Usual Adult Dose for Hyperuricemia Secondary to Chemotherapy

0.2 mg/kg as a 30-minute IV infusion once a day for up to 5 days

Comments:

• Use beyond 5 days or administration of more than 1 course of therapy is not recommended
• The exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgement.
• This drug is only approved for a single course of treatment.

Use: For the initial management of plasma uric acid levels in patients with leukemia, lymphoma, and solid tumor malignancies who are receiving chemotherapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Usual Pediatric Dose for Hyperuricemia Secondary to Chemotherapy

0.2 mg/kg as a 30-minute IV infusion once a day for up to 5 days

Comments:

• Use beyond 5 days or administration of more than 1 course of therapy is not recommended.
• The exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgement.
• This drug is only approved for a single course of treatment.

Use: For the initial management of plasma uric acid levels in patients with leukemia, lymphoma, and solid tumor malignancies who are receiving chemotherapy expected to result in tumor lysis and subsequent elevation of plasma uric acid

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

For any patient who develops a severe hypersensitivity reaction, hemolysis, or methemoglobinemia: This drug should be immediately and permanently discontinued.

Precautions

US BOXED WARNINGS:
HYPERSENSITIVITY REACTIONS:

• This drug can cause serious and fatal hypersensitivity reactions, including anaphylaxis.
• Immediately and permanently discontinue this drug in patients who experience a serious hypersensitivity reaction.

HEMOLYSIS:

• Do not administer to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Immediately and permanently discontinue this drug in patients developing hemolysis.
• Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting treatment.

METHEMOGLOBINEMIA:

• This drug can result in methemoglobinemia in some patients.
• Immediately and permanently discontinue this drug in patients developing methemoglobinemia.

INTERFERENCE WITH URIC ACID MEASUREMENTS:

• This drug 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.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer by IV infusion; do not give by IV bolus injection.
• Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after administration.
• Do not use filters during infusion.

Storage requirements:

• Prior to reconstitution, store lyophilized product and diluent at 2C to 8C (36F to 46F); protect from light; do not freeze.
• Use immediately; reconstituted or diluted solution may be stored at 2C to 8C for up to 24 hours after reconstitution if needed.

Reconstitution/preparation techniques:

• Must be reconstituted with the diluent provided.
• Reconstitute 1.5 mg vial with 1 mL of diluent; reconstitute 7.5 mg vial with 5 mL of diluent.
• Mix by swirling; do not shake or vortex; only clear, colorless solutions should be used; discard if particulate matter is visible or product is discolored.
• Inject calculated dose into an infusion bag containing the appropriate amount of 0.9% NS to achieve a final total volume of 50 mL.
• Do not use filters during reconstitution or infusion.

IV compatibility:

• Use separate line or flush line with at least 15 mL of normal saline prior to and after administration.
• Do not dilute in glucose solution as there is a potential for incompatibility.

General:

• Administration of this drug should be under the supervision of a physician trained in chemotherapy of hematological malignancies.
• Safety and efficacy have only been established for a single course of treatment.

Monitoring:

• Monitor uric acid levels; it is important to ensure proper handling of blood samples as this drug will enzymatically degrade uric acid in blood samples left at room temperature resulting in inaccurate uric acid measurements.

Patient advice:

• Patients should be informed of the risk of serious hypersensitivity reactions and should be instructed to immediately notify their healthcare professional if they experience an allergic reaction, bronchospasm, chest pain or tightness, dyspnea, hypoxia, hypotension, or urticaria.