Amgen announced that the Neulasta (pegfilgrastim) Delivery Kit is now available in the United States (US). 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 hospitalisation 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 hospitalisations in 2009 in the U.S.3-7.
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.
Amgen is committed to helping clinically appropriate patients access Neulasta. One of the most common side effects of myelosuppressive chemotherapy is a low white blood cell count. An abnormally low level of neutrophils, important infection-fighting white blood cells, is called neutropenia. The fewer neutrophils a patient has and the longer the neutrophil count remains low the greater the risk of developing a potentially serious infection.
Febrile neutropenia is neutropenia complicated by a fever. Fever is frequently a sign of infection and, in patients receiving myelosuppressive chemotherapy, it can sometimes be the only sign. Febrile neutropenia is a medical emergency and is associated with several potential downstream consequences.
Neulasta is a leukocyte growth factor approved by the FDA in 2002, and is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilisation of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
In a pivotal clinical trial, in patients with nonmyeloid malignancies undergoing myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia, treatment with Neulasta has been shown to significantly reduce the incidence of febrile neutropenia as well as hospitalisations related to febrile neutropenia and the use of IV antibiotics.