Oncology Nurses Talk About Neulasta® (pegfilgrastim) Onpro®
Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
IMPORTANT SAFETY INFORMATION
Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
Splenic rupture, including fatal cases, can occur following the administration of Neulasta®. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta®.
Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta® for ARDS. Discontinue Neulasta® in patients with ARDS.
Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® in patients with serious allergic reactions.
Allergies to Acrylics
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.
Use in Patients With Sickle Cell Disorders
Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.
Glomerulonephritis has been reported in patients receiving Neulasta®. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of Neulasta®. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta®.
White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.
Capillary Leak Syndrome
Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including Neulasta®, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
The G-CSF receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.
The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.
Special Instructions for the On-body Injector for Neulasta®
A healthcare provider must fill the On-body Injector with Neulasta® using the co-packaged prefilled syringe and then apply the On-body Injector to the patient's skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the On-body Injector. Approximately 27 hours after the On-body Injector is applied to the patient's skin, Neulasta® will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the On-body Injector on the same day as the administration of cytotoxic chemotherapy, as long as the On-body Injector delivers Neulasta® no less than 24 hours after the administration of cytotoxic chemotherapy.
The prefilled syringe co-packaged in the Neulasta® Onpro kit contains additional solution to compensate for liquid loss during delivery through the On-body Injector. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the On-body Injector, the patient may receive less than the recommended dose.
Do not use the On-body Injector to deliver any other drug product except the Neulasta® prefilled syringe co-packaged with the On-body Injector. Use of the On-body Injector for Neulasta® has not been studied in pediatric patients.
The On-body Injector should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an On-body Injector failure or leakage. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection.
Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.
Refer to the Healthcare Provider Instructions for Use for the On-body Injector for full administration information.
For any On-body Injector problems, call Amgen at 1-800-772-6436 or 1-844-MYNEULASTA (1-844-696-3852).
Please see full Prescribing Information.
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