Product image of Joflupaan (123i) Rotop (Ioflupane (123i)) supplied by GNH India

Joflupaan (123i) Rotop

Active Ingredient:
Ioflupane (123i)
Origin:
EU

Joflupaan (123i) Rotop (Ioflupane (123i))

Ioflupane, the active ingredient in Joflupaan (123i) Rotop, is a radiopharmaceutical presented as an injectable solution for intravenous use. It enables single‑photon emission computed tomography (SPECT) imaging of presynaptic dopamine transporters to aid diagnosis of Parkinsonian syndromes, movement‑disorder differentials, and dementia with Lewy bodies in adult patients.

GNH India supplies Joflupaan (123i) Rotop as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to stringent quality standards and providing full regulatory documentation for global distribution through established logistics networks.

Manufacturer / TM Owner

Rotop Radiopharmacy Gmbh

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Indications & Clinical Uses

Ioflupane is used in SPECT imaging of the dopaminergic system to evaluate several movement‑related disorders.

  • Parkinsonian syndromes: provides quantitative assessment of striatal dopamine transporter availability, supporting diagnosis and disease staging.
  • Differential diagnosis of movement disorders: differentiates idiopathic Parkinson's disease from atypical parkinsonian disorders such as multiple system atrophy and progressive supranuclear palsy.
  • Dementia with Lewy bodies: reveals characteristic reduction in dopamine transporter binding, aiding distinction from Alzheimer's disease and other dementias.

How It Works

  • Ioflupane is a radiolabeled analogue of the neurotransmitter dopamine that binds with high affinity to presynaptic dopamine transporters (DAT) located on nigrostriatal neurons. After intravenous injection, the compound crosses the blood‑brain barrier and accumulates in regions with intact DAT. The attached iodine‑123 isotope emits gamma photons detectable by single‑photon emission computed tomography (SPECT), producing a visual map of dopaminergic neuronal integrity.

Side Effects

Ioflupane may be associated with adverse reactions related to the radiopharmaceutical itself or the injection procedure.

Common Side Effects

  • Nausea: mild to moderate nausea occurring shortly after injection.
  • Headache: transient headache reported by some patients.
  • Injection site pain: brief discomfort at the venous access point.
  • Dizziness: temporary light‑headedness during or after the procedure.
  • Fatigue: mild tiredness that resolves without intervention.

Serious or Rare Side Effects

  • Allergic reaction: urticaria, rash, or anaphylaxis requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure following injection.
  • Radiation‑induced tissue injury: rare localized tissue damage at high cumulative doses.
  • Pulmonary embolism: extremely rare but possible if particulate matter is introduced.
  • Nephrotoxicity: rare kidney function impairment in susceptible individuals.

Precautions & Warnings

Before using Ioflupane, clinicians should observe several precautionary measures to ensure patient safety and product integrity.

  • Pregnancy: avoid use unless the potential diagnostic benefit outweighs unknown fetal risk.
  • Breastfeeding: discontinue breastfeeding or consider alternative imaging, as iodine‑123 may be excreted in milk.
  • Renal impairment: assess kidney function; reduced clearance may increase radiation exposure.
  • Thyroid disorders: evaluate thyroid status because iodine‑123 can affect thyroid hormone balance.
  • Concomitant medications: review drugs that may interfere with dopamine transporter binding, such as certain antidepressants or stimulants.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the vial.

Avoid Interactions

Ioflupane can interact with other substances that affect dopamine transporter binding or alter iodine metabolism.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAO‑I): may significantly alter DAT binding and confound imaging results.
  • Certain antidepressants (e.g., bupropion, sertraline): can competitively inhibit DAT, leading to false‑negative scans.
  • Iodine‑containing contrast agents: excess iodine may compete with iodine‑123, reducing image quality.

Moderate Interactions (Monitor Closely)

  • Antipsychotics (e.g., haloperidol, risperidone): may affect DAT availability; timing of medication should be considered.
  • Stimulants (e.g., methylphenidate, amphetamines): can modify DAT occupancy, requiring dose adjustment or washout period.
  • Thyroid medications (levothyroxine): monitor thyroid function as iodine load may influence radiotracer distribution.

Frequently Asked Questions

Joflupaan (123i) Rotop contains Ioflupane, a radiopharmaceutical used for single‑photon emission computed tomography (SPECT) imaging of presynaptic dopamine transporters. It helps clinicians evaluate Parkinsonian syndromes, differentiate among movement disorders, and assess dementia with Lewy bodies by visualising dopaminergic neuron integrity.

Ioflupane is a dopamine analogue labeled with iodine‑123. After intravenous administration it crosses the blood‑brain barrier and binds selectively to dopamine transporters on nigrostriatal neurons. The emitted gamma photons are captured by SPECT, producing a quantitative image of dopamine transporter distribution and function.

The administered activity of Ioflupane is determined by the prescribing physician based on the patient’s age, weight, and the imaging protocol of the nuclear medicine department. Dosage is expressed in megabecquerels (MBq) and is tailored to achieve optimal image quality while minimizing radiation exposure.

Safety data for Ioflupane in pregnant or lactating women are limited. The product should be avoided unless the diagnostic benefit clearly outweighs the potential risk to the fetus or infant. If use is essential, the prescriber must consider alternative imaging strategies and discuss risks with the patient.

Enquiries are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and the necessary import documentation.

The primary alternative is 123I‑FP‑CIT (commercially known as DaTscan). Both agents target dopamine transporters, but Ioflupane may offer slightly different kinetic profiles and image contrast. Choice of agent often depends on regional regulatory approval, availability, and the specific imaging protocol preferred by the nuclear medicine facility.

The injectable solution must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. Vials are supplied in shielding containers to limit radiation exposure. Prior to use, inspect the vial for particulate matter and ensure the cold chain has been maintained throughout transport.

Administration is performed by qualified nuclear medicine personnel. The prescribed activity is injected intravenously, typically into a peripheral vein. After injection, a waiting period of about 3–6 hours allows optimal brain uptake before the patient undergoes SPECT imaging according to the centre’s protocol.

Serious adverse events, although rare, include severe allergic reactions such as anaphylaxis, marked hypotension, and radiation‑induced tissue injury at high cumulative doses. Prompt recognition and management of these events are essential, and patients should be monitored closely during and after the injection.

Contraindications include known hypersensitivity to Ioflupane or any component of the formulation, severe uncontrolled thyroid disease, and patients in whom the diagnostic information will not influence clinical management. Caution is also advised for individuals with significant renal impairment or those receiving medications that markedly interfere with dopamine transporter binding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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