ioflupane I 123 (Rx)

Brand and Other Names:DaTscan
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

intravenous injection: Schedule II

  • 185 MBq/2.5mL
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Dopamine Transporter Visualization

Radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adults with suspected Parkinsonian syndromes (PS)

May be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy)

Measure patient dose by a suitable radioactivity calibration system immediately prior to administration

Administer thyroid-blocking agent (eg, potassium iodide oral solution or potassium perchlorate) at least 1 hr before dose

Recommended dose is 111-185 MBq (3-5 mCi)

Begin SPECT imaging between 3 and 6 hr post-injection

Thyroid blockade

  • Administer 1 hr before DaTscan dose
  • Potassium iodide oral solution (or Lugol’s Solution) equivalent to 100 mg iodide, OR
  • Potassium perchlorate 400 mg

Renal Impairment

Excreted by kidneys

Severe renal impairment may increase radiation exposure to patient and alter images

Safety and efficacy not established

In the 2 principal clinical studies, 45% of the subjects were aged 65 yr or older

There were no differences in response compared to younger subjects that would require a dose adjustment

Other reported clinical experience has not identified differences in responses between the elderly and younger patients

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Interactions

Interaction Checker

and ioflupane I 123

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    Contraindicated

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            Adverse Effects

            <1%

            Headache

            Nausea

            Dizziness

            Vertigo

            Xerostomia

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            Warnings

            Contraindications

            Hypersensitivity to active substance, excipients, or iodine

            Cautions

            Emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients

            May cause hypersensitivity reactions depicted by skin erythema and pruritus; these reactions may resolve spontaneously or following the administration of corticosteroids and antihistamines

            Have medications and medical support to respond to anaphylaxis readily available

            Thyroid accumulation may occur; use thyroid blocking drugs before administration; failure to block thyroid uptake of I123 may result in an increased long term risk for thyroid neoplasia; avoid use of potassium iodide oral solution or Lugol's solution in patients sensitive to such products

            Bladder protection: To minimize radiation dose to the bladder, encourage hydration prior to and following administration in order to permit frequent voiding; encourage the patient to void frequently for the first 48 hr following administration

            Amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, sertraline, citalopram and paroxetine may interfere with imaging

            Effects of dopamine agonists and antagonists on Datscan imaging have not been established

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            Pregnancy & Lactation

            Pregnancy Category: C; Like all radiopharmaceuticals, has a potential to cause fetal harm

            The likelihood of fetal harm depends on the stage of fetal development, and the magnitude of the radionuclide dose

            Administration of DaTscan 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

            Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function

            Lactation: Excretion in breast milk unknown; based on the physical half-life of iodine 123 (13.2 hr), nursing women may consider interrupting nursing and pumping and discarding breast milk for 6 days after administration in order to minimize risks to a nursing infant

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Binds reversibly to the human recombinant dopamine transporter (DaT) (Ki = 0.62 nM; IC50 = 0.71 nM)

            Following administration, radioactive decay of the iodine123 emits gamma radiation which can be detected externally using gamma detectors, allowing visualization of the brain striata through SPECT imaging

            Pharmacokinetics

            Half-Life: 13.2 hr

            Brain uptake: 7% of injected radioactivity at 10 min post-injection; decreased to 3% at 5 hr post-injection

            Onset: ~7% of radioactivity in brain within 10 min

            Metabolism: Decays to 123Te by electron capture

            Excretion: feces (14% by 48 hr), urine (60% by 48 hr)

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            Administration

            IV Preparation

            IV injection: Use aseptic procedures and radiation shielding during preparation and administration

            Inspect vial prior to administration and do not use it if the vial contains particulate matter or discoloration

            IV Administration

            Slow IV injection (administered over a period of not less than 15-20 seconds) via an arm vein

            Storage

            Store within original lead container or equivalent radiation shielding

            Do not use after expiration date and time stated on label

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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