Gadoterate Meglumine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: November 17, 2025🚩 Report this page

Gadoterate Meglumine

Active ingredient

Sold as DOTAREM

CA Health Canada

Drug class: -
Availability: See label
Routes: Intravenous
Markets covered: 1
Products on record: 1

Overview

Gadoterate Meglumine is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	November 17, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised November 17, 2025[1]

DOTAREM (gadoterate meglumine injection) is a medicinal product for diagnostic use only. DOTAREM is indicated in adults and pediatrics (from term neonates) for: • contrast enhancement during cranial and spinal MRI investigations. 2 Recommended Dose and Dosage Adjustment for specific dosage recommendations.
1 Pediatrics Pediatrics (0-18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of DOTAREM in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use.
See 1 INDICATIONS. Use of macrocyclic agents may be preferable in potentially vulnerable patients such as children. 3 Pharmacokinetics - Special Populations and Conditions – Pediatrics, 4 DOSAGE AND ADMINISTRATION, and 14 CLINICAL TRIALS – Cardiac Effects: QT Interval.
2 Geriatrics Geriatrics (> 65 years): No special precautions are required in elderly patients unless renal function is impaired (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS – Renal).

Sources & citations

[1]Health Canada (DPD) · 02459329 · revised November 17, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised November 17, 2025[1]

1 Adverse Reaction Overview As with other contrast media, delayed allergoid reactions occurring hours or days after administration have been observed, though rarely. Anaphylactoid reactions may occur. Patients with a history of previous reaction to contrast media, allergic disposition or bronchial asthma suffer more frequently from hypersensitivity reactions than others (see 7 WARNINGS AND PRECAUTIONS – Hypersensitivity).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 9 years). 1%), mostly mild or moderate in intensity. 6%) were assessed to be related to DOTAREM.
No adverse drug reaction occurred at a rate greater than 1%. 3%). Overall Safety profile The data described below reflect DOTAREM exposure in 2867 patients, including 185 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded the ethnic distribution was 80% Caucasian, 12% Asian, 4% Black, and 4% others.
1 to 97 years). 0% of patients reported at least one adverse reaction, primarily occurring immediately or several days following DOTAREM administration. Most adverse reactions were mild or moderate in severity and transient in nature.
0%. 2% patients who received DOTAREM. 1 Clinical Trial Adverse Reactions – Pediatrics During clinical trials, 185 pediatric patients (52 aged < 24 months, 33 aged 2 - 5 years, 57 aged 6 - 11 years and 43 aged 12 - 17 years) received DOTAREM.
5%) reported at least one adverse reaction following DOTAREM administration. For the patient below 2 years, the adverse reaction was a rash of moderate intensity. 5%). Other adverse reactions reported for no more than one patient were pruritus, dizziness, nausea, vomiting, haematuria, asthenia, injection site urticaria.
Most adverse events were mild in intensity and transient in nature, and all patients recovered without treatment. All adverse events, regardless of relationship to product administration, reported in pediatric patients below 2 years of age in the clinical study DGD-44-063 are listed in table 4.
3 Less Common Clinical Trial Adverse Reactions Less Common Clinical Trial Adverse Drug Reactions (<1%) Table 5 lists all adverse events considered as drug-related. 1%) Cardiac disorders Palpitations Eye disorders Eyelid oedema Gastrointestinal disorders Nausea Diarrhoea Abdominal pain upper Dry mouth Vomiting Abdominal pain Abdominal pain lower Oral discomfort Paraesthesia oral Salivary hypersecretion General disorders and administration site conditions Injection site pain Injection site coldness Fatigue Feeling hot Feeling cold Asthenia Injection site inflammation Pain Injection site extravasation Injection site swelling Injection site warmth Extravasation Catheter site haemorrhage Chest pain Chills Injection site discomfort Injection site pruritus Injection site urticaria Vessel […]

CAOfficial regulatory label· Warnings and precautions· revised November 17, 2025[1]

– Renal). 2 CONTRAINDICATIONS • Gadoterate meglumine injection is contraindicated for subarachnoid (or epidural) administration. • Gadoterate meglumine injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING (see 7 WARNINGS AND PRECAUTIONS – Hypersensitivity). 73m2). In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast-enhanced magnetic resonance imaging (MRI).
NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. 2 Recommended Dose and Dosage Adjustment) and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.
) NOT FOR INTRATHECAL USE Intrathecal administration of GBCAs can cause serious, life-threatening, and fatal reactions. DOTAREM is not approved for intrathecal use (see 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Risks of Intrathecal Use).
1 Dosing Considerations • DOTAREM is for intravenous administration only. • Use of macrocyclic agents may be preferable in certain patients such as those for whom repeated GBCA doses may need to be considered due to individual clinical circumstances and in other potentially vulnerable patients such as children and pregnant women (See 7 WARNINGS AND PRECAUTIONS).
• Pediatrics < 2 years of age: DOTAREM should be administered intravenously with manual bolus injection at a rate of about 1-2 mL/sec followed by saline flush at the same flow rate. A patient IV line has to be established and maintained throughout the examination.
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.
Product Monograph DOTAREM Gadoterate meglumine injection Page 7 of 43 Protected B / Protégé B • For special populations (pediatrics, geriatrics, hepatic impairment, renal impairment), no dosage adjustment is recommended and the adult dose applies.

This is not medical advice. Consult a qualified healthcare professional.