Advanced Consumer Information

rasburicase (Intravenous route)

ras-BURE-i-kase

Intravenous routePowder for Solution

Anaphylaxis
- Rasburicase may cause severe hypersensitivity reactions including anaphylaxis. Rasburicase should be immediately and permanently discontinued in any patient developing clinical evidence of a serious hypersensitivity reaction.
Hemolysis
- Rasburicase administered to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency can cause severe hemolysis. Rasburicase administration should be immediately and permanently discontinued in any patient developing hemolysis. It is recommended that patients at higher risk for G6PD deficiency (eg, patients of African or Mediterranean ancestry) be screened prior to starting rasburicase therapy.
Methemoglobinemia
- Rasburicase use has been associated with methemoglobinemia. Rasburicase administration should be immediately and permanently discontinued in any patient identified as having developed methemoglobinemia.
Interference with Uric Acid Measurements
- Rasburicase will cause enzymatic degradation of the uric acid within blood samples left at room temperature, resulting in spuriously low uric acid levels. To ensure accurate measurements, blood must be collected into pre-chilled tubes containing heparin anticoagulant and immediately immersed and maintained in an ice water bath; plasma samples must be assayed within 4 hours of sample collection .

Rasburicase may cause severe hypersensitivity reactions including anaphylaxis, hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, and methemoglobinemia. Therapy should be immediately and permanently discontinued in any patient developing these conditions. Rasburicase will cause enzymatic degradation of the uric acid within blood samples left at room temperature, resulting in spuriously low uric acid levels .

Commonly used brand name(s):

In the U.S.

Elitek

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Enzyme

Uses For rasburicase

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

rasburicase is available only with your doctor's prescription.

Before Using rasburicase

In deciding to use a medicine, the risks of taking 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 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

rasburicase 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.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of rasburicase

You should take only one course of treatment (once a day for 5 days) of rasburicase unless your doctor tells you differently. It is important that you follow your doctor's instructions to avoid a serious allergic reaction to rasburicase.

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 amount of medicine that you take depends on the strength of the medicine. Also, 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 using the medicine.

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

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using rasburicase

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 rasburicase.

It is very important to use rasburicase 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.

rasburicase Side Effects

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 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.

Some 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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