Approval Status: FDA Approved January 2002
Specific Treatments: Neutropenia
Neulasta is approved as a treatment for patients undergoing chemotherapy, to decrease the incidence of infection by febrile neutropenia. It is administered in a single fixed dose per each cycle of chemotherapy. Neutropenia is a serious and frequent complication of chemotherapy, especially common in the elderly. As well as killing cancer cells, chemotherapy destroys normal cells. A large drop in neutrophils, a type of white blood cell, renders the body unable to defend itself against most types of infection.
It provides a great advantage over currently available white blood cell stimulating products, by requiring less frequent dosing. This means fewer painful injections, fewer office visits and fewer disruptions in daily life. Amgen’s original neutropenic protectant, Neupogen, requires up to two weeks of daily injections after each chemotherapy cycle, with half of patients needing ten or more each day, as opposed to one injection of Neulasta.
With approximately 1.4 million patients receiving chemotherapy in the United States in 2001, protection against neutropenic infection is very important. This is especially true for the elderly, who in the next 20 years, will represent the majority of patients receiving chemotherapy.
Approval was supported by two phase III clinical trials involving subjects with breast cancer, who were undergoing up to four cycles of chemotherapy. In six randomized clinical studies, 465 subjects received one injection of Neulasta per chemotherapy cycle, while 331 subjects received multiple Neupogen injections per cycle. Neulasta provided protection from neutropenic infection comparable to an average of 11 daily injections of Neupogen.
Adverse events associated with the use of Neulasta may include (but are not limited to) the following:
- Bone pain
- Muscle ache
- Injection site reaction
MECHANISM OF ACTION
Neulasta (pegfilgrastim) is a protein that stimulates the production of neutrophils, a type of white blood cell that is depleted during cytotoxic chemotherapy. The stimulating factor acts on hematopoietic cells by binding to specific cell surface receptors to stimulate proliferation, differentiation, commitment and end cell functional activation.