Cyclolux Special Precautions

Exposure to gadolinium-based contrast agents (GBCAs) increases the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with: acute or chronic severe renal insufficiency (glomerular filtration rate < 30mL/min/1.73m²), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.
Avoid use of GBCAs unless the diagnotic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).
Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.
When administering a GBCA, do not exceed the dose recommended in product labelling.
Allow sufficient time for elimination of the GBCA prior to any readministration.
Do not use by intrathecal route. Take care to maintain strictly intravenous injection: extravasation may result in local intolerance reactions, requiring the usual local care.
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.
Hypersensitivity: As with other gadolinium containing contrast media hypersensitivity reactions can occur, including life-threatening (see Adverse 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.
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.
Before any contrast medium is injected, the patient should be questioned for a 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, supervision by a physician is necessary. 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.
Cardiovascular disease: In patients with severe cardiovascular disease Cyclolux should only be administrated after careful risk benefit assessment because only limited data are available so far.
CNS 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.
Impaired renal function: Prior to administration of Cyclolux, 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 Cyclolux, 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.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Ambulant patients while driving vehicles or operating machinery should take into account that nausea may incidentally occur.
Use in the 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.
Use in Children: Neonates and infants: Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Cyclolux should only be used in these patients after careful consideration.