|
|
|
|
Indicated for
Cardiac Magnetic
Resonance (MR)
Imaging
|
|
|
|
Gadavist is the first and
only GBCA specifically
researched and
developed for cardiac
MRI in adult patients in
2 well-controlled
clinical trials.
|
|
|
Indications
|
Gadavist® (gadobutrol) injection is a
gadolinium-based contrast agent indicated for use with
magnetic resonance imaging (MRI):
-
To detect and visualize areas with disrupted blood brain barrier and/or
abnormal vascularity of the central nervous system in adult and pediatric
patients including term neonates.
-
To assess the presence and extent of malignant breast disease in adult patients.
-
To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult
patients with known or suspected coronary artery disease (CAD).
|
Gadavist® is indicated for use in magnetic resonance angiography (MRA):
-
To evaluate known or suspected supra-aortic or renal artery disease
in adult and pediatric patients including term neonates.
|
|
|
|
Important Safety Information
|
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.
|
|
Please see additional Important Safety Information below.
|
|
|
|
Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
|
|
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).
|
|
|
|
Important Safety Information (continued)
|
|
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.
|
|
Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist®
MRA for detecting arterial segments with significant stenosis (>50% renal, >70%
supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA
study alone should not be used to rule out significant stenosis.
|
|
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%).
|
|
Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
|
|
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).
|
|
Bayer, the Bayer Cross, and Gadavist are trademarks owned by
and/or registered to Bayer in the U.S. and/or other countries.
© 2022 Bayer. This material may not be reproduced, displayed, modi?ed or
distributed without the express prior written consent of Bayer.
100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981.
You are encouraged to report side effects or quality complaints of products to the
FDA by visiting
www.fda.gov/medwatch or calling
1-800-FDA-1088. For Bayer
products, you can report these directly to Bayer by
clicking here.
This message is brought to you by the Pharmaceutical Division of Bayer.
Privacy Policy
| Terms of Use
| Contact Us
PP-GADA-US-0716-1 December 2022
|
|
|
|
|
|
|
|
AuntMinnie.com, 671 N Glebe Road, Suite #1610, Arlington, VA 22203 USA
+1 520-298-1000
|
