Granulocyte colony-stimulating factors (G-CSFs) such as filgrastim are used in oncology to address neutropenia, a low neutrophil count that raises the risk of serious infection during chemotherapy. Several items bear on how they are discussed: the American Society of Clinical Oncology (ASCO) published an updated guideline on white blood cell growth factors in 2026, the US prescribing information for the reference filgrastim product (Neupogen) was revised in July 2026 with a May 2026 change adding large and medium vessel arteritis, and India’s drug regulator has circulated revised guidelines on similar biologics. This article summarises what those sources report, for oncology pharmacists, hospital procurement teams and institutions. Axokine 300 mcg (filgrastim) is listed on our product page.
A.K. Pharma, a medicine distributor in Delhi and pharmaceutical distributor in Delhi, supplies imported and specialty oncology and hospital medicines to healthcare institutions across India. We are not clinicians, and we do not advise on which patient should receive a G-CSF, when, or at what dose. What follows is reporting on published sources, with the originals linked throughout.
1. Why Neutropenia and G-CSF Therapy Are in the Conversation
The table places the main guideline, label and regulatory items in sequence. Dates are as reported by each source.
1.1 Timeline of Key Sources
| Date | Event | Source |
|---|---|---|
| 1991 | Initial US approval of Neupogen (filgrastim), the reference filgrastim product | FDA label |
| 2012 and 2016 | CDSCO and the Department of Biotechnology issue, then revise, India’s Guidelines on Similar Biologics | CDSCO |
| 2015 | Previous ASCO guideline on WBC growth factors published | J Clin Oncol |
| 6 May 2025 | CDSCO invites comments on revised Guidelines on Similar Biologics (2025 draft) | CDSCO |
| Mar 2026 | ASCO publishes its updated WBC growth factors guideline (J Clin Oncol 2026;44:812-824) | ASCO / PubMed |
| May 2026 | Neupogen US label adds Warnings and Precautions section 5.15, large and medium vessel arteritis | FDA label |
| Jul 2026 | Neupogen US label revision date | FDA label |
Framing note: Axokine is a different product from Neupogen. The label and trial information below describe the reference product and the drug class; Axokine’s own approved particulars are set out in its Indian product information.
2. What the Sources Mean by Neutropenia and Febrile Neutropenia
The Neupogen label uses the phrase “febrile neutropenia” as “neutropenia with fever” and frames the first indication around decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs. The ASCO guideline addresses prevention and treatment of neutropenic events in adults with cancer.
2.1 Two Different Settings
| Setting | How the sources describe it |
|---|---|
| Chemotherapy-induced neutropenia | Addressed by the first label indication and by the ASCO guideline’s prophylaxis and treatment recommendations |
| Severe chronic neutropenia (congenital, cyclic or idiopathic) | A separate label indication; the label states the diagnosis should be confirmed before treatment |
3. What Filgrastim Is, According to the Label
The Neupogen prescribing information describes Neupogen (filgrastim) as a leukocyte growth factor for subcutaneous or intravenous use. It is supplied as a clear, colourless, preservative-free solution in single-dose vials (300 mcg/mL and 480 mcg/1.6 mL) and single-dose prefilled syringes (300 mcg/0.5 mL and 480 mcg/0.8 mL). The label lists a history of serious allergic reactions to human G-CSFs such as filgrastim or pegfilgrastim as the contraindication.
3.1 What Our Product Page Lists for Axokine
The A.K. Pharma listing for Axokine gives the pack as 300 mcg, 1 x prefilled syringe, with filgrastim as the active substance. We do not reproduce Axokine’s approved indications, strength or storage here; these are set out in its Indian product information.
4. Labelled Indications of the Reference Product
The Neupogen label lists six indications. The table summarises them as worded in the label, without dosing.
4.1 Indications in the US Label (Section 1)
| Label section | Indication as stated |
|---|---|
| 1.1 | To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever |
| 1.2 | To reduce time to neutrophil recovery and duration of fever following induction or consolidation chemotherapy for acute myeloid leukaemia |
| 1.3 | To reduce the duration of neutropenia and related sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation |
| 1.4 | Mobilisation of autologous haematopoietic progenitor cells into peripheral blood for collection by leukapheresis |
| 1.5 | To reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with congenital, cyclic or idiopathic neutropenia |
| 1.6 | To increase survival in patients acutely exposed to myelosuppressive doses of radiation (haematopoietic syndrome of acute radiation syndrome) |
Dosing, monitoring and dose adjustment for each indication are in section 2 of the label and are matters for the prescribing physician working from the current approved label.
5. The 2026 ASCO Guideline Update: Evidence Base and Prophylaxis
According to the PubMed abstract of the guideline (J Clin Oncol, 2026), a systematic review searched PubMed and the Cochrane Library for articles published from 1 September 2014 to 22 August 2025 and included 33 randomised controlled trials and 16 systematic reviews. The authors note that the evidence now includes new CSFs, additional biosimilars and an additional CXCR4 inhibitor used for stem-cell mobilisation.
5.1 Recommendations on Primary and Secondary Prophylaxis, as Reported
| Question | What the guideline states |
|---|---|
| Primary prophylaxis, higher-risk regimens (rec. 1.1) | Patients should be offered primary prophylaxis with a G-CSF when the febrile neutropenia risk from the chemotherapy regimen is approximately 20% or higher, unless an alternative regimen of comparable efficacy and safety that does not require G-CSF is available |
| Primary prophylaxis, lower-risk regimens (rec. 1.2) | Should be offered if the patient is at high risk of febrile neutropenia complications based on age, comorbidities or disease characteristics, and no comparable alternative regimen exists |
| Affordability or availability (rec. 1.3) | If G-CSF is not affordable or available, antibiotic prophylaxis may be offered; the qualifying statement says it is not a preferred option because of antimicrobial resistance, gut microbiome disturbance, C. difficile infection and other adverse effects |
| Secondary prophylaxis (rec. 2.1) | Recommended after a neutropenic complication in a previous cycle where a reduced dose or delay may compromise cure rates or survival; the guideline adds that dose reduction or delay may be a reasonable alternative in many situations |
6. ASCO on Treatment, Transplant, Radiation and Product Choice
6.1 Other Recommendations, as Reported
| Question | What the guideline states |
|---|---|
| Afebrile neutropenia (rec. 3.1) | A CSF should not be routinely used |
| Adjunct to antibiotics in fever and neutropenia (rec. 3.2) | A CSF should not be routinely used as adjunctive treatment |
| High-risk fever and neutropenia (rec. 3.3) | A CSF may be offered where there is high risk of infection-associated complications or poor prognostic factors |
| Stem-cell mobilisation (rec. 4.1) | A CSF may be used alone, after chemotherapy, or with plerixafor or motixafortide |
| After autologous or allogeneic transplant (recs. 4.2 and 4.3) | A CSF should be given after autologous transplant, and may be given after allogeneic transplant, to reduce the duration of severe neutropenia |
| Concurrent chemoradiation (rec. 5.1) | CSFs are not recommended, particularly where radiation involves the mediastinum |
| Choice of agent (rec. 6.1) | Filgrastim, pegfilgrastim, eflapegrastim and biosimilars can be used; the choice depends on cost, patient convenience, availability, accessibility, health-system context, disease subtype and treatment regimen |
These are the guideline’s own statements as summarised in a secondary source (OncoPrescribe summary); the published guideline carries the full wording and qualifying statements.
7. Risk Factors the Guideline Lists
The guideline summary lists factors that increase febrile neutropenia risk in addition to the chemotherapy regimen and malignancy type. They are reproduced below as reported.
7.1 Factors Listed
- Age 65 or older, or frailty on geriatric assessment; advanced disease
- Previous chemotherapy or radiation; pre-existing neutropenia or bone marrow tumour involvement
- Active or recent infection; colonisation with multidrug-resistant organisms
- Open wounds or recent surgery; poor performance or nutritional status or low BMI
- Poor renal function; liver dysfunction, notably elevated bilirubin
- Cardiovascular disease; HIV; multiple comorbidities
8. Safety Information as Stated in the Label
The Neupogen label’s Warnings and Precautions include the following. We report them as the label states them; the full list, including section 5.15 added in May 2026, is in the label.
8.1 Selected Warnings (Section 5)
| Section | Warning as stated |
|---|---|
| 5.1 | Splenic rupture, including fatal cases; the label states patients reporting left upper abdominal or shoulder pain should be evaluated for an enlarged spleen or splenic rupture |
| 5.2 | Acute respiratory distress syndrome (ARDS) |
| 5.3 | Serious allergic reactions including anaphylaxis, most often on initial exposure; the label states Neupogen is permanently discontinued in serious allergic reactions |
| 5.4 | Severe and sometimes fatal sickle cell crises in patients with sickle cell disorders |
| 5.5 | Glomerulonephritis |
| 5.7 | Capillary leak syndrome |
| 5.8 | Myelodysplastic syndrome and acute myeloid leukaemia, in severe chronic neutropenia (risk appears confined to congenital neutropenia) and in patients with breast and lung cancer receiving it with chemotherapy or radiotherapy |
| 5.9 | Thrombocytopenia |
| 5.15 | Large and medium vessel arteritis (added 05/2026) |
8.2 Most Common Adverse Reactions Listed
The label lists pyrexia, pain, rash, cough and dyspnoea in patients with nonmyeloid malignancies receiving myelosuppressive drugs; bone pain, pyrexia and headache in progenitor-cell mobilisation; and pain, anaemia, epistaxis, diarrhoea, hypoaesthesia and alopecia in severe chronic neutropenia.
9. Handling and Administration Points in the Label
Section 2.6 of the label covers presentation-specific handling. Without reproducing dosing, it states that:
9.1 Selected Handling Statements
- vials and prefilled syringes are removed from the refrigerator and allowed to reach room temperature (20–25 °C) for at least 30 minutes and at most 24 hours, and anything left at room temperature longer than 24 hours is discarded;
- the solution is inspected and not used if particulates or discolouration are seen;
- unused portions are discarded;
- the prefilled syringe needle cap contains dry natural rubber derived from latex;
- for intravenous dilution, the label names 5% dextrose and states the product should not be diluted with sodium chloride because it may precipitate.
We have not reproduced section 16 (storage and handling) in full; the label or product information of the specific brand stocked governs.
10. India: What the Regulatory Documents Say About Similar Biologics
CDSCO’s revised Guidelines on Similar Biologics (draft circulated 6 May 2025) describe the Indian pathway for products claiming similarity to an already authorised reference biologic. They state that a “similar biologic” under the NDCT Rules 2019 is a biological product similar in quality, safety and efficacy to a reference product licensed in India or an innovator product approved in ICH member countries, and that the guidelines cover products developed in India or imported for marketing authorisation.
10.1 Points Stated in the Guidelines
| Topic | As stated |
|---|---|
| History | First guidelines in 2012 (CDSCO with DBT), revised in 2016, with a revised version circulated for comment in 2025 |
| Standard of evidence | Similarity is shown by the totality of evidence: structural, functional, nonclinical and clinical data, with no clinically meaningful differences from the reference product |
| Scope | Well-characterised proteins made with recombinant DNA technology |
| CDSCO’s role | Clinical trial approval, import permission for trials, and permission for import and manufacture for sale or distribution |
A published systematic review of filgrastim and its biosimilars reports that filgrastim was effective and safe in reducing febrile neutropenia and related complications compared with placebo or no treatment. Whether a particular brand was approved under the similar-biologics pathway is set out in that brand’s own regulatory documents, which we have not reviewed for Axokine.
11. Axokine at A.K. Pharma and Sourcing Considerations
Filgrastim is a biologic that the label directs be refrigerated, so cold-chain handling during distribution is part of the product’s labelled handling. A.K. Pharma lists Axokine 300 mcg in its cancer category; the Axokine page also shows Innograst 300 mcg/mL as a related listing. For general background on imported-medicine sourcing, see our articles on why some medicines are imported, how we ensure genuine supply and the cost of sourcing from the wrong distributor.
11.1 Contacting Us
For availability or to request a quote, contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827. Prescription medicines are supplied only against a valid prescription.
12. Related Oncology Medicines at A.K. Pharma
What is filgrastim?
Filgrastim is a granulocyte colony-stimulating factor (G-CSF). The Neupogen prescribing information describes it as a leukocyte growth factor given by subcutaneous or intravenous route.
What indications does the reference Neupogen label list?
The label lists six: reducing infection (febrile neutropenia) in patients with nonmyeloid cancers on myelosuppressive chemotherapy, AML after induction or consolidation, bone marrow transplantation, autologous progenitor-cell mobilisation, severe chronic neutropenia, and acute radiation exposure.
What does the 2026 ASCO guideline say about primary prophylaxis?
It states patients should be offered G-CSF primary prophylaxis when the chemotherapy regimen’s febrile neutropenia risk is about 20% or higher, unless an equally effective and safe regimen not needing G-CSF is available.
What does ASCO say about G-CSF in afebrile neutropenia?
The guideline states a CSF should not be routinely used in afebrile neutropenia, or routinely as an adjunct to antibiotics in fever and neutropenia. It states a CSF may be offered in high-risk fever and neutropenia.
Which warnings does the label list?
They include splenic rupture, ARDS, serious allergic reactions, sickle cell crises, glomerulonephritis, capillary leak syndrome, MDS/AML, thrombocytopenia and, since May 2026, large and medium vessel arteritis.
Is Axokine the same as Neupogen?
No. Axokine is a different product listed by A.K. Pharma as filgrastim 300 mcg. The label and data in this article describe the reference product and drug class; Axokine’s own particulars are in its Indian product information.
How does India regulate similar biologics?
CDSCO’s Guidelines on Similar Biologics (2012, revised 2016, with a revised draft circulated in 2025) describe a totality-of-evidence pathway for products claiming similarity to a reference biologic.
How can institutions enquire about supply through A.K. Pharma?
Contact A.K. Pharma on 011 4172 6999 or WhatsApp +91 9810034827. Prescription medicines are supplied only against a valid prescription.
Is this article medical advice?
No. A.K. Pharma is a medicine distributor, not a healthcare provider. The article summarises published sources, and treatment decisions rest solely with the treating physician.
Disclaimer
A.K. Pharma is a licensed medicine distributor. It is not a hospital, clinic, doctor or healthcare provider. This article is published for general educational and informational purposes and for procurement planning by healthcare institutions. It summarises publicly available guidelines, regulatory labelling and regulatory documents, and it cites the original sources so readers can review them directly.
This is not medical advice. Nothing in this article is a recommendation to use, start, stop, switch or dose any medicine, or a statement about whom any treatment suits. Guidelines describe population-level statements, labels describe approved use in the country of approval, and none of these replaces individual clinical judgement.
Treatment decisions rest solely with the treating physician. Whether a patient receives a G-CSF, which product, and how it is used are decisions for the treating oncologist or haematologist. Patients should consult a qualified doctor and follow the approved prescribing information. Prescription medicines are supplied only against a valid prescription.
Information is reported as of the publication date and is drawn from third-party sources that may be updated or corrected. The label cited is for the reference product Neupogen, not for Axokine. Trademarks belong to their respective owners. A.K. Pharma makes no claim of endorsement by, or affiliation with, any manufacturer or organisation named.
About A.K. Pharma — Medicine Distributor in Delhi
A.K. Pharma is a licensed medicine distributor and pharmaceutical distributor in Delhi supplying genuine specialty and hospital medicines — including oncology agents, supportive-care injectables, biologics and anti-infectives — to healthcare institutions across India. Products are stored and dispatched under manufacturer-recommended conditions. Our supply network serves hospitals, clinics and pharmacies across Delhi NCR and nationwide.
📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052
📞 011 4172 6999 | 📱 WhatsApp: +91 9810034827 | 🌐 akpharma.in
