RASBURICASE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Elitek

In Canada?

• Fasturtec

Category

• Antineoplastic adjunct

Description

Rasburicase (raz-BYOOR-i-case) helps yourbody remove the uric acid waste (hyperuricemia) from treatments for some typesof cancer.

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

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In decidingto use a medicine, the risks of using the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Forrasburicase, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to rasburicase. Also tell your doctor and pharmacistif 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 beendone in either animals or humans. Before taking this medicine, make sure yourdoctor knows if you are pregnant or if you may become pregnant.

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

Children?This medicine has been tested in children (1 monthto 17 years of age). Children less than 2 years of age may be at increasedrisk for adverse effects.

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

Note:

Patients of African or Mediterranean ancestry should be tested forglucose 6 phosphate dehydrogenase (G6PD) deficiency. These patients may beat increased risk for severe hemolysis.

Other medical problems?The presence of other medical problems mayaffect the use of rasburicase. Make sure you tell your doctor if you haveany other medical problems, especially:

• Anaphylaxis, hypersensitivity reaction, or a sudden, severe allergicreaction (or history of) or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditarymetabolic disorder affecting red blood cells) or
• Hemolytic reactions (or history of) or
• Methemoglobinemia reactions (or history of)?Rasburicase shouldnot be used if you have or have had any of these medical problems

• Tumor lysis syndrome, risk of?Fluids may be injected into thevein.

Proper Use of This Medicine

Dosing?You should only take only one course of treatment (once aday for 5 days) of this medicine, unless your doctor tells you differently.It is important that you follow your doctor's instructions to avoid a seriousallergic reaction to rasburicase.

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 yourdoctor tells you to do so.

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

• For parenteral dosage form (injection):
  • For preventing or treating medical problems that may occur if certaintreatments 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 bodyweight in a solution to be injected over 30 minutes into a vein as a singledaily dose for five days. Chemotherapy should be initiated 4 to 24 hours afterthe 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 and8 ?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 yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

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

Patients of African or Mediterranean ancestry are at higher risk of seriousside effects and should be carefully evaluated by their healthcare professionalbefore starting this medicine.

It is very important to use this medicine properly. The medicine must begiven over time, and not administered all at once. There is a very specific5 day treatment regimen that must be followed, and chemotherapy must be started4 to 24 hours after the first dose of rasburicase.

About This Medicine

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

Side Effects of This Medicine

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

Check with your doctoror 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; bleedinggums; 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 producesa 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; increasedthirst; 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; sorethroat; stopping of heart; stupor; sudden onset of shortness of breath for noapparent reason; sudden loss of coordination; sudden onset of slurred speech; sunkeneyes; sweating; swellingof 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, lipsor tongue; yellow eyes or skin.

Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you about ways to prevent or reducesome of these side effects. Check with your health care professional if anyof the following side effects continue or are bothersome or if you have anyquestions 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 theface, neck, arms and occasionally, upper chest; shivering

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