Last update Aug. 22, 2022

Filgrastim

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Filgrastim is a non-glycosylated stimulating factor of granulocyte colonies (G-CSF) which is obtained by recombinant technology. The naturally occurring product is found in breast milk. Pegfilgrastim and Lipegfilgrastim are Filgrastim conjugated with monomethoxy polyethylene glycol (PEG). They are used to induce the production of granulocytes and lower infection risk after myelosuppressive therapy. Intravenous or subcutaneous administration.

A very high molecular weight explains the insignificant or no excretion into milk that has been observed both with Lenograstim and Filgrastim. (Nelson 2018, Kaida 2007, Shibata 2003)

Its low oral bioavailability hampers absorption into infant plasma from the breast milk ingested, as for their proteic nature it is degraded in the gastrointestinal tract, not being absorbed. Filgrastim is not absorbed by the infant's gut even during the neonatal period or prematurity. (Calhoun 2003)

The granulocyte colony-stimulating factor has been used in premature newborns, both on prevention and treatment of neonatal sepsis and/or necrotizing enterocolitis without adverse effects being observed among treated infants. (Canpolat 2006, Carr 2003, Bedford 2001, Gillan 1994))

Granulocyte colony-stimulating factor (G-CSF) is a normal component of breastmilk. The bovine G-CSF is found in the usual diet of meat eaters. (Pessach 2013)

Expert authors consider the use of this medication to be safe or very probably safe during breastfeeding. (LactMed, Briggs 2015, Pistilli 2013)

Alternatives

We do not have alternatives for Filgrastim since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Filgrastim is also known as


Filgrastim in other languages or writings:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight Fil: 18.800 ; Pegfil: 39.000 daltons
VD Fil: 0.15 ; Pegfil: 2.4 l/Kg
Tmax Fil: 2 - 8 ; Pegfil: 24 - 48 hours
Fil: 3.5 ; Pegfil: 42 hours
Theoretical Dose 0.000028 - 0.00009 mg/Kg/d
Relative Dose 0.13 - 0.56 %
Ped.Relat.Dose 0.28 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  2. Nelson RC. Granulocyte colony-stimulating factor (G-CSF) in breastmilk of a nursing donor during hematopoietic progenitor cells (HPC) mobilization. Transfusion 2018;58 (Suppl S2):169A. Abstract PHP9. (Abstract Presentations from the AABB Annual Meeting Boston, MA October 13–16, 2018) Full text (link to original source) Full text (in our servers)
  3. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  4. AEMPS. Filgrastim. Ficha técnica. 2014 Full text (in our servers)
  5. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  6. Pessach I, Shimoni A, Nagler A. Granulocyte-colony stimulating factor for hematopoietic stem cell donation from healthy female donors during pregnancy and lactation: what do we know? Hum Reprod Update. 2013 Abstract Full text (link to original source) Full text (in our servers)
  7. EMA. Filgrastim Drug Summary. 2011 Full text (in our servers)
  8. Kaida K, Ikegame K, Fujioka T, Taniguchi Y, Inoue T, Hasei H, Tamaki H, Yoshihara S, Kawase I, Ogawa H. Kinetics of granulocyte colony-stimulating factor in the human milk of a nursing donor receiving treatment for mobilization of the peripheral blood stem cells. Acta Haematol. 2007 Abstract Full text (link to original source) Full text (in our servers)
  9. Canpolat FE, Yurdakök M, Korkmaz A, Yiğit S, Tekinalp G. Enteral granulocyte colony-stimulating factor for the treatment of mild (stage I) necrotizing enterocolitis: a placebo-controlled pilot study. J Pediatr Surg. 2006 Abstract
  10. Martino M, Console G, Irrera G, Callea I, Condemi A, Dattola A, Messina G, Pontari A, Pucci G, Furlò G, Bresolin G, Iacopino P, Morabito F. Harvesting peripheral blood progenitor cells from healthy donors: retrospective comparison of filgrastim and lenograstim. J Clin Apher. 2005 Abstract
  11. Carr R, Modi N, Doré C. G-CSF and GM-CSF for treating or preventing neonatal infections. Cochrane Database Syst Rev. 2003 Abstract
  12. Calhoun DA, Maheshwari A, Christensen RD. Recombinant granulocyte colony-stimulating factor administered enterally to neonates is not absorbed. Pediatrics. 2003 Abstract
  13. Shibata H, Yamane T, Aoyama Y, Nakamae H, Hasegawa T, Sakamoto C, Terada Y, Koh G, Hino M. Excretion of granulocyte colony-stimulating factor into human breast milk. Acta Haematol. 2003 Abstract Full text (link to original source) Full text (in our servers)
  14. Bedford Russell AR, Emmerson AJ, Wilkinson N, Chant T, Sweet DG, Halliday HL, Holland B, Davies EG. A trial of recombinant human granulocyte colony stimulating factor for the treatment of very low birthweight infants with presumed sepsis and neutropenia. Arch Dis Child Fetal Neonatal Ed. 2001 Abstract Full text (link to original source) Full text (in our servers)
  15. Gillan ER, Christensen RD, Suen Y, Ellis R, van de Ven C, Cairo MS. A randomized, placebo-controlled trial of recombinant human granulocyte colony-stimulating factor administration in newborn infants with presumed sepsis: significant induction of peripheral and bone marrow neutrophilia. Blood. 1994 Abstract Full text (link to original source) Full text (in our servers)

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