rasburicase (Intravenous route)

ras-BURE-i-kase

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

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

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

Geriatric

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

Pregnancy

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.

Other Medical Problems

The presence of other medical problems may affect the use of rasburicase. 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 rasburicase

A nurse or other trained health professional will give you or your child rasburicase in a hospital or clinic. rasburicase 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 rasburicase

It is very important that your doctor check you or your child while you are receiving rasburicase 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.

rasburicase 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 rasburicase.

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 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 or nurse immediately if any of the following side effects occur:

• Cracked lips
• diarrhea
• difficulty with swallowing
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth

• 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

• 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:

• 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.

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