Keyword Analysis & Research: asparaginase fda


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Frequently Asked Questions

Is the asparaginase shortage over?

Now, there is hope that the shortages may be over. On June 30, FDA approved a new form of asparaginase, erwinia chrysanthemi (recombinant)-rywn (Rylaze), which was developed to address the ongoing shortages of Erwinia asparaginase.

What's new in Erwinia asparaginase?

The recent FDA approval of Rylaze, a new form of Erwinia asparaginase, was based on data from 102 children and adults with ALL or LBL who were allergic to E. coli asparaginase or experienced silent inactivation.

What is asparaginase Erwinia chrysanthemi?

According to the prescribing information, asparaginase Erwinia chrysanthemi is indicated as part of a multi-agent treatment regimen for patients with hypersensitivity to E. coli –derived asparaginase.

Can asparaginase be given intramuscular?

Giving the recommended dosage by injection into a muscle every 48 hours provided the target level of asparaginase activity in the blood in 94% of patients, the study found. A second part of the study is looking at injecting the drug into a vein. Asparaginases in general can be given either intramuscularly or intravenously.


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