OREANDA-NEWS. Amgen (NASDAQ: AMGN) today announced that the Neulasta® (pegfilgrastim) Delivery Kit is now available in the United States (U.S.). The Neulasta Delivery Kit includes a specially designed single-use prefilled syringe co-packaged with the new On-body Injector for Neulasta. The Neulasta Delivery Kit will enable the healthcare provider (HCP) to initiate administration of Neulasta on the same day as cytotoxic chemotherapy – with delivery of the patient's full dose of Neulasta the day following chemotherapy administration, consistent with the Neulasta prescribing information (PI).
One of the most common side effects of myelosuppressive chemotherapy is a low white blood cell count, or neutropenia. Febrile neutropenia (neutropenia with fever) is a medical emergency and is associated with an increased risk of hospitalization and use of IV anti-infective drugs. Among all cancer patients, including those who did or did not receive a granulocyte-colony stimulating factor (G-CSF), neutropenia and infectious complications resulted in an estimated 200,000 to 330,000 hospitalizations in 2009 in the U.S.

Although Neulasta has been available for 12 years, some patients still do not receive their Neulasta at least 24 hours after cytotoxic chemotherapy as specified in the Neulasta PI.

Among appropriate patients receiving myelosuppressive chemotherapy, many return to their HCP one day after chemotherapy treatment for the sole purpose of receiving a Neulasta injection; however, a portion of patients requiring Neulasta may not be able to return to their HCP,  which means they may not be in accordance with PI recommended dosing. With the Neulasta Delivery Kit, HCPs now have an administration option for patients who would not need to return to the clinic or hospital the day after chemotherapy for anything other than their Neulasta injection.

Results from a Phase 1 pharmacokinetic study demonstrated that the On-body Injector for Neulasta offers comparable pharmacokinetics to Neulasta delivered via the prefilled syringe for manual use.

In addition to the On-body Injector, the Neulasta Delivery Kit includes a specifically designed Neulasta prefilled syringe along with HCP and Patient Instructions for Use and a Quick Reference Guide. On the same day as a chemotherapy session, the HCP initiates Neulasta administration by using the co-packaged syringe to fill the injector and activate it. The On-body Injector is then applied to the patient, to deliver Neulasta approximately 27 hours after the administration of cytotoxic chemotherapy. Activation of the injector leads to the subsequent insertion of the subcutaneous cannula while under HCP supervision. The HCP then reviews and  provides the patient with the Patient Instructions for Use, which includes information about the On-body Injector for Neulasta and what the patient can expect while wearing it.