Ioflupane I 123 (Page 2 of 5)

2.7 Image Interpretation

Interpret Ioflupane I 123 Injection images visually, based upon the appearance of the striata. Reconstructed pixel size should be between 3.5 mm and 4.5 mm with slices 1 pixel thick. Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line.

Determine whether an image is normal or abnormal by assessing the extent (as indicated by shape) and intensity of the striatal signal. Image interpretation does not involve integration of the striatal image appearance with clinical signs and/or symptoms.

Normal: In transaxial images, normal images are characterized by two symmetric comma- or crescent-shaped focal regions of activity mirrored about the median plane. Striatal activity is distinct, relative to surrounding brain tissue (Figure 1).

Abnormal: Abnormal Ioflupane I 123 Injection images fall into at least one of the following three categories (all are considered abnormal).

  • Activity is asymmetric, e.g., activity in the region of the putamen of one hemisphere is absent or greatly reduced with respect to the other. Activity is still visible in the caudate nuclei of both hemispheres resulting in a comma or crescent shape in one and a circular or oval focus in the other. There may be reduced activity between at least one striatum and surrounding tissues (Figure 2).
  • Activity is absent in the putamen of both hemispheres and confined to the caudate nuclei. Activity is relatively symmetric and forms two roughly circular or oval foci. Activity of one or both is generally reduced (Figure 3).
  • Activity is absent in the putamen of both hemispheres and greatly reduced in one or both caudate nuclei. Activity of the striata with respect to the background is reduced (Figure 4).
Figure 1,2,3,4
(click image for full-size original)

3 DOSAGE FORMS AND STRENGTHS

Injection: clear, colorless solution containing 185 MBq (5 mCi) in 2.5 mL at a concentration of 74 MBq/mL (2 mCi/mL) of ioflupane I-123 at calibration date and time supplied in single-dose vials.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

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 [see Dosage and Administration ( 2.1)].

6 ADVERSE REACTIONS

The following clinically significant adverse reaction is described elsewhere in the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions ( 5.1) ]

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.

Immune system disorders: Hypersensitivity, including dyspnea, edema, rash, erythema, and pruritus

General disorders and administration site conditions: Injection site pain

7 DRUG 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.

8 USE IN SPECIFIC POPULATIONS

8. 1 Pregnancy

Risk Summary

Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of an appropriate thyroid blocking agent is recommended before use of Ioflupane I 123 Injection in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see Dosage and Administration ( 2.2) ].

There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with ioflupane I-123. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Administration of Ioflupane I 123 Injection at a dose of 185 MBq (5 mCi) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mGy). Radiation doses greater than 15 rad (150 mGy) have been associated with congenital anomalies but doses under 5 rad (50 mGy) generally have not. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of Ioflupane I 123 Injection.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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