Filgrastim

Generic name
Filgrastim
Brand name
ATC Code
L03AA02
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Filgrastim

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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Neutropenia resulting from cytotoxic chemotherapy
  • Intravenous
    • 1 month up to 18 years
      [3]
      • 5 microg./kg/day in 1 dose
      • Duration of treatment:

        Start at least 24 hours after chemotherapy. Continue treatment until the neutrophil count has normalized.

  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 5 microg./kg/day in 1 dose (= 0.5 million U/kg/day).
      • Duration of treatment:

        Start at least 24 hours after chemotherapy. Continue treatment until the neutrophil count has normalized.
Neutropenia in myeloablative therapy followed by bone marrow transplant
  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 10 microg./kg/day in 1 dose Titrate according to the neutrophil response:
        > 1.0 x 109/l for 3 consecutive days: Reduce to 5 mcg/kg/day.
        Then, if ANC remains > 1.0 x 109/l for the 3 following days: Stop filgrastim.
        If ANC drops to < 1.0 x 109/l during the treatment period, the Neupogen dosage should be raised again as per the steps listed above..
      • Duration of treatment:

        Start at least 24 hours after chemotherapy.

  • Intravenous
    • 1 month up to 18 years
      [3]
      • 10 microg./kg/day in 1 dose Titrate according to the neutrophil response:
        > 1.0 x 109/l for 3 consecutive days: Reduce to 5 mcg/kg/day.
        Then, if ANC remains > 1.0 x 109/l for the 3 following days: Stop filgrastim.
        If ANC drops to < 1.0 x 109/l during the treatment period, the Neupogen dosage should be raised again as per the steps listed above..
      • Duration of treatment:

        Start at least 24 hours after chemotherapy.
Mobilization of stem cells
  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 5 - 10 microg./kg/day in 1 dose Alternative: continuous subcutaneous infusion..
Severe congenital neutropenia
  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 12 microg./kg/day in 1 dose Titrate depending on the effect: Neutrophil count between 1.5-10 x109/l.
Chronic neutropenia in HIV
  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 1 - 4 microg./kg/day in 1 dose

      • After correction of neutropenia has been achieved, the minimum effective dose at which a normal neutrophil count is maintained must be determined
Idiopathic or cyclic neutropenia
  • Subcutaneous
    • 1 month up to 18 years
      [3]
      • 5 microg./kg/day in 1 dose

      • Titrate depending on the effect: Neutrophil count between 1.5-10 x 109/l

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Muscular and skeletal pain, dysuria, proteinuria, haematuria, vasculitis.
Cases of decreased bone density and osteoporosis have been reported in paediatric patients with severe
chronic neutropenia receiving chronic treatment with filgrastim [SmPC Neupogen].

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Assessment by measuring the neutrophils, reticulocytes, gamma-GT, alkaline phosphatase and transaminases.
Caution is recommended with myeloid malignancies: remaining malignant clones can develop via GM-CSF.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOSTIMULANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Berg van den, HB et al, Werkboek Kinderhematologie, VU Uitgeverij, 2001, 2e druk
  3. Diverse fabrikanten, SmPC Neupogen (RVG 14662), Accofil (EU/1/14/946), Nivestim (EU1/10/631/004-4), Zarzio (EU/1/08/495/001-006), www.cbg-meb.nl

Changes

Therapeutic Drug Monitoring


Overdose