IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

RASBURICASE - INJECTION

(ras-BYUR-ih-case)

COMMON BRAND NAME(S): Elitek

WARNING: This drug can cause a severe allergic reaction. If you develop new symptoms such as chest pain, trouble breathing, severe dizziness, or rash/hives, stop using this medication and seek immediate medical attention. Do not restart this medication if this severe allergic reaction has occurred. Consult the doctor or pharmacist for more details. Do not take this medication if you have a metabolic condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency because it can severely damage your red blood cells leading to anemia (hemolysis). If you are of African or Mediterranean descent, you may be at higher risk for G6PD deficiency and you should be tested to see if you have this condition before starting this medication. This medication can cause a condition that affects the ability of your red blood cells to carry oxygen (methemoglobinemia). Do not restart this medication if this effect occurs; consult the doctor for details. This medication can interfere with accurate measurement of uric acid in the blood, resulting in falsely low levels (see Drug Interactions section). Be sure to tell all laboratory personnel that you are using this drug.

USES: This medication is used to prevent high blood levels of uric acid from occurring in children with cancer (e.g., leukemia, lymphoma, solid malignant tumors) who are about to receive cancer chemotherapy treatment. When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream. This medication allows uric acid to more easily be removed from the body by the kidneys.

HOW TO USE: Inject this medication directly into a vein (IV) slowly over 30 minutes, or as directed by your doctor. Do not give as a rapid (bolus) infusion. This medication should be started in a hospital/clinic. Rasburicase is given once a day for 5 days. Correct timing of cancer chemotherapy and rasburicase doses is important. Start chemotherapy 4 to 24 hours after the first dose of rasburicase. Follow all instructions for proper mixing and dilution with correct IV fluids. When mixing the drug, swirl gently. Do not shake the vial. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not use a filter when injecting this medication. This drug should be given through a separate IV line from other medications if possible. If you have questions regarding the use of this medication, consult the pharmacist. Intravenous (IV) fluids should be given with this medication to also help decrease your uric acid levels.

SIDE EFFECTS: Also see the Warnings section. Vomiting, nausea, headache, stomach pain, constipation, diarrhea, mouth sores/ulcers or rash may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent sore throat, fever, chills. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: chest pain, trouble breathing, severe dizziness, weakness, yellowing eyes and skin, dark urine, blue or gray skin color. If you notice other effects not listed above, contact the doctor or pharmacist.

PRECAUTIONS: Also see the Warnings section. This medication should not be used if you have certain medical conditions. Before using this medicine, consult the doctor or pharmacist if you have: previous severe allergic reaction to this medication, certain metabolic conditions (e.g., G6PD deficiency), previous red blood cell damage (e.g., hemolysis, methemoglobinemia) with this medication. Before using this medication, tell the doctor the medical history, especially of: kidney disease, dehydration, any allergies. Caution is advised when using this drug in children less than 2 years old because they may be more sensitive to the side effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Breast-feeding is not recommended while using this drug.

DRUG INTERACTIONS: Tell the doctor of all prescription and nonprescription medication you may use, especially: allopurinol. This medication can interfere with the uric acid in the blood sample tubes when the tubes remain at room temperature, therefore leading to falsely low uric acid results. Laboratory personnel must follow special procedures to process the blood sample. Do not start or stop any medicine without doctor or pharmacist approval.

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

NOTES: Laboratory tests (e.g., uric acid levels) should be performed to monitor your progress.

MISSED DOSE: It is important that each dose be used as scheduled. If you miss a dose, contact your doctor immediately. He/she will establish a new dose schedule. Do not "double-up" the dose to catch up.

STORAGE: Store the medication in the refrigerator at 36 to 46 degrees F (2 to 8 degrees C). Do not freeze. Protect from light. Once mixed, the medication may be stored for up to 24 hours in the refrigerator. Discard the medication if it is not given within 24 hours after mixing.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.