Pelgraz

Pegfilgrastim – Granulocyte Colony-Stimulating Factor for Chemotherapy-Induced Neutropenia

Rx – Prescription Only ATC: L03AA13 G-CSF (Colony-Stimulating Factor)
Active Ingredient
Pegfilgrastim
Available Forms
Pre-filled syringe, Pre-filled injector
Strength
6 mg / 0.6 mL
Common Brands
Pelgraz, Neulasta, Fulphila, Nyvepria, Ziextenzo
Medically reviewed | Last reviewed: | Evidence level: 1A
Pelgraz contains pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF) used to reduce the duration and severity of neutropenia in adult patients receiving cytotoxic chemotherapy for cancer. By stimulating the bone marrow to produce more white blood cells (neutrophils), Pelgraz helps protect patients against potentially life-threatening infections during chemotherapy treatment.
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Quick Facts About Pelgraz

Active Ingredient
Pegfilgrastim
PEGylated G-CSF
Drug Class
G-CSF
Colony-Stimulating Factor
ATC Code
L03AA13
Immunostimulant
Common Use
Neutropenia
Chemotherapy Support
Available Forms
Injection
Pre-filled syringe / injector
Prescription Status
Rx Only
Prescription required

Key Takeaways About Pelgraz

  • Prevents chemotherapy-induced infections: Pelgraz significantly reduces the duration of severe neutropenia and the incidence of febrile neutropenia, which are the most dangerous complications of cytotoxic chemotherapy
  • Once-per-cycle dosing: Unlike daily filgrastim injections, Pelgraz requires only a single subcutaneous injection per chemotherapy cycle, improving convenience and adherence
  • Timing is critical: Pelgraz must be administered at least 24 hours after chemotherapy, not within 14 days before or 24 hours after cytotoxic treatment
  • Bone pain is the most common side effect: Mild to moderate bone pain occurs in more than 1 in 10 patients and is caused by bone marrow stimulation – it can usually be managed with paracetamol or ibuprofen
  • Biosimilar availability: Pelgraz is a biosimilar to the originator product Neulasta, offering the same efficacy and safety at potentially lower cost, increasing access to this essential supportive cancer care

What Is Pelgraz and What Is It Used For?

Pelgraz (pegfilgrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) used to reduce the duration of neutropenia and the risk of febrile neutropenia in adults receiving myelosuppressive chemotherapy for cancer. It stimulates the bone marrow to produce more neutrophils, the white blood cells that are essential for fighting infections.

Pelgraz contains pegfilgrastim, a protein produced using biotechnology in bacteria called Escherichia coli (E. coli). Pegfilgrastim is a modified form of filgrastim (recombinant human granulocyte colony-stimulating factor) that has been covalently linked to a 20-kilodalton polyethylene glycol (PEG) molecule. This PEGylation process extends the half-life of the protein, allowing it to remain active in the body for longer and enabling a single injection per chemotherapy cycle rather than the daily injections required with filgrastim.

Pegfilgrastim belongs to a group of proteins called cytokines, which are signalling molecules that regulate the immune system. It is very similar to a naturally occurring protein – granulocyte colony-stimulating factor (G-CSF) – that is produced by the body. G-CSF acts on the bone marrow, the spongy tissue inside bones where blood cells are made, to stimulate the production, maturation, and release of neutrophils into the bloodstream.

Neutrophils are a type of white blood cell that forms the body's first line of defence against bacterial and fungal infections. When patients receive cytotoxic chemotherapy for cancer, these drugs destroy rapidly dividing cells – not only cancer cells but also the rapidly dividing precursor cells in the bone marrow that produce neutrophils. This leads to a period of neutropenia (abnormally low neutrophil counts), typically occurring 7–14 days after chemotherapy, during which patients are highly vulnerable to serious, potentially life-threatening infections.

Febrile neutropenia – defined as a fever (temperature ≥38.3°C or ≥38.0°C sustained for more than one hour) in a patient with an absolute neutrophil count below 0.5 × 109/L – is a medical emergency that often requires hospitalisation for intravenous antibiotics. The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) recommend primary prophylaxis with a G-CSF such as pegfilgrastim when the risk of febrile neutropenia associated with a chemotherapy regimen is 20% or greater.

Good to know:

Pelgraz is a biosimilar medicine. This means it has been developed to be highly similar to an already authorised biological medicine (the reference product Neulasta) and has been shown through extensive quality, non-clinical, and clinical comparability studies to have equivalent efficacy, safety, and immunogenicity. Biosimilars undergo the same rigorous regulatory review as all biological medicines before being approved by the European Medicines Agency (EMA) or other regulatory authorities.

What Should You Know Before Using Pelgraz?

Before using Pelgraz, tell your doctor about all your medical conditions, especially any history of sickle cell disease, lung problems, kidney disease, or splenic disorders. Pelgraz must not be used if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients.

Contraindications

You must not use Pelgraz if:

  • You are allergic to pegfilgrastim, filgrastim, or any other ingredient in this medicine (listed in the contents section below) – allergic reactions may include weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness, flushing, skin rash, and areas of itchy skin

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before using Pelgraz if you experience or have a history of any of the following:

  • Allergic reactions – including anaphylaxis (a severe whole-body allergic reaction causing weakness, blood pressure drop, difficulty breathing, and facial swelling). If you experience signs of a serious allergic reaction, stop using Pelgraz and seek immediate medical attention
  • Latex sensitivity – the grey needle cap on the pre-filled syringe contains a latex derivative, which may cause severe allergic reactions in latex-sensitive individuals
  • Cough, fever, and difficulty breathing – these may be signs of acute respiratory distress syndrome (ARDS), a serious lung condition that requires immediate medical attention
  • Capillary leak syndrome – symptoms include swelling or puffiness (which may be associated with passing urine less frequently than usual), breathing difficulty, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms tend to develop quickly and require immediate treatment
  • Pain in the upper left abdomen or tip of the left shoulder – this may indicate problems with the spleen (splenomegaly or splenic rupture). Some cases of splenic rupture have been fatal. Contact your doctor immediately if you experience these symptoms
  • Recent serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease), or abnormal chest X-ray findings (pulmonary infiltration)
  • Abnormal blood cell counts – including elevated white blood cells, anaemia, or low platelet counts (thrombocytopenia, which reduces blood clotting). Your doctor may want to monitor your blood counts more frequently
  • Sickle cell disease – pegfilgrastim may trigger sickle cell crises in patients with sickle cell trait or sickle cell disease. Your doctor will monitor you more closely
  • Breast cancer or lung cancer – Pelgraz in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include fatigue, fever, easy bruising, and bleeding
  • Symptoms of aortic inflammation (aortitis) – rarely reported in cancer patients and healthy donors receiving G-CSF. Symptoms may include fever, abdominal pain, malaise, back pain, and elevated inflammatory markers (e.g. C-reactive protein and white blood cell count)

Your doctor will arrange regular blood and urine tests during treatment because Pelgraz can damage the small filters in your kidneys, a condition known as glomerulonephritis.

Severe skin reactions (Stevens–Johnson syndrome) have been reported with pegfilgrastim use. Stop using Pelgraz and seek medical attention immediately if you develop reddish target-like or circular patches on the trunk, often with central blisters, skin peeling, or ulcers of the mouth, throat, nose, genitals, or eyes, preceded by fever and flu-like symptoms.

Use in Children and Adolescents

The safety and efficacy of Pelgraz in children have not yet been established. Talk to your doctor or pharmacist before using any medicine in children. While pegfilgrastim is used in some paediatric settings, this is typically under specialist supervision and with careful dose considerations based on body weight.

Pregnancy and Breastfeeding

Pelgraz has not been studied in pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is important to tell your doctor if you become pregnant during treatment with Pelgraz.

If you are breastfeeding, you should stop breastfeeding during Pelgraz treatment unless your doctor gives you specific advice to the contrary. It is not known whether pegfilgrastim passes into breast milk, and a risk to the nursing infant cannot be excluded.

Driving and Operating Machinery

Pelgraz has no or negligible effect on the ability to drive and use machines. However, as with any medical treatment, if you feel unwell after receiving Pelgraz, you should avoid driving or operating machinery until you feel well enough to do so safely.

Other Medicines and Pelgraz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The most important interaction to be aware of is with cytotoxic chemotherapy itself – Pelgraz must not be given within the period from 14 days before to 24 hours after receiving chemotherapy, as doing so could result in the rapidly dividing neutrophil precursors stimulated by Pelgraz being killed by the chemotherapy drugs, potentially worsening neutropenia rather than improving it.

Lithium may enhance the release of neutrophils and should be mentioned to your doctor if you are taking it, as dose adjustments or additional monitoring may be required.

Important Information About Pelgraz Ingredients

This medicine contains 30 mg sorbitol (E420) per pre-filled injector, equivalent to 50 mg/mL. Additionally, this medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, meaning it is essentially “sodium-free”.

How Does Pelgraz Interact with Other Drugs?

The most critical interaction involves the timing of Pelgraz relative to chemotherapy: it must be administered at least 24 hours after chemotherapy and not within 14 days before the next cycle. Lithium may enhance neutrophil release and should be monitored. No other significant drug interactions have been identified in clinical studies.

Unlike many oral medications, pegfilgrastim has a limited drug interaction profile because it is a biological protein that is cleared from the body through neutrophil-mediated endocytosis rather than hepatic metabolism. It does not interact with the cytochrome P450 enzyme system. However, certain precautions are important.

Known Drug Interactions with Pelgraz (Pegfilgrastim)
Drug / Category Type Effect Recommendation
Cytotoxic chemotherapy Critical timing interaction Giving Pelgraz too close to chemotherapy can cause the stimulated neutrophil precursors to be destroyed by the cytotoxic drugs, worsening neutropenia Administer Pelgraz at least 24 hours after chemotherapy; do not give within 14 days before the next cycle
Lithium Pharmacodynamic Lithium promotes neutrophil release from the bone marrow, potentially enhancing the effects of Pelgraz and causing excessive leukocytosis Monitor white blood cell counts more frequently if used concomitantly
Radiation therapy Combined toxicity Concurrent use with chemotherapy and radiation may increase the risk of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) Discuss risks and benefits with your oncologist; close monitoring required
Other G-CSF products Duplication Using multiple G-CSF products simultaneously offers no benefit and may increase side effects Do not combine with filgrastim or other G-CSF products

Always inform your medical team about all medicines you are taking, including over-the-counter drugs, vitamins, and herbal supplements. Although pegfilgrastim has limited interactions, your oncology team needs a complete picture of your medications to provide the safest and most effective cancer care.

What Is the Correct Dosage of Pelgraz?

The recommended dose of Pelgraz is a single 6 mg subcutaneous injection given once per chemotherapy cycle. It must be administered at least 24 hours after the last dose of chemotherapy. Do not shake the solution vigorously as this may affect its efficacy.

Always use Pelgraz exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure about anything. Pelgraz is intended for use in adults aged 18 years and older.

Adults

Standard Dose – All Indications

Dose: 6 mg (0.6 mL) subcutaneous injection

Frequency: Once per chemotherapy cycle

Timing: At least 24 hours after the last dose of cytotoxic chemotherapy

The injection should be given under the skin (subcutaneously). Suitable injection sites include the abdomen (stomach area) or the front of the thigh. If someone else is giving the injection, the back of the upper arm may also be used.

Self-Injection Instructions

Your doctor may decide that it is best for you to inject Pelgraz yourself at home. Your doctor or nurse will show you how to give yourself the injection. Do not try to inject yourself unless you have been properly trained.

  • Remove the pre-filled injector from the refrigerator and allow it to reach room temperature by leaving it out for approximately 30 minutes, or warm it gently in your hand for a few minutes. Do not heat it in any other way (e.g. microwave or hot water)
  • Check the expiry date on the label. Do not use if the date has passed
  • Inspect the solution – it must be a clear, colourless liquid. Do not use if it contains particles or appears cloudy
  • Wash your hands thoroughly with soap and water
  • Clean the injection site with an alcohol swab and allow it to air-dry
  • Remove the bottom cap by twisting and pulling. Keep your hands away from the needle guard after removal
  • Inject within 5 minutes of removing the cap
  • Place the injector at approximately 90 degrees to the skin and press the handle straight down. The injection is complete when you hear a click and the orange body is no longer visible
  • Lift the injector straight up. The yellow band indicates the needle guard is locked
  • Dispose of the used injector in an approved sharps container. Never place it in household waste

Children and Adolescents

Paediatric Use

The safety and efficacy of Pelgraz in children have not been established. Dosing in paediatric patients, when used under specialist supervision, is generally weight-based. Consult your child's oncologist for specific guidance.

Missed Dose

If you inject Pelgraz yourself and have forgotten a dose, contact your doctor as soon as possible to discuss when you should inject the next dose. Because Pelgraz is given once per chemotherapy cycle, missed doses are uncommon but should be addressed promptly to ensure adequate neutrophil protection.

Overdose

Overdose Warning:

If you use more Pelgraz than you should, contact your doctor, pharmacist, or nurse immediately. Overdose with pegfilgrastim may result in an excessive increase in white blood cells (leukocytosis) and exacerbation of bone pain. There is no specific antidote; treatment is supportive and based on monitoring of blood counts and clinical symptoms.

Stopping Pelgraz

Your doctor will tell you when to stop using Pelgraz. It is entirely normal to have several courses of Pelgraz treatment, typically one injection per chemotherapy cycle throughout your course of chemotherapy. Do not stop using Pelgraz without discussing it with your doctor, as premature discontinuation may leave you unprotected against chemotherapy-induced neutropenia and serious infections.

What Are the Side Effects of Pelgraz?

The most common side effect of Pelgraz is bone pain, which affects more than 1 in 10 people and is caused by the stimulation of bone marrow activity. Other common side effects include headache, nausea, injection site pain, and musculoskeletal pain. Most side effects are manageable and temporary.

Like all medicines, Pelgraz can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, contact your doctor immediately.

Seek immediate medical attention if you experience:
  • Swelling or puffiness with decreased urination, difficulty breathing, abdominal swelling and fullness, and general tiredness – these may be signs of capillary leak syndrome (uncommon, may affect up to 1 in 100 people), which requires immediate treatment
  • Pain in the upper left abdomen or shoulder tip pain – may indicate splenic enlargement or rupture (some cases have been fatal)
  • Sudden signs of allergy such as rash, itching, hives, facial swelling, shortness of breath, or wheezing – signs of severe allergic reaction (anaphylaxis)
  • Reddish target-like patches, blisters, skin peeling, or mouth/eye ulcers – may indicate Stevens–Johnson syndrome

Very Common

May affect more than 1 in 10 people

  • Bone pain – your doctor can recommend appropriate pain relief (e.g. paracetamol or ibuprofen)
  • Headache
  • Nausea

Common

May affect up to 1 in 10 people

  • Injection site pain or reactions
  • General joint and muscle pain (musculoskeletal pain)
  • Chest pain not related to heart disease or heart attack
  • Temporary increase in white blood cell count (leukocytosis)
  • Decrease in platelet count (thrombocytopenia), which may lead to easy bruising

Uncommon

May affect up to 1 in 100 people

  • Allergic-type reactions including redness, flushing, skin rash, and raised itchy areas of skin
  • Serious allergic reactions (anaphylaxis) including weakness, blood pressure drop, difficulty breathing, and facial swelling
  • Splenic enlargement (splenomegaly)
  • Splenic rupture – some cases have been fatal
  • Breathing problems (cough, fever, difficulty breathing)
  • Sweet syndrome (painful, plum-coloured, raised skin lesions on arms, legs, and sometimes face and neck, with fever)
  • Cutaneous vasculitis (inflammation of blood vessels in the skin)
  • Kidney damage (glomerulonephritis) – affecting the small filters in the kidneys
  • Injection site redness
  • Abnormal blood tests: lactate dehydrogenase, uric acid, alkaline phosphatase
  • Abnormal liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
  • Coughing up blood (haemoptysis)
  • Blood disorders: myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)

Rare

May affect up to 1 in 1,000 people

  • Inflammation of the aorta (aortitis) – the large blood vessel carrying blood from the heart to the body
  • Pulmonary haemorrhage (bleeding in the lungs)
  • Stevens–Johnson syndrome – serious skin reaction with reddish target-like or circular patches on the trunk, often with central blisters, skin peeling, and ulcers of the mouth, throat, nose, genitals, or eyes, preceded by fever and flu-like symptoms

If you experience any side effects not listed here, or if any side effect becomes severe or persistent, contact your doctor, pharmacist, or nurse. Reporting suspected side effects helps ensure continuous monitoring of the medicine's benefit–risk balance.

How Should You Store Pelgraz?

Store Pelgraz in a refrigerator at 2–8°C, protected from light in its original carton. It may be stored at room temperature (up to 25°C) for a maximum of 15 days. Do not freeze. Do not use if the solution is cloudy or contains particles.

Keep this medicine out of the sight and reach of children. Do not use after the expiry date stated on the carton and the pre-filled injector label (EXP). The expiry date refers to the last day of the stated month.

Pelgraz may be stored at room temperature (not exceeding 25°C ± 2°C) for a maximum of 15 days. Any Pelgraz that has been stored at room temperature for longer than 15 days must be discarded. If you have questions about storage, speak to your doctor, nurse, or pharmacist.

Do not freeze. Accidental freezing for up to 24 hours does not impair the stability of Pelgraz. However, if the medicine has been frozen for longer than 24 hours, or has been frozen on more than one occasion, it must not be used.

Keep the pre-filled injector in its carton to protect it from light. Do not use this medicine if it is cloudy or contains visible particles. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

What Does Pelgraz Contain?

Each pre-filled injector of Pelgraz contains 6 mg pegfilgrastim in 0.6 mL of solution. The solution is clear and colourless. Inactive ingredients include sodium acetate, sorbitol (E420), polysorbate 20, and water for injections.

Active Ingredient

The active substance is pegfilgrastim. Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL of solution (equivalent to 10 mg/mL). Pegfilgrastim is produced by recombinant DNA technology in Escherichia coli (E. coli) and subsequently PEGylated with a 20 kDa monomethoxy polyethylene glycol molecule.

Inactive Ingredients (Excipients)

The other ingredients are:

  • Sodium acetate – a buffer that maintains the solution at the correct pH
  • Sorbitol (E420) – a stabiliser (30 mg per pre-filled injector, equivalent to 50 mg/mL)
  • Polysorbate 20 – a surfactant that prevents protein aggregation
  • Water for injections – the solvent

Sodium Content

This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, meaning it is essentially “sodium-free”. This is relevant for patients on a sodium-restricted diet.

Appearance and Packaging

Pelgraz is a clear, colourless solution for injection in a pre-filled injector with injection needle. Each pre-filled injector contains 0.6 mL of solution. Pelgraz is supplied in a pack of 1 pre-filled injector in a mono-carton with an alcohol swab.

Marketing Authorisation Holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, Spain.

How Does Pelgraz Work in the Body?

Pelgraz works by binding to the G-CSF receptor on neutrophil precursor cells in the bone marrow, stimulating their proliferation, maturation, and release into the bloodstream. The PEGylation of filgrastim extends its half-life through reduced renal clearance, and the drug has a unique self-regulating clearance mechanism tied to neutrophil count recovery.

Granulocyte colony-stimulating factor (G-CSF) is a naturally occurring cytokine that plays a central role in the regulation of granulopoiesis – the process by which the bone marrow produces granulocytes (neutrophils, eosinophils, and basophils). Pegfilgrastim, the active ingredient in Pelgraz, acts on the same receptor (the G-CSF receptor, also known as CD114) as endogenous G-CSF, but with a prolonged duration of action.

When pegfilgrastim binds to the G-CSF receptor on myeloid progenitor cells in the bone marrow, it triggers an intracellular signalling cascade involving the JAK-STAT pathway (Janus kinase–signal transducer and activator of transcription). This promotes:

  • Proliferation of neutrophil precursor cells
  • Differentiation of precursors into mature neutrophils
  • Accelerated maturation and earlier release of neutrophils from the bone marrow into the peripheral blood
  • Enhanced functional activation of mature neutrophils, including improved chemotaxis, phagocytosis, and bactericidal activity

The PEGylation of filgrastim (addition of a polyethylene glycol molecule) is the key innovation that distinguishes pegfilgrastim from filgrastim. The PEG moiety dramatically reduces renal clearance because the larger molecular size prevents filtration through the kidney glomeruli. Instead, pegfilgrastim is cleared primarily through neutrophil-mediated endocytosis – the neutrophils themselves take up and degrade the drug. This creates an elegant self-regulating mechanism: when neutrophil counts are low (during the nadir), pegfilgrastim concentrations remain high because there are few neutrophils to clear it; as neutrophil counts recover, clearance accelerates, preventing excessive stimulation.

This pharmacokinetic profile means that a single 6 mg dose of pegfilgrastim provides sustained neutrophil stimulation throughout the entire period of chemotherapy-induced neutropenia – typically 10–14 days. In contrast, filgrastim (the non-PEGylated form) has a short half-life of 3–4 hours and requires daily subcutaneous injections throughout the neutropenic period.

Frequently Asked Questions About Pelgraz

Pelgraz (pegfilgrastim) is used to reduce the duration of neutropenia (low white blood cell count) and the incidence of febrile neutropenia (low white blood cells accompanied by fever) in adults receiving cytotoxic chemotherapy for cancer. White blood cells, particularly neutrophils, are essential for fighting infections. Chemotherapy can severely reduce their numbers, leaving patients vulnerable to serious infections. Pelgraz stimulates the bone marrow to produce more neutrophils, restoring the body's ability to fight infections more quickly.

Pelgraz is given as a single 6 mg subcutaneous injection (under the skin) once per chemotherapy cycle. It must be administered at least 24 hours after the last dose of chemotherapy. The injection can be given in the abdomen (stomach area), the front of the thigh, or the back of the upper arm (if administered by someone else). Patients can be trained to self-inject at home using the pre-filled syringe or pre-filled injector device, which has a built-in needle guard for safety.

Pelgraz is a biosimilar of the originator product Neulasta. Both contain the same active substance (pegfilgrastim 6 mg) and are administered in the same way – as a single subcutaneous injection per chemotherapy cycle. Biosimilars undergo rigorous testing to demonstrate equivalent quality, safety, and efficacy compared to the reference product. Pelgraz has been approved by the European Medicines Agency (EMA) based on comprehensive comparability studies. Other approved biosimilars of Neulasta include Fulphila, Nyvepria, and Ziextenzo.

Bone pain is the most common side effect of Pelgraz, occurring in more than 1 in 10 people. It is caused by the stimulation of bone marrow activity – as the bone marrow expands to produce large numbers of neutrophils, it exerts pressure within the bone cavities, causing pain that is typically felt in the hips, lower back, sternum (breastbone), and long bones. The pain is usually mild to moderate and can be managed with standard pain relievers such as paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. If the pain is severe or persistent, inform your doctor.

Yes, Pelgraz may be stored at room temperature (up to 25°C) for a maximum of 15 days. After this period, it must be discarded even if not used. The preferred storage is in a refrigerator at 2–8°C, protected from light in its original carton. Never freeze Pelgraz, although accidental freezing for up to 24 hours does not impair its stability. If it has been frozen for longer than 24 hours or frozen more than once, do not use it.

Pelgraz begins stimulating neutrophil production in the bone marrow within hours of injection. However, because it takes time for neutrophil precursors to mature and be released into the bloodstream, the clinical effect – a measurable increase in circulating neutrophils – is typically seen within 1–3 days after administration. The drug remains active throughout the entire neutropenic nadir period (typically 7–14 days after chemotherapy) due to its self-regulating clearance mechanism, which maintains high drug levels when neutrophil counts are low and clears the drug as counts recover.

References

This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.

  1. European Medicines Agency (EMA). Pelgraz – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
  2. Klastersky J, de Naurois J, Rolston K, et al. Management of febrile neutropaenia: ESMO Clinical Practice Guidelines. Annals of Oncology. 2016;27(suppl 5):v111–v118. doi:10.1093/annonc/mdw325
  3. Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. Journal of Clinical Oncology. 2015;33(28):3199–3212. doi:10.1200/JCO.2015.62.3488
  4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors. Version 1.2025.
  5. Crawford J, Dale DC, Kuderer NM, et al. Risk and timing of neutropenic events in adult cancer patients receiving chemotherapy: the results of a prospective nationwide study of oncology practice. Journal of the National Comprehensive Cancer Network. 2008;6(2):109–118.
  6. Holmes FA, O’Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. Journal of Clinical Oncology. 2002;20(3):727–731.
  7. Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Annals of Oncology. 2003;14(1):29–35.
  8. World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.

Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in haematology, medical oncology, and clinical pharmacology.

Medical Writers

Board-certified physicians specialising in haematology, oncology, and clinical pharmacology with documented academic and clinical experience in supportive cancer care.

Medical Reviewers

Independent review board ensuring clinical accuracy, adherence to international guidelines (ESMO, ASCO, NCCN, WHO), and evidence level 1A standards.

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All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.