In the U.S.—

In Canada—

• Antineoplastic adjunct

Rasburicase (raz-BYOOR-i-case) helps your body remove the uric acid waste (hyperuricemia) from treatments for some types of cancer.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rasburicase, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rasburicase. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, dyes, fungi or yeasts. Tell your doctor if you have chest pain, trouble breathing, dizziness or lightheadedness, hives or skin rash during treatment with rasburicase.

Pregnancy—Studies on the effects in pregnancy have not been done in either animals or humans. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether rasburicase passes into breast milk. Mothers who are taking this medicine and wish to breast feed should discuss this with their health care professional.

Children—This medicine has been tested in children (1 month to 17 years of age). Children less than 2 years of age may be at increased risk for adverse effects.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way that they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of rasburicase in the elderly with use in other age groups.

• Anaphylaxis, hypersensitivity reaction, or a sudden, severe allergic reaction (or history of) or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells) or
• Hemolytic reactions (or history of) or
• Methemoglobinemia reactions (or history of)—Rasburicase should not be used if you have or have had any of these medical problems

• Tumor lysis syndrome, risk of—Fluids may be injected into the vein.

Before you have any laboratory tests, tell the medical doctor in charge that you are receiving this medicine. The results of these laboratory tests may be affected by this medicine.

Dosing—

The dose of rasburicase will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of rasburicase. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking rasburicase.

• For parenteral dosage form (injection):
  • For preventing or treating medical problems that may occur if certain treatments increase the amount of uric acid in the blood:
    • Adults—See the dose for children
    • Children—0.15 or 0.2 milligram (mg) per kilogram (kg) of body weight in a solution to be injected over 30 minutes into a vein as a single daily dose for five days. Chemotherapy should be initiated 4 to 24 hours after the first dose of rasburicase.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store vial of dry powder between 2 and 8 °C (36 and 46 °F).
• The reconstituted or diluted solution can be stored between 2 and 8 °C (36 and 46 °F) up to 24 hours
• Do not freeze
• Protect from light
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

If your symptoms do not improve within a few days or if they become worse, check with your doctor. This is especially important for children under two years of age since they may have an increased level of side effects.

It is especially important to notify your healthcare professional immediately if you have any signs or symptoms of an allergic reaction, such as chest pain, dizziness, hives, skin rash, or trouble breathing.

Patients of African or Mediterranean ancestry are at higher risk of serious side effects and should be carefully evaluated by their healthcare professional before starting this medicine.

It is very important to use this medicine properly. The medicine must be given over time, and not administered all at once. There is a very specific 5 day treatment regimen that must be followed, and chemotherapy must be started 4 to 24 hours after the first dose of rasburicase.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• More common
  • Cracked lips;  diarrhea;  difficulty in swallowing;  sores, ulcers, or white spots on lips, tongue, or inside mouth 
  
  

• Less common
  • Abdominal pain;  agitation;  black or red, tarry, stools;  bleeding gums;  bluish color of fingernails, lips, skin, palms, or nail beds;  changes in skin color;  changes in vision;  coma;  confusion;  convulsions (seizures);  chest pain or discomfort;  chills;  cough;  coughing that sometimes produces a pink, frothy sputum;  coughing up blood;  decreased urination;  depression;  dilated neck veins;  dizziness;  dry mouth;  fainting;  fast, slow, or irregular heartbeat;  fatigue;  fever;  headache;  hostility;  increased menstrual flow or vaginal bleeding ;  increased sweating;  increased thirst;  irritability;  itching, pain, redness, swelling, tenderness or warmth on skin;  lightheadedness;  lower back or side pain;  muscle twitching;  nausea;  no blood pressure or pulse;  nosebleeds ;  pain or discomfort in arms, jaw, back or neck;  pain, tenderness, swelling of foot or leg;  painful or difficult urination;  pains in chest, groin, or legs, especially calves of legs;  pale skin;  paralysis;  prolonged bleeding from cuts ;  red or dark brown urine;  severe constipation;  severe headaches of sudden onset ;  shortness of breath;  skin rash;  sneezing;  sore throat;  stopping of heart;  stupor;  sudden onset of shortness of breath for no apparent reason;  sudden loss of coordination;  sudden onset of slurred speech;  sunken eyes;  sweating;  swelling of face, fingers, feet, or lower legs;  swollen glands ;  temporary blindness;  thirst;  tightness in chest;  troubled breathing;  unconsciousness;  unexplained or unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting;  weight gain;  wheezing;  wrinkled skin 
  
  

• Rare
  • Back pain;  hives;  itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  yellow eyes or skin. 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• More common
  • Difficulty having a bowel movement 
  
  

• Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings;  feeling of warmth;  feeling unusually cold;  redness of the face, neck, arms and occasionally, upper chest;  shivering 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.