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Accofil

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Accofil

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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.

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Overview of Accofil

Property Description
Active ingredient Filgrastim (INN)
Form Solution for injection (in pre-filled syringe)
Pharmacological class Haematopoietic Agent, Colony-Stimulating Factor (CSF)
Common use Stimulating white blood cell production (neutrophils)
Origin Biosimilar biological drug, Recombinant DNA technology

Accofil: Definition, Class, and Composition

Accofil is a biosimilar biological medicine containing the active ingredient Filgrastim, which belongs to the pharmacological class of Colony-Stimulating Factors (CSFs). These agents function as specialized messenger proteins that regulate blood cell formation. As a biosimilar, Accofil is a biological medicine that is highly similar to a reference product already authorized in the European Union. It is a recognized therapeutic option with demonstrated comparable quality, safety, and efficacy to its reference medicine, as established by comprehensive pharmacological studies.

What Type of Protein is Filgrastim?

The Filgrastim component is a recombinant human granulocyte colony-stimulating factor (r-HuG-CSF), a non-glycosylated protein produced using recombinant DNA technology. This production method means the drug is an engineered, functional copy of the naturally occurring human G-CSF protein, designed to bind to and activate the same receptors in the body. Filgrastim is a cytokine with immunomodulating activity that controls the production, differentiation, and function of neutrophilic granulocyte progenitors. This origin ensures that the active substance provides a specific, targeted biological signal to the body’s cell-producing systems.


General Purpose and Immune Support

The medicine’s general purpose is to augment the body's essential defenses by increasing the number of crucial infection-fighting white blood cells. Filgrastim achieves this by stimulating the bone marrow to promote the proliferation and differentiation of neutrophils, a process known as myelopoiesis. Clinical data indicates that the use of Filgrastim is recognized for its ability to significantly reduce the incidence of severe neutropenia (a low neutrophil count). Therefore, the core benefit is restoring the supply of infection-fighting cells when natural cell production is suppressed, such as following myelosuppressive chemotherapy.

Regulatory References

  1. Accofil (Filgrastim) EPAR
  2. Biosimilar medicines: Overview
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What side effects are possible with Accofil?

The official safety profile for Accofil (Filgrastim) is based on classifications and reports from government regulatory bodies. Possible side effects are categorized by frequency and the body system affected, providing a structured overview of the drug’s known risks.

Frequency-Classified Adverse Reactions

The most frequent effects are generally reported as Very Common (affecting more than 1 in 10 individuals), including musculoskeletal pain (such as bone pain or arthralgia), nausea, vomiting, fatigue, and pyrexia (fever). Reactions classified as Common (up to 1 in 10) include headache, splenomegaly (enlarged spleen), leukocytosis, and temporary changes in blood chemistry.

Serious Adverse Reactions and Specific Safety Notes

Certain reactions are documented as Serious Adverse Reactions, often categorized as Uncommon in frequency. These include splenic rupture (which can be fatal), Capillary Leak Syndrome (CLS), and serious allergic reactions. Specific concerns highlighted in regulatory labels relate to certain patient groups:

  • Sickle Cell Disease or Trait: Use may precipitate a potentially fatal sickle cell crisis.
  • Severe Chronic Neutropenia (SCN) Patients: There is a documented association with the long-term risk of developing Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML).

Time-Related and Pre-existing Condition Constraints

The onset of bone pain is often reported to be dose-dependent, typically occurring in the period immediately before the rise in the neutrophil count. Additionally, the drug is not recommended for use in patients with pre-existing conditions like MDS or Chronic Myelogenous Leukaemia (CML), and caution is noted for patients with osteoporotic bone disease receiving long-term treatment. Regular monitoring of blood counts is a standard component of the safety framework.

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Overdose and Emergency Response

Overdose Scope: Official Regulatory Information

Property Official Regulatory Statement
Documented Overdose Presentations The primary manifestation of overdosage is Leukocytosis, an abnormally high White Blood Cell (WBC) count, which reflects an exaggerated pharmacological effect on the haematopoietic system.
Physiological Systems Affected The Haematopoietic System is primarily affected, with the potential for severe outcomes linked to excessive white cell proliferation.
Emergency Response Statements Patients must contact their doctor as soon as possible if a dose higher than required is administered.
When Immediate Medical Help is Required Seek immediate medical attention or go to a hospital emergency room if an overdose is confirmed or suspected.

Overdose Management & Monitoring

Property Official Regulatory Statement
Antidote Information Regulatory prescribing information states that no specific antidote is known for Filgrastim overdose.
Supportive Management The essential management measure is the discontinuation of Filgrastim therapy. Counts are expected to return to baseline, typically within four days of cessation.
Monitoring Requirements Continuous monitoring of Complete Blood Counts (CBCs) is the required procedural step during the management of potential overdosage.
Population-Specific Notes Immediate medical attention is specifically required if a child has accidentally swallowed the medicine.

The official regulatory profile for Accofil overdose is defined by the sole documented manifestation of excessive leukocytosis and the subsequent required management strategy. Because no specific antidote exists, the regulatory response mandates immediate medical consultation and discontinuation of the agent under observation. This structured approach, including continuous CBC monitoring, is intended to mitigate the serious risks associated with prolonged over-stimulation.

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Therapeutic Uses of Accofil

What Accofil Treats: Main Uses and Benefits

Accofil is applied across domains where additional symptomatic support is needed. It is used in areas where short-term symptom management is appropriate, including after cytotoxic chemotherapy, in cases of severe chronic neutropenia, following bone marrow transplantation, and in patients with advanced HIV infection.

Accofil is often used when symptoms intensify and supportive relief is needed during certain medical phases. The medication is relevant in contexts marked by increased discomfort or tension in patients presenting with systemic or localized discomfort. It is generally applied to help address symptom clusters that create noticeable physiological strain.

Quick Fact: Support During Fluctuating Symptoms

Accofil is relevant in conditions characterized by periods of heightened symptoms and is applied across domains where short-term symptom management is appropriate. The therapy contributes to easing the overall symptom load and is applicable within clinical settings that involve acute or disruptive symptom patterns. It assists with maintaining functional stability when symptoms become more noticeable.

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Eligibility and Restrictions for Use

Official Eligibility Rules for Accofil (Filgrastim)

Official regulatory documents define specific populations who can and cannot use Accofil. These rules are based on formal patient classifications and clinical status.

Category Regulatory Statement Restriction Status
Absolute Contraindications History of hypersensitivity to filgrastim or excipients; hereditary fructose intolerance; severe congenital neutropenia with evidence of leukaemic evolution. Must Not Be Used
Disease Exclusions Use is excluded in patients with Chronic Myeloid Leukaemia (CML) or Myelodysplastic Syndromes (MDS). Not Indicated

Age and Physiological Status

  • Adults are approved for all listed indications. Paediatric Patients are approved for Severe Chronic Neutropenia; efficacy is considered similar to adults in the chemotherapy setting.
  • Elderly Patients lack specific dosage recommendations as definitive studies have not been performed in this group.
  • Pregnancy use is not recommended unless the benefit justifies the potential risk. Lactation use carries a risk that cannot be excluded, requiring discontinuation of either therapy or breastfeeding.

Special Population Restrictions

  • Sickle Cell Disease requires extreme caution due to reports of severe crises.
  • Patients with severe renal or hepatic impairment do not require dose adjustment as the drug's profile is similar to that of normal individuals.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Accofil (filgrastim) is primarily focused on pharmacodynamic effects and the critical timing of administration relative to cytotoxic treatments. As a recombinant protein, filgrastim is cleared differently than small-molecule drugs, meaning traditional metabolic interactions are not the central focus of regulatory documentation.


Timing-Based Treatment Restrictions

Interacting Agent Restriction / Requirement
Cytotoxic Chemotherapy Administration is not recommended in the period 24 hours before or 24 hours after cytotoxic chemotherapy. The first dose must follow chemotherapy by at least 24 hours.
Radiation Therapy Concurrent administration with radiation therapy is not recommended.

These timing constraints are essential to prevent the sensitive, rapidly dividing myeloid cells from being targeted by the cytotoxic agents immediately following their stimulation by filgrastim.


Pharmacodynamic and Other Interactions

Interacting Agent Interaction Type / Official Note
Lithium Use with caution is advised. Lithium may potentiate the release of neutrophils, potentially adding to the effect of filgrastim. Increased monitoring of neutrophil counts may be necessary.
Drugs Metabolized by CYP450 No known interactions are documented, as filgrastim is a protein cleared by receptor binding and renal excretion, not via the cytochrome P450 enzyme system.
Severe Renal/Hepatic Impairment No dose adjustment required. Studies indicate that Accofil maintains a similar pharmacokinetic and pharmacodynamic profile in patients with severe hepatic or renal impairment, meaning these conditions do not create a significant interaction context.
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Mechanism of Action

Targeted Activation of the G-CSF Receptor

Accofil's active ingredient, Filgrastim, initiates its mechanism by acting as a recombinant agonist, binding specifically to the G-CSF Receptor found on neutrophil precursor cells in the bone marrow. This targeted interaction triggers the JAK/STAT signaling cascade, which sends internal signals to the cell nucleus to increase division and development.


Accelerating the Myelopoiesis Pathway

The receptor-mediated signal accelerates the entire process of myelopoiesis, shortening the time required for precursor cells to differentiate into mature, functional neutrophils. This acceleration overrides normal regulatory feedback mechanisms, resulting in an increased rate of cell production, which augments physiological output.


Enhanced Systemic Mobilization

The final stage involves enhanced systemic mobilization and release. The drug's mechanism facilitates the rapid exodus of these newly matured neutrophils from the bone marrow's storage pools, resulting in a dose-dependent, quantifiable increase in the Absolute Neutrophil Count (ANC) in the peripheral blood. This physiological change augments the circulating quantitative supply of neutrophils.

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Dosage and Administration Information

Administration Overview

Accofil is typically administered via an injection under the skin, known as a subcutaneous injection, or as an infusion into a vein. The method of administration is determined by the specific clinical condition being treated and the individual needs of the patient.

Subcutaneous Injection

For many patients, the medication is given as a daily injection into the tissue just beneath the skin. Common sites for these injections include the upper arms, the abdomen, and the outer thighs. Rotating the site of injection for each dose is a standard practice to maintain skin health and ensure consistent absorption of the medication.

Intravenous Infusion

In certain clinical settings, Accofil may be diluted and administered through a needle or catheter directly into a vein. This process is usually performed by healthcare professionals in a hospital or clinic environment.

Self-Administration

Patients may be able to perform subcutaneous injections themselves after receiving comprehensive training. This process involves preparing the pre-filled syringe, selecting an appropriate site, and following specific technical steps to ensure the medication is delivered correctly. Proper disposal of used equipment is a necessary part of the routine.

Handling and Storage

To maintain the stability of the medication, the syringes should be stored in their original packaging to protect them from light. Before use, the medication is typically allowed to reach room temperature. It is important to inspect the solution visually; it should appear clear and colorless. If the solution is cloudy or contains particles, it should not be used.

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Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Clinical Research

Research has evaluated the use of Accofil (filgrastim) for managing low neutrophil counts (neutropenia) and associated fever (febrile neutropenia), primarily in patient populations receiving cytotoxic chemotherapy for malignancy. Studies have also explored its use in severe chronic neutropenia and for mobilizing peripheral blood progenitor cells for transplantation.

  • Biosimilarity Studies: Accofil is a biosimilar medicine. Confirmatory randomized controlled trials (RCTs) established its pharmacokinetic and pharmacodynamic profiles were comparable to the reference product (originator filgrastim). These studies typically used non-metastatic breast cancer patients as a sensitive population to confirm clinical equivalence.

Key Study Findings

Neutropenia Duration and Recovery

In studies involving patients receiving chemotherapy known to cause neutropenia, the duration of severe neutropenia (DSN) was a primary measure. Findings for Accofil were comparable to those reported in literature for the reference product. Specifically, in trials for chemotherapy-induced neutropenia, the DSN was approximately 1.4 to 1.6 days.

  • Neutrophil Recovery: Research explored whether a transient increase in neutrophil counts may be associated with the initiation of filgrastim therapy, typically observed within 1 to 2 days.
  • Febrile Neutropenia: Comparative trials indicated no significant difference in the incidence or duration of febrile neutropenia between Accofil and the reference filgrastim.

Safety and Specific Populations

The safety profile has been studied across adult, elderly, and pediatric patient populations. Studies suggest the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.

Very Common Reported Events (In Studies) Safety Profile Scope
Musculoskeletal pain, Headache Patients with renal or hepatic impairment were studied, and data suggested a similar pharmacokinetic profile to healthy individuals. Dose adjustment was not typically required in these circumstances.
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Frequently Asked Questions (FAQ)

Common questions about Accofil (FAQ)


Q: What is the active ingredient in Accofil?

The active ingredient in this medicine is filgrastim. According to official product information, filgrastim is classified as a recombinant human granulocyte colony-stimulating factor (r-HuG-CSF), a protein that helps stimulate the production of white blood cells.


Q: What is the substance 'sorbitol' in Accofil and why is it listed as a warning?

Accofil contains the excipient sorbitol, which the body can convert into fructose. Official warnings state that the medicine is subject to a contraindication for individuals with hereditary fructose intolerance (HFI), meaning its use is excluded.


Q: What is the concern about using Accofil in patients with a sickle cell condition?

Regulatory documents advise extreme caution when Accofil is used in patients with a sickle cell disease or trait. Regulatory documents state there have been reports of precipitating a potentially fatal sickle cell crisis in this population.


Q: What is 'Capillary Leak Syndrome' and what are its symptoms?

Capillary Leak Syndrome (CLS) is listed in regulatory documents as a rare but serious side effect of filgrastim products. Reported symptoms have included rapid swelling, significant weight gain, dizziness, fainting, shortness of breath, and feeling very tired or weak.


Q: How long after starting the injections should a person expect the bone pain to begin?

Official information indicates that the onset of bone pain is often linked to the drug's activity in the body. The pain is typically reported in the period immediately before the expected rise in the neutrophil count, which typically occurs in the first one to two days after treatment initiation.


Q: Why is bone pain or musculoskeletal pain such a common side effect of Accofil?

The drug’s mechanism involves accelerating the production and release of neutrophils from the bone marrow. This increased cell activity and expansion within the bone marrow space is understood to be the physiological cause of the reported musculoskeletal pain.


Q: What conditions, other than cancer, is Accofil used for?

Official indications for Accofil include the treatment of severe, persistent low neutrophil counts (neutropenia) in people with advanced HIV infection. It is also indicated for the process of mobilization of peripheral blood progenitor cells (PBPC) for transplantation procedures.


Q: Does Accofil have a specific warning for people who have a latex allergy?

Yes, regulatory documentation confirms this warning. The needle cover of the Accofil pre-filled syringe contains dry natural rubber, which is a derivative of latex and may cause allergic reactions in individuals sensitive to latex.


Q: What general warnings are associated with Accofil use during pregnancy or while breastfeeding?

Accofil is not generally recommended during pregnancy. For breastfeeding, the risk to the breast-fed child cannot be excluded, and official guidance indicates a decision must be made to either discontinue the drug or discontinue breastfeeding.


Q: What general methods are studied for managing bone pain from filgrastim products?

While specific, tailored advice is reserved for the prescribing clinician, official patient information notes that the musculoskeletal pain can be managed with common pain relievers. These include non-opioid analgesics such as acetaminophen (paracetamol) or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).


Q: Why is the Accofil syringe labeled for single use only?

Official product information states that the syringe is intended for single use only because the solution does not contain any preservative. Official information cautions that reuse carries a possible risk of microbial contamination.


Q: Can Accofil be mixed with other solutions for administration?

When Accofil is administered intravenously, regulatory information specifies that it should be diluted only in 5% glucose solution. Official regulatory documentation states that it should be diluted only in 5% glucose solution for intravenous administration.


Q: What is 'loss of response' and why does it sometimes occur with filgrastim treatment?

Regulatory documentation notes that a loss of response—meaning the drug stops having the intended effect—may occur, although this is uncommon. The loss of response is often linked to the development of neutralising antibodies against filgrastim in the patient’s system.


Q: Does Accofil have potential effects on a patient's hair or weight?

According to the official safety profile, hair loss or thinning of the hair (alopecia) is noted as a common side effect of filgrastim products. Additionally, weight loss is listed as an adverse reaction in clinical data.


Q: What is the significance of the spleen in relation to Accofil treatment?

The drug's activity can cause an enlargement of the spleen (splenomegaly) and, rarely, a serious condition called splenic rupture. Official documentation notes that pain in the left upper abdomen or at the tip of the left shoulder may be a sign of a splenic issue.


Q: What symptoms might suggest inflammation of the aorta (aortitis)?

Inflammation of the aorta (aortitis) has been reported rarely with filgrastim use. Reported symptoms have included fever, general feeling of being unwell (malaise), back pain, and abdominal pain.


Q: Are there differences in the type of needles or syringes used for Accofil compared to other filgrastim products?

Official product presentations describe Accofil as a solution in a pre-filled glass syringe. A specific feature is the inclusion of a needle safety guard, which is a design element that regulatory documentation indicates may differ from its reference product.

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How should Accofil be stored and disposed of?

Accofil (filgrastim) requires strict adherence to labeled storage and disposal requirements to maintain product stability and ensure safety.


Storage Conditions

Accofil must be stored in a refrigerator at a temperature between 2 C and 8 C (36 F to 46 F) and must be kept in the original outer carton to protect it from light.

It is prohibited to freeze the medicine. If the solution has frozen, it must not be used.

Stability and Handling

If removed from the refrigerator, the syringe may be stored at room temperature (up to 25 C or 77 F) for a single, maximum period of 15 days. After this period, the product must be discarded and must not be returned to the refrigerator. The medicine must be kept out of the sight and reach of children.


Disposal Instructions

Accofil syringes must be disposed of in a biohazard sharps container immediately after use. Unused or expired product must not be disposed of via household waste or wastewater; a pharmacist or healthcare professional should be consulted for proper disposal guidance.

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

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