Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 1.5mg/vial
- 7.5 mg/vial
Hyperuricemia Caused by Tumor Lysis
Indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid
0.2 mg/kg IV infused over 30 minutes qDay for up to 5 days
Dosing Considerations
Limitation of use: indicated only for a single course of treatment
Dosing beyond 5 days or administration of more than 1 course is not recommended
Dosage Forms & Strengths
injection, powder for reconstitution
- 1.5mg/vial
- 7.5 mg/vial
Hyperuricemia Caused by Tumor Lysis
Indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid
≥1 month: 0.2 mg/kg IV infused over 30 min qDay for up to 5 days
Dosing Considerations
Limitation of use: indicated only for a single course of treatment
Dosing beyond 5 days or administration of more than 1 course is not recommended
Adverse Effects
>10%
Vomiting (50%)
Fever (46%)
Nausea (27%)
Headache (26%)
Abdominal pain (20%)
Constipation (20%)
Diarrhea (20%)
Mucositis (15%)
Rash (13%)
1-10%
Neutropenia (2-4%)
Respiratory distress (3%)
Hyperphosphatemia (<10%)
Sepsis (3%)
Neutropenic fever (4%)
<1%
Anaphylaxis
Hemolysis
Methemoglobinemia
Severe rash
Dehydration
Acute renal failure
Pancytopenia
Myocardial infarction
Cellulitis
Cardiac failure
Hot flashes
Postmarketing results
Central nervous system disorders: Convulsion, muscle contractions involuntary
Anaphylaxis
Warnings
Black Box Warnings
May cause serious hypersensitivity reactions, including anaphylaxis. Should be immediately and permanently discontinued in any patient developing clinical evidence of a serious hypersensitivity reaction.
When administered to patients with G-6-PD deficiency, this agent can cause severe hemolysis.
Should be immediately and permanently discontinued in any patient developing hemolysis. It is recommended that patients at a higher risk for G-6-PD deficiency (eg, patients of African or Mediterranean ancestry) be screened prior to starting rasburicase.
Rasburicase use has been associated with methemoglobinemia. Should be immediately and permanently discontinued in any patient developing methemoglobinemia.
Rasburicase causes 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 prechilled 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.
Contraindications
Hypersensitivity
G6PD deficiency
History of hemolysis or methemoglobinemia reactions to rasburicase
Cautions
Hypersensitivity reactions can occur at any time during treatment including first dose; signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria; immediately and permanently discontinue administration in any patient developing clinical evidence of a serious hypersensitivity reaction; safety and efficacy have been established only for a single course of treatment once daily for 5 days
Screen patients for G6PD deficiency (eg, patients of African or Mediterranean ancestry); contraindicated in patients with G6PD deficiency because hydrogen peroxide is one of the major by-products of the conversion of uric acid to allantoin; severe hemolytic reactions may occur within 2-4 days of the start of therapy; immediately and permanently discontinue therapy in any patient developing hemolysis; institute appropriate patient monitoring and support measures (eg, transfusion support)
Patients should receive adequate hydration as part of uric acid management
Efficacy may be reduced with subsequent courses of therapy due to its immunogenic characteristics; can elicit an antibody response
Methemoglobinemia has included cases of serious hypoxemia requiring intervention with medical support measures; not known whether patients with deficiency of cytochrome b5 reductase (formerly known as methemoglobin reductase) or of other enzymes with antioxidant activity are at increased risk for methemoglobinemia or hemolytic anemia; immediately and permanently discontinue therapy in any patient identified as having developed methemoglobinemia; institute appropriate monitoring and support measures (eg, transfusion support, methylene-blue administration)
Interferes with serum uric acid measurement unless blood sample chilled immediately and assayed within 4 hr
Pregnancy & Lactation
Pregnancy
The limited available data in pregnant women are insufficient to inform a drug- associated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes; consider benefits and risks of therapy and possible risks to fetus when prescribing therapy to a pregnant woman
Animal data
- Based on findings in animals, drug may cause fetal harm when administered to pregnant women; in animal reproduction studies, intravenous administration to pregnant rabbits during organogenesis at 5-times human exposure (based on AUC) at recommended human dose of 0.2 mg/kg resulted in adverse developmental outcomes, including structural abnormalities, embryo-fetal mortality, and alterations to growth
Lactation
There are no available data on presence of drug in human breast milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child, advise patients that breastfeeding is not recommended during treatment, and for 2 weeks after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant urate oxidase; catalyzes the oxidation of uric acid into allantoin, a soluble metabolite of uric acid
Pharmacokinetics
Half-Life, Terminal: 15.7-22.5 hr
Onset: Within 4 hr of initial administration
Vd: 110-127 mL/kg (peds); 75.8-138 mL/kg (adults)
Administration
IV Preparation
Reconstitute with 1.5 mg vial w/ 1mL and 7.5 mg vial w/ 5 mL of supplied diluent
Mix by gently swirling; do not shake or vortex
Discard if discolored
Further dilute dose in NS to a final volume of 50 mL
Reconstituted solution may be refrigerated but administered within 24 hr
IV Administration
Infuse over 30 min
Do not administer bolus
Do not filter during infusion
If not possible to administer through a separate line, IV line should be flushed with at least 15 mL NS prior to and following rasburicase infusion
Initiate chemotherapy 4-24 hr after 1st dose
Discontinue if signs of hypersensitivity, hemolysis, or methemoglobinemia occur
Monitor: Plasma uric acid
Storage
Prior to reconstitution, store drug and diluent at 2-8°C (36-46°F)
Do not freeze; protect from light
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Elitek intravenous - | 7.5 mg vial |  | |
| Elitek intravenous - | 1.5 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
rasburicase intravenous
RASBURICASE - INJECTION
(ras-BURE-i-kase)
COMMON BRAND NAME(S): Elitek
WARNING: This drug can cause a severe allergic reaction. If you develop new symptoms such as chest pain, trouble breathing, severe dizziness, itching/swelling (especially of the face/tongue/throat), or rash/hives, stop using this medication and get medical help right away. Do not restart this medication if this severe allergic reaction has occurred. Consult the doctor or pharmacist for more details.Do not take this medication if you have a metabolic condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency because it can severely damage your red blood cells leading to anemia (hemolysis). If you are of African or Mediterranean descent, you may be at higher risk for G6PD deficiency and you should be tested to see if you have this condition before starting this medication.This medication can cause a condition that affects the ability of your red blood cells to carry oxygen (methemoglobinemia). Do not restart this medication if this effect occurs; consult the doctor for details.This medication can interfere with accurate measurement of uric acid in the blood, resulting in falsely low levels (see Drug Interactions section). Be sure to tell all laboratory personnel that you are using this drug.
USES: This medication is used to prevent high blood levels of uric acid from occurring in children with cancer (such as leukemia, lymphoma, solid malignant tumors) who are about to receive cancer chemotherapy treatment. When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream. This medication allows uric acid to more easily be removed from the body by the kidneys.
HOW TO USE: This medication is given by injection into a vein as directed by your doctor, usually over 30 minutes. Rasburicase is given once a day for 5 days. Timing of cancer chemotherapy and rasburicase doses is important. Chemotherapy is usually started 4 to 24 hours after the first dose of rasburicase.Fluids are also given into the vein with this medication to help decrease your uric acid levels.
SIDE EFFECTS: See also Warning section.Nausea, vomiting, headache, stomach pain, constipation, diarrhea, or mouth sores/ulcers may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of infection (such as sore throat that doesn't go away, fever, chills).Get medical help right away if you have any very serious side effects, including: weakness, yellowing eyes/skin, dark urine, blue/gray skin color.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain metabolic conditions (such as G6PD deficiency), previous red blood cell damage (such as hemolysis, methemoglobinemia) with this medication, kidney disease, dehydration.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children less than 2 years old may be more sensitive to the side effects of this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 2 weeks after stopping treatment.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication can interfere with the uric acid in the blood sample tubes when the tubes remain at room temperature, leading to falsely low uric acid results. Laboratory personnel must follow special procedures to process the blood sample.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as uric acid levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new schedule.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Information last revised November 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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