Ioflupane I 123

Ioflupane I 123 is an iodinated contrast media used as a diagnostic aid during single photon emission computed tomography (SPECT) brain imaging. 

• Ioflupane I 123 is available under the following different brand names: DaTscan.

Common side effects of Ioflupane I 123 include:

• Pain, swelling, burning, or irritation around the IV needle,
• Headache,
• Dizziness,
• Spinning sensation,
• Dry mouth, and
• Nausea

Serious side effects of Ioflupane I 123 include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Itching, and
• Skin redness

Rare side effects of Ioflupane I 123 include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravenous injection: Schedule II

• 185 MBq/2.5 mL

Dopamine Transporter Visualization

Adult dosage

• Measure the dose with a suitable radioactivity calibration system immediately before administering.
• Administer thyroid-blocking agent (e.g, potassium iodide oral solution, potassium perchlorate) at least 1 hour before the dose
• The recommended dose is 111-185 MBq (3-5 mCi)
• Begin SPECT imaging 3–6-hour post-injection
• Thyroid blockade
  • Administer 1 hour before the DaTscan dose.
  • Potassium iodide oral solution (or Lugol’s Solution) equivalent to 100 mg iodide, OR
  • Potassium perchlorate 400 mg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ioflupane I 123 has severe interactions with no other drugs.
• Ioflupane I 123 has serious interactions with no other drugs.
• Ioflupane I 123 has moderate interactions with the following drugs:
  • amoxapine
  • benztropine
  • bupropion
  • buspirone
  • citalopram
  • cocaine topical
  • dextroamphetamine
  • escitalopram
  • iodixanol
  • metformin
  • methamphetamine
  • norepinephrine
  • paroxetine
  • phentermine
  • selegiline
  • selegiline transdermal
  • sertraline
  • voclosporin
• Ioflupane I 123 has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Known serious hypersensitivity to ioflupane I 123

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ioflupane I 123?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ioflupane I 123?”

Cautions

• May cause hypersensitivity reactions depicted by skin erythema and pruritus; these reactions have generally occurred within minutes of administration and have either resolved spontaneously or following administration of corticosteroids and antihistamines; contraindicated with known hypersensitivity to ioflupane I 123; have treatment measures available and monitor patients for symptoms or signs of a hypersensitivity reaction
• Thyroid accumulation of iodine-123 may occur; to decrease thyroid accumulation of Iodine-123, block the thyroid gland (e.g., potassium iodide) before administration of therapy; failure to block thyroid uptake of I-123 may result in an increased long-term risk for thyroid neoplasia
• Radiation risk
  • Contributes to a patient's overall long-term cumulative radiation exposure and its associated increased risk for cancer.
  • Ensure safe handling to minimize radiation exposure to patients and clinicians.
• Bladder protection
  • Minimize radiation dose to the bladder by encouraging hydration before and following administration.
  • Encourage the patient to void frequently for the first 48 hours following administration.
• Drug interaction overview
• Drugs that bind to the dopamine transporter with high affinity may interfere with the image.
• Effects of dopamine agonists and antagonists on ioflupane I 123 imaging have not been established.
• Drugs that may interfere with ioflupane binding include.
• Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, sertraline
• Drugs that may increase or decrease ioflupane binding include
• Citalopram and paroxetine

Pregnancy and Lactation

• Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function; administration of an appropriate thyroid-blocking agent is recommended before use in a pregnant woman to protect the woman and fetus from the accumulation of iodine.
• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; advise pregnant women of potential risks of fetal exposure to radiation doses with the administration of the product.
• Lactation
  • Iodide 123 (I 123), the radionuclide, is present in human milk; there is no information on its effects on the breastfed infant or milk production; advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (above 10 physical half-lives) after administration to minimize radiation exposure to a breastfed infant.