Registered Kenya · PPB

FILGRASTIM 30MIU

FILGRASTIM

H2019/CTD7130/13857 30 MIU GENERIC/BIOSIMILARS antineoplastic and immunomodulating agents INN generic

What it does

Filgrastim is a medication that helps increase the number of white blood cells in the body.

Commonly used for: neutropenia (low white blood cell count), prevention of infections in chemotherapy patients

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2019/CTD7130/13857
Registration date
2019-04-26 00:00:00
Expiry date
-
Status
Registered
Active ingredient
FILGRASTIM
Dosage form
30 MIU
Strength
-
Pack size
PRE FILLED SYRINGE
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
L03AA - Colony stimulating factors
RxNorm RxCUI
68442
Manufacturer / MAH
Ripple Pharmaceuticals
Applicant / LTR
CADILA HEALTHCARE LIMITED
Country of origin
FOREIGN
Manufacturer location
Swaminarayan Road/ Laxcon Court Mezzanine, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:22:53 · updated 2026-07-26 09:22:11

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Filgrastim is a medication that helps increase the number of white blood cells in the body.

What it treats

  • neutropenia (low white blood cell count)
  • prevention of infections in chemotherapy patients

How it works

It stimulates the bone marrow to produce more white blood cells, which help fight infections.

Who it's for

This medication is for people who have low white blood cell counts, often due to cancer treatments or certain medical conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Filgrastim

BNF-referenced

Filgrastim is a recombinant human granulocyte-colony stimulating factor (rhG-CSF) that stimulates the production of neutrophils from the bone marrow. It is primarily used for the management of neutropenia, particularly in patients undergoing chemotherapy or those with bone marrow disorders. By enhancing neutrophil counts, filgrastim helps reduce the risk of infections and the duration of neutropenia associated with myelosuppressive therapies.

Indications

  • Neutropenia associated with chemotherapy
  • Reduction in duration of neutropenia after myeloablative therapy followed by bone marrow transplantation
  • Mobilisation of peripheral blood progenitor cells for autologous infusion
  • Severe congenital neutropenia
  • Persistent neutropenia in HIV infection

Dosage

Adults: For adults, filgrastim is typically administered as follows: 10 micrograms/kg daily, starting at least 24 hours after cytotoxic chemotherapy or within 24 hours of bone marrow infusion

Mechanism of action

Filgrastim acts by binding to the granulocyte-colony stimulating factor receptor (G-CSFR) on hematopoietic progenitor cells in the bone marrow. This binding stimulates the proliferation, differentiation, and activation of neutrophil precursors, leading to increased production and release of neutrophils into the bloodstream. Additionally, filgrastim enhances the survival and function of mature neutrophils.

Pharmacodynamics

Filgrastim enhances the myeloid lineage of hematopoiesis, promoting the formation of neutrophils, which are crucial for the immune response against infections. It has a pharmacodynamic profile characterized by a rapid increase in circulating neutrophil counts, typically observed within 24 hours after administration. The duration of action is influenced by the dosing regimen and the patient's response to treatment.

Pharmacokinetics

Filgrastim is administered via subcutaneous or intravenous routes. It has a volume of distribution of approximately 0.1 L/kg and a clearance rate of about 0.6 mL/min/kg. The half-life of filgrastim is approximately 3 to 4 hours, but it may vary based on individual patient factors and dosing. The drug is not metabolized in the liver and is primarily eliminated via renal pathways. Dosage adjustments may be necessary in patients with renal impairment.

Contra-indications

  • Hypersensitivity to filgrastim or any of its components
  • Severe congenital neutropenia with history of severe or recurrent infections
  • Malignant myeloid conditions or pre-malignant myeloid conditions
  • Sickle cell disease with crisis

Adverse effects

  • Arthralgia
  • Headache
  • Dyspnoea
  • Leukocytosis
  • Spleen abnormalities
  • Cutaneous vasculitis
  • Pulmonary infiltrates leading to acute respiratory distress syndrome
  • Capillary leak syndrome
  • Hypoxia
  • Pulmonary oedema
  • Acute febrile neutrophilic dermatosis

Precautions

  • Monitor for signs of splenomegaly and rupture during treatment
  • Full blood counts including differential white cell and platelet counts should be monitored
  • Patients with a history of pulmonary infiltrates or pneumonia may be at higher risk for acute respiratory distress syndrome

Pregnancy

Manufacturers advise avoiding use due to potential toxicity observed in animal studies.

Breast-feeding

There is no evidence for safe use during breastfeeding, and manufacturers advise avoiding their use.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

Formulations

  • Subcutaneous injection
  • Intravenous infusion
BNF 85 (British National Formulary) p.1157 BNF for Children 2019-2020 p.621 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.