IOFLUPANE I-123 Drug Interactions: What You Need to Know

INTERACTIONS Ioflupane I 123 binds to the dopamine transporter [ see Clinical Pharmacology ( 12.1 ) ]. Drugs that bind to the dopamine transporter with high affinity may interfere with the image obtained following Ioflupane I 123 Injection administration. These potentially interfering drugs consist of: amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline. Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter. Whether discontinuation of these drugs prior to Ioflupane I 123 Injection administration may minimize the interference with a Ioflupane I 123 Injection image is unknown. The impact of dopamine agonists and antagonists upon Ioflupane I 123 Injection imaging results has not been established. Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, phenylpropanolamine, selegiline, sertraline, citalopram and paroxetine may interfere with Ioflupane I 123 Injection imaging. The effects of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging have not been established. ( 7 )

Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to ioflupane I-123 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to ioflupane I 123 ( 4 )

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. ( 2.1 , 5.3 ) 5. 1 Hypersensitivity Reactions Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration [ see Adverse Reactions ( 6.2 ) ]. The reactions have generally occurred within minutes of Ioflupane I 123 Injection administration and have either resolved spontaneously or following the administration of corticosteroids and antihistamines. Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to ioflupane I-123 [ see Contraindications ( 4 ) ]. Have treatment measures available and monitor patients for symptoms or signs of a hypersensitivity reaction.

5.2 Thyroid Accumulation of Iodine-123 Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of iodine-123, block the thyroid gland before administration of Ioflupane I 123 Injection [ see Dosage and Administration ( 2.2 ) ].

5.3 Radiation Risk Ioflupane I 123 Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to patients and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 )]</span>.