Ioflupane I-123

Dosage Forms & Strengths

intravenous injection: Schedule II

• 185 MBq/2.5mL

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

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

• If you have an allergy to ioflupane or any other part of ioflupane I 123.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

(eye oh FLOO pane eye one TWEN tee three)

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.

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

Monitor for signs/symptoms of hypersensitivity reactions.

• 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.