Pronunciation:

ras-BURE-i-kase

Brand Names:

• Elitek

Dosage Forms:

• Powder for Solution

Warnings:

Hypersensitivity Reactions, Hemolysis, Methemoglobinemia, and Interference with Uric Acid MeasurementsHypersensitivity Reactions: Rasburicase can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue rasburicase if a serious hypersensitivity reaction occurs.Hemolysis: Do not administer rasburicase to patients with glucose-6- phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue rasburicase if hemolysis occurs. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting rasburicase therapy.Methemoglobinemia: Rasburicase can result in methemoglobinemia in some patients. Immediately and permanently discontinue rasburicase if methemoglobinemia occurs.Interference with uric acid measurements: Rasburicase enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Enzyme

Uses of This Medicine:

Rasburicase injection treats high uric acid blood levels (hyperuricemia) that are caused by cancer treatment. This medicine is used in adults and children with certain types of cancer (e.g., leukemia, lymphoma, or solid tumors).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rasburicase injection in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rasburicase injection in the elderly. M

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.

Other 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.

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (e.g., hemolysis, methemoglobinemia), history of or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so the needle will need to stay in place for up to 30 minutes.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child while you are receiving this medicine to make sure the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; dizziness; lightheadedness; swelling of your hands, face, or mouth; trouble with breathing; or chest pain after you get the injection.

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

Check with your doctor right away if you or your child develop any of the following symptoms: bluish-colored lips, fingernails, or palms; dark urine; fever; headache; pale skin; rapid heart rate; shortness of breath; sore throat; or unusual bleeding or bruising after you receive this medicine.

Side Effects of This Medicine:

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 with swallowing

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

Less common

Abdominal or stomach pain

agitation

black or red, tarry, stools

bleeding gums

bluish color of the fingernails, lips, skin, palms, or nail beds

changes in skin color

changes in vision

chest pain or discomfort

chills

coma

confusion

convulsions (seizures)

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

fever

headache

hostility

increased menstrual flow or vaginal bleeding

increased sweating

increased thirst

irritability

itching, pain, redness, swelling, tenderness, or warmth on the skin

lightheadedness

lower back or side pain

muscle twitching

nausea

no blood pressure or pulse

nosebleeds

pain or discomfort in the arms, jaw, back, or neck

pain, tenderness, or swelling of the foot or leg

painful or difficult urination

pains in the chest, groin, or legs, especially calves of the 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 loss of coordination

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

sunken eyes

sweating

swelling of the face, fingers, feet, or lower legs

swollen glands

temporary blindness

thirst

tightness in the 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:

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.