Dyrupeg (Pegfilgrastim)
Granulocyte colony-stimulating factor (G-CSF) for prevention of chemotherapy-induced neutropenia
Dyrupeg is a biosimilar medicine containing pegfilgrastim, a pegylated granulocyte colony-stimulating factor (G-CSF). It is used to reduce the duration and severity of neutropenia (low white blood cell count) in adults receiving cytotoxic chemotherapy for cancer. Administered as a single subcutaneous injection of 6 mg per chemotherapy cycle, Dyrupeg stimulates the bone marrow to produce neutrophils, helping restore immune defences after chemotherapy.
Quick Facts
Key Takeaways
- Dyrupeg is a biosimilar pegfilgrastim approved in the EU to prevent chemotherapy-induced neutropenia and febrile neutropenia in adult cancer patients.
- It is administered as a single 6 mg subcutaneous injection approximately 24 hours after each chemotherapy cycle, providing sustained white blood cell support.
- The most common side effect is bone pain, which can typically be managed with paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs).
- Dyrupeg must not be given in the 14 days before or within 24 hours after cytotoxic chemotherapy administration.
- Store in a refrigerator (2°C to 8°C). The pre-filled syringe can be kept at room temperature for a maximum of 48 hours before use.
What Is Dyrupeg and What Is It Used For?
Quick Answer: Dyrupeg (pegfilgrastim) is a biosimilar G-CSF injection used to prevent neutropenia and febrile neutropenia in adult cancer patients undergoing cytotoxic chemotherapy. It stimulates the bone marrow to produce more white blood cells (neutrophils) to help the immune system recover faster.
Dyrupeg contains the active substance pegfilgrastim, which is a covalent conjugate of filgrastim (a recombinant human granulocyte colony-stimulating factor, or G-CSF) with a single 20-kilodalton polyethylene glycol (PEG) molecule. This PEGylation process significantly extends the half-life of the drug compared to standard filgrastim, allowing it to remain active in the body for a longer period. As a result, a single injection per chemotherapy cycle is sufficient, whereas non-pegylated filgrastim typically requires daily injections for up to 14 days.
Neutropenia is one of the most common and potentially dangerous side effects of cytotoxic chemotherapy. When neutrophil counts drop below a critical threshold (typically below 0.5 × 109/L), patients become severely immunocompromised and are at high risk of developing life-threatening infections. Febrile neutropenia — defined as an absolute neutrophil count below 0.5 × 109/L accompanied by a fever of 38.3°C or higher — is a medical emergency that often requires hospitalisation, intravenous antibiotics, and potentially delays or dose reductions in subsequent chemotherapy cycles.
By stimulating the production and release of neutrophils from the bone marrow, Dyrupeg helps to reduce both the duration and severity of neutropenia following chemotherapy. Clinical studies have demonstrated that pegfilgrastim significantly reduces the incidence of febrile neutropenia, the number of days with severe neutropenia, and the need for hospitalisation due to neutropenic complications. This allows patients to maintain their planned chemotherapy schedule, which is critical for achieving optimal treatment outcomes.
Dyrupeg is a biosimilar medicine — it is highly similar to the reference medicine Neulasta, which has been authorised in the European Union since 2002. The European Medicines Agency (EMA) has confirmed that Dyrupeg meets the stringent quality, safety, and efficacy standards required for biosimilar approval. Biosimilar medicines provide patients with access to well-established biological therapies, often at reduced cost, helping to improve the sustainability of healthcare systems.
Mechanism of Action
Pegfilgrastim binds to specific G-CSF receptors on the surface of haematopoietic progenitor cells in the bone marrow. This binding activates intracellular signalling cascades — primarily the JAK-STAT, MAPK, and PI3K/AKT pathways — that promote the survival, proliferation, differentiation, and functional activation of neutrophil precursors. The mature neutrophils are then released into the bloodstream, where they can combat bacterial and fungal infections.
A key pharmacological feature of pegfilgrastim is its self-regulating clearance mechanism. The drug is primarily cleared from the body by neutrophils themselves through receptor-mediated endocytosis. When neutrophil counts are low (as after chemotherapy), clearance is minimal, allowing drug levels to remain high and stimulate neutrophil production. As neutrophil counts recover, clearance increases, and drug levels decline naturally. This mechanism ensures that the drug remains active for as long as it is needed and then is efficiently eliminated once the neutrophil count has recovered.
Dyrupeg is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukaemia and myelodysplastic syndromes.
What Should You Know Before Taking Dyrupeg?
Quick Answer: Do not use Dyrupeg if you are allergic to pegfilgrastim, filgrastim, or any of the excipients. Tell your doctor about all medical conditions, especially sickle cell disease, kidney problems, or if you are pregnant or breastfeeding. Dyrupeg must not be given within 14 days before or 24 hours after chemotherapy.
Contraindications
Dyrupeg must not be used in patients with a known hypersensitivity to pegfilgrastim, filgrastim, or to any of the excipients listed in the product information. Allergic reactions, including anaphylaxis, have been reported with pegfilgrastim and filgrastim products. If a serious allergic reaction occurs, appropriate treatment should be administered and the medicine permanently discontinued.
Dyrupeg is not indicated for patients with chronic myeloid leukaemia (CML) or myelodysplastic syndromes (MDS). The safety and efficacy of pegfilgrastim have not been established in these conditions, and G-CSF may theoretically stimulate the growth of myeloid malignant cells. Similarly, Dyrupeg should not be used for the purpose of mobilising peripheral blood progenitor cells for transplantation.
Warnings and Precautions
Before starting treatment with Dyrupeg, patients should discuss their complete medical history with their doctor, including any of the following conditions:
- Sickle cell trait or disease: Severe sickle cell crises, sometimes fatal, have been reported in patients with sickle cell disease receiving G-CSF products. Patients with sickle cell trait should also be monitored. If sickle cell crisis occurs, treatment should be discontinued.
- Splenic disorders: Cases of splenic rupture, including fatal cases, have been reported in patients receiving pegfilgrastim. Patients should be evaluated for an enlarged spleen or splenic rupture if they develop left upper abdominal pain or left shoulder tip pain.
- Pulmonary conditions: Acute respiratory distress syndrome (ARDS) has been reported in patients receiving G-CSF products. Patients who develop fever, lung infiltrates, or respiratory distress should be evaluated for ARDS. If ARDS is diagnosed, Dyrupeg should be discontinued and appropriate treatment initiated.
- Aortitis: Inflammation of the aorta has been reported in patients receiving G-CSF, including pegfilgrastim. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., C-reactive protein, white blood cell count).
- Glomerulonephritis: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Usually resolves after dose reduction or discontinuation.
- Capillary leak syndrome: This condition, characterised by hypotension, hypoalbuminaemia, oedema, and haemoconcentration, has been reported with G-CSF use and can be life-threatening if treatment is delayed.
- Myelodysplastic syndrome and acute myeloid leukaemia: In patients with breast and lung cancer receiving pegfilgrastim together with chemotherapy and/or radiotherapy, cases of MDS and AML have been reported. Patients should be monitored for signs and symptoms of MDS/AML.
Do not administer Dyrupeg in the period between 14 days before and 24 hours after the administration of cytotoxic chemotherapy. Concurrent use with chemotherapy can increase the sensitivity of rapidly dividing myeloid cells to the cytotoxic effects of chemotherapy, potentially worsening neutropenia.
Pregnancy and Breastfeeding
There are limited data on the use of pegfilgrastim in pregnant women. Animal studies have shown reproductive toxicity. Dyrupeg is not recommended during pregnancy unless the clinical condition of the woman requires treatment, and the potential benefit justifies the potential risk to the foetus. Women of childbearing potential should use effective contraception during treatment.
It is not known whether pegfilgrastim or its metabolites are excreted in human breast milk. A risk to newborns and infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Effects on Ability to Drive and Use Machines
Dyrupeg has no or negligible influence on the ability to drive and use machines. However, patients should be aware that fatigue is a commonly reported side effect, and they should assess their own ability to perform these tasks before doing so.
How Does Dyrupeg Interact with Other Drugs?
Quick Answer: Dyrupeg has relatively few drug interactions. The most important interaction is with cytotoxic chemotherapy — it must not be given within 14 days before or 24 hours after chemotherapy. Lithium may enhance neutrophil production when combined with Dyrupeg and should be used with caution.
Although pegfilgrastim has a relatively limited drug interaction profile, it is important for patients to inform their doctor about all medications they are currently taking, including prescription medicines, over-the-counter products, herbal supplements, and vitamins. The primary interactions of clinical significance involve the timing of chemotherapy administration and co-administration with certain drugs that affect white blood cell counts.
The pharmacokinetic interaction between pegfilgrastim and cytotoxic chemotherapy agents is of paramount importance. Because pegfilgrastim stimulates the rapid proliferation of myeloid precursor cells, administering cytotoxic chemotherapy during this period of active cell division could paradoxically worsen neutropenia. The rapidly dividing cells would be more susceptible to the cytotoxic effects of the chemotherapy, potentially leading to deeper and more prolonged neutropenia. For this reason, strict adherence to the timing window is essential.
No formal drug interaction studies have been conducted with Dyrupeg specifically, but the interaction profile is expected to be identical to that of the reference product Neulasta, based on the established biosimilarity. Post-marketing experience with pegfilgrastim over more than two decades provides a comprehensive understanding of its interaction profile.
| Interacting Drug | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Cytotoxic chemotherapy | Pharmacodynamic | Major — may worsen neutropenia | Do not give within 14 days before or 24 hours after chemotherapy |
| Lithium | Pharmacodynamic | Moderate — may potentiate neutrophil release | Monitor white blood cell counts more frequently |
| Clozapine | Pharmacodynamic | Moderate — clozapine can cause neutropenia | Close monitoring of neutrophil counts required |
| Topotecan | Pharmacodynamic | Moderate — prolonged duration of neutropenia reported | Careful timing; follow prescribing information |
| Bleomycin | Pharmacodynamic | Potential — increased pulmonary toxicity reported with G-CSF | Monitor for pulmonary symptoms; use with caution |
Major Interactions
The most clinically significant interaction is with cytotoxic chemotherapy agents. The timing of Dyrupeg administration relative to chemotherapy is critical. Administering Dyrupeg too close to chemotherapy can result in worsened myelosuppression because rapidly dividing myeloid cells are more sensitive to cytotoxic agents. The recommended timing is to administer Dyrupeg at least 24 hours after the last dose of chemotherapy in each cycle, and not within 14 days before the next chemotherapy dose.
Minor Interactions
Lithium is known to promote the release of neutrophils from the bone marrow and may enhance the effects of G-CSF. While this interaction is generally not dangerous, patients taking lithium concurrently with Dyrupeg should have their white blood cell counts monitored more frequently to detect any excessive increase in neutrophils (leukocytosis).
There are no known interactions between pegfilgrastim and food or beverages. Pegfilgrastim is administered subcutaneously and is not affected by gastrointestinal absorption, so timing relative to meals is not relevant.
What Is the Correct Dosage of Dyrupeg?
Quick Answer: The recommended dose is a single 6 mg subcutaneous injection given approximately 24 hours after the completion of each chemotherapy cycle. No dose adjustment is needed based on body weight. Dyrupeg should only be initiated and supervised by a physician experienced in oncology or haematology.
Dyrupeg is available as a fixed-dose, single-use pre-filled syringe containing 6 mg of pegfilgrastim in 0.6 mL of solution. Unlike filgrastim, which requires weight-based dosing and daily injections, pegfilgrastim is given as a single fixed dose per chemotherapy cycle regardless of body weight. Clinical studies have demonstrated that the 6 mg dose provides effective neutrophil recovery across a wide range of patient body weights.
Treatment with Dyrupeg should be initiated and supervised by a physician experienced in the treatment of cancer or haematological disorders. The decision to use Dyrupeg should be based on the patient's individual risk of developing febrile neutropenia, taking into account the type of chemotherapy regimen, prior history of febrile neutropenia, patient age, comorbidities, and overall treatment goals.
Adults
Standard Adult Dose
Dose: 6 mg (one pre-filled syringe) subcutaneously once per chemotherapy cycle
Timing: Approximately 24 hours after the last dose of each chemotherapy cycle
Duration: One injection per cycle for as many cycles as chemotherapy continues
Note: No dose adjustment required based on body weight, age, or renal function
The injection can be given by a healthcare professional or, after appropriate training, by the patient or a caregiver at home. Injection sites include the abdomen (at least 5 cm from the navel), the front of the thigh, or the back of the upper arm (if injected by another person). Patients should rotate injection sites with each dose to minimise the risk of injection site reactions.
Children and Adolescents
Paediatric Dose
Children weighing 45 kg or more: 6 mg subcutaneously once per chemotherapy cycle
Children weighing less than 45 kg: Pegfilgrastim is available in weight-based formulations for paediatric patients in some markets. Consult the prescribing information or a paediatric oncologist.
Note: The safety and efficacy of Dyrupeg specifically in children under 18 years has not been established. Refer to local prescribing guidelines.
Elderly
No dose adjustment is required for elderly patients. Clinical studies of pegfilgrastim included patients aged 65 years and older, and no overall differences in safety or efficacy were observed compared with younger patients. However, elderly patients may be at increased risk of some adverse effects, including splenic complications, and should be monitored accordingly.
Renal and Hepatic Impairment
No dose adjustment is required in patients with renal or hepatic impairment. Pegfilgrastim is primarily cleared by neutrophil-mediated endocytosis rather than through renal or hepatic metabolism. Therefore, changes in kidney or liver function are not expected to significantly affect drug clearance or efficacy.
Missed Dose
If a dose of Dyrupeg is missed, patients should contact their healthcare provider as soon as possible to arrange for the injection. The timing of the next dose relative to the chemotherapy cycle is important, and the physician will advise on the appropriate course of action. Patients should not attempt to self-administer a double dose to compensate for a missed one.
Overdose
There is limited clinical experience with pegfilgrastim overdose. In cases of accidental overdose, patients should be monitored for signs of excessive leukocytosis (elevated white blood cell counts), bone pain, and other known adverse effects. Treatment is supportive and symptomatic. Pegfilgrastim cannot be removed by haemodialysis. The self-regulating clearance mechanism means that as neutrophil counts rise, clearance of the drug will increase naturally, which provides an inherent safety mechanism against sustained over-exposure.
| Patient Group | Dose | Frequency | Special Considerations |
|---|---|---|---|
| Adults (≥18 years) | 6 mg SC | Once per chemo cycle | Give ~24 hours after chemotherapy |
| Children ≥45 kg | 6 mg SC | Once per chemo cycle | Same as adult dosing |
| Children <45 kg | Weight-based | Once per chemo cycle | Consult paediatric oncologist |
| Elderly (≥65 years) | 6 mg SC | Once per chemo cycle | No dose adjustment; monitor for splenic complications |
| Renal/Hepatic impairment | 6 mg SC | Once per chemo cycle | No dose adjustment required |
What Are the Side Effects of Dyrupeg?
Quick Answer: The most common side effect is bone pain, affecting more than 1 in 10 patients. Other common effects include musculoskeletal pain, headache, and injection site reactions. Rare but serious side effects include splenic rupture, ARDS, and severe allergic reactions.
Like all medicines, Dyrupeg can cause side effects, although not everybody gets them. The safety profile of pegfilgrastim has been well characterised through extensive clinical trials and more than 20 years of post-marketing experience with the reference product Neulasta. As a biosimilar, Dyrupeg has been demonstrated to have a comparable safety profile.
Most side effects associated with Dyrupeg are mild to moderate in severity and are manageable. Bone pain, the most frequently reported adverse reaction, is thought to result from the expansion of neutrophil precursors in the bone marrow. This pain is typically most noticeable in the lower back, pelvis, and legs, and usually occurs within the first few days after injection. It generally resolves spontaneously within a few days and can be effectively managed with standard analgesics.
The side effects are categorised below by frequency, based on clinical trial data and post-marketing surveillance reports from the EMA and FDA:
Very Common
- Bone pain (most frequently reported; often in lower back, pelvis, legs)
Common
- Musculoskeletal pain (pain in muscles, bones, joints, and connective tissues)
- Headache
- Nausea
- Injection site reactions (pain, redness, swelling, or itching at injection site)
- Fatigue and asthenia (general weakness)
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Back pain
- Pain in extremity
- Thrombocytopenia (low platelet count)
Uncommon
- Chest pain (non-cardiac)
- Leukocytosis (excessively high white blood cell count)
- Dyspnoea (shortness of breath)
- Skin rash
- Elevated liver enzymes (alkaline phosphatase, lactate dehydrogenase)
- Splenomegaly (enlarged spleen)
- Hypersensitivity reactions (urticaria, facial oedema)
Rare
- Splenic rupture (potentially fatal — seek immediate medical attention for left upper abdominal pain)
- Acute respiratory distress syndrome (ARDS)
- Anaphylaxis and severe allergic reactions
- Aortitis (inflammation of the aorta)
- Capillary leak syndrome
- Glomerulonephritis (kidney inflammation)
- Sweet's syndrome (acute febrile neutrophilic dermatosis)
- Cutaneous vasculitis (inflammation of blood vessels in the skin)
- Sickle cell crisis (in patients with sickle cell disease)
- Myelodysplastic syndrome and acute myeloid leukaemia (in cancer patients receiving concurrent chemotherapy/radiotherapy)
Contact your healthcare provider or go to the emergency department immediately if you experience any of the following: severe allergic reaction (difficulty breathing, swelling of face/lips/tongue, rapid heartbeat); sudden or severe pain in the left upper abdomen or left shoulder; fever above 38°C with shortness of breath; or signs of capillary leak syndrome (rapid swelling, feeling faint, reduced urine output).
Managing Bone Pain
Bone pain is the most frequently reported side effect and occurs in approximately 20–30% of patients receiving pegfilgrastim. The American Society of Clinical Oncology (ASCO) guidelines recommend the use of non-opioid analgesics as first-line treatment. Paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen are typically effective. In some cases, healthcare providers may prescribe antihistamines (such as loratadine) prophylactically, as some studies have suggested a modest reduction in bone pain with prophylactic antihistamine use, although the evidence is not conclusive.
If bone pain is severe or does not respond to non-opioid analgesics, your healthcare provider may prescribe opioid analgesics for short-term use. It is important to report persistent or severe bone pain to your oncology team so they can help manage your symptoms and assess whether any dose modification or additional supportive measures are needed.
Laboratory Abnormalities
Pegfilgrastim commonly causes transient increases in white blood cell counts, which is expected given its mechanism of action. Elevations in alkaline phosphatase and lactate dehydrogenase (LDH) have also been observed and are generally reversible upon discontinuation. These laboratory changes are usually clinically insignificant but should be monitored, particularly in patients with underlying conditions that may be affected by these changes.
How Should You Store Dyrupeg?
Quick Answer: Store Dyrupeg in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. The pre-filled syringe may be kept at room temperature (up to 25°C) for a maximum of 48 hours.
Proper storage of Dyrupeg is essential to maintain the effectiveness and safety of the medicine. As a biological product, pegfilgrastim is sensitive to temperature extremes and must be handled and stored correctly. Improper storage can lead to degradation of the active substance, reduced efficacy, and potentially altered safety profile.
Standard Storage Conditions
- Refrigerated storage: Store at 2°C to 8°C (36°F to 46°F) in a refrigerator.
- Keep in original carton: Protect from light by keeping the pre-filled syringe in its original outer carton until ready for use.
- Do not freeze: If accidentally frozen, allow to thaw in the refrigerator. Do not use if frozen more than once. If there is any doubt about whether the product has been frozen, do not use it.
- Do not shake: Vigorous shaking may denature the protein, reducing its biological activity.
Room Temperature Storage
The pre-filled syringe may be removed from the refrigerator and stored at room temperature (up to 25°C / 77°F) for a single period of up to 48 hours. Once removed from the refrigerator, the syringe should not be placed back in the refrigerator. If not used within 48 hours at room temperature, the syringe must be discarded. Allow the syringe to reach room temperature for approximately 30 minutes before administration to reduce discomfort at the injection site.
Before Use Inspection
Before each injection, visually inspect the solution. The solution should be clear and colourless to slightly yellowish. Do not use if the solution is cloudy, discoloured, or contains visible particles. Also check the expiry date on the carton and syringe — do not use after the stated expiry date.
Dispose of used syringes and needles in an approved sharps disposal container immediately after use. Never recap needles. Do not throw syringes in household waste. Return full sharps containers to your pharmacy or healthcare provider for safe disposal, in accordance with local regulations.
Keep Dyrupeg out of the sight and reach of children. Do not use the medicine after the expiry date stated on the carton and the syringe label. Any unused product or waste material should be disposed of in accordance with local requirements for pharmaceutical waste.
What Does Dyrupeg Contain?
Quick Answer: Each pre-filled syringe of Dyrupeg contains 6 mg of pegfilgrastim in 0.6 mL of solution. Pegfilgrastim is filgrastim conjugated with a 20 kDa polyethylene glycol molecule, produced in Escherichia coli by recombinant DNA technology.
Active Substance
Each 0.6 mL pre-filled syringe contains 6 mg of pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF, also known as filgrastim) with a single 20-kilodalton (kDa) monomethoxypolyethylene glycol (mPEG) molecule. The filgrastim component is produced in Escherichia coli (E. coli) by recombinant DNA technology and consists of 175 amino acids with a molecular weight of approximately 19 kDa. The total molecular weight of pegfilgrastim is approximately 39 kDa.
The PEGylation of filgrastim serves a critical pharmacokinetic purpose. The PEG moiety reduces renal clearance by increasing the molecular size of the protein above the threshold for glomerular filtration. This means that the primary route of elimination shifts from renal excretion (as in filgrastim) to neutrophil-mediated clearance. The result is a substantially longer plasma half-life — approximately 15 to 80 hours for pegfilgrastim compared with 3.5 to 3.8 hours for filgrastim — enabling once-per-cycle dosing rather than daily injections.
Excipients
The solution also contains the following inactive ingredients (excipients):
- Sodium acetate trihydrate
- Acetic acid, glacial (for pH adjustment)
- Sorbitol (E420)
- Polysorbate 20
- Water for injections
The solution has a pH of approximately 4.0 and is isotonic. The excipients serve to maintain the stability, solubility, and correct pH of the pegfilgrastim solution throughout its shelf life. Polysorbate 20 acts as a surfactant to prevent protein aggregation, while sorbitol serves as a stabiliser and tonicity agent.
This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, meaning it is essentially sodium-free. This is relevant for patients on a controlled sodium diet.
Pharmaceutical Form
Dyrupeg is presented as a solution for injection in a pre-filled syringe with an automatic needle guard. The syringe is equipped with a stainless steel injection needle and a needle cap containing dried natural rubber (a derivative of latex). Patients with known latex allergy should inform their healthcare provider before use. The solution is clear and colourless to slightly yellowish in appearance.
Frequently Asked Questions About Dyrupeg
Dyrupeg is a biosimilar of Neulasta. Both contain the same active substance — pegfilgrastim — at the same concentration (6 mg in 0.6 mL). They work in the same way and have the same therapeutic indication. The European Medicines Agency (EMA) has confirmed that Dyrupeg is highly similar to Neulasta in terms of quality, safety, and efficacy through a rigorous comparative programme including analytical, non-clinical, and clinical studies. The main difference may be in cost, as biosimilars are often more affordable than the reference product.
Yes, after receiving appropriate training from a healthcare professional, patients or their caregivers can administer Dyrupeg at home. Your healthcare team will teach you the correct injection technique, including how to prepare the syringe, choose and clean the injection site, administer the subcutaneous injection, and safely dispose of the used syringe. It is important to follow all instructions carefully and to contact your healthcare provider if you have any questions or concerns.
Dyrupeg begins stimulating neutrophil production within hours of administration, but the full effect on neutrophil recovery typically takes several days. Most patients experience a nadir (lowest point) in their white blood cell count approximately 5 to 7 days after chemotherapy, followed by a recovery that is accelerated by pegfilgrastim. The duration of severe neutropenia is typically reduced by 1 to 3 days compared with no G-CSF support. Your healthcare team will monitor your blood counts to assess the response.
Bone pain is the most common side effect of Dyrupeg and usually occurs within the first few days after injection. It is typically mild to moderate and can be managed with over-the-counter pain relievers such as paracetamol (acetaminophen) or ibuprofen. Some studies suggest that taking an antihistamine like loratadine may help reduce bone pain, though the evidence is mixed. If your bone pain is severe, does not respond to over-the-counter medications, or lasts longer than a few days, contact your oncology team for advice on additional pain management options.
Dyrupeg is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus. Animal studies have shown reproductive toxicity at high doses. If you are pregnant, planning to become pregnant, or think you may be pregnant, inform your doctor before starting treatment. Women of childbearing potential should use effective contraception during treatment with Dyrupeg. The decision to use Dyrupeg during pregnancy should be made by the treating oncologist after careful consideration of the risks and benefits.
All information is based on the European Medicines Agency (EMA) EPAR assessment report for Dyrupeg, the Summary of Product Characteristics (SmPC), ASCO Guidelines for the use of white blood cell growth factors (2023), ESMO Clinical Practice Guidelines for myeloid growth factor prophylaxis, NCCN Guidelines for hematopoietic growth factors, and peer-reviewed studies published in journals such as the Journal of Clinical Oncology, The Lancet Oncology, and the Annals of Oncology. All medical claims are supported by Level 1A evidence from systematic reviews and randomised controlled trials.
References
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- Lyman GH, Yau L, Nakov R, Krendyukov A. Overall survival and risk of second malignancies with cancer chemotherapy and G-CSF support. Ann Oncol. 2018;29(7):1603-1609. doi:10.1093/annonc/mdy151.
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- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors. Version 1.2024.
- Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8-32.
- European Medicines Agency (EMA). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMA/CHMP/BMWP/42832/2005 Rev1.
- Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol. 2012;7(Suppl 1):S57-S67.
- Bondarenko I, Blindar V, Gorbunova V, et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer. 2013;13:386.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List (2023). Geneva: WHO; 2023.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology, haematology, and clinical pharmacology. Our editorial process follows the GRADE evidence framework and adheres to international guidelines from the EMA, ASCO, ESMO, and NCCN.
iMedic Medical Editorial Team — specialists in oncology and clinical pharmacology with experience in biosimilar medicine assessment and chemotherapy support care.
iMedic Medical Review Board — independent panel of medical experts who review all content according to international guidelines (EMA, ASCO, ESMO, NCCN).
Level 1A evidence based on systematic reviews and meta-analyses of randomised controlled trials. GRADE framework applied to all recommendations.
No commercial funding, pharmaceutical sponsorship, or advertising. Independent medical editorial content with full conflict-of-interest disclosure.