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|Amgen Announces Launch Of New Neulasta® (Pegfilgrastim) Delivery Kit|
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.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.2 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.2
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.
About Febrile Neutropenia
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.
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 hospitalizations related to febrile neutropenia and the use of IV antibiotics.9
Important Safety Information
Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture in patients with left upper abdominal or shoulder pain. Acute respiratory distress syndrome (ARDS) can occur. Evaluate for ARDS in patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur. Permanently discontinue Neulasta in patients with serious allergic reactions. The On-body Injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. Severe and sometimes fatal sickle cell crises have been reported.
Most common adverse reactions (≥ 5 percent difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.
Please see the Neulasta Full Prescribing Information by clicking here http://pi.amgen.com/united_states/neulasta/neulasta_pi_hcp_english.pdf.
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