Presentation and Status in Health Basket
Pre-filled Syringe (solution for injection)
The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults, children and infants. In angiography, depending on the results of the examination being performed, a second injection may be administered during the same session if necessary.
In some exceptional cases, as in the confirmation of isolated metastasis or the detection of leptomeningeal tumours, a second injection of 0.2 mmol/kg can be administered.
Impaired renal function: Dotarem should only be used in patients with severe renal impairment (GFR < 30 mL/min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. If it is necessary to use Dotarem, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotarem injections should not be repeated unless the interval between injections is at least 7 days.
Neonates up to 4 weeks of age and infants up to 1 year of age: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Dotarem should only be used in these patients after careful consideration, at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotarem injections should not be repeated unless the interval between injections is at least 7 days. Dotarem is not recommended for angiography in children under the age of 18 because of insufficient data on the efficacy and safety in this indication.
Elderly (aged 65 years and above): No dosage adjustment is considered necessary. Caution should be exercised in elderly patients.
Magnetic resonance imaging for: Enhancement of contrast in magnetic resonance imaging: Encephalic and spinal pathologies:
– brain tumours
– tumours of the spine and the surrounding tissue
– intervertebral disk prolapse
– infectious diseases
– Abdominal pathologies:
– primary and secondary liver tumours
– Osteo-articular pathology:
– bone and soft tissue tumours
– synovial diseases
– and other whole-body pathologies (including angiography)
Hypersensitivity to gadoteric acid, to meglumine or to any medicinal products containing gadolinium.
Administer only by intravenous injection. Ensure strict intravenous injection: in the event of extravasation, local intolerance reactions can occur, requiring standard local treatment. Gadoteric acid must not be administered by subarachnoid (or epidural) injections. There is always a risk of hypersensitivity regardless of the dose injected. The usual precaution measures for MRI examination should be taken, such as exclusion of patients with pacemakers, ferromagnetic vascular clips, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporal metallic foreign bodies, particularly in the eye.
Special warnings: All MRI contrast agents can be responsible for minor or major, life-threatening hypersensitivity reactions. Hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non allergic. They can be either immediate (less than 60 minutes), or delayed (up to 7 days). Anaphylactic reactions occur immediately and can be fatal. They are independent of the dose, can occur after even the first dose of the product, and are often unpredictable. There is always a risk of hypersensitivity regardless of the dose injected. Resuscitation equipment must be immediately at hand due to the risk of major reactions. Patients who have already experienced a reaction during previous administration of a gadolinium-containing MRI contrast agent present an increased risk of experiencing another reaction on subsequent administration of the same product, or possibly other products, and are therefore considered to be at high risk. The injection of gadoteric acid may aggravate symptoms of an existing asthma. In patients with asthma unbalanced by the treatment, the decision to use gadoteric acid must be made after careful evaluation of the risk/benefit ratio.
As known from the use of iodinated contrast media, hypersensitivity reactions can be aggravated in patients on beta-blockers, and particularly in the presence of bronchial asthma. These patients may be refractory to standard treatment of hypersensitivity reactions with beta-agonists
Precautions for use
Hypersensitivity to MRI contrast agents
Before the examination:
– identify high-risk subjects by detailed clinical interview of the patient’s history of allergy (e.g. seafood allergy, hay fever, hives), sensitivity to contrast media and bronchial asthma as the reported incidence of adverse reactions to contrast media is higher in patients with these conditions and premedication with antihistamines and/or glucocorticoids may be considered.
During the examination:
– ensure medical surveillance
– maintain an intravenous line
– if hypersensitivity reactions occur, administration of the contrast medium must be discontinued immediately and – if necessary – specific therapy instituted. A venous access should thus be kept during the entire examination. To permit immediate emergency countermeasures, appropriate drugs (e.g. epinephrine and antihistamines), an endotracheal tube and a respirator should be ready at hand.
After the examination:
– After administration of a contrast agent, the patient must be kept under observation for at least 30 minutes, as the majority of serious adverse reactions occur during this period.
– The patient must be warned about the possibility of delayed reactions (for up to 7 days)
Impaired renal function: Prior to administration of gadoteric acid, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadoliniumcontaining contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 mL/min/1.73m2). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with gadoteric acid, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. Haemodialysis shortly after gadoteric acid administration may be useful at removing gadoteric acid from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.
Neonates and infants: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, gadoteric acid should only be used in these patients after careful consideration. In neonates and infants the required dose should be administered by hand. Depending on the amount of gadoteric acid to be given to the child, it is preferable to use gadoteric acid vials with a single use syringe of a volume adapted to this amount in order to have a better precision of the injected volume.
Elderly: As the renal clearance of gadoteric acid may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Central nervous system disorders: Like with other gadolinium containing contrast agents special precaution is necessary in patients with a low threshold for seizures. Precautionary measures should be taken, e.g. close monitoring. All equipment and drugs necessary to counter any convulsions which may occur must be made ready for use beforehand.
During clinical studies on 1,941 patients, 3.6% of patients experienced an adverse reaction related to administration of gadoteric acid, the most common being pain and coldness at the injection site and nausea. Adverse reactions related to the use of gadoteric acid are generally mild to moderate, and transient. During clinical trials, headache and paresthesia were very commonly observed (>1/10), and nausea, vomiting and skin reactions such as erythematous rash and pruritus were commonly observed (>1/100 – <1/10). The adverse reactions most commonly reported during administration of gadoteric acid since marketing are nausea, vomiting, pruritus, and hypersensitivity reactions. The effects most commonly observed during hypersensitivity reactions are skin rashes, which can be localized, extensive or generalized. These reactions are usually immediate (during the injection or over the hour following the start of the injection) or sometimes delayed (one hour to several days after the injection), and then appear in the form of adverse skin reactions. Immediate reactions comprise one or several, successive or concomitant effects, usually including skin reactions, respiratory and/or cardiovascular disorders, which may be the first signs of shock, which can rarely be fatal. Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with gadoteric acid, most of which were in patients co-administered other gadolinium-containing contrast agents.
No interactions with other medicinal products have been observed. Formal drug interaction studies have not been carried out.
Concomitant medications to be taken into account: Beta-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists: these medicinal products decrease the efficacy of the mechanisms of cardiovascular compensation for blood pressure disorders: the radiologist must be informed before injection of gadolinium complexes, and resuscitation equipment must be at hand.
Pregnancy and Lactation
Pregnancy: There are no data from the use of gadoteric acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Gadoteric acid should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteric acid.
Lactation: Gadolinium-containing contrast agents are excreted into breast milk in very small amounts. At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of gadoteric acid, should be at the discretion of the doctor and lactating mother.
No overdose has been reported.
Following administration of very high doses, fluid and electrolyte losses must be compensated by appropriate rehydration. Renal function must be monitored for at least three days. Gadoteric acid can be removed by haemodialysis. However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).