What is Dotarem used for?
DOTAREM® (gadoterate meglumine) injection is a prescription 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 …
How much does Dotarem cost?
The cost for Dotarem intravenous solution (376.9 mg/mL (0.5 mmol/mL)) is around $304 for a supply of 50 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How long does Dotarem stay in your system?
HOW LONG DOES GADOLINIUM STAY IN THE BODY? The length of retention in different parts of the body varies, but almost all is removed urine within 24 hours.
Is Dotarem safe?
Dotarem can cause a life-threatening condition in people with advanced kidney disease. You should not receive this medicine if you have kidney disease or if you are on dialysis. Gadoterate meglumine can stay in your body for months or years after you receive this medicine.
What are the side effects of Dotarem?
Common side effects of Dotarem include:
- headache.
- nausea.
- feeling cold.
- rash.
- sleepiness.
- fatigue.
- dizziness.
- vomiting.
How do you use Dotarem?
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.
Where is Dotarem manufactured?
Raleigh, North Carolina
Princeton, N.J. – April 21, 2020 Guerbet (GBT), a global leader in medical imaging, announced today that it received FDA approval to manufacture Dotarem® (gadoterate meglumine) injection at its Raleigh, North Carolina facility.
What is Dotarem made of?
DOTAREM contains gadoteric acid, which is made from gadolinium oxide (a magnetic agent) and DOTA, which binds with the gadolinium oxide to make a contrast agent to help diagnosis in MRI (magnetic resonance imaging). This is injected into your veins just before a MRI examination.
Is Dotarem safer than gadolinium?
The U.S. Food and Drug Administration has approved Dotarem as safe for use in MRI scans. However, patients with severe kidney disease or gadolinium contrast allergy should consult with their radiologist before receiving gadolinium contrast.
Who manufactures Dotarem?
Guerbet
Guerbet Announces FDA Approval to Manufacture Dotarem Injection in the United States. April 21, 2020 — Guerbet announced that it received U.S. Food and Drug Administration (FDA) approval to manufacture Dotarem (gadoterate meglumine) injection at its Raleigh, N.C., facility.
Is Dotarem safe in renal failure?
Renal Safety Evaluation After Dotarem®-Enhanced MRI (RESCUE) Brief Summary: Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial.
Where is Dotarem made?
Princeton, N.J. – April 21, 2020 Guerbet (GBT), a global leader in medical imaging, announced today that it received FDA approval to manufacture Dotarem® (gadoterate meglumine) injection at its Raleigh, North Carolina facility. Until late 2019, Dotarem® was manufactured exclusively outside of the United States.
How is the dose of Dotarem delivered?
The dose is delivered by manual or power injection. ( 2) DOTAREM Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine and is available in vials and pre-filled syringes. ( 3) Clinically important hypersensitivity reactions to DOTAREM.
What is the composition of Dotarem (Dotarem)?
Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below:
What is a Dotarem syringe?
DOTAREM 0.5 mmol/mL is a sterile, clear, colorless to yellow, aqueous solution for intravenous injection containing 376.9 mg/mL gadoterate meglumine and is available in vials and pre-filled syringes. History of clinically important hypersensitivity reactions to DOTAREM [see Warnings and Precautions (5.2)].
What does Dotarem stand for?
DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol