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Neupogen & Neulasta: Buckle Up for a Wild Ride

Chemo causes neutropenia and once a patient has entered the immune-compromised basement, any infection may be fatal. The body lacks defenses to protect itself from invaders even as the chemo show must go on. Neulasta and Neupogen, two variations of the same type of medication, come to the rescue by forcing bone marrow to create more white blood cells. With the boost they deliver, the cancer patient develops a modicum of protection against infection even as chemo pushes the immune system’s gas tank to empty.

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Articles of Interest

The science behind Neupogen

In the clinical setting, Neupogen is frequently used as an adjunct to chemotherapy. Many chemotherapeutic agents are designed to destroy actively dividing cells, as cancer cells tend to have a high proliferation rate. As a consequence, certain normal cells which have a high turnover, such as those of the bone marrow, are also targeted. Effective treatment of cancer requires management of these side effects. Neupogen – to stimulate neutrophil production... In addition, Neupogen increases the peripheral blood white cell count and allows the mobilisation of stem cells which are harvested for stem cell transplants.

A systematic literature review of the efficacy, effectiveness, and safety of filgrastim

Filgrastim (NEUPOGEN®) is the originator recombinant human granulocyte colony-stimulating factor widely used for preventing neutropenia-related infections and mobilizing hematopoietic stem cells. This report presents findings of a systematic literature review and meta-analysis of efficacy and safety of originator filgrastim to update previous reports.

F.D.A. Approves Zarxio, Its First Biosimilar Drug

The drug, called Zarxio, produced by Sandoz, is used to help prevent infections in cancer patients receiving chemotherapy. It is a close copy of an existing medication called Neupogen, made by Amgen. It was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because no regulatory pathway existed to bring biosimilars — approximate copies of drugs in a class known as biologics — to market.

How filgrastim has helped control neutropenia and prevent sepsis

Before the first granulocyte colony-stimulating factor (G-CSF) filgrastim (Neupogen) was launched in the UK in 1991, little could be done to prevent the neutropenia and potentially life-threatening infection associated with some of the chemotherapy regimens of the day.

Neupogen's New Indication: Nuke Mishaps and Terrorism

Neupogen, a drug widely used in oncology, recently received an FDA approval for boosting survival in people acutely exposed to myelosuppressive doses of radiation, also known as hematopoietic syndrome or acute radiation syndrome. Neupogen (filgrastim)—a myeloid growth factor, a class of drugs that includes GM-CSF and Neulasta—as well as other similar drugs have been used to treat victims of radiation and nuclear accidents since Chernobyl.

Study of Neupogen vs Biosimilars Draws Fire

When Shruti Rastogi, MPharma, and her fellow investigators published a study suggesting that biosimilar filgrastims have a higher incidence of certain adverse events than the originator product, Neupogen, they immediately drew fire from 2 established experts on biosimilar development, Paul Cornes, MD, and Michael Muenzberg, MD, both of the Comparative Outcomes Group.

The Safety Profile of Filgrastim and Pegfilgrastim

The discovery of endogenous proteins that regulate hematopoiesis led to the identification of human granulocyte colony-stimulating factor (G-CSF). With the advent of recombinant DNA technology, it became possible to manufacture bioactive recombinant proteins for medicinal use. Since the approval of recombinant human G-CSF (rHuG-CSF), such as filgrastim in 1991 and pegfilgrastim in 2002, millions of patients at risk for severe myelosuppression have received these products. Overall, filgrastim and pegfilgrastim have a high margin of safety for short-term use; however, rare severe adverse events have emerged and questions remain regarding the long-term safety and consequences of use of these products.

What's the danger in longterm use of filgrastim (Neupogen)?

These medications can be a doubled edged sword. Yes, there may be potential risks for long term use of these products, but in my understanding, the greater risk at this time would be to not receive these medications. The Retacrit is stimulating the development of red blood cells to help him avoid being transfusion dependent. And without Neupogen his white blood count may become dangerously low to where he no longer can fight infections. As a side note, often for people who are taking Neupogen, it’s suggested to take Claritin antihistamine capsules for several days surrounding the injection. It helps with bone pain.

Resources

Neulasta

Neulasta® Onpro® is designed to automatically deliver Neulasta® the next day—so you don't have to leave your home to go back to the doctor's office ...

Neupogen

NEUPOGEN® helps to reduce the risk of infection (marked by fever) in patients with certain types of cancer who are receiving strong chemotherapy that decreases the number of infection-fighting white blood cells. This type of infection is called febrile neutropenia (neutropenia with fever). Studies have shown that some people have a greater risk of a low white blood cell count or infection when treated with strong chemotherapy.

Chemo Care

FILGRASTIM (fil GRA stim) lowers the risk of infection in people who are receiving chemotherapy. It works by helping your body make more white blood cells, which protects your body from infection. It may also be used to help people who have been exposed to high doses of radiation. It can be used to help prepare your body before a stem cell transplant.

StatPearls

Filgrastim was approved in the US in 1991 and is the original short-acting recombinant methionyl human G-CSF. It has since remained in use with long-acting versions (pegfilgrastim) and biosimilars increasingly being made since the originator approval with similar indications.