Ioflupane I 123- Ioflupane I-123 injection, Solution

Ioflupane I 123 Injection 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

• Administer a thyroid-blocking agent at least one hour before the dose of Ioflupane I 123 Injection. (
  2.2

  Thyroid Blockade Before Ioflupan

  e I 123

  Injection

  Administration

  Administer Potassium Iodide Oral Solution or Strong Iodine Solution (e.g., Lugol's Solution) equivalent to 100 mg iodide to block uptake of iodine-123 by the patient's thyroid at least one hour before the dose of Ioflupane I 123 Injection [

  see

  Warnings and Precautions

  (

  5.2

  )

  ].
  )
  
  
• The recommended dose of Ioflupane I 123 Injection in adult patients is 111 MBq to 185 MBq (3 mCi to 5 mCi) administered intravenously over at least 20 seconds. (
  2.3

  Recommended Dos

  age

  The recommended dose of Ioflupane I 123 Injection in adult patients is 111 MBq to 185 MBq (3 mCi to 5 mCi) administered intravenously over at least 20 seconds.
  )
  
  
• Measure patient dose using a dose calibrator immediately prior to administration. (
  2.000000000000000e+00

  4

  Preparation and Administration

  • Assess pregnancy status before administering Ioflupane I 123 Injection to a female of reproductive potential [
    see
    Use in Specific Populations
    (
    8.1
    )
    ].
    
    
  • Use aseptic procedures and radiation shielding during preparation and administration.
    
    
  • Inspect the Ioflupane I 123 Injection vial for particulate matter and discoloration prior to administration and do not use it if the vial contains particulate matter or discoloration.
    
    
  • Measure patient dose using a dose calibrator immediately prior to administration.
    
    
  • Discard unused portion.
  )
  
  
• Begin SPECT imaging between 3 hours and 6 hours post-injection. (
  2.6

  Imaging

  Instructions

  Begin SPECT imaging 3 hours to 6 hours following Ioflupane I 123 Injection administration.

  Use 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 at least 120 views over 360 degrees.

  Position the patient supine with the head on an off-the-table headrest, use a flexible head restraint such as a strip of tape across the chin or forehead if necessary to help avoid movement, and set a circular orbit for the detector heads with the radius as small as possible (typically 11 cm to 15 cm).

  Obtain images with matrix size and zoom factors selected to give a pixel size of 3.5 mm to 4.5 mm. Collect a minimum of 1.5 million counts for optimal images.
  )

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.

• Pregnancy: May cause fetal harm. (
  8.000000000000000e+00

  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.
  )
  
  
• Lactation: Advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days after Ioflupane I 123 Injection administration. (
  8.2

  Lactation

  Risk Summary

  Iodine-123, the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on the breastfed infant or on milk production. Advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after Ioflupane I 123 Injection administration in order to minimize radiation exposure to a breastfed infant.
  )