Last update: Dec. 19, 2018

Gadobutrol

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

Gadolinium chelate that has a similar action and use than gadopentetic acid.

At latest update no published data on excretion into breast milk were found.

It has been used in the pediatric and neonatal age.

The various contrast media that are gadolinium derivatives and used for explorations with Magnetic Resonance Imaging (MRI) are considered compatible with breastfeeding because they are quickly eliminated (elimination half-life of less than 2 hours). They undergo very little metabolic changes and are virtually non-absorbable orally. They are structurally very similar to each other. Some have been shown to have no or minimal excretion into the milk. Less than 0.04% of the dose given to the mother ends just going into the milk (ACR 2018 p99, Wang 2012, Rubik 2000, Rofsky 1993).

Due to its low oral bioavailability, intestinal absorption should be less than 1% of the dose took by the infant.
The maximum dose received by the infant is considered less than 0.0004% of the maternal dose, which is much less than the dose administered to a newborn infant who undergoes a MRI scan.

Most Radiology Scientific Societies agree that after an MRI scan is not necessary to temporarily stop breastfeeding (ACR 2018 p99, Puac 2017, Cova 2014, Quintana 2014, Patenaude 2014, Sachs 2013, Tremblay 2012, Wang 2012, Chen 2008, Newman 2007, Webb 2005).

Some authors recommend avoiding the use on lactating women of some Gadolinium contrast media that would pose a high risk for developing Systemic Nephrogenic Fibrosis, especially in the neonatal period, like gadoversetamide, and gadodiamide dimeglumine, by using instead low-risk ones like gadoterate, gadoteridol and gadobutrol (Puac 2017, Quintana 2014, EMA 2010).

Alternatives

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

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Gadobutrol in other languages or writings:

Group

Gadobutrol belongs to this group or family:

Tradenames

Main tradenames from several countries containing Gadobutrol in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 5 %
Molecular weight 605 daltons
Protein Binding < 5 %
T1/2 1,8 hours

References

  1. ACR-American College of Radiology Committee on Drugs and Contrast Media. ACR Manual on Contrast Media v10.3 2018 Abstract Full text (link to original source) Full text (in our servers)
  2. Puac P, Rodríguez A, Vallejo C, Zamora CA, Castillo M. Safety of Contrast Material Use During Pregnancy and Lactation. Magn Reson Imaging Clin N Am. 2017 Abstract
  3. AEMPS. Gadobutrol. Ficha técnica. 2015 Full text (in our servers)
  4. Quintana Rodríguez I. Uso de contrastes radiológicos en la mujer lactante y en niños.. CbSERAM nº 8/14 – Agosto 2014 Abstract Full text (link to original source) Full text (in our servers)
  5. Cova MA, Stacul F, Quaranta R, Guastalla P, Salvatori G, Banderali G, Fonda C, David V, Gregori M, Zuppa AA, Davanzo R. Radiological contrast media in the breastfeeding woman: a position paper of the Italian Society of Radiology (SIRM), the Italian Society of Paediatrics (SIP), the Italian Society of Neonatology (SIN) and the Task Force on Breastfeeding, Ministry of Health, Italy. Eur Radiol. 2014 Abstract
  6. Patenaude Y, Pugash D, Lim K, Morin L; Diagnostic Imaging Committee, Lim K, Bly S, Butt K, Cargill Y, Davies G, Denis N, Hazlitt G, Morin L, Naud K, Ouellet A, Salem S; Society of Obstetricians and Gynaecologists of Canada. The use of magnetic resonance imaging in the obstetric patient. J Obstet Gynaecol Can. 2014 Abstract
  7. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  8. Wang PI, Chong ST, Kielar AZ, Kelly AM, Knoepp UD, Mazza MB, Goodsitt MM. Imaging of pregnant and lactating patients: part 1, evidence-based review and recommendations. AJR Am J Roentgenol. 2012 Abstract Full text (link to original source) Full text (in our servers)
  9. Tremblay E, Thérasse E, Thomassin-Naggara I, Trop I. Quality initiatives: guidelines for use of medical imaging during pregnancy and lactation. Radiographics. 2012 Abstract Full text (link to original source) Full text (in our servers)
  10. FDA. Gadobutrol. Drug Summary. 2011 Full text (in our servers)
  11. EMA. Assessment report for Gadolinium-containing contrast agents. 2010 Full text (in our servers)
  12. Chen MM, Coakley FV, Kaimal A, Laros RK Jr. Guidelines for computed tomography and magnetic resonance imaging use during pregnancy and lactation. Obstet Gynecol. 2008 Abstract
  13. Newman J. Breastfeeding and radiologic procedures. Can Fam Physician. 2007 Abstract Full text (link to original source) Full text (in our servers)
  14. Lin SP, Brown JJ. MR contrast agents: physical and pharmacologic basics. J Magn Reson Imaging. 2007 Abstract
  15. Webb JA, Thomsen HS, Morcos SK; Members of Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). The use of iodinated and gadolinium contrast media during pregnancy and lactation. Eur Radiol. 2005 Abstract
  16. Kubik-Huch RA, Gottstein-Aalame NM, Frenzel T, Seifert B, Puchert E, Wittek S, Debatin JF. Gadopentetate dimeglumine excretion into human breast milk during lactation. Radiology. 2000 Abstract
  17. Hylton NM. Suspension of breast-feeding following gadopentetate dimeglumine administration. Radiology. 2000 Abstract
  18. Rofsky NM, Weinreb JC, Litt AW. Quantitative analysis of gadopentetate dimeglumine excreted in breast milk. J Magn Reson Imaging. 1993 Abstract
  19. Schmiedl U, Maravilla KR, Gerlach R, Dowling CA. Excretion of gadopentetate dimeglumine in human breast milk. AJR Am J Roentgenol. 1990 Abstract

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