Filgrastim Schedule (India)

Schedule H

Filgrastim Routes

Subcutaneous, Intravenous infusion

Filgrastim Formulations

Injection: 300 mcg/0.5 mL pre-filled syringe

Injection: 480 mcg/0.8 mL pre-filled syringe

Injection: 300 mcg/mL vial

Injection: 480 mcg/1.6 mL vial

Filgrastim Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

▶ 1. Chemotherapy-Induced Neutropenia (CIN) — Prophylaxis and Treatment

Parameter Recommendation

Starting dose 5 mcg/kg/day subcutaneously or IV infusion

Titration May increase to 10 mcg/kg/day if inadequate response

Usual maintenance dose 5 mcg/kg/day

Maximum dose 10 mcg/kg/day

Key Clinical Notes:

Initiate ≥24 hours after completion of cytotoxic chemotherapy

Do not administer within 24 hours before chemotherapy

Continue until ANC recovers to normal range (typically ≥2.0 × 10⁹/L post-nadir)

Duration usually 7–14 days depending on chemotherapy regimen and nadir depth

Round dose to nearest vial/syringe size to avoid wastage

▶ 2. Neutropenia Following Bone Marrow Transplantation

Parameter Recommendation

Starting dose 10 mcg/kg/day as continuous 24-hour IV infusion

Titration Adjust based on ANC response

Usual maintenance dose 10 mcg/kg/day

Maximum dose 10 mcg/kg/day

Key Clinical Notes:

Initiate ≥24 hours after bone marrow infusion

Continue until ANC >1.0 × 10⁹/L for 3 consecutive days

May switch to subcutaneous administration once clinically stable

▶ 3. Severe Chronic Neutropenia (SCN) — Congenital, Cyclic, or Idiopathic

Parameter Recommendation

Starting dose Congenital: 12 mcg/kg/day SC in 1–2 divided doses; Idiopathic/Cyclic: 5 mcg/kg/day SC

Titration Adjust by 1–2 mcg/kg/day every 1–2 weeks based on ANC (target ANC 1.5–10 × 10⁹/L)

Usual maintenance dose 1–10 mcg/kg/day (highly variable)

Maximum dose 24 mcg/kg/day (congenital); 10 mcg/kg/day (cyclic/idiopathic)

Key Clinical Notes:

Long-term therapy required; lifelong in congenital neutropenia

Monitor for splenomegaly with prolonged use

Regular bone marrow examination recommended to assess for myelodysplasia/AML risk

Dose requirements may be higher in congenital forms

▶ 4. Peripheral Blood Progenitor Cell (PBPC) Mobilisation

For Autologous Collection (Monotherapy):

Parameter Recommendation

Starting dose 10 mcg/kg/day subcutaneously

Titration Not applicable

Usual maintenance dose 10 mcg/kg/day

Maximum dose 10 mcg/kg/day

Key Clinical Notes:

Administer for 4–5 consecutive days

Leukapheresis typically on days 5, 6 (and day 7 if needed)

Optimal collection when CD34+ cell count ≥20 cells/µL in peripheral blood

Following Myelosuppressive Chemotherapy (for mobilisation):

Parameter Recommendation

Starting dose 5 mcg/kg/day subcutaneously

Titration Not applicable

Usual maintenance dose 5 mcg/kg/day

Maximum dose 5 mcg/kg/day

Key Clinical Notes:

Begin when WBC nadir expected or when WBC begins to rise post-chemotherapy

Continue until last leukapheresis completed

Monitor CD34+ cell counts to optimise collection timing

For Healthy Allogeneic Donors:

Parameter Recommendation

Starting dose 10 mcg/kg/day subcutaneously

Titration Not applicable

Usual maintenance dose 10 mcg/kg/day

Maximum dose 10 mcg/kg/day

Filgrastim Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

▶ 1. Chemotherapy-Induced Neutropenia

Parameter Recommendation

Starting dose 5 mcg/kg/day subcutaneously or IV

Titration May increase to 10 mcg/kg/day if inadequate response

Usual maintenance dose 5 mcg/kg/day

Maximum dose 10 mcg/kg/day

Key Clinical Notes:

Initiate ≥24 hours after completion of chemotherapy

Continue until ANC >1.5 × 10⁹/L post-nadir

Same weight-based dosing as adults

▶ 2. Severe Chronic Neutropenia (Congenital, Cyclic, Idiopathic)

Parameter Recommendation

Starting dose Congenital: 6–12 mcg/kg/day SC in 1–2 divided doses; Cyclic/Idiopathic: 5 mcg/kg/day SC

Titration Adjust by 1–2 mcg/kg/day every 1–2 weeks to achieve target ANC

Usual maintenance dose 1–10 mcg/kg/day

Maximum dose 24 mcg/kg/day (congenital neutropenia may require higher doses)

Key Clinical Notes:

Long-term/lifelong therapy in congenital forms

Monitor spleen size clinically and by ultrasound every 6–12 months

Annual bone marrow evaluation to monitor for myelodysplasia/leukaemic transformation

▶ 3. PBPC Mobilisation (Autologous)

Parameter Recommendation

Starting dose 10 mcg/kg/day subcutaneously

Titration Not applicable

Usual maintenance dose 10 mcg/kg/day

Maximum dose 10 mcg/kg/day

Key Clinical Notes:

Administer for 4–5 days prior to leukapheresis

Paediatric haematology/oncology supervision mandatory

Safety Monitoring (All Paediatric Indications):

CBC with differential: daily during active therapy; weekly during chronic use

Platelet count monitoring (risk of thrombocytopenia)

Spleen size assessment (clinical examination; ultrasound if prolonged use)

Bone pain assessment — analgesics as required

Bone marrow examination annually in SCN patients

⚠️ Not recommended in infants <1 year for non-SCN indications except under specialist haematologist supervision

Secondary Indications — Paediatrics (Off-label)

Indication Age Dose Duration Notes

HIV-associated Neutropenia — OFF-LABEL >1 year 1–5 mcg/kg/day SC As needed Specialist only; Evidence: Limited paediatric data; Indian tertiary centre experience

Neonatal Sepsis with Neutropenia — OFF-LABEL Neonates 5–10 mcg/kg/day SC or IV 3–5 days Specialist only (neonatologist); Evidence: Meta-analyses show variable benefit

Kostmann Syndrome — OFF-LABEL (as specific entity) Any age 6–12 mcg/kg/day SC, titrated to response Lifelong Specialist only; Evidence: International registries; tertiary centre protocols

Filgrastim Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation

Mild to severe impairment Standard dosing

Haemodialysis Standard dosing; monitor ANC closely; no supplemental dose required post-dialysis

Peritoneal dialysis Standard dosing; limited data

Filgrastim Hepatic adjustment

Hepatic Impairment	Recommendation
Mild impairment (Child-Pugh A)	No dose adjustment required
Moderate impairment (Child-Pugh B)	No dose adjustment required; monitor ANC and liver enzymes
Severe impairment (Child-Pugh C)	Use with caution — limited data; monitor liver function tests during treatment

Filgrastim Contraindications

Known hypersensitivity to filgrastim, pegfilgrastim, or any excipient

Hypersensitivity to E. coli-derived proteins (filgrastim is recombinant product from E. coli)

Patients with myeloid malignancy not in remission (may stimulate leukaemic blast proliferation)

Filgrastim Cautions

Myeloid malignancies (AML, CML, MDS) — use only in remission phase under close specialist supervision

Sickle cell disease or sickle cell trait — risk of severe sickle cell crisis; use only if absolutely essential with close monitoring

Splenomegaly — risk of splenic rupture; monitor spleen size with prolonged use

Pre-existing pulmonary disease — risk of acute respiratory distress syndrome (ARDS)

Pre-existing cardiac disease — fluid retention may exacerbate heart failure

Osteoporosis — long-term use may affect bone density

History of allergic reactions to G-CSF products

Concurrent myelosuppressive chemotherapy or radiotherapy — ensure adequate timing separation (≥24 hours)

Filgrastim Pregnancy

Aspect Details

Risk category Limited human data; animal studies show embryo/fetal toxicity at very high doses

Safety statement Use only if benefit clearly outweighs potential risk to fetus

Preferred alternatives None — filgrastim is the standard G-CSF when indicated in pregnancy

When to use Severe chemotherapy-induced neutropenia with high infection risk; haematology/oncology input essential

Monitoring Maternal ANC, platelet count; fetal growth surveillance

Filgrastim Lactation

Aspect Details

Compatibility Likely compatible with breastfeeding

Drug levels in milk Expected to be very low (large molecular weight protein; poor oral bioavailability)

Preferred alternatives None — filgrastim acceptable during lactation if indicated

Infant monitoring Routine monitoring only; no specific adverse effects expected

Filgrastim Elderly

Aspect Recommendation

Starting dose Same as younger adults (5 mcg/kg/day for CIN)

Titration Consider slower titration; monitor tolerance

Extra risks Increased bone pain; higher risk of splenic complications; reduced marrow reserve may affect response; monitor for pulmonary toxicity

Monitoring More frequent CBC; assess for fluid retention in those with cardiac disease

Filgrastim Major drug interactions

Interacting Drug Mechanism / Effect Management

Cytotoxic chemotherapy Concurrent use may damage rapidly dividing myeloid progenitors stimulated by G-CSF; reduced filgrastim efficacy; increased toxicity Administer filgrastim ≥24 hours after chemotherapy completion; do not give within 24 hours before next chemotherapy cycle

Radiotherapy Similar mechanism — damage to stimulated progenitor cells Separate administration by ≥24 hours

Bleomycin Possible increased pulmonary toxicity when used with G-CSF Use with caution; monitor for respiratory symptoms

Filgrastim Moderate drug interactions

Interacting Drug Mechanism / Effect Management

Lithium May enhance neutrophil release; additive leucocytosis Monitor WBC closely; may potentiate filgrastim effect

Topoisomerase II inhibitors (etoposide, doxorubicin) Theoretical concern of myeloid clonal expansion with prolonged concurrent use Use with standard oncology protocols; monitor for myelodysplastic changes

NSAIDs May mask bone pain induced by filgrastim Use for symptom relief; does not affect efficacy

Corticosteroids May affect neutrophil distribution (demargination) ANC interpretation may be affected; no dose adjustment required

Filgrastim Common Adverse effects

Bone pain (20–30%) — most common; usually mild to moderate

Headache

Fatigue / malaise

Nausea

Injection site reactions (erythema, pain, induration)

Transient leucocytosis

Arthralgia / myalgia

Elevated lactate dehydrogenase (LDH)

Elevated alkaline phosphatase

Elevated uric acid

Filgrastim Serious Adverse effects

Adverse Effect Clinical Action

Splenic rupture Life-threatening; presents as left upper quadrant or shoulder tip pain; discontinue immediately; surgical evaluation

Acute respiratory distress syndrome (ARDS) Discontinue; supportive care; ICU admission may be required

Capillary leak syndrome Discontinue; supportive management with IV fluids and vasopressors

Severe allergic reactions (anaphylaxis, angioedema) Discontinue immediately; standard anaphylaxis management; do not rechallenge

Sickle cell crisis In patients with sickle cell disease; discontinue; supportive care; may be fatal

Severe thrombocytopenia Monitor platelets; may require dose reduction or discontinuation

Glomerulonephritis Rare; monitor renal function; discontinue if confirmed

Aortitis Rare; presents with fever and abdominal/back pain; discontinue; anti-inflammatory treatment

Sweet syndrome (acute febrile neutrophilic dermatosis) Dermatology referral; may require discontinuation

Filgrastim Monitoring requirements

Timing	Parameters
Baseline	CBC with differential; platelet count; liver enzymes (ALT, AST, ALP); renal function; clinical spleen size assessment; chest examination (if pulmonary disease history)

During active treatment (CIN, BMT) ANC: daily or every other day until recovery; platelet count: every 2–3 days; assess bone pain severity

PBPC mobilisation CD34+ cell count in peripheral blood to optimise leukapheresis timing (target ≥20 cells/µL); platelet count

Long-term use (SCN) CBC weekly initially, then monthly once stable; spleen size (clinical ± ultrasound) every 6 months; annual bone marrow examination (cytogenetics, morphology) to detect myelodysplasia/AML

Filgrastim Brands in India

Grafeel Dr. Reddy's Biosimilar

Neukine Intas Biosimilar

Emgrast Emcure Biosimilar

Nufil Biocon Biosimilar

Zarzio Sandoz/Novartis Biosimilar

Neupogen Amgen (limited availability) Reference product

Filgrastim (various) Cipla, Hetero, Glenmark, others Multiple biosimilars available

Note: Multiple biosimilars approved in India with established bioequivalence; verify specific brand quality and regulatory approval status.

Filgrastim Price range (INR)

Formulation	Approximate Price (per tablet)
300 mcg pre-filled syringe ₹1,200–₹3,000 Wide variation between biosimilars and reference product
480 mcg pre-filled syringe ₹1,800–₹4,500

NLEM Status Not included in NLEM 2022 Not price-controlled

Government Supply Available through government cancer centres, PMJAY schemes Significantly lower costs (often ₹500–₹800 for 300 mcg)

Filgrastim Clinical pearls

Timing with chemotherapy is critical: Always administer ≥24 hours after chemotherapy completion; never give within 24 hours before next chemotherapy cycle — concurrent use reduces efficacy and increases toxicity

Bone pain management: Most common adverse effect; usually responds to paracetamol or NSAIDs; severe pain may require opioid analgesia; typically resolves 2–3 days after stopping filgrastim

Do not stop for leucocytosis alone: Transient leucocytosis is expected and not harmful; continue until adequate ANC recovery; base decisions on clinical context

Pre-filled syringe handling: Allow refrigerated syringes to reach room temperature (15–30 minutes) before injection to reduce pain; do not shake; do not freeze

Splenic rupture awareness: Rare but potentially fatal; educate patients about left upper quadrant or shoulder pain; requires immediate evaluation

Biosimilars are cost-effective: Multiple high-quality biosimilars available in India at significantly lower cost; no clinically meaningful difference from reference filgrastim

Filgrastim Tags

Filgrastim; G-CSF; neutropenia; chemotherapy-induced neutropenia; PBPC mobilisation; bone marrow transplant; severe chronic neutropenia; oncology supportive care; biosimilar; haematology; renal-safe; Schedule H

Filgrastim Version

RxIndia v1.0 — 02 Apr 2025

Filgrastim Reference

CDSCO approved product information

Indian Pharmacopoeia / NFI

API Textbook of Medicine, 11th Edition

AIIMS Oncology Supportive Care Protocols

ICMR Guidelines for Cancer Supportive Care

National Cancer Grid India — Supportive Care Guidelines

Goodman & Gilman's The Pharmacological Basis of Therapeutics

Harrison's Principles of Internal Medicine

International RCTs and meta-analyses (for off-label indications: HIV-associated neutropenia, neonatal sepsis)

RxIndia

The Drug Registry

Filgrastim