Last update March 24, 2019

Cyclophosphamide

Very High Risk

Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Comment.

Cyclophosphamide, together with its active metabolites, aldophosphamide, acrolein and nitrogenated mustard, is an antineoplastic from the group of nitrogen mustards with very marked immunosuppressive properties.

Cyclophosphamide is excreted in breast milk (Wiernik 1971) in relatively low amount (Fierro 2019), but in two studies, breastfed infants developed neutropenia, thrombocytopenia, and anemia. (Durodola 1979, Amato 1977).

Given the variability in interindividual pharmacokinetics, potential pharmacokinetic changes with co-administration with other medication and its serious side effects, it is prudent not to breastfeed during treatment (Anderson 2016, Götestam 2016, Grunewald 2015, Pistilli 2013, Østensen 2006, WHO 2002, Pediatrics 2001).

It is known via Pharmacokinetics that after 3 elimination half-lives (T½) 87.5% of the drug is eliminated from the body; after 4 T½ 94%, after 5 T½ 96.9%, after 6 T½ 98.4% and after 7 T½ 99%. Plasma drug concentrations in the body are negligible after 7 T½. In general, a period of al least five half-lives may be considered a safe waiting period before returning to breastfeeding (Anderson 2016).

Taking the longest published T½ of all the active metabolites as a reference, these 5 T½ would correspond to 60 hours. Due to major side effects, it would be advisable to wait 7 T½, which would correspond to 84 hours. Meanwhile, express and discard milk from the breast regularly to maintain production
Expert authors recommend waiting 72 hours after the last dose (6 T½) to restart breastfeeding (Hale 2017 p239).

When possible, detection in breast milk of each patient to determine the total elimination of the drug would be the best indicator for resuming breastfeeding between two rounds of chemotherapy.

Given the strong evidence that exists on the benefits of breastfeeding for the development of babies and the health of mothers, it is advisable to evaluate the risk-benefit of any maternal treatment, including chemotherapy, individually advising each mother that wishes to continue with breastfeeding (Koren 2013).


See below the information of this related product:

  • Maternal Cancer ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)

Alternatives

We do not have alternatives for Cyclophosphamide.

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

Cyclophosphamide in other languages or writings:

Group

Cyclophosphamide belongs to this group or family:

Tradenames

Main tradenames from several countries containing Cyclophosphamide in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 75 %
Molecular weight 261 daltons
Protein Binding 13 - 20 %
VD 0.4 - 0.7 l/Kg
Tmax 3 - 5 hours
7.5 (3 - 12) hours
Theoretical Dose 0.47 - 2.27 mg/Kg/d
Relative Dose 0.9 - 4.8 %

References

  1. Fierro ME, Datta P, Rewers-Felkins K, Smillie CM, Bresnahan A, Baker T, Hale TW. Cyclophosphamide Use in Multiple Sclerosis: Levels Detected in Human Milk. Breastfeed Med. 2019 Mar;14(2):128-130. Abstract
  2. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  3. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  4. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  5. Grunewald S, Jank A. New systemic agents in dermatology with respect to fertility, pregnancy, and lactation. J Dtsch Dermatol Ges. 2015 Abstract Full text (link to original source) Full text (in our servers)
  6. AEMPS. Ciclofosfamida. Ficha técnica. 2014 Full text (in our servers)
  7. FDA. Cyclophosphamide. Drug Summary. 2013 Full text (in our servers)
  8. 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
  9. Koren G, Carey N, Gagnon R, Maxwell C, Nulman I, Senikas V; Society of Obstetricians and Gynaecologists of Canada. Cancer chemotherapy and pregnancy. J Obstet Gynaecol Can. 2013 Mar;35(3):263-278. Abstract Full text (link to original source) Full text (in our servers)
  10. Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Abstract Full text (link to original source) Full text (in our servers)
  11. Temprano KK, Bandlamudi R, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005 Abstract
  12. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  13. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  14. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice guidelines. Can Fam Physician. 2000 Sep;46:1753-7. Review. Abstract Full text (link to original source) Full text (in our servers)
  15. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000 Abstract Full text (link to original source) Full text (in our servers)
  16. Durodola JI. Administration of cyclophosphamide during late pregnancy and early lactation: a case report. J Natl Med Assoc. 1979 Feb;71(2):165-6. Abstract Full text (link to original source) Full text (in our servers)
  17. Amato D, Niblett JS. Neutropenia from cyclophosphamide in breast milk. Med J Aust. 1977 Mar 12;1(11):383-4. No abstract available. Abstract
  18. Wiernik PH, Duncan JH. Cyclophosphamide in human milk. Lancet. 1971 May 1;1(7705):912. No abstract available. Abstract

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