Description
Indication & Scope
FASTURTEC® is a prescription recombinant urate oxidase indicated for the management and prevention of acute hyperuricemia associated with tumor lysis syndrome (TLS) in pediatric patients with leukemia or lymphoma who are at high risk of rapid tumor cell lysis during chemotherapy. In many countries, it is also approved for adults at risk of TLS. Rasburicase rapidly converts uric acid into the more soluble metabolite allantoin, helping prevent uric acid nephropathy and acute kidney injury.
- Mechanism: Rasburicase is a recombinant urate oxidase enzyme that catalyzes the oxidation of uric acid into allantoin, which is readily excreted by the kidneys.
- Drug class: Recombinant urate oxidase (urate-lowering enzyme).
- Clinical use: Prevention and treatment of chemotherapy-related hyperuricemia in patients at high risk of tumor lysis syndrome.
| Generic Name | Rasburicase for Injection |
| Brand Name | FASTURTEC® |
| Ingredient | Rasburicase |
| Dosage Form | Lyophilized Powder for Injection |
| Package | 1.5 mg/vial, 3 vials with 3 solvent ampoules/carton |
| Conditions Treated | Tumor lysis syndrome-associated hyperuricemia |
| Taboos | G6PD deficiency, hypersensitivity to rasburicase or yeast proteins, history of hemolysis or methemoglobinemia after rasburicase |
| Place of origin | Italy |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store refrigerated at 2–8°C. Protect from light. Do not freeze. |
| Manufacturer | Sanofi S.r.l. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval Number | SJ20180024 |
| Approval Date | April 13, 2023 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: The recommended dose is 0.2 mg/kg administered by intravenous infusion once daily for up to 5 days. Treatment beyond one course is generally not recommended.
Time: Administer as a 30-minute intravenous infusion, preferably before or at the start of chemotherapy in patients at risk of tumor lysis syndrome.
Instructions for use: Reconstitute each vial only with the supplied diluent and further dilute with 0.9% sodium chloride before intravenous infusion. Do not shake the vial vigorously or administer as an intravenous bolus. Blood samples for uric acid measurement should be collected on ice and analyzed promptly to avoid falsely low results.
Interaction: No clinically significant CYP-mediated drug interactions are known. Concomitant use with allopurinol is generally unnecessary because both medicines lower uric acid through different mechanisms.
Side effects: Common adverse reactions include nausea, vomiting, fever, headache, abdominal pain, diarrhea, and rash. Serious adverse reactions include hypersensitivity, anaphylaxis, hemolysis, methemoglobinemia, and infusion-related reactions, particularly in patients with G6PD deficiency.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is FASTURTEC® used for?
FASTURTEC® is used to rapidly reduce high blood uric acid levels in patients at risk of tumor lysis syndrome during chemotherapy.
Who should not receive FASTURTEC®?
Patients with G6PD deficiency, previous severe hypersensitivity to rasburicase, or a history of rasburicase-induced hemolysis or methemoglobinemia should not receive this medicine.
How quickly does FASTURTEC® work?
Rasburicase begins lowering uric acid within hours after administration and is generally more rapid than xanthine oxidase inhibitors such as allopurinol.
Can FASTURTEC® be used in adults?
Although the current NMPA indication is primarily for pediatric leukemia and lymphoma patients, rasburicase is approved in many countries for both adults and children at high risk of tumor lysis syndrome.
FASTURTEC® | Rasburicase | Tumor Lysis Syndrome | DengYueRX
INN: Rasburicase
Indications: Tumor lysis syndrome-associated hyperuricemia
Dosage Form: Lyophilized Powder for Injection
Strength: 1.5 mg/Vial
Original price was: $1,759.66.$1,495.71Current price is: $1,495.71.
