DOTAREM 376.9 mg/mL
gadoterate meglumine · INJECTION · Guerbet LLC
DOTAREM is a injection containing gadoterate meglumine at 376.9 mg/mL, taken intravenous. Manufactured by Guerbet LLC.
Key Facts
- Brand Name
- DOTAREM
- Generic Name
- gadoterate meglumine
- NDC Code (Product)
67684-2000- Manufacturer
- Guerbet LLC
- Strength
- 376.9 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA204781
- Marketing Start
- 04/26/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult and pediatric patients: The recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1 - 2 mL/second for pediatric patients (including term neonates). The dose is delivered by manual or power injection. 2.1 Dosing Guidelines For adult and pediatric patients (including term neonates), the recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 - 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes. Table 1: Volumes of DOTAREM Injection by Body Weight Body Weight Volume Pounds (lb) Kilograms (kg) Milliliters (mL) 5.5 2.5 0.5 11 5 1 22 10 2 44 20 4 66 30 6 88 40 8 110 50 10 132 60 12 154 70 14 176 80 16 198 90 18 220 100 20 242 110 22 264 120 24 286 130 26 308 140 28 330 150 30 To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection. 2.2 Drug Handling Visually i…
Contraindications
4 CONTRAINDICATIONS History of clinically important hypersensitivity reactions to DOTAREM [see Warnings and Precautions ( 5.2 )]. Clinically important hypersensitivity reactions to DOTAREM.
Drug Interactions
7 DRUG INTERACTIONS Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with DOTAREM have not been conducted.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions ( 5.2 )] . Hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] . Gadolinium Retention [see Warnings and Precautions ( 5.4 )] The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect DOTAREM exposure in 2867 patients, representing 2682 adults and 185 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded, the ethnic distribution was 81% Caucasian, 11% Asian, 4% Black, and 4% others. The average a…
Frequently Asked Questions
What is DOTAREM used for?
DOTAREM contains gadoterate meglumine. It is a injection taken intravenous. Consult your doctor for specific uses.
Is DOTAREM a controlled substance?
DOTAREM is not classified as a controlled substance by the DEA.
What is the generic name for DOTAREM?
The generic name for DOTAREM is gadoterate meglumine. There are 7 other brand versions of gadoterate meglumine.
What is the NDC code for DOTAREM 376.9 mg/mL?
The NDC (National Drug Code) for DOTAREM 376.9 mg/mL is 67684-2000, listed by Guerbet LLC.