Rasburnat — Rasburicase for Injection 1.5 mg, 1 Vial Cold chain · Storage +2…+8 °C

Rasburnat is supplied as a lyophilized powder for solution for infusion with solvent.

Qualitative and Quantitative Composition:

• Active Ingredient: Rasburicase — 1.5 mg per vial.
• Excipients (Lyophilisate): Mannitol, alanine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate.
• Solvent: Water for injections (containing poloxamer 188 in the solvent vial/ampoule).

Packaging and Presentation: White to off-white lyophilized powder or porous cake in a colorless glass vial. Supplied with solvent. The outer carton contains 1 vial of lyophilisate (1.5 mg) and 1 ampoule/vial of solvent, along with prescribing information. Labeled with Rasburnat (Rasburicase for Injection 1.5 mg) and Natco Pharma corporate graphics.

Pharmacodynamics:
Uric acid is the final product of purine catabolism in humans. Rasburicase is a recombinant urate-oxidase enzyme that catalyzes the enzymatic oxidation of uric acid into allantoin (an inert, highly soluble substance easily excreted by the kidneys). Enzymatic cleavage generates minor amounts of hydrogen peroxide. The drug induces rapid drops in plasma uric acid within 4 hours, preventing renal tubular precipitation.

Pharmacokinetics:

• Absorption & Distribution: Administered intravenously, achieving 100% bioavailability. Volume of distribution is approximately 110–127 ml/kg, comparable to extracellular fluid volume.
• Metabolism: As a protein, rasburicase is degraded in the body into peptides and amino acids via endogenous proteases.
• Elimination: Renal excretion of unchanged rasburicase is minimal. Clearance is approximately 3.5–5.0 ml/h/kg. Terminal half-life ($T_{1/2}$) averages 18–21 hours.

Rasburnat 1.5 mg is indicated in adult and pediatric patients (aged 0 to 18 years) for:

• Prevention and Treatment of Acute Hyperuricemia: Management and prevention of acute hyperuricemia in patients with hematologic malignancies (acute leukemia, aggressive non-Hodgkin lymphoma) with high tumor burden at risk of rapid tumor lysis syndrome (TLS) upon initiation of chemotherapy.

Rasburnat is administered exclusively via intravenous infusion (over 30 minutes) through a separate infusion line (do not mix or co-administer with glucose solutions).

Preparation Instructions:
Reconstitute the contents of one vial (1.5 mg) with the provided solvent (typically 1 ml of water for injections). Swirl gently to dissolve (do not shake!). Dilute the resulting solution in 0.9% sodium chloride injection (typically to a total volume of 50 ml) for IV infusion.

Dosing Regimen:
The recommended dose is 0.20 mg/kg body weight daily. Administered as a daily intravenous infusion for 5 to 7 days depending on uric acid response and chemotherapy duration.

Administration of Rasburnat is contraindicated in:

• Hypersensitivity: Known hypersensitivity to rasburicase, other uricases, or any excipient.
• G6PD Deficiency: Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and other cellular metabolic disorders prone to hemolysis (due to hydrogen peroxide generation during urate oxidation).
• Pregnancy and Lactation: Contraindicated in pregnant or breastfeeding women due to lack of safety data.

Because rasburicase cleaves uric acid enzymatically and is eliminated via proteolysis, it does not involve the cytochrome P450 system:

• Allopurinol and Xanthine Oxidase Inhibitors: Do not affect rasburicase pharmacokinetics, though co-administration is generally unwarranted as rasburicase acts faster and more potently.
• Laboratory Sampling (Important!): Blood samples for uric acid assays must be immediately placed on ice and transported to the laboratory chilled, as rasburicase continues to degrade uric acid in vitro at room temperature, leading to falsely low results.

Pregnancy:
Data regarding rasburicase use in pregnant women are lacking. Animal studies have demonstrated reproductive toxicity. Contraindicated during pregnancy.

Lactation:
It is unknown whether rasburicase is excreted in human breast milk. Breastfeeding must be discontinued during treatment.

Adverse reactions are generally infrequent, but may include:

• Allergic Reactions: Anaphylaxis, anaphylactoid reactions, rash, urticaria, bronchospasm (due to proteinaceous nature).
• Hematologic: Hemolysis or methemoglobinemia (in patients with G6PD deficiency).
• Gastrointestinal Tract: Nausea, vomiting, diarrhea, abdominal pain, constipation.
• General Disorders: Fatigue, headache, pyrexia, peripheral edema.
• Metabolic Changes: Hypophosphatemia, hypocalcemia.

Symptoms:
Acute overdose cases have not been reported. Overdose would manifest as an exaggerated pharmacologic effect (undetectable plasma uric acid) alongside potential adverse reactions.

Treatment:
No specific antidote exists. Supportive and symptomatic care should be initiated with monitoring of laboratory parameters and vital organ function.

Storage Requirements for Rasburnat 1.5 mg (Critical!):

• 🌡️ Temperature Range: Store in a refrigerator protected from light at temperatures between 2 °C and 8 °C. Do not freeze!
• 💧 Transportation: Transport in a cold chain thermal container (2–8 °C).
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: Stated on packaging. Reconstituted infusion solutions should be used immediately (or stored refrigerated for up to 24 hours). Prescription-only hospital medicine.

To verify authenticity of genuine Rasburnat 1.5 mg manufactured by Natco Pharma, inspect the following features:

• ✅ Corporate Logo: Distinctive blue-green Natco Pharma corporate logo printed on the outer carton and vial label.
• ✅ Packaging Markings: Clear factory printing displaying Batch No., Mfg. Date, Exp. Date, and product designation Rasburnat (Rasburicase for Injection 1.5 mg).
• ✅ Kit Contents: Carton contains exactly 1 vial of lyophilisate (1.5 mg) and 1 vial/ampoule of solvent.
• ✅ Print Quality: High-grade tamper-evident packaging artwork without typography errors.