Ioflupane I 123

IOFLUPANE I 123- ioflupane i-123 injection, solution
Curium US LLC

1 INDICATIONS AND USAGE

Ioflupane I 123 Injection is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). In these patients, Ioflupane I 123 Injection may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). Ioflupane I 123 Injection is an adjunct to other diagnostic evaluations.

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety

Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Ioflupane I 123 Injection dosing is based upon the radioactivity determined using a suitably calibrated instrument immediately prior to administration.

To minimize radiation dose to the bladder, encourage hydration prior to and following Ioflupane I 123 Injection administration in order to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following Ioflupane I 123 Injection administration [see Dosage and Administration ( 2.5) ].

2.2 Thyroid Blockade Before Ioflupane I 123 Injection

Before administration of Ioflupane I 123 Injection, administer Potassium Iodide Oral Solution or Lugol’s Solution (equivalent to 100 mg iodide) or potassium perchlorate (400 mg) to block uptake of iodine 123 by the patient’s thyroid. Administer the blocking agent at least one hour before the dose of Ioflupane I 123 Injection [see Warnings and Precautions ( 5.2) ].

2.3 Preparation and Administration

  • Assess pregnancy status before administering Ioflupane I 123 Injection to a female of reproductive potential.
  • Use aseptic procedures and radiation shielding during preparation and administration. Inspect the Ioflupane I 123 Injection vial prior to administration and do not use it if the vial contains particulate matter or discoloration [see Description ( 11) ]. Administer Ioflupane I 123 Injection as a slow intravenous injection (administered over a period of not less than 15 to 20 seconds) via an arm vein.

2.4 Recommended Dose

The recommended dose is 111 to 185 MBq (3 to 5 mCi) administered intravenously [see Clinical Studies ( 14) ].

2.5 Radiation Dosimetry

The estimated radiation absorbed doses to an average adult from intravenous injection of Ioflupane I 123 Injection are shown in Table 1. The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (iodine 123 is a known Auger electron emitter).

Table 1 Esti mated Radiation Absorbed Doses from Ioflupane I 123 Injection

Table 1
(click image for full-size original)

Table 1

* The absorbed dose to the colon wall is the mass- weighted sum of the absorbed doses to the upper and lower large intestine walls, D Colon = 0.57 D ULI + 0.43D LLI [Publication 80 of the ICRP (International Commission on Radiological Protection); Annals of the ICRP 28 (3). Oxford: Pergamon Press; 1998]

The Effective Dose resulting from a Ioflupane I 123 Injection administration with an administered activity of 185 MBq (5 mCi) is 3.94 mSv in an adult.

2.6 Imaging Guidelines

Begin SPECT imaging 3 to 6 hours following Ioflupane I 123 Injection administration. Acquire images using a gamma camera fitted with high-resolution collimators and set to a photopeak of 159 keV with a ± 10% energy window. Angular sampling should be not less than 120 views over 360 degrees. Position the subject supine with the head on an off-the-table headrest, a flexible head restraint such as a strip of tape across the chin or forehead may be used to help avoid movement, and set a circular orbit for the detector heads with the radius as small as possible (typically 11 to 15 cm).

Experimental studies with a striatal phantom suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5 to 4.5 mm. Collect a minimum of 1.5 million counts for optimal images.

2.7 Image Interpretation

Ioflupane I 123 Injection images are interpreted visually, based upon the appearance of the striata. Reconstructed pixel size should be between 3.5 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. Determination of whether an image is normal or abnormal is made 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

Single-dose vials containing 185 MBq (5 mCi) in 2.5 mL sterile solution for intravenous injection [74 MBq (2 mCi) per mL at calibration time].

4 CONTRAINDICATIONS

Ioflupane I 123 Injection is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients, or to iodine.

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