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rasburicase

Fasturtec · ATC code V03AF07

Also known as: Rasburikaz

Key facts
Active substance
rasburicase
ATC code
V03AF07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-28

Key facts

Rasburicase (Fasturtec) is a recombinant urate oxidase that breaks down uric acid and is used to treat and prevent acute hyperuricaemia at the start of chemotherapy for haematological malignancies.

What it is used for

  • Treatment and prophylaxis of acute hyperuricaemia, to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy, high tumour burden and risk of rapid tumour lysis at initiation of chemotherapy.

Dosing

  • 0.20 mg/kg/day as a once-daily 30-minute intravenous infusion in 50 ml sodium chloride 9 mg/ml (0.9%), immediately prior to and during the initiation of chemotherapy.
  • Duration up to 7 days, based on plasma uric acid monitoring and clinical judgement.
  • Children: same dose; no adjustment in renal or hepatic impairment.
  • Infuse through a different line from chemotherapy or flush with saline; plasma uric acid samples need special handling (degradation in vitro).

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia (hydrogen peroxide is a by-product).

Important warnings

  • Allergic reactions up to anaphylactic shock with potentially fatal outcome; stop immediately and permanently if severe. Caution with a history of atopic allergies.
  • Methaemoglobinaemia and haemolysis: discontinue immediately and permanently.
  • Insufficient data on repeated treatment courses; anti-rasburicase antibodies have been detected.

Side effects

  • Most common: nausea, vomiting, headache, fever and diarrhoea.
  • Uncommon: haemolysis, haemolytic anaemia and methaemoglobinaemia (especially with G6PD deficiency); allergic reactions such as rash and urticaria.

Interactions

  • No interaction studies; as an enzyme, rasburicase is an unlikely candidate for drug interactions.

Pregnancy and breastfeeding

  • Use in pregnancy only if strictly necessary; not recommended in women of childbearing potential not using contraception.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • FasturtecSanofi Winthrop Industrie · EMEA/H/C/000331

Source: European Medicines Agency (EMA), product information

Turkey

  • FasturtecSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Fasturtec
Liechtenstein
Fasturtec
Norway
Fasturtec

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Fasturtec – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/fasturtec-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.