Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] The following adverse reactions were reported at ≤1%: headache, nausea, vertigo, dry mouth and dizziness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CURIUM US LLC at 1-866-789-2211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Ioflupane I 123 Injection cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data from clinical trials reflect exposure to Ioflupane I 123 Injection in 942 subjects with a mean age of 66 years (range 25 years to 90 years).
Among these subjects, 42% were female and 99% White.
Subjects received 88 MBq to 287 MBq (2 mCi to 8 mCi) [median 173 MBq (4.7 mCi)] intravenously as a single dose.
The recommended dose of Ioflupane I 123 Injection is 111 MBq to 185 MBq (3 mCi to 5 mCi) [ see Dosage and Administration ( 2.3 ) ].
The following adverse reactions were reported at a rate of 1% or less: headache, nausea, vertigo, dry mouth, and dizziness.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Ioflupane I 123 Injection.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions including dyspnea, edema, rash, erythema, and pruritus have been reported.
Have treatment measures available prior to Ioflupane I 123 Injection administration.
( 5.1 ) Thyroid Accumulation of Iodine-123: Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia.
( 2.2 , 5.2 ) Radiation Risk: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers.
Advise patients to hydrate before and after administration and to void frequently after administration.
Like all medications, Ioflupane I 123 can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: