Gadopiclenol

What is Gadopiclenol?

• Gadopiclenol (Elucirem) is a gadolinium-based contrast agent, which contains gadopiclenol, a paramagnetic macrocyclic non-ionic complex of gadolinium.

Gadopiclenol

What are the uses of this medicine?

• Gadopiclenol (Elucirem) is a prescription medicine called a gadolinium-based contrast agent (GBCA). Elucirem, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
• An MRI exam with a GBCA, including Elucirem, helps your healthcare provider to see problems better than an MRI exam without a GBCA.

Gadopiclenol (Elucirem) is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:

• the central nervous system (brain, spine, and associated tissues),
• the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

How does this medicine work?

• A gadolinium-based paramagnetic contrast agent, with potential imaging enhancing activity upon magnetic resonance imaging (MRI).
• Upon administration of gadopiclenol and placement in a magnetic field, this agent produces a large magnetic moment and creates a large local magnetic field, which can enhance the relaxation rate of nearby protons.
• This change in proton relaxation dynamics, increases the MRI signal intensity of tissues in which this agent has accumulated; therefore, contrast and visualization of those tissues is enhanced compared to unenhanced MRI.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a severe allergic reaction to Elucirem.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Gadopiclenol was approved for medical use in the United States in September 2022.

How should this medicine be used?

Recommended dosage:

• The recommended dose for adult and pediatric patients aged 2 years and older is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.

Administration:

• Elucirem comes as a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution for intravenous use.
• Visually inspect Elucirem for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored.
• Do not mix with other medications because of the potential for chemical incompatibility.
• Prime intravenous line before use.
• Administer Elucirem as an intravenous bolus injection, manually or by compatible power injector. The recommended injection rate is approximately 2 mL/second.
• Flush the intravenous line with 0.9% Sodium Chloride Injection, USP after the administration of Elucirem.
• Contrast MRI can begin immediately following the injection of Elucirem.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 0.5 mmol/mL of gadopiclenol in single-dose vials, single-dose prefilled syringes, and pharmacy bulk packages

This medicine is available in fallowing brand namesː

• Elucirem

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site pain, headache, nausea, injection site coldness, injection site warmth, dizziness, and localized swelling.

Less common, but serious side effects may include:

• Allergic reactions
• Nephrogenic Systemic Fibrosis
• Hypersensitivity Reactions

What special precautions should I follow?

• 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 Elucirem.
• Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support.
• Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs following Elucirem administration even in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs.
• Inform the patient that Elucirem may cause reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site.
• In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Do not exceed the recommended dose.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• headache and nausea were the most frequently reported adverse reactions.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Gadopiclenol can be removed from the body by hemodialysis.

Can this medicine be used in pregnancy?

• It is not known if Elucirem can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Elucirem is received during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Elucirem for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) have been established in pediatric patients aged 2 years and older.
• The safety and effectiveness of Elucirem have not been established in pediatric patients younger than 2 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: gadopiclenol
• Inactive ingredients: tetraxetan; trometamol; hydrochloric acid or sodium hydroxide for pH adjustment; and water for injection

Who manufactures and distributes this medicine?

• Manufactured by: Liebel-Flarsheim Company LLC, 8800 Durant Road, Raleigh, North Carolina (NC, USA
• Distributed by: Guerbet LLC, 214 Carnegie Center, Suite 300, Princeton, New Jersey, USA

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).
• Do not freeze Pre-filled syringes.

• Dailymed label info on Gadopiclenol
• FDA Gadopiclenol

Gadopiclenol Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski

• Need help finding a doctor or specialist anywhere in the world? WikiMD's DocFinder can help with millions of doctors!

This article is a stub. Help WikiMD grow by registering to expand it. Editing is available only to registered and verified users. About WikiMD: A comprehensive, free health & wellness encyclopedia.

‎