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Rasburicase (Intravenous route)

Pronunciation:

ras-BURE-i-kase

Brand Names:

  • Elitek

Dosage Forms:

  • Powder for Solution

Warnings:

Intravenous route(Powder for Solution)

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 .

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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.


Last Updated: 4/4/2014

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