Chemical formula: C₁₇H₂₉GdN₄O₇ Molecular mass: 558.68 g/mol PubChem compound: 60714
Gadoteridol interacts in the following cases:
Gadoteridol 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 gadoteridol, 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, gadoteridol injections should not be repeated unless the interval between injections is at least 7 days.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing 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 gadoteridol, 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 gadoteridol administration may be useful at removing gadoteridol 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.
There are no data from the use of gadoteridol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Gadoteridol should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.
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 gadoteridol, should be at the discretion of the doctor and lactating mother.
There are no fertility data.
On the basis of the pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of gadoteridol on the ability to drive or use machines.
The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when gadoteridol is used for contrast enhancement.
The following adverse reactions have been reported with gadoteridol. adverse reactions from clinical trials have been included with an indication of the frequency. Adverse reactions from spontaneous reporting are included with the frequency “not known”. There were no adverse reactions with an incidence greater than 2%.
Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), Not known (cannot be estimated from the available data)
Rare: anaphylactic/anaphylactoid reactions***
Rare: anxiety
Uncommon: headache, paraesthesia, dizziness, taste disturbance
Rare: mental impairment, abnormal coordination, convulsion
Not known: loss of consciousness, coma, vasovagal reactions*
Uncommon: increased lacrimation
Rare: tinnitus
Rare: nodal arrhythmia
Not known: cardiac arrest
Uncommon: flushing, hypotension
Rare: laryngospasm, dyspnoea, rhinitis, cough, apnea, wheezing
Not known: respiratory arrest, pulmonary oedema
Common: nausea
Uncommon: dry mouth, vomiting
Rare: abdominal pain, tongue oedema, oral pruritus, gingivitis, loose stools
Uncommon: pruritus, rash, urticaria
Rare: oedema face
Rare: musculoskeletal stiffness
Not known: acute renal failure**
Uncommon: injection site pain, injection site reaction****, asthenia
Rare: chest pain, pyrexia
Uncommon: heart rate increased
Vasovagal reactions, rarely leading to vasovagal syncope have been reported during or immediately after gadoteridol administration. The condition is often related to emotional distress or painful/unpleasant stimuli (e.g. needle puncture for IV placement). Symptoms commonly experienced include nausea, dizziness and diaphoresis.
In severe cases possibly leading to syncope, patients are usually pale and diaphoretic with altered state of consciousness and bradycardia. In addition patients could frequently experience apprehension, restlessness, faintness and salivary hypersecretion. Proper recognition of this reaction and differential diagnosis with hypersensitivity/anaphylactoid reaction is vital in order to apply the appropriate treatment measures to revert the vagal stimulation.
Cases of acute renal failure have been reported in patients with pre-existing severe renal impairment.
As with other gadolinium chelates, there have been reports of anaphylactic/anaphylactoid/ hypersensitivity reactions with gadoteridol. These reactions manifested with various degrees of severity, including anaphylactic shock or death. They involved one or more body systems, mostly respiratory, cardiovascular and/or mucocutaneous systems. Commonly reported symptoms include throat tightness, throat irritation, dyspnoea, chest discomfort, feeling hot, dysphagia, burning sensation, oedema in pharynx or larynx, and hypotension.
Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with gadoteridol, most of which were in patients co-administered other gadolinium-containing contrast agents.
Gadoteridol safety profile is similar in children and adults.
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