Dotarem

Generic name: gadoterate meglumine
Drug class: Magnetic resonance imaging contrast media

Medically reviewed by  A Ras MD.

What is Dotarem?

Dotarem is a prescription medicine called a gadolinium-based contrast agent (GBCA). Dotarem, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner. An MRI exam with a GBCA, including Dotarem, helps your doctor to see problems better than an MRI exam without a GBCA. Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.

Description

DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C23H42O13N5Gd (anhydrous basis).

The structural formula of gadoterate meglumine in solution is as follows:

CAS Registry No. 92943-93-6

DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. 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:

The thermodynamic stability constants for gadoterate (log Ktherm and log Kcond at pH 7.4) are 25.6 and 19.3, respectively.

 Mechanism of Action

Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.

In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with:

1. differences in proton density
2. differences of the spin-lattice or longitudinal relaxation times (T1)
3. differences in the spin-spin or transverse relaxation time (T2)

When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

What is the most important information I should know about Dotarem?

• Dotarem contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
• It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.
• Rarely patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
• There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist or ProHance.
• People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
• Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive Dotarem.

Who should not take Dotarem?

Do not receive Dotarem if you have had a severe allergic reaction to Dotarem.

What should I tell my healthcare provider before taking Dotarem?

Before receiving Dotarem, tell your healthcare provider about all your medical conditions, including if you:

• have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.
• are pregnant or plan to become pregnant. It is not known if Dotarem can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Dotarem is received during pregnancy.
• have kidney problems, diabetes, or high blood pressure.
• have had an allergic reaction to dyes (contrast agents) including GBCAs.

How should I use Dotarem?

Dotarem, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.

What are the possible side effects of Dotarem?

• See “What is the most important information I should know about Dotarem?”
• Allergic reactions. Dotarem can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction.

The most common side effects of Dotarem include: nausea, headache, pain, or cold feeling at the injection site, and rash.
These are not all the possible side effects of Dotarem.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Dotarem

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about Dotarem that is written for health professionals.

How should I store Dotarem?

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].

What are the ingredients in Dotarem?

Active ingredient: gadoterate meglumine
Inactive ingredients: DOTA, water for injection

Label

• INCIPAL PACKAGE DISPLAY – GLASS VIALS AND SYRINGES

   

  

  

  SRC: NLM .