The Basics
What is Gadobutrol?
Given by injection before an MRI to help diagnose problems in the brain, spine, breast, and other parts of your body.
Brand names for Gadobutrol
Gadavist
How Gadobutrol is classified
Contrast Media, Diagnostic Agents
Gadobutrol During Pregnancy
Gadobutrol pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Gadobutrol while pregnant
GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data). In animal reproduction studies, although teratogenicity was not observed, embryolethality was observed in monkeys, rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 times and above the recommended human dose. Retardation of embryonal development was observed in rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 and 12 times, respectively, the recommended human dose . Because of the potential risks of gadolinium to the fetus, use Gadavist only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and is 15 to 20%, respectively.
Taking Gadobutrol While Breastfeeding
What are recommendations for lactation if you're taking Gadobutrol?
There is no published experience with gadobutrol during breastfeeding. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a gadolinium-containing contrast medium.[1][2][3][4] Gadobutrol is one of the most stable gadolinium agents, theoretically making it one of the safer drugs to use during breastfeeding. However, because there is no published experience with gadobutrol during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
Maternal / infant drug levels
There is no published experience with gadobutrol during breastfeeding. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a gadolinium-containing contrast medium.[1][2][3][4] Gadobutrol is one of the most stable gadolinium agents, theoretically making it one of the safer drugs to use during breastfeeding. However, because there is no published experience with gadobutrol during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
Possible effects of Gadobutrol on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Gadobutrol
Gadobutrol, Gadopentetate, Gadoteridol, Gadoterate.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. American College of Radiology Committee on Drugs and Contrast Media. Administration of contrast media to breast-feeding mothers. In, ACR manual on contrast media. 2017;Version 10.3:102-3. https://www.acr.org/~/media/37D84428BF1D4E1B9A3A2918DA9E27A3.pdf
2. Patenaude Y, Pugash D, Lim K et al. The use of magnetic resonance imaging in the obstetric patient. J Obstet Gynaecol Can. 2014;36:349-55. PMID: 24798674
3. Committee Opinion No. 723: Guidelines for Diagnostic Imaging During Pregnancy and Lactation. Obstet Gynecol. 2017;130:e210-e216. PMID: 28937575
4. European Society of Urogenital Radiology. ESUR guidelines on contrast media. 2018;Version 10.0. http://www.esur-cm.org/index.php/en/
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
