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gadobutrol
Overview
What is Gadavist?
Gadavist (gadobutrol) injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging. The chemical name for gadobutrol is 10–[(1SR,2RS)–2,3–dihydroxy–1–hydroxymethylpropyl]–1,4,7,10–tetraazacyclododecane–1,4,7–triacetic acid, gadolinium complex. Gadobutrol has a molecular formula of CHGdNO and a molecular weight of 604.72.
Gadavist is a sterile, clear, colorless to pale yellow solution containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol/mL) as the active ingredient and the excipients calcobutrol sodium, trometamol, hydrochloric acid (for pH adjustment) and water for injection. Gadavist contains no preservatives.
The main physicochemical properties of Gadavist (1 mmol/mL solution for injection) are listed below:
The thermodynamic stability constants for gadobutrol (log Ktherm and log Kcond at pH 7.4) are 21.8 and 15.3, respectively.
What does Gadavist look like?
What are the available doses of Gadavist?
Gadavist injection contains 604.72 mg gadobutrol/mL (equivalent to 1 mmol gadobutrol/mL ()
What should I talk to my health care provider before I take Gadavist?
How should I use Gadavist?
Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
The recommended dose of Gadavist for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered.
What interacts with Gadavist?
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What are the warnings of Gadavist?
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What are the precautions of Gadavist?
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What are the side effects of Gadavist?
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What should I look out for while using Gadavist?
Gadavist is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist.
What might happen if I take too much Gadavist?
The maximum dose of Gadavist tested in healthy volunteers, 1.5 mL/kg body weight (1.5 mmol/kg; 15 times the recommended dose), was tolerated in a manner similar to lower doses. Gadavist can be removed by hemodialysis.
How should I store and handle Gadavist?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Entecavir tablets, USP, are available in the following strengths:StorageEntecavir tablets should be stored in a tightly closed container at 20-25C (68-77F); excursions permitted between 15-30C (59-86F) [see USP Controlled Room Temperature]. Keep the container out of light.Entecavir tablets, USP, are available in the following strengths:StorageEntecavir tablets should be stored in a tightly closed container at 20-25C (68-77F); excursions permitted between 15-30C (59-86F) [see USP Controlled Room Temperature]. Keep the container out of light.Entecavir tablets, USP, are available in the following strengths:StorageEntecavir tablets should be stored in a tightly closed container at 20-25C (68-77F); excursions permitted between 15-30C (59-86F) [see USP Controlled Room Temperature]. Keep the container out of light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with:
When placed in a magnetic field, Gadavist shortens the T and T relaxation times. The extent of decrease of T and T relaxation times, and therefore the amount of signal enhancement obtained from Gadavist, is based upon several factors including the concentration of Gadavist in the tissue, the field strength of the MRI system, and the relative ratio of the longitudinal and transverse relaxation times. At the recommended dose, the T shortening effect is observed with greatest sensitivity in T-weighted magnetic resonance sequences. In T*-weighted sequences the induction of local magnetic field inhomogeneities by the large magnetic moment of gadolinium and at high concentrations (during bolus injection) leads to a signal decrease.
Non-Clinical Toxicology
Gadavist is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist.No drug interactions have been identified. Studies with famotidine in man, in animal models, and have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73m) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73m). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following Gadavist administration to Bayer Healthcare (1-888-842-2937) or FDA (1-800-FDA-1088 or ).
Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. 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 prior to re-administration. For patients receiving hemodialysis, consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown
The following serious adverse reactions are discussed elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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