Generic Name: gadoterate meglumine
Date of Approval: March 20, 2013
Company: Guerbet LLC
Treatment for: Use in Magnetic Resonance Imaging
FDA Approves Dotarem
The U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Highlights of Prescribing Information
These highlights do not include all the information needed to use Dotarem safely and effectively. See full prescribing information for Dotarem.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning 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-contra sted MRI or other modalities.
- The risk for 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.
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 (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
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. The dose is delivered by manual or power injection.
Dosage Forms and Strengths
Dotarem Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine and is available in vials and pre-filled syringes.
Clinically important hypersensitivity reactions to Dotarem.
Warnings and Precautions
- Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk.
- Hypersensitivity: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support.
Dotarem side effects
The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.
Patient Counseling Information
- Nephrogenic Systemic Fibrosis Instruct patients to inform their healthcare provider if they:
- have a history of kidney disease, or
- have recently received a GBCA.
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF:
- Describe the clinical manifestations of NSF.
- Describe procedures to screen for the detection of renal impairment.
Instruct the patients to contact their physician if they develop signs or symptoms of NSF following Dotarem administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.
- Common Adverse Reactions Inform patients that they may experience:
- Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site.
- Side effects of headache, nausea, abnormal taste and feeling hot.
- General Precautions Instruct patients receiving Dotarem to inform their physician if they:
- Are pregnant or breastfeeding.
- Have a history of allergic reaction to contrast media, bronchial asthma or allergy.
- Are taking any medications.