The MERIT study published in AJNR MultiHance®
The MERIT study published in AJNR MultiHance®
significantly improved CNS lesion visualization* vs gadobutrol(1)
:
significantly improved CNS lesion visualization* vs gadobutrol(1)
* Significantly better contrast enhancement, definition of lesion extent, delineation of lesion borders, and depiction of lesion internal morphology; greater enhancement of lesion-brain contrast- to-noise ratio (CNR) and lesion-to-brain ratio. 1. Does Higher Gadolinium Concentration Play a Role in the Morphologic Assessment of Brain Tumors? Results of a Multicenter Intraindividual Crossover Comparison of Gadobutrol versus Gadobenate Dimeglumine (the MERIT study); Seidl et al, AJNR, Published online before print March 1, 2012, doi: 10.3174/ ajnr.A3033, AJNR 2012.
MULTIHANCE - SUMMARY OF PRODUCT CHARACTERISTICS MultiHance, 0.5 M solution for injection Composition 1 ml of solution for injection contains: gadobenic acid 334 mg (0.5 M) as the dimeglumine salt. [Gadobenate dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195 mg]. Excipients Water for injections. Therapeutic indications and dosage This medicinal product is for diagnostic use only. MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: MRI of the brain and spine for patients 2 years and older where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI (0.2 mL/kg); Contrast-enhanced MR-angiography for adult patients where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries (0.2 mL/kg). MRI of the liver for the detection of focal liver lesions in adult patients with known or suspected primary liver cancer (e.g. hepatocellular carcinoma) or metastatic disease (0.1 mL/kg) Contra- indications MultiHance is contra-indicated in: patients with hypersensitivity to any of the ingredients; in patients with a history of allergic or adverse reactions to other gadolinium chelates. Special warnings and special precaution for use MultiHance should not be admixed with any other drug; the product should not be frozen, and it should be used immediately after drawing into the syringe. Patients should be kept under close supervision for 15 minutes following the injection as the majority of severe reactions occur at this time. The patient should remain in the hospital environment for one hour after the time of injection. The accepted general safety procedures for Magnetic Resonance Imaging, in particular the exclusion of ferromagnetic objects, for example cardiac pace-makers or aneurysm clips, are also applicable when MultiHance is used. Caution is advised in patients with cardiovascular disease. The use of diagnostic contrast media, such as MultiHance, should be restricted to hospitals or clinics staffed for intensive care emergencies and where cardiopulmonary resuscitation equipment is readily available. Small quantities of benzyl alcohol (< 0.2%) may be released by gadoben- ate dimeglumine during storage. Thus MultiHance should not be used in patients with a history of sensitivity to benzyl alcohol. As with other gadolinium-chelates, a contrast-enhanced MRI should not be performed within 7 hours of a MultiHance-enhanced MRI examination to allow for clearance of MultiHance from the body. Impaired renal function Prior to administration of MultiHance, 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 gadolinium containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m2
* Significantly better contrast enhancement, definition of lesion extent, delineation of lesion borders, and depiction of lesion internal morphology; greater enhancement of lesion-brain contrast- to-noise ratio (CNR) and lesion-to-brain ratio. 1. Does Higher Gadolinium Concentration Play a Role in the Morphologic Assessment of Brain Tumors? Results of a Multicenter Intraindividual Crossover Comparison of Gadobutrol versus Gadobenate Dimeglumine (the MERIT study); Seidl et al, AJNR, Published online before print March 1, 2012, doi: 10.3174/ ajnr.A3033, AJNR 2012.
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 MultiHance, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI. Haemodialysis shortly after MultiHance administration may be useful at removing MultiHance 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. Elderly As the renal clearance of gadobenate dimeglumine may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction. Undesirable effects The following adverse events were seen during the clinical development of MultiHance among 2637 adult subjects. There were no adverse reactions with a frequency greater than 2%. Common (≥ 1/100, < 1/10): Nervous system disorders; Headache. Gastrointestinal disorders; Nausea. General disorders and administration site conditions; Injection site reaction, feeling hot. Uncommon (≥ 1/1,000, < 1/100): Infections and infestations; Nasopharyngitis. Nervous system disorders; Paraesthesia, dizziness, syncope, parosmia. Cardiac disorders; Tachycardia, atrial fibrillation, first-degree atrioventricular block, ventricular extrasystoles, sinus bradycardia. Vascular disorders; Hypertension, hypotension. Respiratory, thoracic and mediastinal disorders; Rhinitis. Gastrointestinal disorders; Dry mouth, taste perversion, diarrhoea, vomiting, dyspepsia, salivation, abdominal pain. Skin & subcutaneous tissue disorders; Pruritus, rash, face oedema, urticaria, sweating. Musculoskeletal, connective tissue and bone disorders; Back pain, myalgia. General disorders and administration site conditions; Asthenia, fever, chills, chest pain, pain, injection site pain, injection site extravasation. Investigations; Abnormal laboratory tests, abnormal ECG, prolonged QT. Rare (≥ 1/10,000, < 1/1,000): Nervous system disorders; Hyperaesthesia, tremor, intracranial hypertension, hemiplegia. Eye disorders; Conjunctivitis. Ear and labyrinth disorders; Tinnitus. Cardiac disorders; Arrhythmia, myocardial ischaemia, prolonged PR interval. Respiratory, thoracic and mediastinal disorders; Dyspnoea N.O.S., laryngospasm, wheezing, pulmonary congestion, pulmonary oedema. Gastrointestinal disorders; Constipation, faecal incontinence, necrotising pancreatitis. Renal and urinary disorders; Urinary incontinence, urinary urgency. General disorders and administration site conditions; Injection site inflammation. Additional safety information Laboratory abnormalities cited above include hypochromic anaemia, leukocytosis, leukopenia, basophilia, hypoproteinaemia, hypocalcaemia, hyperkalaemia, hyperglycaemia or hypoglycaemia, albuminuria, glycosuria, haematuria, hyperlipidaemia, hyperbilirubinaemia, serum iron increased, and increases in serum transaminases, alkaline phosphatase, lactic dehydrogenase, and in serum creatinine and were reported in equal or less than 0.4% of patients following the administration of MultiHance. However these findings were mostly seen in patients with evidence of pre-existing impairment of hepatic function or pre-existing metabolic disease. The majority of these events were non-serious, transient and spontaneously resolved without residual effects. There was no evidence of any correlation with age, gender or dose administered. Paediatric In paediatric patients enrolled in clinical trials the most commonly reported adverse reactions included vomiting (1.4%), pyrexia (0.9%) and hyperhydrosis (0.9%). The frequency and nature of adverse reactions was similar to that in adults. In marketed use, adverse reactions were reported in fewer than 0.1% of patients. Most commonly reported were: nausea, vomiting, signs and symptoms of hypersensitivity reactions including anaphylactic shock, anaphylactoid reactions, angioedema, laryngeal spasm and rash. Injection site reactions due to extravasation of the contrast medium leading to local pain or burning sensations, swelling and blistering have been reported. Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with MultiHance in patients co-administered other gadolinium-containing contrast agents. Please note The peel-off tracking label on the vials should be stuck onto the patient records to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. Consult the locally approved package insert. The Marketing Authorisation Holder, the Marketing Authorisation number and the date of approval may be different in different countries. Date of revision of this text December 2011.
MULTIHANCE - SUMMARY OF PRODUCT CHARACTERISTICS MultiHance, 0.5 M solution for injection Composition 1 ml of solution for injection contains: gadobenic acid 334 mg (0.5 M) as the dimeglumine salt. [Gadobenate dimeglumine 529 mg = gadobenic acid 334 mg + meglumine 195 mg]. Excipients Water for injections. Therapeutic indications and dosage This medicinal product is for diagnostic use only. MultiHance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: MRI of the brain and spine for patients 2 years and older where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI (0.2 mL/kg); Contrast-enhanced MR-angiography for adult patients where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries (0.2 mL/kg). MRI of the liver for the detection of focal liver lesions in adult patients with known or suspected primary liver cancer (e.g. hepatocellular carcinoma) or metastatic disease (0.1 mL/kg) Contra- indications MultiHance is contra-indicated in: patients with hypersensitivity to any of the ingredients; in patients with a history of allergic or adverse reactions to other gadolinium chelates. Special warnings and special precaution for use MultiHance should not be admixed with any other drug; the product should not be frozen, and it should be used immediately after drawing into the syringe. Patients should be kept under close supervision for 15 minutes following the injection as the majority of severe reactions occur at this time. The patient should remain in the hospital environment for one hour after the time of injection. The accepted general safety procedures for Magnetic Resonance Imaging, in particular the exclusion of ferromagnetic objects, for example cardiac pace-makers or aneurysm clips, are also applicable when MultiHance is used. Caution is advised in patients with cardiovascular disease. The use of diagnostic contrast media, such as MultiHance, should be restricted to hospitals or clinics staffed for intensive care emergencies and where cardiopulmonary resuscitation equipment is readily available. Small quantities of benzyl alcohol (< 0.2%) may be released by gadoben- ate dimeglumine during storage. Thus MultiHance should not be used in patients with a history of sensitivity to benzyl alcohol. As with other gadolinium-chelates, a contrast-enhanced MRI should not be performed within 7 hours of a MultiHance-enhanced MRI examination to allow for clearance of MultiHance from the body. Impaired renal function Prior to administration of MultiHance, 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 gadolinium containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m2
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 MultiHance, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI. Haemodialysis shortly after MultiHance administration may be useful at removing MultiHance 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. Elderly As the renal clearance of gadobenate dimeglumine may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction. Undesirable effects The following adverse events were seen during the clinical development of MultiHance among 2637 adult subjects. There were no adverse reactions with a frequency greater than 2%. Common (≥ 1/100, < 1/10): Nervous system disorders; Headache. Gastrointestinal disorders; Nausea. General disorders and administration site conditions; Injection site reaction, feeling hot. Uncommon (≥ 1/1,000, < 1/100): Infections and infestations; Nasopharyngitis. Nervous system disorders; Paraesthesia, dizziness, syncope, parosmia. Cardiac disorders; Tachycardia, atrial fibrillation, first-degree atrioventricular block, ventricular extrasystoles, sinus bradycardia. Vascular disorders; Hypertension, hypotension. Respiratory, thoracic and mediastinal disorders; Rhinitis. Gastrointestinal disorders; Dry mouth, taste perversion, diarrhoea, vomiting, dyspepsia, salivation, abdominal pain. Skin & subcutaneous tissue disorders; Pruritus, rash, face oedema, urticaria, sweating. Musculoskeletal, connective tissue and bone disorders; Back pain, myalgia. General disorders and administration site conditions; Asthenia, fever, chills, chest pain, pain, injection site pain, injection site extravasation. Investigations; Abnormal laboratory tests, abnormal ECG, prolonged QT. Rare (≥ 1/10,000, < 1/1,000): Nervous system disorders; Hyperaesthesia, tremor, intracranial hypertension, hemiplegia. Eye disorders; Conjunctivitis. Ear and labyrinth disorders; Tinnitus. Cardiac disorders; Arrhythmia, myocardial ischaemia, prolonged PR interval. Respiratory, thoracic and mediastinal disorders; Dyspnoea N.O.S., laryngospasm, wheezing, pulmonary congestion, pulmonary oedema. Gastrointestinal disorders; Constipation, faecal incontinence, necrotising pancreatitis. Renal and urinary disorders; Urinary incontinence, urinary urgency. General disorders and administration site conditions; Injection site inflammation. Additional safety information Laboratory abnormalities cited above include hypochromic anaemia, leukocytosis, leukopenia, basophilia, hypoproteinaemia, hypocalcaemia, hyperkalaemia, hyperglycaemia or hypoglycaemia, albuminuria, glycosuria, haematuria, hyperlipidaemia, hyperbilirubinaemia, serum iron increased, and increases in serum transaminases, alkaline phosphatase, lactic dehydrogenase, and in serum creatinine and were reported in equal or less than 0.4% of patients following the administration of MultiHance. However these findings were mostly seen in patients with evidence of pre-existing impairment of hepatic function or pre-existing metabolic disease. The majority of these events were non-serious, transient and spontaneously resolved without residual effects. There was no evidence of any correlation with age, gender or dose administered. Paediatric In paediatric patients enrolled in clinical trials the most commonly reported adverse reactions included vomiting (1.4%), pyrexia (0.9%) and hyperhydrosis (0.9%). The frequency and nature of adverse reactions was similar to that in adults. In marketed use, adverse reactions were reported in fewer than 0.1% of patients. Most commonly reported were: nausea, vomiting, signs and symptoms of hypersensitivity reactions including anaphylactic shock, anaphylactoid reactions, angioedema, laryngeal spasm and rash. Injection site reactions due to extravasation of the contrast medium leading to local pain or burning sensations, swelling and blistering have been reported. Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with MultiHance in patients co-administered other gadolinium-containing contrast agents. Please note The peel-off tracking label on the vials should be stuck onto the patient records to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. Consult the locally approved package insert. The Marketing Authorisation Holder, the Marketing Authorisation number and the date of approval may be different in different countries. Date of revision of this text December 2011.
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