EUSA Pharma: Products: Erwinase®

Erwinase^®

10 000 Units, Lyophilisate for solution for injection.
Crisantaspase (Asparaginase from Erwinia chrysanthemi; Erwinia L-asparaginase)

ERWINASE is used in combination with other anti-neoplastic agents to treat Acute Lymphoblastic Leukemia (ALL). It may also be used in other neoplastic conditions where depletion of asparaginase might be expected to have a useful effect.*

Asparagine is an amino acid that is essential for cell growth; it is produced by most cells. Neoplastic cells associated with ALL are lacking asparagine synthetase activity and rely on asparagine circulating in the blood for growth. L-Asparaginase is an enzyme that lowers circulating asparagine levels in the blood thereby depriving the mutated blood cells of asparagine and inhibiting their growth producing anti-neoplastic effect.

There are different types of L-asparaginase available, each derived from a different bacterium. Patients receiving treatment with L-asparaginase derived from Escherichia coli, who develop hypersensitivity to that form of the enzyme, may be able to continue treatment with ERWINASE as the enzymes are immunologically distinct*. Antibodies targeting E. coli derived L-Asparaginase have been shown not to cross-react with ERWINASE.

ERWINASE is registered in the United Kingdom, Portugal, Netherlands, Austria, Ireland, Canada and Lebanon with registration in process in other countries. In many countries a physician may request ERWINASE be made available to named patients who fulfil a defined criteria. In the US, Erwinase is an Investigational New Drug (IND) which can only be made available on a named patient basis, the latest information on current Erwinase trials can be found at www.clinicaltrials.gov

* UK SmPC.
Please note the exact wording of the approved indication may differ from country to country.

Product

Availability

Description

Erwinase^®:
Lyophilisate for solution for injection (Erwinia chrysanthemiL-asparaginase; crisantaspase).

Europe:
Austria, Cyprus³, Czech Republic³, Denmark², Estonia³, France³, Germany², Greece², Hungary³, Republic of Ireland, Latvia³, Lithuania³, The Netherlands, Norway², Poland³, Portugal, Romania³, Slovakia³, Slovenia³, Spain³, Sweden³, United Kingdom¹

Rest of World:
Albania³, Algeria³, Andorra³, Argentina³, Australia³, Bolivia³, Bosnia³, Brazil³, Canada, Columbia³, Croatia³, Ecuador³, Egypt², Herzigovina³, Hong Kong², Iceland³, India³, Israel³, Kosovo³, Lebanon², Macedonia³, Malaysia², Mexico³, Montenegro³, New Zealand², Palestine³, Paraguay³, Peru³, Philippines³, Saudi Arabia³, Serbia³, South Africa³, South Korea³, Taiwan³, Thailand², Tunisia³, Turkey³, Uruguay³, US⁴

Erwinase is used in combination with other anti-neoplastic agents to treat Acute Lymphoblastic Leukemia. It may also be used in other neoplastic conditions where depletion of asparagine might be expected to have a useful effect. Patients receiving treatment with L-asparaginase derived from Escherichia coli, who develop hypersensitivity to that enzyme, may be able to continue treatment with ERWINASE as the enzymes are immunologically distinct. (UK SmPC)

¹ Local Marketing Authorisation Holder : the Health Protection Agency

² Erwinase is not yet fully approved in these countries but upon the request of a physician, Erwinase may be made available to named patients who fulfil a defined criteria.

³ Erwinase is not yet registered in these countries but upon the request of a physician, Erwinase may be made available to named patients who fulfil a defined criteria.

⁴ Only available as part of a treatment IND.

For information on our full range of products, where they are available and prescribing information, please see the Summary table.