Datscan

DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). DATSCAN is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).

( 1 )

DATSCAN 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 )

Hypersensitivity Reactions: Hypersensitivity reactions including dyspnea, edema, rash, erythema, and pruritus have been reported. Have treatment measures available prior to DATSCAN administration. ( 5.1 ) Thyroid Accumulation of Iodine-123: Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. ( 2.3 , 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 , 2.3 , 5.3 )

5.1Hypersensitivity Reactions

Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following DATSCAN administration [see Adverse Reactions (6.2) ] . The reactions have generally occurred within minutes of DATSCAN administration and have either resolved spontaneously or following the administration of corticosteroids and antihistamines. DATSCAN 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.

5.2Thyroid Accumulation of Iodine-123

DATSCAN 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 DATSCAN [see Dosage and Administration (2.3) ] .