Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bracco International B.V., Strawinskylaan 3051, 1077 ZX, Amsterdam, The Netherlands
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other gadolinium-based contrast.
ProHance is contraindicated in children under 6 months of age.
Patients with a history of allergy, drug reactions, or other hypersensitivity-like disorders should be closely observed during the procedure and the contrast medium administration, as well as for the time the physician deems useful given the patient condition.
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.
Anaphylactic shock has been very rarely been reported with the use of gadoteridol
Appropriate drugs and instruments for emergency measures must be readily available.
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.
Transitory changes in serum iron (within normal range in the majority of cases) have been observed in some patients after administration of ProHance and these changes were shown not to be clinically significant.
Caution during injection of any contrast media is necessary to avoid extravasation.
Since Gadoteridol is renally cleared from the body, caution should be exercised in patients with severely impaired renal function.
Prior to administration of ProHance, 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 <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 ProHance, 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 ProHance administration may be useful at removing ProHance 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.
Due to immature renal function in infants up to 1 year of age, ProHance should only be used in patients 6 to 12 months of age after careful consideration.
As the renal clearance of gadoteridol may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
There are no known drug interactions with gadoteridol.
No clinically significant changes or trends in laboratory tests were seen in clinical trials with ProHance.
There are no fertility data.
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 (see section 5.3). ProHance 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 (see section 5.3). 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 ProHance, should be at the discretion of the doctor and lactating mother.
On the basis of the pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of ProHance on the ability to drive or use machines.
The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement.
The following adverse reactions have been reported with ProHance. 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 (≥1/1000 - <1/100)
Rare (≥1/10,000 - <1/1000)
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 ProHance 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 ProHance, most of which were in patients co-administered other gadolinium-containing contrast agents (see section 4.4).
The ProHance safety profile is similar in children and adults.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
ProHance should not be admixed with any other drug.
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