PDVUETM is an injection-based radiopharmaceutical to be used for the diagnosis of Parkinson’s disease. As an imaging agent for positron emission tomography (PET) scanners, PDVUETM offers clear visual images for accurate diagnosis. PDVUETM is injected to determine the dopamine transporter density in the striatum of potential Parkinson’s disease patients, resulting in an instant and definitive diagnosis of Parkinson’s disease. 

A single clear, colorless glass vial containing a transparent colorless liquid. Not sensitive to light. Rx only.

Take 185 MBq (5 mCi) from vial and inject intravenously to Parkinsonsonnsonsonto light. t. olorless liquid. Not sensitive to light. ts, resulting in an instant and definitive diagnosis of Parkinson’s disease. r a breast-feeding mothern
As with all radiopharmaceuticals with relatively short half-life times, timing is critical. Before the drug is administered, the proper dosage must be calculated using proprietary decay constant and time of EOS (end of synthesis). The radioactivity of the drug should also be determined using the dose calibrating system right before each use. For best results, the patient should be encouraged to visit the restroom before being PET-scanned to prevent the need to halt the procedure once the scanning has begun.

1. PDVUETM is NOT intended for use by the following patients: 
            1) patients with known sensitivities to PDVUETM or its ingredients
            2) women who are, or may possibly be, pregnant.

            2. Use with caution under direct medical supervision on the folowing patients:
            1) patients with liver damage: This drug contains 10%(v/v) ethanol, therefore should be administered with caution unto patients with liver failure or other liver conditions.

            3. General warning
            1) PDVUETM is a radiopharmaceutical that should only be administered by medical doctors who have been thoroughly trained and certified in safe handling and use of radioactive isotopes.
            2) Always watch out for possible allergic reactions or sensitivities, though no side effects have been reported from radioactivity irradiation from the drug.

            4. Caution for patients
            1) It is recommended for patients to drink water for several hours after being injected with PDVUETM, for faster removal of radioactive materials from the body.
            2) To protect the patient and other people from irradiation, the patient should flush the toilet several times and wash hands and the sink basin thoroughly.

            5. Adverse reaction
            1) In a clinical study with 78 people, adverse reactions were only observed in the group of essential tremor patients and healthy volunteers. Three incidents (7.69%) were reported: singular cases of chill (1), hyperbilirubinemia (1), and leukocyte increase (1). Only the chill was graded to be ‘a possible effect of the drug’. In the severity test, the hyperbilirubinemia was Grade 2, and the two others were Grade 1. No severe side effects were observed during the clinical trial studies.
            2) No statistically significant difference was observed between the adverse events of this drug and other drugs approved for the Korean market, upon extensive and conclusive analysis of their adverse events re-examination and spontaneous side effect reports.

            6. Drug interactions
            No drug interactions have been examined.

            7. Usage in pregnancy or lactation
            1) Pregnant women: No reproductive testing has been done on animals, therefore the effects of this drug on a developing fetus or reproductive systems are unknown. This drug should only be used on pregnant women in cases where the benefits of the drug surpass the possible risk to the fetus.
            2) Breast-feeding women: It is not known whether this drug passes into breast milk. Many drugs, though not all, do. As it may or may not pass on to a nursing child, this drug should be used on breast-feeding women under a doctor’s careful supervision.

            8. Minors
            This drug is not recommended for minors, due to differences in weight and limited testing. A minimal/optimal dose has not been established for minors.

            9. Seniors
            PDVUETM should be administered unto seniors under careful medical supervision and consideration due to their usually lowered metabolism.

            10. In case of overdose
            Encourage excretion by urination.

            11. Storage and handling
            This injection is a radiopharmaceutical in a glass vial. Thus, it should be kept in a lead-shielded container and should always be handled behind a lead-shield to minimize the risk of irradiation.

            12. Others
            1) The safety and effectiveness of PDVUETM has been clinically tested on 39 patients with PDVUETM disease and 39 healthy volunteers and Essential Tremor patients.
            a) PDVUETM has been tested in its sensitivity and specificity in the detection and quantification of dopamine transporter (DAT) in the striatum.
            b) Tests using PDVUETM proved that there is a definite correlation between positively identified Hoehn and Yahr stage Parkinsonnson a definite correlation between positively identified
            2) No studies have been done on any possible carcinogenic, mutagenic, reproductive effects the drug may or may not have.			

PDVUETM is a radiopharmaceutical, and should be stored in the original vial in a lead-shielded container, at 15°C to 25°C (59°F to 77°F). Do not refrigerate. PDVUETM is effective for 6 hours from initial production. 

This drug must be administered with a sterilized, single-use/disposable syringe. Never use rubber-tipped syringes as a substantial portion of this drug may be absorbed by the rubber. 

1. [18F]FP-CIT has strong binding affinity to dopamine transporters located on dopamine presynaptic terminals. This will cause high uptake in the striatum and substantia nigra where dopamine neurons are dense. It will also show weak binding affinity to serotonin transporters and norepinephrine transporters, thus appearing in the midbrain, the hypothalamus, and the raphe nuclei in the pons in high-definition PET images.

2. In dynamic PET images of [18F]FP-CIT, the specific uptake to DAT in striatum in healthy volunteers reached pseudoequilibrium state at 90 minutes. The lower the level of DAT in Parkinson DAT in Parkinsonudoequilibrium state at 90 minutes. The lowpseudoequilibrium.

3. FP-CIT testing results are from phase III clinical trials with 78 adults with and without Parkinson’s disease, and patients with essential tremor.

4. While there was no difference in the [18F]FP-CIT PET images of DAT in striatum levels between healthy volunteers and essential tremor patients, the [18F]FP-CIT PET images of Parkinsonum levels between healthy volunteers and essential tremor patients, the [disease, and patients with e

5. In the [18F]FP-CIT images, the bilateral striatum of healthy volunteers and essential tremor patients were symmetrical from similar uptake on either side of the brain, whereas Parkinson’s disease patients were asymmetric owing to reduced uptake indicating lower DAT levels. In more developed patients, the loss was most pronounced in the posterior putamen in the side of the brain that is opposite to the limb most affected by the disease.

6. Diagnostic sensitivity/specificity rates for visual diagnosis of Parkinsonr patients were symmetrical from similar uptake o

7. The density levels of DAT in the striatum obtained through [18F]FP-CIT PET analysis demonstrated significant correlations with clinical history records of Parkinsonsonnal from

8. Of the 78 [18F]FP-CIT clinical trial patients, one patient (1.3%) experienced temporary chills. No other side effects were observed for all others.

9. The images of the levels of DAT in striatum will differ slightly by the type and resolution of the PET scanner used, or the diagnosis protocol as well as the analysis method employed. In general, the density levels of DAT in striatum reduce with age. Therefore, for accurate clinical diagnosis through quantitative analysis of density of DAT in striatum, standard quantification data from a healthy person, of similar age as the patient, obtained from the same PET scanner and analysis method,

etc. should be consulted.