Lonquex
Long-Acting G-CSF for Prevention of Chemotherapy-Induced Neutropenia
Quick Facts About Lonquex
Key Takeaways About Lonquex
- Once-per-cycle dosing: Lonquex is given as a single injection approximately 24 hours after each chemotherapy cycle, eliminating the need for daily G-CSF injections
- Reduces infection risk: By stimulating neutrophil production, Lonquex shortens the period when patients are most vulnerable to serious infections during chemotherapy
- Approved for adults and children: Lonquex can be used in patients aged 2 years and older, with weight-based dosing for paediatric patients
- Common side effect – bone pain: Musculoskeletal pain is the most frequent side effect, occurring in more than 1 in 10 patients
- Requires medical supervision: Lonquex is a prescription-only biological medicine administered by healthcare professionals, with regular blood monitoring recommended
What Is Lonquex and What Is It Used For?
Lonquex (lipegfilgrastim) is a long-acting pegylated granulocyte colony-stimulating factor (G-CSF) used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults and children aged 2 years and older who are receiving cytotoxic chemotherapy for cancer.
Lonquex contains the active substance lipegfilgrastim, a modified protein produced through biotechnology in Escherichia coli bacteria. It belongs to a group of proteins called cytokines and is closely related to a naturally occurring protein in the body known as granulocyte colony-stimulating factor (G-CSF). This natural protein plays a critical role in regulating the production and release of neutrophils – the white blood cells that form the body’s first line of defence against bacterial infections.
Cytotoxic chemotherapy, while effective at destroying cancer cells, also damages rapidly dividing healthy cells, including the white blood cell precursors in the bone marrow. This leads to a condition called neutropenia, defined as an abnormally low neutrophil count (typically below 0.5 × 109/L for severe neutropenia). When neutropenia is accompanied by fever (temperature ≥38.3°C or ≥38.0°C sustained for one hour), it is termed febrile neutropenia – a potentially life-threatening medical emergency that often requires hospitalisation and intravenous antibiotics.
How Lonquex Works
Lipegfilgrastim stimulates the bone marrow to increase the production of neutrophils. It binds to specific G-CSF receptors on the surface of neutrophil progenitor cells, triggering a signalling cascade that promotes their proliferation, differentiation, and maturation. The newly produced neutrophils are then released into the bloodstream, restoring the body’s ability to fight bacterial and fungal infections.
What distinguishes Lonquex from short-acting G-CSF products (such as filgrastim) is its pegylation – the covalent attachment of a polyethylene glycol (PEG) molecule via a carbohydrate linker. This modification significantly reduces renal clearance, extending the drug’s half-life and allowing it to maintain therapeutic serum concentrations throughout the entire period of chemotherapy-induced neutropenia. As a result, a single subcutaneous injection per chemotherapy cycle is sufficient, compared to the daily injections required with non-pegylated G-CSF products.
Clinical trials, including the pivotal phase III study (Bondarenko et al., 2013), demonstrated that lipegfilgrastim is non-inferior to pegfilgrastim in reducing the duration of severe neutropenia during the first chemotherapy cycle in patients with breast cancer receiving doxorubicin/docetaxel. The European Medicines Agency (EMA) approved Lonquex in 2013 for use across the European Union.
What Should You Know Before Taking Lonquex?
Lonquex must not be used if you are allergic to lipegfilgrastim or any of its other ingredients. Several important warnings apply, including risks of splenic rupture, respiratory complications, and capillary leak syndrome. Inform your doctor about all medical conditions and medications before starting treatment.
Contraindications
Lonquex is contraindicated in patients with a known hypersensitivity to lipegfilgrastim or any of the excipients listed in the product formulation. Hypersensitivity reactions, including anaphylaxis, have been reported with G-CSF products. If you have previously experienced allergic reactions to similar medications (such as filgrastim, lenograstim, or pegfilgrastim), there may be an increased risk of cross-reactivity with Lonquex, and your doctor should be informed before treatment begins.
Warnings and Precautions
Before and during treatment with Lonquex, it is essential to be aware of the following potential complications. Talk to your doctor, pharmacist, or nurse immediately if you experience any of the symptoms described below:
- Splenic complications: Enlarged spleen (splenomegaly) has been reported as an uncommon side effect, and cases of splenic rupture – some fatal – have occurred with similar G-CSF products. Contact your doctor immediately if you experience pain in the upper left side of your abdomen or pain radiating to your left shoulder tip.
- Pulmonary complications: Cough, fever, and difficulty breathing may indicate serious lung problems such as pneumonitis or acute respiratory distress syndrome (ARDS), which can be life-threatening. Seek immediate medical attention if these symptoms develop.
- Sickle cell disease: Patients with sickle cell anaemia are at risk of sickle cell crises when treated with G-CSF products. Your doctor should use Lonquex with caution and monitor you closely if you have this condition.
- Capillary leak syndrome: Symptoms include swelling or fluid retention, reduced urination, difficulty breathing, abdominal distension, and a general feeling of fatigue. These symptoms can develop rapidly and require immediate medical treatment.
- Aortitis: Inflammation of the aorta has been reported rarely with G-CSF products. Symptoms may include fever, abdominal pain, malaise, back pain, and elevated inflammatory markers.
- Glomerulonephritis: Kidney inflammation has been reported with similar G-CSF products. Your doctor will perform regular urine tests to monitor kidney function.
Your doctor will take regular blood samples to monitor various blood components and their levels. Blood count monitoring is particularly important to detect leucocytosis (elevated white blood cell count), thrombocytopenia (low platelet count), and changes in blood potassium levels.
Children and Adolescents
Lonquex is approved for use in children aged 2 years and older. It is not recommended for children under 2 years of age due to insufficient safety and efficacy data in this age group. Paediatric dosing is based on body weight, and your child’s doctor will determine the appropriate dose.
Pregnancy and Breastfeeding
Lonquex has not been studied in pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby, as your doctor may decide that you should not use this medicine. The potential risk to the unborn child is unknown, and a decision should be made by your healthcare provider weighing the benefits of treatment against the potential risks.
It is not known whether lipegfilgrastim passes into breast milk. As a precautionary measure, breastfeeding should be discontinued during treatment with Lonquex. Your doctor will advise you on the appropriate time to resume breastfeeding after your last dose.
Driving and Operating Machinery
Lonquex has no or negligible effect on the ability to drive or use machines. However, some patients may experience fatigue or dizziness as side effects of chemotherapy or the underlying condition, which should be taken into account.
Excipient Information
Lonquex contains sorbitol (30 mg per vial). Patients with hereditary fructose intolerance should be aware of this. The medicine also contains less than 1 mmol sodium (23 mg) per vial, meaning it is essentially sodium-free.
How Does Lonquex Interact with Other Drugs?
Lonquex has limited known drug interactions, but it must not be administered within 24 hours before or after cytotoxic chemotherapy. Certain medications, particularly lithium, may enhance the effect of G-CSF on neutrophil production and require additional monitoring.
Because Lonquex stimulates the production of rapidly dividing neutrophil precursor cells, administering it too close to chemotherapy could paradoxically increase the damage caused by cytotoxic agents to these rapidly dividing cells. For this reason, Lonquex should be given approximately 24 hours after the completion of chemotherapy, never on the same day or within 24 hours before chemotherapy.
Always inform your doctor or pharmacist about all medications you or your child are currently taking, have recently taken, or might take. This includes prescription medicines, over-the-counter products, vitamins, and herbal supplements.
| Interacting Drug | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Cytotoxic chemotherapy | Timing-dependent | High – may reduce efficacy or increase toxicity | Administer Lonquex at least 24 hours after last chemo dose |
| Lithium | Pharmacodynamic | Moderate – may potentiate neutrophil release | Monitor neutrophil counts more frequently |
| Other G-CSFs (filgrastim, pegfilgrastim) | Therapeutic duplication | High – risk of excessive leucocytosis | Do not use concurrently; choose one G-CSF product |
| Topotecan | Timing-dependent | Moderate – prolonged neutropenia if given concurrently | Adhere strictly to the 24-hour timing interval |
No formal drug interaction studies have been conducted with lipegfilgrastim. However, based on the pharmacological class and the experience with similar G-CSF products, the interactions listed above are clinically relevant. Your oncologist will carefully coordinate the timing of Lonquex administration with your chemotherapy schedule to ensure optimal efficacy and safety.
What Is the Correct Dosage of Lonquex?
The recommended adult dose of Lonquex is 6 mg (one 0.6 ml injection) given once per chemotherapy cycle, approximately 24 hours after the last chemotherapy dose. For children aged 2 years and older, the dose is based on body weight.
Lonquex is normally administered by a doctor or nurse as a subcutaneous injection (under the skin). The injection can be given in the abdomen, upper arm, or thigh. Lonquex is a single-use vial, and any unused solution must be discarded. It should not be mixed with other medicinal products.
Adults
Standard Adult Dose
6 mg (0.6 ml) subcutaneously, once per chemotherapy cycle, approximately 24 hours after the last chemotherapy dose. This dose applies to all adults regardless of body weight.
Children and Adolescents (2 years and older)
The recommended dose for children and adolescents is based on body weight. Your child’s doctor will calculate the correct dose.
| Body Weight | Dose per Cycle | Volume |
|---|---|---|
| < 10 kg | 0.6 mg | 0.06 ml |
| ≥ 10 to < 20 kg | 1.5 mg | 0.15 ml |
| ≥ 20 to < 30 kg | 2.5 mg | 0.25 ml |
| ≥ 30 to < 45 kg | 4.0 mg | 0.40 ml |
| ≥ 45 kg | 6.0 mg | 0.60 ml |
Lonquex is also available as a 6 mg pre-filled syringe for adults and children weighing at least 45 kg. For children requiring smaller doses, the vial formulation should be used with an appropriate graduated syringe to ensure accurate dosing.
Elderly Patients
No dose adjustment is required for elderly patients. The standard adult dose of 6 mg per chemotherapy cycle applies. However, elderly patients may be at increased risk for certain adverse effects, and your doctor will monitor you closely, paying particular attention to splenic complications and pulmonary events.
Timing of Administration
Correct timing is critical for the safety and efficacy of Lonquex. The injection should be given approximately 24 hours after the last dose of cytotoxic chemotherapy in each treatment cycle. Administering Lonquex too soon after chemotherapy (within 24 hours) may reduce its effectiveness, as the drug would stimulate the production of rapidly dividing cells that could then be damaged by residual chemotherapy agents. Administering it too late may not provide adequate neutrophil recovery before the nadir period.
Missed Dose
If a dose of Lonquex is missed or delayed, contact your doctor or nurse as soon as possible. They will determine whether the dose should be given late or whether adjustments are needed. Do not attempt to administer a double dose to make up for a missed injection.
Overdose
Overdose with Lonquex has not been reported in clinical trials. In the event of accidental overdose, the main expected effect would be excessive leucocytosis (an elevated white blood cell count). Monitoring of blood counts and supportive care would be the appropriate management. There is no specific antidote for lipegfilgrastim.
What Are the Side Effects of Lonquex?
Like all medicines, Lonquex can cause side effects, although not everybody gets them. The most common side effects are musculoskeletal pain (bone, joint, and muscle pain) and nausea, affecting more than 1 in 10 patients. Serious but less common effects include allergic reactions, splenic complications, and lung problems.
The side effect profile of Lonquex is consistent with the known class effects of G-CSF products. Most adverse reactions are mild to moderate in severity and resolve without specific treatment. However, certain side effects require immediate medical attention. Below is a comprehensive overview of reported side effects organised by frequency.
Very Common
Affects more than 1 in 10 people
- Musculoskeletal pain (bone pain, joint pain, muscle pain, limb pain, chest pain, neck pain, back pain)
- Nausea
Common
Affects up to 1 in 10 people
- Decreased platelet count (thrombocytopenia) – increased risk of bleeding or bruising
- Headache
- Skin reactions such as redness (erythema) or rash
- Low blood potassium levels (hypokalaemia) – may cause muscle weakness, twitching, or irregular heartbeat
- Chest pain
- Haemoptysis (coughing up blood)
Uncommon
Affects up to 1 in 100 people
- Allergic reactions including skin rash, itchy raised areas of skin, and severe reactions with weakness, drop in blood pressure, breathing difficulties, and facial swelling
- Enlarged spleen (splenomegaly)
- Increased white blood cell count (leucocytosis)
- Injection site reactions such as pain or hardening at the injection site
- Pulmonary haemorrhage (bleeding from the lungs)
- Laboratory abnormalities detected on routine blood tests
Rare or Not Known Frequency
Frequency cannot be estimated from available data
- Splenic rupture (some cases fatal with similar G-CSF products)
- Capillary leak syndrome – blood leaks from small blood vessels into the body
- Aortitis – inflammation of the aorta
- Acute respiratory distress syndrome (ARDS)
- Glomerulonephritis – inflammation of the tiny filters in the kidneys
- Sickle cell crises in patients with sickle cell anaemia
- Sweet’s syndrome (acute febrile neutrophilic dermatosis)
- Cutaneous vasculitis – inflammation of blood vessels in the skin
Managing Bone Pain
Musculoskeletal pain, particularly bone pain, is the most frequently reported side effect of G-CSF therapy. It is caused by the expansion of the bone marrow as it increases neutrophil production. In most cases, bone pain can be effectively managed with standard analgesics such as paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. If you experience severe musculoskeletal pain, inform your doctor, who may recommend additional pain management strategies. Some studies suggest that antihistamines (such as loratadine) may help reduce G-CSF–associated bone pain, although this use is off-label.
Reporting Side Effects
It is important to report suspected side effects after the medicine has been authorised. This makes it possible to continuously monitor the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report adverse reactions through their national reporting systems, such as the Yellow Card Scheme in the United Kingdom or the MedWatch programme in the United States.
How Should You Store Lonquex?
Lonquex must be stored in a refrigerator at 2–8°C. Do not freeze. Keep the vials in the outer carton to protect from light. Once removed from the refrigerator, it may be stored at room temperature (up to 25°C) for a maximum of 7 days.
Proper storage of Lonquex is essential to maintain the integrity and efficacy of this biological medicine. As a protein-based product, lipegfilgrastim is sensitive to temperature extremes, light exposure, and physical agitation. Incorrect storage can lead to protein degradation, aggregation, or loss of biological activity.
- Refrigeration (2–8°C): Store Lonquex in a refrigerator at all times when not in use. The vials should be kept in the original outer carton to protect from light.
- Do not freeze: Freezing can damage the protein structure of lipegfilgrastim and render the medicine inactive. If Lonquex has been accidentally frozen, it must not be used.
- Room temperature storage: If needed, Lonquex can be removed from the refrigerator and stored at room temperature (up to 25°C) for a maximum of 7 days. Once removed from refrigeration, the medicine must be used within this 7-day period or discarded – it must not be returned to the refrigerator.
- Before injection: Allow the solution to reach a comfortable temperature (15–25°C) before injection. Do not warm by any artificial means (such as a microwave or hot water).
- Visual inspection: Before use, inspect the solution visually. Only clear, colourless solutions without particles should be used. Do not use if the solution is cloudy, discoloured, or contains visible particles.
- Avoid vigorous shaking: Excessive shaking can cause protein aggregation (clumping) and render the solution biologically inactive.
- Expiry date: Do not use after the expiry date stated on the outer carton and vial label (after “EXP”). The expiry date refers to the last day of the stated month.
Keep this medicine out of the sight and reach of children. Lonquex is for single use only. Any unused solution remaining in the vial must be disposed of appropriately according to local requirements for biological waste.
What Does Lonquex Contain?
The active substance is lipegfilgrastim (6 mg per 0.6 ml vial, equivalent to 10 mg/ml). Inactive ingredients include glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20, and water for injections.
Each 0.6 ml vial of Lonquex contains 6 mg of lipegfilgrastim as the active ingredient. The concentration is 10 mg per ml. Lipegfilgrastim is a glycopegylated form of recombinant human G-CSF (filgrastim), where a single polyethylene glycol (PEG) molecule is attached via an O-glycan carbohydrate linker. This unique pegylation method contributes to the drug’s extended half-life and once-per-cycle dosing regimen.
Inactive Ingredients (Excipients)
- Glacial acetic acid: Acts as a buffer to maintain the pH of the solution within an optimal range for protein stability
- Sodium hydroxide: Used for pH adjustment
- Sorbitol (E420): A sugar alcohol that acts as a stabiliser and tonicity agent (30 mg per vial)
- Polysorbate 20: A surfactant that prevents protein aggregation and helps maintain the solution’s clarity
- Water for injections: The solvent base for the solution
Appearance and Packaging
Lonquex is a clear, colourless solution for injection supplied in a glass vial. It is available in packs containing 1 or 6 vials. Not all pack sizes may be marketed in all countries. Lonquex is also available as a 6 mg pre-filled syringe with an automatic needle guard, intended for adult patients and children weighing at least 45 kg.
The marketing authorisation holder is Teva B.V. (Haarlem, Netherlands), and the medicine is manufactured by Teva Biotech GmbH and Merckle GmbH (both in Ulm, Germany).
Frequently Asked Questions About Lonquex
Both Lonquex (lipegfilgrastim) and Neulasta (pegfilgrastim) are long-acting pegylated G-CSF products that require only one injection per chemotherapy cycle. The key difference lies in their pegylation chemistry: lipegfilgrastim uses a site-specific glycoPEGylation method where the PEG molecule is attached via a carbohydrate linker, whereas pegfilgrastim uses a random N-terminal pegylation. Clinical trials have demonstrated that lipegfilgrastim is non-inferior to pegfilgrastim in reducing the duration of severe neutropenia. Both medicines have similar safety profiles and are considered interchangeable from a clinical efficacy standpoint.
After subcutaneous injection, lipegfilgrastim reaches peak serum concentrations in approximately 30 to 36 hours. The bone marrow begins increasing neutrophil production shortly after the drug reaches therapeutic levels. The full effect on neutrophil recovery depends on the severity and timing of the chemotherapy-induced nadir. In clinical trials, patients treated with Lonquex experienced a mean duration of severe neutropenia of approximately 0.7 to 1.1 days during the first chemotherapy cycle, compared to untreated patients who may experience severe neutropenia lasting 5 to 7 days or longer.
While Lonquex is typically administered by a healthcare professional, the pre-filled syringe formulation can potentially be used for self-administration after appropriate training. However, the vial formulation requires accurate dose measurement and is generally administered in a clinical setting. Your doctor or nurse will advise you whether home administration is appropriate for your situation. If self-injection is recommended, you will receive thorough training on proper injection technique, site selection, and safe disposal of used materials before attempting it at home.
Yes, Lonquex is typically administered once per chemotherapy cycle for the entire duration of your chemotherapy treatment. Your oncologist will decide whether G-CSF prophylaxis is needed based on the neutropenia risk associated with your specific chemotherapy regimen and your individual risk factors. In some cases, G-CSF support may be discontinued if the chemotherapy regimen is changed to one with lower neutropenia risk, or if other clinical circumstances change. Never skip or stop Lonquex without first consulting your doctor.
If you develop a fever (temperature ≥38.0°C) during chemotherapy – even while receiving Lonquex – you should contact your oncology team or go to a hospital emergency department immediately. Fever during a period of potential neutropenia (febrile neutropenia) is a medical emergency that typically requires prompt evaluation, blood cultures, and initiation of empirical broad-spectrum intravenous antibiotics. While Lonquex significantly reduces the risk and duration of neutropenia, it does not eliminate the possibility entirely. Early treatment of febrile neutropenia is associated with better outcomes.
The most common side effect, bone pain, typically begins 1 to 3 days after the injection and usually resolves within a few days as the bone marrow expansion stabilises. Over-the-counter analgesics such as paracetamol or ibuprofen can help manage the discomfort. Nausea, headache, and injection site reactions are also generally transient and resolve without intervention. If any side effects persist for more than a few days or become severe, inform your doctor. Serious side effects such as allergic reactions, splenic complications, or respiratory problems require immediate medical attention regardless of timing.
References
- European Medicines Agency (EMA). Lonquex – Summary of Product Characteristics. Updated 2024. Available at: EMA – Lonquex EPAR.
- Bondarenko I, Gladkov OA, Elsaesser R, Buchner A, Bias P. 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. doi:10.1186/1471-2407-13-386.
- Kubo K, Miyata Y, Kosaka Y, et al. A randomized, double-blind, phase 3 trial of pegfilgrastim versus lipegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in breast cancer (GRAN-T): results of the Japanese subpopulation. Int J Clin Oncol. 2021;26(5):865–873.
- 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.
- 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. J Clin Oncol. 2015;33(28):3199–3212.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors. Version 1.2025.
- Klastersky J, de Naurois J, Rolston K, et al. Management of febrile neutropaenia: ESMO Clinical Practice Guidelines. Ann Oncol. 2016;27(suppl 5):v111–v118.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
About the Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians specialising in haematology, oncology, and clinical pharmacology. Our editorial process follows the GRADE evidence framework and adheres to international clinical guidelines from ESMO, ASCO, NCCN, and WHO.
Last medical review: | Next scheduled review: