WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
- • The risk of NSF appears highest among patients with:
– Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
– Acute kidney injury
- • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
- • For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
Contraindication and Important Information about Hypersensitivity Reactions: Gadavist
® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist
®. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist
® administration. Before Gadavist
® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Gadavist
®.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.
Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.
Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist
®. Extravasation into tissues during Gadavist
® administration may result in moderate irritation.
Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist
® MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.
Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.7%), nausea (1.2%) and dizziness (0.5%).
Gadavist
® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI) to assess the presence and extent of malignant breast disease in adult patients.
Please see Full Prescribing Information for Gadavist®
(Vials and Syringes).
Please see Full Prescribing Information for Gadavist®
(Imaging Bulk Package).
Reference: 1. Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR. American College of Radiology website.
https://www.jacr.org/article/S1546-1440(17)31524-7/fulltext. Accessed June 9, 2020.
The individuals depicted in this material are actors and not actual health care providers or patients.
This promotional content is brought to you by the Pharmaceutical Division at Bayer.
Bayer, the Bayer Cross, and Gadavist are trademarks owned by and/or registered to Bayer in the U.S. and/or other countries. Other trademarks and company names mentioned herein are properties of their respective owners and are used herein solely for informational purposes. No relationship or endorsement should be inferred or implied.
© 2021 Bayer. This material may not be reproduced, displayed, modified or distributed without the express prior written consent of Bayer.
PP-GADA-US-0536-1
September 2021
