busulfan. Symptoms include trouble breathing; or persistent cough or congestion. Report any symptoms promptly. Even though this is an anti-cancer drug, busulfan may infrequently cause a new cancer to develop. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE BUSULFEX:
BUSULFEX: Give BUSULFEX by vein (IV) over 2 hours, diluted in a solution (e.g., saline, dextrose), usually 4 times daily for 4 days; or as directed by your doctor. To minimize side effects, you may be given other medications (e.g., anti-nausea, anti-seizure agents) to take in addition to BUSULFEX. Follow all directions for the proper use of other medications; consult your doctor or pharmacist. Drink plenty of fluids while using BUSULFEX, unless instructed otherwise. Follow all instructions for proper preparation, use, handling, and safe disposal of BUSULFEX. Ask your pharmacist if you have questions regarding busulfan. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

BUSULFEX WARNING:
BUSULFEX can lower the body's ability to fight an infection or cancer, as well as preventing normal blood clotting. Notify your doctor immediately if you develop any signs of an infection such as fever, chills, persistent sore throat; easy bruising/bleeding or unusual tiredness/fatigue.

BUSULFEX USES:
Busulfan is used in combination with cyclophosphamide in the treatment of leukemia (chronic myelogenous leukemia) before stem cell transplant. It works by stopping cancer cells from multiplying, but also affects some normal cells, such as bone marrow cells.

BUSULFEX PRECAUTIONS:
Tell your doctor your medical history, especially of seizures, head injury, blood disorders (thalassemia), diabetes, lung disease, any serious infections, and of any allergies you may have. Because BUSULFEX can lower your body's ability to fight an infection, do not touch your eyes or the inside of your nose without first washing your hands. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine. Use caution with sharp objects like safety razors or nail cutters, and avoid activities that might cause injury. Caution is advised when using BUSULFEX in children because they may clear the drug from their system faster, and therefore may require special dosing and monitoring. BUSULFEX may also cause fertility problems. BUSULFEX is not recommended for use during pregnancy. Busulfan may cause fetal harm. Avoid becoming pregnant while using BUSULFEX. Consult your doctor for more details. It is not known whether BUSULFEX passes into breast milk. Because of the potential risk to the infant, breast-feeding while using BUSULFEX is not recommended. Consult your doctor before breast-feeding.

BUSULFEX DRUG INTERACTIONS:
Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use, especially of azole antifungals (e.g., itraconazole,); thioguanine, acetaminophen; drugs that can cause seizures (e.g., bupropion); drugs that can increase seizure risk (e.g., phenothiazines such as chlorpromazine); other drugs which affect the bone marrow/immune system (e.g., other anti-cancer drugs, or cyclosporine). Check your prescription and nonprescription labels carefully for acetaminophen-containing products. These should be used cautiously 3 days before and during therapy with busulfan. Acetaminophen may increase busulfan blood levels and side effects. If acetaminophen is used, do not exceed recommended daily doses. Do not start or stop any medicine without doctor or pharmacist approval.

BUSULFEX OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe fatigue, persistent sore throat, fever; or easy bruising or bleeding.

BUSULFEX NOTES:
Do not share BUSULFEX with others. Laboratory tests (e.g., blood, liver) will be performed to monitor your progress.

MISSED BUSULFEX DOSE:
If you miss a dose, or the dose is interrupted, contact your doctor or pharmacist immediately to establish a new dosing schedule.

BUSULFEX STORAGE:
Store the vials at refrigerator temperature between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After mixing and dilution in correct IV fluids (consult your pharmacist for details), the drug is stable at room temperature for 8 hours. Discard any unused liquid. Busulfan diluted in saline solution is stable for up to 12 hours if refrigerated as noted above. 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