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rasburicase (Rx)Brand and Other Names:Elitek

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, powder for reconstitution

  • 1.5mg/vial
  • 7.5 mg/vial
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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
more...

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 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

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Adverse Effects

>10%

Vomiting (50%)

Fever (46%)

Nausea (27%)

Headache (26%)

Abd pain (20%)

Constipation (20%)

Diarrhea (20%)

Mucositis (15%)

Rash (13%)

1-10%

Neutropenia (2-4%)

Resp distress (3%)

Hyperphosphatemia (<10%)

Sepsis (3%)

Neutropenic fever (4%)

<1%

Anaphylaxis

Hemolysis

Methemoglobinemia

Severe rash

Denydration

Acute renal failure

Pancytopenia

Myocardial infarction

Cellulitis

Cardiac failure

Hot flashes

Postmarketing results

Central nervous system disorders: Convulsion, muscle contractions involuntary

Anaphylaxis

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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

Screen patients for G6PD deficiency; immediately and permanently discontinue therapy in any patient developing hemolysis; institute appropriate patient monitoring and support measures (e.g., transfusion support)

Patients should receive adequate hydration as part of uric acid management

Safety & efficacy beyond 5 day or >1 course unknown

Efficacy may be reduced with subsequent courses of therapy due to its imonogenic characteristics; can elicit and antibody response

Immediately and permanently discontinue therapy in any patient identified as having developed methemoglobinemia; institute appropriate monitoring and support measures (e.g., transfusion support, methylene-blue administration)

Interferes with serum uric acid measurement unless blood sample chilled immediately and assayed within 4 hr

Discontinue therapy in any patient developing clinical evidence of a serious hypersensitivity reaction

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known if excreted in breast milk, discontinue drug or do not nurse

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.

more...
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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)

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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

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Images

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Formulary

FormularyPatient Discounts

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  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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