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Ioflupane I-123: Drug information

Ioflupane I-123: Drug information
(For additional information see "Ioflupane I-123: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • DaTscan
Brand Names: Canada
  • DaTscan
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult

Note: Thyroid protective agents (potassium iodide [SSKI] or Lugol solution) equivalent to 100 mg iodide should be given at least 1 hour prior to ioflupane I 123 administration.

Brain imaging

Brain imaging: IV: 3 to 5 mCi (111 to 185 MBq).

Dosing: Kidney Impairment: Adult

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: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

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

Solution, Intravenous:

DaTscan: 185 MBq/2.5 mL (1 ea) [pyrogen free; contains alcohol, usp]

Generic Equivalent Available: US

No

Dosage Forms: Canada

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

Solution, Intravenous:

DaTscan: 74 MBq/mL (2.5 mL, 5 mL) [contains alcohol, usp]

Administration: Adult

IV: Administer by slow IV injection over at least 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.

Use: Labeled Indications

Brain imaging: Striatal dopamine transporter (DaT) visualization using single photon emission computed tomography (SPECT) brain imaging in conjunction with other diagnostic evaluations to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).

Medication Safety Issues
Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Gastrointestinal: Nausea (≤1%), xerostomia (≤1%)

Nervous system: Dizziness (≤1%), headache (≤1%), vertigo (≤1%)

Postmarketing:

Hypersensitivity: Hypersensitivity reaction

Local: Pain at injection site

Contraindications

Known severe hypersensitivity to ioflupane I 123 or any components of the formulation.

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 dyspnea, edema, erythema, pruritus, and/or rash; reactions usually resolved spontaneously or following administration of corticosteroids and antihistamines.

• Malignancy: Patients are exposed to some radiation during treatment; large cumulative amounts of radiation exposure may increase the risk of cancer.

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 potassium iodide oral solutions or strong iodine solution (eg, Lugol's solution) equivalent to 100 mg iodide 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.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

Armodafinil: May diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

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

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

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

Cocaine (Topical): May diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

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

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

Modafinil: May diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

Phentermine: May diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

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

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

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential.

Pregnancy Considerations

Radioactive iodine crosses the placenta and may impair fetal thyroid function.

All radiopharmaceuticals have the potential to cause fetal harm. If use is needed during pregnancy, an appropriate thyroid-blocking agent is recommended to protect the mother and fetus from accumulation of I 123. Brain imaging during pregnancy for suspected Parkinsonian syndromes is not recommended in pregnant women (SNM [Djang 2012]).

Breastfeeding Considerations

The radiolabeled component of ioflupane, iodine 123, is present in breast milk.

If testing is needed, it is recommended that lactating women pump and discard milk for 1 to 6 days after administration of ioflupane I 123 to minimize risk to infant (SNM [Djang 2012]).

Monitoring Parameters

Monitor for signs/symptoms of hypersensitivity reactions. Evaluate pregnancy status prior to use in females of reproductive potential.

Mechanism of Action

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.

Pharmacokinetics

Note: DaTscan contains iodine-123 labeled ioflupane. The kinetics of the drug molecule ioflupane are not equivalent to the kinetics/half-life of the radiolabeled ioflupane iodine 123. The kinetics presented correspond to the radioactive ioflupane I 123.

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

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.

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

Half-life elimination: Iodine 123: 13.2 hours

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

Pricing: US

Solution (DaTscan Intravenous)

185 mbq/2.5 mL (per each): $2,961.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • DaTSCAN (AT, BE, DK, ES, FI, HR, HU, IE, IT, LU, NO, PL, PT, SI);
  • Datscan (CH, CZ, EE, FR, IL, IS, LT, MT, NL, RO, SE, SK);
  • Iodophen (RU);
  • MIBGen (AU)


For country code abbreviations (show table)
  1. DaTscan (ioflupane I 123) [prescribing information]. Arlington Heights, IL: GE Healthcare/Medi-Physics Inc; November 2022.
  2. Djang DS, Janssen MJ, Bohnen N, et al. SNM practice guideline for dopamine transporter imaging with 123I-ioflupane SPECT 1.0. J Nucl Med. 2012;53(1):154‐163. doi:10.2967/jnumed.111.100784 [PubMed 22159160]
  3. Tolosa E, Borght TV, Moreno E; DaTSCAN Clinically Uncertain Parkinsonian Syndromes Study Group. Accuracy of DaTSCAN (123I-Ioflupane) SPECT in diagnosis of patients with clinically uncertain parkinsonism: 2-year follow-up of an open-label study. Mov Disord. 2007;22(16):2346‐2351. doi:10.1002/mds.21710 [PubMed 17914722]
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