Does Neupogen (filgrastim) cause side effects?

Neupogen (filgrastim) is a colony-stimulating factor used to prevent infectious complications associated with low white blood cells (neutropenia). Neupogen is a man-made protein similar to the naturally occurring protein, granulocyte-colony stimulating factor (G-CSF). G-CSF is produced in the body by the immune system and stimulates the formation of one type of white blood cell, the neutrophil.

Neutrophils take part in the inflammatory reaction. They are responsible for detecting and destroying harmful bacteria and some fungi. Neupogen is called a colony-stimulating factor because of its ability to stimulate cells in the bone marrow to multiply and form colonies of new cells. 

Common side effects of Neupogen include

Serious side effects of Neupogen include

Drug interactions of Neupogen include lithium, and you may need more frequent blood tests. If you or your child are receiving Neupogen because you are also receiving chemotherapy, the last dose of Neupogen should be injected at least 24 hours before your next dose of chemotherapy.

It is unknown if Neupogen will harm a fetus. There are no studies to determine if Neupogen is excreted into breast milk. Consult your doctor before breastfeeding

What are the important side effects of Neupogen (filgrastim)?

The most common side effects are:

Other important side effects include:

Uric acid, lactate dehydrogenase, and alkaline phosphatase levels may rise and spontaneously return to normal levels. Heart attacks and abnormal heart rhythm.

Neupogen (filgrastim) side effects list for healthcare professionals

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions In Patients With Cancer Receiving Myelosuppressive Chemotherapy

The following adverse reaction data in Table 2 are from three randomized, placebo-controlled studies in patients with:

A total of 451 patients were randomized to receive subcutaneous Neupogen 230 mcg/m² (Study 1), 240 mcg/m² (Study 2) or 4 or 5 mcg/kg/day (Study 3) (n = 294) or placebo (n = 157). The patients in these studies were median age 61 (range 29 to 78) years and 64% were male.

  • The ethnicity was
    • 95% Caucasian,
    • 4% African American, and
    • 1% Asian.

Table 2: Adverse Reactions in Patients with Cancer Receiving Myelosuppressive Chemotherapy (With ≥ 5% Higher Incidence in Neupogen Compared to Placebo)

System Organ Class
Preferred Term
Neupogen
(N = 294)
Placebo
(N = 157)
Blood and lymphatic system disorders
Thrombocytopenia38%29%
Gastrointestinal disorders
Nausea43%32%
General disorders and administration site conditions
Pyrexia48%29%
Chest pain13%6%
Pain12%6%
Fatigue20%10%
Musculoskeletal and connective tissue disorders
Back pain15%8%
Arthralgia9%2%
Bone pain11%6%
Pain in extremity*7%3%
Nervous system disorders
Dizziness14%3%
Respiratory, thoracic and mediastinal disorders
Cough14%8%
Dyspnea13%8%
Skin and subcutaneous tissue disorders
Rash14%5%
Investigations
Blood lactate dehydrogenase increased6%1%
Blood alkaline phosphatase increased6%1%
* Percent difference (Neupogen - Placebo) was 4%.

Adverse events with ≥ 5% higher incidence in Neupogen patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy delivered included

Adverse Reactions In Patients With Acute Myeloid Leukemia

Adverse reaction data below are from a randomized, double-blind, placebo-controlled study in patients with AML (Study 4) who received an induction chemotherapy regimen of intravenous daunorubicin days 1, 2, and 3; cytosine arabinoside days 1 to 7; and etoposide days 1 to 5 and up to 3 additional courses of therapy (induction 2, and consolidation 1, 2) of intravenous daunorubicin, cytosine arabinoside, and etoposide.

The safety population included 518 patients randomized to receive either 5 mcg/kg/day Neupogen (n = 257) or placebo (n = 261). The median age was 54 (range 16 to 89) years and 54% were male.

Adverse reactions with ≥ 2% higher incidence in Neupogen patients compared to placebo included

  • epistaxis,
  • back pain,
  • pain in extremity,
  • erythema, and
  • rash maculo-papular.

Adverse events with ≥ 2% higher incidence in Neupogen patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy included

Adverse Reactions In Patients With Cancer Undergoing Bone Marrow Transplantation

The following adverse reaction data are from one randomized, no treatment-controlled study in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma receiving high-dose chemotherapy (cyclophosphamide or cytarabine, and melphalan) and total body irradiation (Study 5) and one randomized, no treatment-controlled study in patients with Hodgkin's disease (HD) and NHL undergoing high-dose chemotherapy and autologous bone marrow transplantation (Study 6).

Patients receiving autologous bone marrow transplantation only were included in the analysis. A total of 100 patients received either 30 mcg/kg/day as a 4-hour infusion (Study 5) or 10 mcg/kg/day or 30 mcg/kg/day as a 24-hour infusion (Study 6) Neupogen (n = 72), no treatment control or placebo (n = 28). The median age was 30 (range 15 to 57) years, 57% were male.

Adverse reactions with ≥ 5% higher incidence in Neupogen patients compared to patients receiving no Neupogen included rash and hypersensitivity.

Adverse reactions in patients receiving intensive chemotherapy followed by autologous BMT with ≥ 5% higher incidence in Neupogen patients compared to patients receiving no Neupogen included

Adverse Reactions In Patients With Cancer Undergoing Autologous Peripheral Blood Progenitor Cell Collection

The adverse reaction data in Table 3 are from a series of 7 trials in patients with cancer undergoing mobilization of autologous peripheral blood progenitor cells for collection by leukapheresis.

Patients (n = 166) in all these trials underwent a similar mobilization/collection regimen: Neupogen was administered for 6 to 8 days, in most cases the apheresis procedure occurred on days 5, 6, and 7. The dosage of Neupogen ranged between 5 to 30 mcg/kg/day and was administered subcutaneously by injection or continuous infusion. The median age was 39 (range 15 to 67) years, and 48% were male.

Table 3: Adverse Reactions in Patients with Cancer Undergoing Autologous PBPC in the Mobilization Phase (≥ 5% Incidence in Neupogen Patients)

System Organ Class
Preferred Term
Mobilization Phase
(N = 166)
Musculoskeletal and connective tissue disorders
Bone pain30%
General disorders and administration site conditions
Pyrexia16%
Investigations
Blood alkaline phosphatase increased11%
Nervous system disorders
Headache10%

Adverse Reactions In Patients With Severe Chronic Neutropenia

The following adverse reaction data were identified in a randomized, controlled study in patients with SCN receiving Neupogen (Study 7). 123 patients were randomized to a 4-month observation period followed by subcutaneous Neupogen treatment or immediate subcutaneous Neupogen treatment. The median age was 12 years (range 7 months to 76 years) and 46% were male. The dosage of Neupogen was determined by the category of neutropenia. Initial dosage of Neupogen:

  • Idiopathic neutropenia: 3.6 mcg/kg/day
  • Cyclic neutropenia: 6 mcg/kg/day
  • Congenital neutropenia: 6 mcg/kg/day divided 2 times per day

The dosage was increased incrementally to 12 mcg/kg/day divided 2 times per day if there was no response.

Adverse reactions with ≥ 5% higher incidence in Neupogen patients compared to patients receiving no Neupogen included

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including

  • assay methodology,
  • sample handling,
  • timing of sample collection,
  • concomitant medications, and
  • underlying disease.

For these reasons, comparison of the incidence of antibodies to filgrastim in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

The incidence of antibody development in patients receiving Neupogen has not been adequately determined. While available data suggest that a small proportion of patients developed binding antibodies to filgrastim, the nature and specificity of these antibodies has not been adequately studied. In clinical studies using Neupogen, the incidence of antibodies binding to filgrastim was 3% (11/333). In these 11 patients, no evidence of a neutralizing response was observed using a cell based bioassay.

Cytopenias resulting from an antibody response to exogenous growth factors have been reported on rare occasions in patients treated with other recombinant growth factors.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Neupogen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

What drugs interact with Neupogen (filgrastim)?

No Information provided

Summary

Neupogen (filgrastim) is a colony-stimulating factor used to prevent infectious complications associated with low white blood cells (neutropenia). Common side effects of Neupogen include nausea, vomiting, bone pain, fever, fatigue, hair loss, diarrhea, headache, weight loss, shortness of breath, mouth sores, and rash. It is unknown if Neupogen will harm a fetus. There are no studies to determine if Neupogen is excreted into breast milk.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 10/31/2019
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.