Amgen – Amgen : Celebrating Over One Million Cancer Patients Who Have Received Neulasta® (pegfilgrastim) Onpro®
For more than 15 years, one of Amgen’s foundational oncology products, Neulasta®, has been used to help reduce the risk of infection due to a low white blood cell count in people with non-myeloid cancer who receive chemotherapy that can cause fever and low white blood cell count.
Now Neulasta Onpro® has reached the remarkable milestone of being prescribed to more than one million cancer patients without having to go back for a next-day injection only visit.
In the U.S., each year more than half a million patients with cancer are treated with strong chemotherapy, which can weaken the immune system and put patients at risk for developing a life-threatening infection, specifically febrile neutropenia (FN).1,2 Considered an oncologic emergency, FN is a condition that occurs when a patient with a low white blood cell count develops a fever.3 Neulasta is meant to be given the day after chemotherapy to help protect against FN, but some cancer patients find it difficult to return to their physician’s office the next day. Neulasta Onpro automatically delivers Neulasta at home to reduce the risk of FN and related hospitalizations.
Important Safety Information Regarding Neulasta® Contraindication
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 granulocyte colony-stimulating factor (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.
Please see additional Neulasta® Safety Information, by visiting https://www.amgen.com/products.
Please see the Neulasta® Full Prescribing Information by clicking here.
Amgen Inc. published this content on 25 March 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 March 2021 19:10:08 UTC.