Ireland based Jazz Pharmaceuticals plc has reported that the U.S. FDA cleared the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a part of a multi-agent chemotherapeutic regimen for the treatment of sufferers with acute lymphoblastic leukemia (ALL) who have developed hyper-sensitivity to E. coli-extracted asparaginase.
Jazz Pharmaceuticals’s M.D and executive vice president Jeffrey Tobias stated”Administration of Erwinaze via an IV infusion offers doctors another choice for patients, such as those who can’t tolerate intramuscular injections”. Getting FDA acceptance of this extended label for Erwinaze reflects our ongoing dedication to enhancing sufferers’ lives.
Before this acceptance, the only accepted route of administration for Erwinaze was via intramuscular injection. With the extended label, the formulation of Erwinaze presently on the market may now be given to sufferers by either IV infusion or IM injection. The modified product label offers data and information to help doctors understand the various administration choices and figure out which route of administration is most acceptable for their sufferers.
The US FDA approval was dependent on a pharmacokinetic research of IV asparaginase Erwinia chrysanthemi subsequent hypersensitivity to E coli-derived asparaginase. The IV administration trial was performed at 10 locations in the U.S. and enrolled a overall of 30 sufferers, of which 24 sufferers were evaluable for the primary endpoint, which was the proportion of sufferers having an asparaginase activity level of higher than 0.1 IU/mL 48 hours after dosing.
US FDA approved Erwinaze® (asparaginase Erwinia chrysanthemi)on Nov. 18, 2011 and it is currently approved in the U.S. for administration via IM injection or via IV infusion in combination with chemotherapy. It is showed as a component of a multi-agent chemotherapeutic regimen for the therapy of sufferers with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. Erwinaze is produced from the bacterium Erwinia chrysanthemi and is for that reason immunologically unique from E. coli-derived asparaginase and appropriate for sufferers with hypersensitivity to E. coli-derived therapies. Outside of the U.S., Erwinaze is marketed under the name Erwinase®.
Erwinaze is contraindicated in sufferers with a record of serious hypersensitivity reactions to Erwinaze, such as anaphylaxis; or where severe pancreatitis, severe thrombosis or severe hemorrhagic situations took place with prior L-asparaginase treatment. Discontinue Erwinaze if severe hypersensitivity, such as anaphylaxis, or serious or hemorrhagic pancreatitis takes place and start suitable therapy. Administer in a setting with resuscitation equipment and other agents essential to deal with anaphylaxis. Glucose intolerance has been claimed which, in some situations may be permanent. Discontinue Erwinaze if a severe thrombotic or hemorrhagic event takes place till symptoms resolve.
The very frequent adverse reactions (incidence 1% or greater) with Erwinaze therapy are hyperglycemia, pancreatitis, systemic hypersensitivity, hyperbilirubinemia, abnormal transaminases, vomiting, local reactions, thrombosis, fever, nausea, abdominal pain/discomfort and diarrhea
About Acute lymphoblastic leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a cancer that impacts the white blood cells. Around 5,000-6,000 new sufferers are clinically diagnosed in the U.S. per year. ALL is the very frequent cancer in children. While treatment results in adult ALL have stayed mostly unchanged, therapy results have considerably enhanced in kids, with 5-year survival rates over 80%. Asparaginase therapy is suggested as an essential component of a multi-agent chemotherapy regimen in ALL.