Jazz Pharmaceuticals has released some new vials of Erwinaze, its leukemia drug for children, that came into short supply in 2016 because of manufacturing issues at Porton Biopharma, the CMO that produces it, but the vials come with special handling instructions.
In a recent letter to providers, the company said that to respond to the ongoing product shortage, the FDA has allowed it to release some vials from a batch of Erwinaze that “were previously segregated due to the presence of visible particulate matter on the stopper.”
It said that the vials may have particulate matter on the underside of the stopper but that studies demonstrated that the particulate “are unlikely to transfer to the product during reconstitution.” It said they can be administered either intramuscularly or intravenously, if providers follow the special instructions and use certain filters. It also warned if any particulate is seen in a vial, either before or after reconstitution, that is not bound to the underside of the stopper, then the drug should not be given.
The FDA last year slammed U.K.-based Porton Biopharma in a warning letter for repeated contamination of batches of Erwinaze, saying “persistent contamination hazards and drug quality issues" had not been resolved, even after a sit-down meeting with the FDA and ongoing discussions.
In November 2016, Jazz alerted providers that problems at Porton could affect supply and it was likely the drug would be unavailable once its current supplies were depleted.