Rasburicase / Rasburicasa 1.5mg
| Product Overview | |
| Generic Name | Rasburicase / Rasburicasa 1.5mg |
| Brand Name(s) | Elitek®, Fasturtec® |
| Product Type | Biosimilar |
| Form | Sterile lyophilized powder + diluent for IV infusion. |
| Strength | 1.5 mg vial; |
| Therapeutic Class | Recombinant urate-oxidase / uricolytic enzyme |
| ATC Code | V03AF07 |
| Manufacturing & Regulatory | |
| Manufacturer | Sanofi / Sanofi-aventis. |
| Country | USA, India, Mexico |
| GMP Compliance | WHO-GMP |
| COFEPRIS | N/A |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | request Module 2/ACTD summary |
Description
Rasburicase is a recombinant urate-oxidase enzyme used for initial management of elevated plasma uric acid in adult and pediatric oncology patients with leukemia, lymphoma, or solid tumors receiving anticancer therapy expected to cause tumor lysis syndrome. Standard labeled dosing is 0.2 mg/kg IV over 30 minutes once daily for up to 5 days.
