Chemical formula: C₂₀H₃₄GdN₅O₁₀ Molecular mass: 661.76 g/mol PubChem compound: 444013
Gadoversetamide interacts in the following cases:
Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions. Most of these reactions occur within half an hour after administering the contrast medium. As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases; however, none were reported in the completed clinical trials.
If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.
During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended. To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
The risk of hypersensitivity reactions is increased in the following cases:
Before the injection of contrast media, patients should be asked whether they have any allergies (e.g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma. Premedication with antihistamines and/or glucocorticoids may be considered.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of gadoversetamide and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m²) and/or acute kidney injury. Gadoversetamide is contraindicated in these patients. Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. Therefore, gadoversetamide must not be used in patients who have had or are undergoing liver transplantation and in neonates.
The risk for development of NSF in patients with moderate renal impairment (GFR 30–59 ml/min/1.73 m²) is unknown; therefore gadoversetamide should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Gadoversetamide is dialysable. Haemodialysis shortly after gadoversetamide administration may be useful at removing gadoversetamide 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.
In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of gadoversetamide. The risk of acute kidney injury may increase with an increased dose of the contrast agent. Administer the lowest dose possible for adequate imaging.
In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.
There are no data from the use of gadoversetamide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Gadoversetamide should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.
It is unknown whether gadoversetamide is excreted in human milk. There is insufficient information on the excretion of gadoversetamide in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued for at least 24 hours after the administration of gadoversetamide.
Non-clinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity. Clinical studies on fertility have not been performed.
Gadoversetamide has no or negligible influence on the ability to drive and use machines. Ambulant patients while driving vehicles or operating machinery should take into account that acute dizziness may uncommonly (≥1/1,000 to <1/100) occur.
Most of the adverse reactions were of mild to moderate intensity and transient in nature. The most common adverse reactions were dysgeusia, feeling hot, headache and dizziness.
The majority of adverse reactions observed after the use of gadoversetamide were found to be adverse reactions of the nervous system, followed by general adverse reactions, gastrointestinal disorders/skin and subcutaneous tissue disorders.
Serious adverse reactions have been reported and include anaphylactic reactions, cardiovascular reactions, and allergic respiratory disorders. Treatment should be symptomatic and immediate access to necessary medicinal products and emergency equipment should be available should a serious event occur.
The following adverse reactions have been reported from clinical trials and from post-marketing use of gadoversetamide. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Uncommon: Anaphylactic reaction
Rare: Decreased appetite
Rare: Anxiety, Sleep disorder, Confusion and disorientation
Common: Headache, Dysgeusia
Uncommon: Dizziness, Hypoaesthesia, Paraesthesia, Parosmia
Rare: Convulsion, Tremor, Somnolence, Burning sensation
Very Rare: Syncope
Rare: Erythema of eyelid, Eye pain, Vision blurred, Conjunctivitis, Ocular hyperaemia
Rare: Tinnitus, Vertigo
Rare: Palpitations, AV block first degree, Extrasystoles, Tachycardia, Arrhythmia
Uncommon: Flushing
Rare: Hypotension, Hypertension
Uncommon: Nasal congestion, Throat irritation
Rare: Dyspnoea, Dysphonia, Rhinorrhoea, Throat tightness, Bronchospasm, Cough, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
Uncommon: Nausea, Diarrhoea
Rare: Salivary hypersecretion, Abdominal pain, Constipation, Dry mouth
Very Rare: Vomiting
Uncommon: Pruritus, Rash
Rare: Urticaria, Cold sweat, Erythema, Hyperhidrosis
Very Rare: Periorbital oedema
Not known: Nephrogenic systemic fibrosis (NSF)
Rare: Blood creatinine increased, Haematuria
Common: Feeling hot
Uncommon: Chest discomfort, Chest pain, Feeling cold (including peripheral coldness), Administration site reactions
Rare: Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral, Feeling abnormal
Uncommon: Blood calcium abnormal
Rare: ALT increased, Urine analysis abnormal, Urine electrolytes abnormal, albumin in urine, CPK Increased, Haemoglobin decreased
Very Rare: Electrocardiogram QT prolonged
Local reactions have occurred at the injection site and may lead to local irritation type reactions.
Cases of nephrogenic systemic fibrosis (NSF) have been reported with gadoversetamide. Cases of gadolinium associated skin plaques, with demonstrated sclerotic bodies on histology, have been reported with some gadolinium-containing contrast agents in patients who do not otherwise have symptoms or signs of nephrogenic systemic fibrosis.
Gadoversetamide has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
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