Neupogen 300

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Neupogen 300

Quick Facts

Property Description
Active Ingredient Filgrastim
Form Solution for injection or infusion (vials and pre-filled syringes)
Pharmacological Class Hematopoietic Growth Factor (Leukocyte Growth Factor)
Common Use Augmenting the body's cellular immune defense
Origin Biotechnology-derived (Recombinant DNA technology)
Status Prescription Drug (Rx)

What Type of Medicine is Neupogen 300 (Filgrastim)?

Neupogen 300 is the original prescription pharmaceutical whose active ingredient, Filgrastim (WHO INN 6739), is classified as a Hematopoietic Growth Factor. Filgrastim is a biotechnology-derived protein, meaning it is synthetically produced using recombinant DNA technology to create a precise replica of the naturally occurring human protein called granulocyte colony-stimulating factor (G-CSF). This product, developed by Amgen Inc., is recognized as the first FDA-approved G-CSF.

The product is presented as a sterile solution for injection or infusion, which must be administered via the parenteral route. Its composition contains Filgrastim as the sole active pharmaceutical ingredient, stabilized in an aqueous base. The numerical designation 300 refers to the measured strength of the product, indicating the presence of 300 micrograms (mcg) of Filgrastim within the container, which is an essential identifier for accurate use.

What is the General Purpose of This Hematopoietic Factor?

The general purpose of Filgrastim is to provide support to the patient's immune system by enhancing its cellular defenses. As a Leukocyte Growth Factor, its mechanism centers on the selective stimulation of bone marrow precursor cells to accelerate the production and maturation of neutrophils. These neutrophils are the white blood cells essential for fighting bacterial and fungal infections. Filgrastim is used for accelerating neutrophil recovery. By raising the level of circulating neutrophils, the medication provides a biological support mechanism for patients who have low counts of these essential cells (neutropenia).

Regulatory References

  1. WHO INN 6739

What side effects are possible with Neupogen 300?

Possible side effects and safety information

The safety profile of Neupogen 300 (Filgrastim) is formally documented in government regulatory sources, classifying adverse reactions by frequency and the body system affected. These classifications reflect how the medicine’s risk profile is structured for communication to patients.

Frequency-Classified Adverse Reactions

Adverse effects are categorized based on their rate of occurrence in clinical use:

  • Very Common (Affecting 1 in 10 or more): Musculoskeletal pain (including bone pain, back pain, and pain in the limbs), headache, fatigue, and fever (pyrexia). Bone pain is a commonly reported effect, often appearing early in the course of treatment.
  • Common (Affecting fewer than 1 in 10 but more than 1 in 100): Nausea, vomiting, diarrhea, alopecia (hair loss), and thrombocytopenia (a reduction in platelet counts).
  • Uncommon (Affecting fewer than 1 in 100): Splenomegaly (asymptomatic increase in spleen size) and hypersensitivity reactions.

Documented Serious Adverse Reactions

The official labeling notes the potential for rare but clinically significant adverse reactions. These include splenic rupture, which may present as pain in the left upper abdomen or shoulder tip, and Acute Respiratory Distress Syndrome (ARDS), a serious pulmonary event. Other serious reactions explicitly documented are Glomerulonephritis (inflammation of the kidney filters) and Serious Allergic Reactions, including anaphylaxis.

Population and Exposure-Related Safety Notes

The safety documentation includes specific constraints for certain patients. Filgrastim is constrained against use in individuals with sickle cell disease or trait due to the risk of fatal sickle cell crisis. Furthermore, the development of osteoporosis is associated with long-term exposure in patients receiving daily therapy for Severe Chronic Neutropenia. Monitoring for excessive leukocytosis (overly high white blood cell counts) is required, as documented in official regulatory materials.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for a Neupogen 300 (filgrastim) overdose is centered on the exaggeration of the medicine's expected pharmacological effect. The documented clinical and physiological manifestation of an excessive dose is Excessive Leukocytosis. This condition is specifically defined by a significant increase in the patient's White Blood Cell ( WBC) counts to a threshold of 100,000/ mm^3 or greater. This specific finding serves as the mandatory trigger for emergency intervention according to regulatory documents.

Immediate Emergency Actions

When WBC counts reach this high threshold, mathbfimmediate medical attention must be sought. The principal action mandated by regulatory authorities is the Discontinuation of Filgrastim Therapy to rapidly manage the potential complications associated with the excessive leukocytosis. The official labeling indicates that no specific antidote is known for filgrastim, making supportive care essential.

Management and Monitoring

Management relies on providing symptomatic and supportive treatment as appropriate for the patient's clinical state. Following the cessation of therapy, mathbfclose monitoring of the patient’s Complete Blood Counts ( CBCs) is required. This observation must continue until the neutrophil and WBC levels decrease and return to acceptable baseline ranges, a process documented to take several days after the medicine is stopped. No population-specific considerations regarding overdose presentation are explicitly documented in the official regulatory sections.

Therapeutic Uses of Neupogen 300

Neupogen 300 (filgrastim) is commonly used to manage conditions characterized by systemic imbalance where the body has a low number of infection-fighting white blood cells (neutropenia). This supportive medication is applied across domains where additional symptomatic support is needed to reduce the risk and duration of severe infections. The core uses center on increasing the body's neutrophil counts, including its application following myelosuppressive chemotherapy, for severe chronic neutropenia (SCN), and in preparation for stem cell transplant and mobilization procedures.

This supportive therapy is relevant when supportive symptom management is appropriate during critical phases. The medication is considered relevant for addressing the risk of febrile neutropenia (fever associated with low neutrophils). This may help reduce the chance of this serious infectious complication. This support helps ease the overall burden of symptoms during difficult episodes.

“This medication is used to support patients during periods of heightened physiological stress and vulnerability to infection.”


Quick Fact: Relief for Infection Risk

Quick Fact: Relief for Infection Risk. The medicine supports the patient by assisting with maintaining functional stability and contributing to easing the overall symptom load during periods of heightened symptoms.

Regulatory References

  1. NIH MedlinePlus overview on Filgrastim

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Neupogen 300 — Official Regulatory Information

Regulatory documents define who can and cannot use filgrastim based on medical history, specific disease status, and physiological condition. The drug is contraindicated for any patient with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs), including filgrastim or pegfilgrastim, or to any of the product's excipients.


Category Official Regulatory Status
Contraindicated Populations History of serious allergic reactions to G-CSFs.
Disease Exclusions Use is not recommended in patients with Chronic Myeloid Leukemia (CML) or Myelodysplastic Syndromes (MDS) for the neutropenia indication.
Conditional Restrictions Use in patients with Sickle Cell Disorders requires caution and mandates discontinuation if a sickle cell crisis occurs. Simultaneous use with chemotherapy or radiation is not recommended; administration must be sequential.
Pregnancy and Lactation Pregnancy: Recommended only if clearly needed and the benefit outweighs the potential fetal risk. Lactation: Breastfeeding is not recommended.
Age-Related Status Children and Adolescents are generally eligible for use in specific indications. Safety in neonates has not been established.
Organ Function Severe renal or hepatic impairment does not require dose adjustment, indicating no restriction for use based on these conditions.

Official eligibility statements strictly prohibit use in hypersensitive individuals and exclude those with CML or MDS to prevent potential complications. Conditional use is permitted for other groups, such as those with organ impairment or pediatric patients, where the regulatory profile indicates a lack of restriction or established safety.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Neupogen 300 (Filgrastim) is structured around two key domains detailed in government regulatory documents.


Timing-Dependent Interaction with Chemotherapy

The most critical interaction involves Cytotoxic Chemotherapy Agents. Regulatory labeling mandates a strict timing-based restriction to prevent the severe outcome of potentiated myelosuppression. Filgrastim must not be administered in the period starting 24 hours before the administration of cytotoxic chemotherapy and ending 24 hours after the administration of cytotoxic chemotherapy. This mandatory separation rule is the defining constraint of the product’s interaction profile.

Pharmacodynamic and Other Interactions

A documented pharmacodynamic interaction exists with agents like Lithium, which independently promote neutrophil release. Co-administration carries the potential for an additive effect that can contribute to enhanced white blood cell counts (leukopoiesis). The official prescribing information notes this potential but confirms a specific investigation into the combined effect has not been performed.

The regulatory profile does not document any formal contraindicated combinations (absolute prohibitions) with other medicinal products. Furthermore, the label does not specify clinically significant pharmacokinetic interactions mediated by CYP enzymes or drug transporters, nor are any known interactions with food, alcohol, or herbal products officially listed.

Mechanism of Action

Neupogen 300 (Filgrastim) functions as a targeted cytokine signaling modulator by structurally mimicking the body’s naturally occurring granulocyte colony-stimulating factor (G-CSF) protein. The drug's primary mechanistic focus is receptor agonism: it selectively binds to and activates the G-CSF receptors expressed on hematopoietic progenitor cells primarily located within the bone marrow.

This engagement initiates specific intracellular signaling cascades, notably the JAK/STAT pathway, which enhance the proliferation (cell division) and differentiation (maturation) of these precursor cells exclusively along the myeloid lineage into neutrophils. In addition to enhancing the production cascade, Filgrastim actively participates in cell trafficking control by modulating the adhesion forces that anchor mature neutrophils to the bone marrow stroma. This results in the accelerated release and mobilization of the newly generated neutrophils into the peripheral bloodstream, leading to a measurable, dose-dependent increase in the circulating Absolute Neutrophil Count (ANC). This mechanistic sequence influences the total circulating cell count by adjusting activity within central hematopoietic pathways.

Dosage and Administration Information

Official Administration Guidelines for Neupogen (Filgrastim)

The instructions for Neupogen (Filgrastim) detail precise, weight-based dosing, administration routes, and timing constraints.

Administration Route and Frequency

Filgrastim is a solution administered by parenteral routes. The standard method is a once-daily subcutaneous (SC) injection. For specific treatments, such as Bone Marrow Transplantation (BMT), the medicine is given as a daily intravenous (IV) infusion (short or continuous).

Standard Labeled Dosing

Dosage is calculated based on body weight, measured in micrograms per kilogram (μg/kg) daily. The starting dose varies by context:

Clinical Context Recommended Starting Dose
Myelosuppressive Chemotherapy 5 μg/kg once daily
Bone Marrow Transplantation (BMT) 10 μg/kg once daily IV infusion
Severe Chronic Neutropenia (SCN) 5 μg/kg to 12 μg/kg daily (depending on type)

Preparation and Use Constraints

  • Timing: The first dose is administered at least 24 hours after cytotoxic chemotherapy is completed, and the medicine is not administered within the 24-hour period prior to chemotherapy.
  • Dilution: If used as an IV infusion, the solution must be diluted in 5% glucose (dextrose) solution; saline solution must not be used.
  • Duration: Daily administration continues until the Absolute Neutrophil Count (ANC) recovers to a specific target, often 10,000/mm³ following chemotherapy. For long-term SCN management, the dose is titrated to maintain the ANC within a stable range.
  • Pediatrics: Dosing rules for children receiving chemotherapy are generally the same as for adults, with no specific dose adjustment required for older adults.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Neupogen 300


Evidence for Use in Chemotherapy-Induced Neutropenia (CIN)

Filgrastim was studied in research exploring low white blood cell counts (neutropenia) following chemotherapy. The primary research approach involved Randomized Controlled Trials (RCTs) designed to examine short-term or episodic symptom patterns, focusing on the duration of severe neutropenia (DSN) and the incidence of febrile neutropenia (FN). Meta-analyses describe patterns in the observed populations related to DSN and FN compared to control groups. The available evidence is concentrated on short-term, acute events within a single chemotherapy cycle; consequently, information for long-term outcomes, such as overall survival rates, is limited.


Evidence for Use in Hematopoietic Stem Cell Mobilization

Research examined filgrastim for use in two procedural settings: preparing patients or donors for transplantation (mobilization) and supporting patients after a bone marrow or stem cell transplant. Controlled trials focused on outcomes related to physiological stress and procedural success. In the mobilization scenario, studies examined the feasibility of collecting blood progenitor cells (CD34+ cells). Findings describe patterns observed in studies related to CD34+ cell counts and neutrophil recovery in the immediate post-transplant period. Comparative evidence against a placebo is lacking in the post-transplant setting, and data reflects comparisons with other regimens or historical cohorts.


Evidence for Use in Severe Chronic Neutropenia (SCN)

For chronic conditions like congenital, cyclic, or idiopathic SCN, the research approach shifted to long-term observational studies. These studies examined patients with conditions characterized by fluctuating manifestations over extended time intervals. The primary focus was on the ability to maintain the Absolute Neutrophil Count (ANC) above a defined threshold and to monitor the incidence and duration of infection-related events. Findings describe patterns observed in the studies related to ANC levels measured over time and monitored changes in antibiotic consumption. Long-term effects are not fully established for every aspect of chronic use, and sample sizes were modest for certain rare forms of SCN.


What the Research Landscape Still Leaves Uncertain

Despite a substantial body of evidence, a key limitation in many core chemotherapy trials is the focus on surrogate outcomes (like ANC levels) rather than long-term clinical outcomes. Evidence quality varies across studies, and comparative evidence is lacking in certain procedural contexts. Findings describe group patterns, not personal outcomes, meaning research does not determine whether an individual will respond similarly.

Key Studies & References

  1. Filgrastim in patients with chemotherapy-induced febrile neutropenia. A double-blind, placebo-controlled trial.

Frequently Asked Questions (FAQ)

Common questions about Neupogen 300 (FAQ)


Q: Should I avoid alcohol while taking Neupogen?

Official regulatory documents and product information do not list a known or specified clinical interaction between Neupogen (filgrastim) and alcohol. Patients are generally advised to discuss their alcohol consumption with a healthcare provider in the context of their medical treatment.

Q: Can I take an over-the-counter painkiller like ibuprofen for bone pain caused by Neupogen?

Bone pain is a very common side effect associated with this medication, and official patient information indicates this pain is often manageable. The pain is frequently relieved by common non-prescription painkillers, such as paracetamol (acetaminophen). Patients who experience persistent or severe pain are encouraged to contact their healthcare provider for guidance.

Q: What do I do with the used needles and syringes after an injection?

Regulatory instructions state that used syringes and needles must be immediately placed in an FDA-cleared sharps disposal container after use. These items should not be thrown into household trash or recycling containers. Disposal of a full sharps container should be done in accordance with local community guidelines.

Q: Does Neupogen interact with any herbal supplements?

Official regulatory documents for Neupogen do not list any known or specified clinical interactions with food, alcohol, or herbal products. It is recommended that patients inform their healthcare provider about all medicines, including herbal products or supplements, they are currently taking.

Q: What should I do if I miss a scheduled dose of Neupogen?

If a dose is missed, patients are advised to contact their healthcare provider immediately for instructions. While some guidance suggests making up a dose within a specific time frame, official guidance warns against attempting to double the dose to compensate for a missed one.

Q: How do I properly store and carry Neupogen when I'm traveling?

The official product labeling requires that Neupogen be stored in the refrigerator at temperatures between 2 C to 8 C (36 F to 46 F). For necessary travel, it may be kept at room temperature (up to 25 C or 77 F) for a single period that must not exceed 24 hours. Consultation with a healthcare provider or pharmacist is recommended for specific travel advice regarding medication storage.

Q: Can I give myself the Neupogen injection, or does a nurse need to do it?

While a healthcare professional often administers this medication, self-administration or administration by a caregiver is possible. Official instructions state that this requires full and proper training on the correct technique be received from a healthcare provider before attempting the injection.

Q: What are the signs of a serious allergic reaction that I need to look out for?

Official documentation notes that serious allergic reactions can occur, though they are uncommon. Signs may include rash, hives, itching, swelling of the face, eyes, or mouth, wheezing, or difficulty breathing. If these signs are observed, seeking immediate emergency medical attention is necessary.

How should Neupogen 300 be stored and disposed of?

Official Storage and Disposal Requirements

Storage Condition Requirement from Regulatory Labeling
Temperature Store in the refrigerator between 2 C to 8 C (36 F to 46 F). Do not freeze.
Light & Handling Keep in the original carton to protect from light. Do not shake the vial or syringe.
Stability Limit Discard if left at room temperature (up to 25 C / 77 F) for a single period longer than 24 hours.
Child Safety Keep the medicine out of the reach of children.
Disposal Used syringes, needles, and vials must be immediately placed in an FDA-cleared sharps disposal container. Any unused product remaining in the single-dose container must be discarded right away.

These official rules define a cold-chain environment for the product and set strict time limits on room-temperature exposure to maintain its integrity. Disposal of used components must follow mandated sharps waste procedures and cannot be placed in household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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