Fasturtec®/Elitek® (rasburicase)

First biotechnology product from Sanofi-Synthelabo's research, Fasturtec® was approved in Europe in 2001. In the United States, the product was approved in July 2002 under the name Elitek®. Fasturtec® is now marketed throughout Europe and the United States, and it is in the process of being made available to healthcare professionals in Australia, Asia and Latin America.

Rasburicase, the active ingredient of Fasturtec®, is an enzyme produced by genetic engineering at a dedicated production centre.

Fasturtec® is indicated for the prevention and teatment of hyperuricemia (uric acid accumulation) caused by the treatment for hematological cancers (leukemia, lymphoma, and myeloma) and solid tumor malignancies.

In the United States, Elitek® (rasburicase) is indicated in pediatric patients with leukemia, lymphoma, and solid tumor malignancies.
In Europe, Elitek® is indicated in patients with hematologic malignant disease with bulky syndrome and high risk of tumor lysis syndrome at the chemotherapy initiation.

After intravenous infusion, Fasturtec®/Elitek® degrades uric acid produced by the degradation of cancerous cells destroyed by chemotherapy. Renal accumulation of uric acid (a frequent symptom of tumorlysis syndrome) is a side effect of treatment for certain cancers that can lead to acute and potentially fatal renal failure.

The risk posed by uric acid accumulation is particularly significant when treating certain pediatric cancers, whose prognosis is often favourable. Fasturtec®/Elitek® was therefore studied in children with cancer.