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Drug overview for ELITEK (rasburicase):
Generic name: RASBURICASE (ras-BURE-i-kase)
Drug class: Hyperuricemia Agents (non-uricosuric)
Therapeutic class: Gout and Hyperuricemia Therapy
Rasburicase, a biosynthetic (recombinant DNA origin) form of urate oxidase, is an enzyme that catalyzes oxidation of uric acid into an inactive and soluble metabolite, allantoin.
No enhanced Uses information available for this drug.
Generic name: RASBURICASE (ras-BURE-i-kase)
Drug class: Hyperuricemia Agents (non-uricosuric)
Therapeutic class: Gout and Hyperuricemia Therapy
Rasburicase, a biosynthetic (recombinant DNA origin) form of urate oxidase, is an enzyme that catalyzes oxidation of uric acid into an inactive and soluble metabolite, allantoin.
No enhanced Uses information available for this drug.
DRUG IMAGES
ELITEK 7.5 MG VIAL
ELITEK 1.5 MG VIAL
The following indications for ELITEK (rasburicase) have been approved by the FDA:
Indications:
Hyperuricemia due to cancer therapy
Professional Synonyms:
Cancer therapy-induced hyperuricemia
Chemotherapy-induced hyperuricemia
Hyperuricemia due to anticancer therapy
Indications:
Hyperuricemia due to cancer therapy
Professional Synonyms:
Cancer therapy-induced hyperuricemia
Chemotherapy-induced hyperuricemia
Hyperuricemia due to anticancer therapy
The following dosing information is available for ELITEK (rasburicase):
The recommended pediatric dosage of rasburicase is 0.15 or 0.2 mg/kg as a single daily dose for 5 days.
Chemotherapy should be initiated 4-24 hours after the first dose of rasburicase. Because the safety and effectiveness of other dosing regimens have not been established, the manufacturer does not recommend administering the drug for more than 5 days or for more than one course of therapy. (See Sensitivity Reactions: Anaphylaxis under Cautions: Warnings/Precautions.)
Chemotherapy should be initiated 4-24 hours after the first dose of rasburicase. Because the safety and effectiveness of other dosing regimens have not been established, the manufacturer does not recommend administering the drug for more than 5 days or for more than one course of therapy. (See Sensitivity Reactions: Anaphylaxis under Cautions: Warnings/Precautions.)
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ELITEK 1.5 MG VIAL | Maintenance | Adults infuse 0.2 mg/kg over 30 minute(s) by intravenous route once daily |
| ELITEK 7.5 MG VIAL | Maintenance | Adults infuse 0.2 mg/kg over 30 minute(s) by intravenous route once daily |
No generic dosing information available.
The following drug interaction information is available for ELITEK (rasburicase):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ELITEK (rasburicase):
Drug contraindication overview.
Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. (See Warnings: Hemolysis under Cautions: Warnings/Precautions.) Known hypersensitivity (e.g., anaphylaxis) or hematologic (e.g., hemolysis, methemoglobinemia) reactions to rasburicase or any ingredient (e.g., excipients) in the formulation.
Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. (See Warnings: Hemolysis under Cautions: Warnings/Precautions.) Known hypersensitivity (e.g., anaphylaxis) or hematologic (e.g., hemolysis, methemoglobinemia) reactions to rasburicase or any ingredient (e.g., excipients) in the formulation.
There are 6 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Hemoglobin H disease |
| Hemolysis |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
| Lactation |
| Methemoglobinemia |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for ELITEK (rasburicase):
Adverse reaction overview.
Adverse effects occurring in at least 10% of patients receiving rasburicase in clinical trials include vomiting, fever, nausea, headache, abdominal pain, constipation, diarrhea, mucositis, and rash. Some of these adverse effects (e.g., vomiting, diarrhea, fever, rash) were observed more frequently in children younger than 2 years of age than in those 2-17 years of age. In addition, vomiting, fever, nausea, diarrhea, and headache reportedly occurred more frequently in patients receiving IV rasburicase than in those receiving oral allopurinol. The incidence of rash was similar in the 2 treatment groups, but severe rash (grade 3 or 4) was reported only in a patient who received rasburicase.
Adverse effects occurring in at least 10% of patients receiving rasburicase in clinical trials include vomiting, fever, nausea, headache, abdominal pain, constipation, diarrhea, mucositis, and rash. Some of these adverse effects (e.g., vomiting, diarrhea, fever, rash) were observed more frequently in children younger than 2 years of age than in those 2-17 years of age. In addition, vomiting, fever, nausea, diarrhea, and headache reportedly occurred more frequently in patients receiving IV rasburicase than in those receiving oral allopurinol. The incidence of rash was similar in the 2 treatment groups, but severe rash (grade 3 or 4) was reported only in a patient who received rasburicase.
There are 16 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hyperbilirubinemia Hypophosphatemia Severe dyspnea Stomatitis |
Bacterial sepsis Hyperphosphatemia |
| Rare/Very Rare |
|---|
|
Acute renal failure Anaphylaxis Cardiac arrhythmia Chest pain Hemolysis Infection Methemoglobinemia Myocardial ischemia Seizure disorder Supraventricular arrhythmias |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Constipation Diarrhea Fever Headache disorder Nausea Peripheral edema Pharyngitis Skin rash Symptoms of anxiety Vomiting |
Body fluid retention |
| Rare/Very Rare |
|---|
|
Muscle spasm |
The following precautions are available for ELITEK (rasburicase):
Safety and efficacy not established in children younger than 2 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
Not known whether rasburicase is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Experience in those 65 years of age and older insufficient to determine whether they respond differently from younger adults.
The following prioritized warning is available for ELITEK (rasburicase):
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 uric acid blood levels, resulting in falsely low levels (see Drug Interactions section). Be sure to tell all lab personnel that you are using this drug.
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 uric acid blood levels, resulting in falsely low levels (see Drug Interactions section). Be sure to tell all lab personnel that you are using this drug.
The following icd codes are available for ELITEK (rasburicase)'s list of indications:
| Hyperuricemia due to cancer therapy | |
| E88.3 | Tumor lysis syndrome |
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