Auto-Inject System for Pegfilgrastim Supports Timely Delivery to Prevent Neutropenia
Ensuring that pegfilgrastim (Neulasta) is administered at the optimal time for the prevention of neutropenia and febrile neutropenia can pose a challenge for busy healthcare practitioners (HCPs).
Ensuring that pegfilgrastim (Neulasta) is administered at the optimal time for the prevention of neutropenia and febrile neutropenia can pose a challenge for busy healthcare practitioners (HCPs). Attendees at the 40th Annual ONS Congress learned about a new strategy to tackle this problem by deploying a system involving a single-use, prefilled syringe and On-body Injector which enables delivery of the drug at the right time and in the comfort of a patient’s home.
Pegfilgrastim was approved by the FDA in 2002 following data from two pivotal phase III studies in patients with breast cancer which demonstrated that the agent reduced the duration of severe neutropenia and the frequency of neutropenia with fever.
Although Neulasta has been available for 12 years, some patients still do not receive the drug at least 24 hours after cytotoxic chemotherapy as recommended. 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.
Raylene M. Langish, BSN, RN, OCN, an oncology nurse educator with Barnabas Health, Clara Maass Medical Center, in Belleville, New Jersey, described the new delivery option at ONS, noting that “Sometimes it’s difficult in your practice to get that right balance in the timing.”
She shared information drawn from insurance claims data based on 500,000 outpatient administrations over a 12-month period in 2014, which showed that between 24 and 72 hours after chemotherapy, 85% of patients received pegfilgrastim, whereas 11% received the drug more than 72 hours after chemotherapy, and 4% received it the same day as chemotherapy was given. Based on these data, she said, “A significant number of patients may be getting the administration outside the indicated timeframe.”
With the On-body Injector, manufactured by Amgen, the HCP initiates Neulasta administration on the same day as a chemotherapy session, using the co-packaged syringe to fill the injector and activate it for delivery of pegfilgrastim approximately 27 hours after it is applied to intact skin at one of two approved sites: the flattest area of the abdomen, where patients can see the device themselves, or to the back of the arm, which requires monitoring by a caregiver, Langish explained.
The kit comes with both HCP and patient instructions, and both groups have access to a 24/7 support line (1-844-MYNEULASTA [1-844-696-3852]).
Patients don’t have to worry about getting the device wet showering or swimming, Langish added, though the area should remain dry for the period 24 hours after placement (3 hours prior to the auto-injection). HCPs provide education to patients about how to monitor and remove the device, confirm dose delivery using “green light/red light” visual cues built into the device, and how to dispose of it, including opting into the manufacturer’s sharps disposal program. The device’s adhesive adheres very well, said Langish, so additional dressings are not recommended.
Langish noted that results from a phase 1 pharmacokinetic study involving 250 patients demonstrated that the On-body Injector for pegfilgrastim was bioequivalent to the prefilled syringe for manual use, though she cautioned that the syringes are not interchangeable. The side effect profile of the two delivery options are the same as well, with the most common adverse reactions to pegfilgrastim being bone pain and pain in extremities.
The manufacturer provides “very comprehensive, very robust,” voluntary, onsite training to HCPs, said Langish, adding that it usually takes approximately 30-45 minutes for a nurse to become comfortable with the new system. Oncology nursing professionals who would like to learn more about the On-body Injector, including safety information and contraindications, instructional videos for HCPs and patients, and copay resources, should visit http://www.neulastahcp.com/.