Recommended Topic Related To:

Neupogen

"Hodgkin lymphoma is a cancer of the immune system. It is one of the most common cancers among adolescents and young adults in the United States. Major advances in treatment for this cancer, such as different types of chemotherapy and more target"...

Neupogen




Neupogen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Neupogen (filgrastim) is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions. It is a man-made form of a protein that stimulates the growth of white blood cells in your body. Common side effects include aching in the bones and muscles. Nosebleeds or injection site reactions such as redness, swelling, itching, lumps or bruising may also occur.

Dose of Neupogen is individualized, and is determined by the condition being treated and the patient's weight. Neupogen may interact with lithium. Other drugs can interact with Neupogen. Tell your doctor all prescription and over-the-counter medications and supplements you use. Neupogen should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Neupogen (filgrastim) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Neupogen in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using filgrastim and call your doctor at once if you have a serious side effect such as:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • rapid breathing or feeling short of breath; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness.

Less serious side effects may include:

  • diarrhea, constipation;
  • bone pain;
  • muscle aches;
  • hair loss;
  • headache, tired feeling;
  • mild skin rash; or
  • itching, swelling, or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Neupogen (Filgrastim)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Neupogen Overview - Patient Information: Side Effects

SIDE EFFECTS: Aching in the bones and muscles may occur. Taking a non-aspirin pain reliever such as acetaminophen may help with this pain. Ask your doctor or pharmacist for more details. Nosebleeds or injection site reactions such as redness, swelling, itching, lumps or bruising may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, bloody urine, bloody vomit, fast/irregular heartbeat, fever, muscle pain, joint pain, fast breathing, trouble breathing.

Rarely, possibly fatal damage to the spleen may occur. Seek immediate medical attention if you experience the following side effects: stomach/abdominal pain, and/or shoulder pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Neupogen (Filgrastim)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Neupogen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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:

  • small cell lung cancer receiving standard dose chemotherapy with cyclophosphamide, doxorubicin, and etoposide (Study 1)
  • small cell lung cancer receiving ifosfamide, doxorubicin, and etoposide (Study 2), and
  • non-Hodgkin's lymphoma (NHL) receiving doxorubicin, cyclophosphamide, vindesine, bleomycin, methylprednisolone, and methotrexate (“ACVBP”) or mitoxantrone, ifosfamide, mitoguazone, teniposide, methotrexate, folinic acid, methylprednisolone, and methotrexate (“VIM3”) (Study 3).

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
  Thrombocytopenia 38% 29%
Gastrointestinal disorders
  Nausea 43% 32%
General disorders and administration site conditions
  Pyrexia 48% 29%
  Chest pain 13% 6%
  Pain 12% 6%
  Fatigue 20% 10%
Musculoskeletal and connective tissue disorders
  Back pain 15% 8%
  Arthralgia 9% 2%
  Bone pain 11% 6%
  Pain in extremity* 7% 3%
Nervous system disorders
  Dizziness 14% 3%
Respiratory, thoracic and mediastinal disorders
  Cough 14% 8%
  Dyspnea 13% 8%
Skin and subcutaneous tissue disorders
  Rash 14% 5%
Investigations
  Blood lactate dehydrogenase increased 6% 1%
  Blood alkaline phosphatase increased 6% 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 anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, edema peripheral, hemoglobin decreased, decreased appetite, oropharyngeal pain, and alopecia.

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 diarrhea, constipation, and transfusion reaction.

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 thrombocytopenia, anemia, hypertension, sepsis, bronchitis, and insomnia.

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 pain 30%
General disorders and administration site conditions
  Pyrexia 16%
Investigations
  Blood alkaline phosphatase increased 11%
Nervous system disorders
  Headache 10%

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 arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, and urinary tract infection (upper respiratory tract infection and urinary tract infection were higher in the NEUPOGEN arm, total infection related events were lower in NEUPOGEN treated patients), epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. 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. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors including timing of sampling, sample handling, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies to filgrastim with the incidence of antibodies to other products may be misleading.

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.

Read the entire FDA prescribing information for Neupogen (Filgrastim)

A A A

Neupogen - User Reviews

Neupogen User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Neupogen sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.