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Ioflupane I 123

Pronunciation

(eye oh FLOO pane eye one TWEN tee three)

Index Terms

  • 123I-Ioflupane
  • DaTSCAN
  • Ioflupane
  • Ioflupane-123 I

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

DaTscan: 185 MBq/2.5 mL (2.5 mL) [pyrogen free; contains alcohol, usp]

Brand Names: U.S.

  • DaTscan

Pharmacologic Category

  • Radiopharmaceutical

Pharmacology

Binds to dopamine transporter (DaT) in brain allowing for visualization of regions of interest in the brain to aid in the diagnosis of Parkinsonian syndromes.

Distribution

~30% of radioactivity from the whole brain attributed to striatal uptake

Excretion

At 48 hours postinjection: Urine (~60% ); fecal (~14%)

Onset of Action

Uptake in the brain reached ~7% at 10 minutes after administration

Duration of Action

Duration of radioactivity: Uptake in the brain reached ~3% after 5 hours. Striata to background ratios were constant between 3 to 6 hours after administration.

Half-Life Elimination

Iodine 123: 13.2 hours

Use: Labeled Indications

Brain imaging: Striatal dopamine transporter (DaT) visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

Use: Unlabeled

DaT visualization using SPECT brain imaging as an adjunct to evaluate patients with suspected Creutzfeldt–Jakob disease

Contraindications

Known hypersensitivity to ioflupane I123 or any components of the formulation, or to iodine.

Dosing: Adult

Note: Thyroid protective agents (potassium iodide [SSKI] or Lugol solution) equivalent to 100 mg iodide or 400 mg potassium perchlorate, should be given at least 1 hour prior to ioflupane I123 administration.

Brain imaging: IV: 3 to 5 mCi (111 to 185 MBq); perform SPECT imaging 3 to 6 hours after ioflupane I 123 administration (refer to manufacturer’s prescribing information for additional imaging information).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. Note: Ioflupane I 123 is renally excreted and patients with severe renal impairment may have increased radiation exposure and altered SPECT images.

Dosing: Hepatic Impairment

There are no dosages adjustments provided in the manufacturer's labeling.

Administration

Administer by slow IV injection over at least 15 to 20 seconds via an arm vein. Begin SPECT imaging 3 to 6 hours following IV administration; refer to manufacturer’s prescribing information for additional imaging information. Ensure adequate hydration before and after administration; void frequently for the first 48 hours post administration to minimize bladder exposure.

Radiopharmaceutical; use appropriate precautions for handling and disposal.

Storage

Store at 20°C to 25°C (68°F to 77°F). Store within the original lead container or equivalent radiation shielding.

Drug Interactions

Amoxapine: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Amphetamines: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Benztropine: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

BuPROPion: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

BusPIRone: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Cocaine: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Dexmethylphenidate: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

FentaNYL: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Methylphenidate: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Norepinephrine: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Phenylephrine (Systemic): May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Selegiline: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Serotonin/Norepinephrine Reuptake Inhibitors: May diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Adverse Reactions

≤1% (Limited to important or life-threatening): Dizziness, headache, nausea, pruritus, skin rash, vertigo, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions have been reported. Use extreme caution in patients with iodine or iodine contrast agent hypersensitivity. Appropriate equipment and emergency medications should be available during use. Hypersensitivity reactions primarily involved skin erythema and/or pruritus; reactions usually resolved spontaneously or following administration of corticosteroids and antihistamines. Monitor for signs/symptoms of hypersensitivity reactions.

Disease-related concerns:

• Renal impairment: Use with caution in patients with severe renal impairment; ioflupane I 123 is eliminated renally. Therefore, patients with severe renal impairment may have increased radiation exposure and altered images. Effect of renal impairment on imaging with ioflupane I 123 has not been established.

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and shielding to minimize exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.

Other warnings/precautions:

• Appropriate use: To limit thyroid gland accumulation of iodine 123 during exposure to ioflupane I 123, administer thyroid-blocking medications (eg, potassium iodide oral solutions, potassium perchlorate) at least 1 hour prior to administration; increased long-term risk for thyroid neoplasia can occur from failure to block thyroid uptake of iodine 123. Note: Avoid the use of potassium iodide oral solution or Lugol solution in patients with past hypersensitivity to iodine or iodide products.

• Bladder exposure: Patients should be adequately hydrated prior to and following administration; instruct patients to void frequently for 48 hours following administration to decrease radiation exposure to bladder.

Monitoring Parameters

Monitor for signs/symptoms of hypersensitivity reactions.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Radiopharmaceuticals have the potential to cause fetal harm and pregnancy should be ruled out prior to administration in women of reproductive age. Radioactive iodine crosses the placenta and may impair fetal thyroid function.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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