Fluorodopa f-18

FDA label, THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH, intravenous, effective 2021-01-15. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Adrenals

Adrenals

Table 1. Estimated Absorbed Radiation Dose (mGy/MBq) for Adult Patients after Intravenous Administration of Fluorodopa F 18 Injectiona
Organ Absorbed Dose per unit activity (mGy/MBq)
Urinary bladder wall 0.30
Heart wall 0.01
Pancreas 0.01
Spleen 0.01
Lungs 0.01
Kidneys 0.03
Ovaries 0.02
Uterus 0.03
Lower Large Intestine wall 0.02
Liver 0.01
Gallbladder wall 0.01
Small Intestine 0.01
Upper Large Intestine wall 0.01
Stomach wall 0.01
Adrenals 0.01
Testes 0.01
Red marrow 0.01
Thymus 0.01
Thyroid 0.01
Muscle 0.01
Bone surfaces 0.01
Breast 0.01
Skin 0.01
Brain 0.01
Remaining organs 0.01
Effective dose (mSv/MBq) 0.03
Table 1. Estimated Absorbed Radiation Dose (mGy/MBq) for Adult Patients after Intravenous Administration of Fluorodopa F 18 Injectiona
Organ Absorbed Dose per unit activity (mGy/MBq)
Urinary bladder wall 0.30
Heart wall 0.01
Pancreas 0.01
Spleen 0.01
Lungs 0.01
Kidneys 0.03
Ovaries 0.02
Uterus 0.03
Lower Large Intestine wall 0.02
Liver 0.01
Gallbladder wall 0.01
Small Intestine 0.01
Upper Large Intestine wall 0.01
Stomach wall 0.01
Adrenals 0.01
Testes 0.01
Red marrow 0.01
Thymus 0.01
Thyroid 0.01
Muscle 0.01
Bone surfaces 0.01
Breast 0.01
Skin 0.01
Brain 0.01
Remaining organs 0.01
Effective dose (mSv/MBq) 0.03

Dosing in liver impairment

Liver

Liver

Preparation and administration

Prepare this dose

Your numbers for fluorodopa f-18. Take vial strength, diluent, and limits from the label below.

Basis

Enter a dose to see draw volume, final concentration, and rates.

Recommended Dosage and Administration Recommended Dose

The recommended dose for adults is 185 megabecquerels (MBq) [5 millicuries (mCi)] administered as an intravenous injection infused over 1 minute.

Minimize the dose of Fluorodopa F 18 Injection consistent with the objectives of the procedure and the nature of the imaging cameras employed. Administration

Use aseptic techniques and radiation shielding during all operations involved in the manipulation and administration of Fluorodopa F 18 Injection.

Calculate the necessary volume to administer based on calibration time and dose.

Inspect Fluorodopa F 18 Injection visually and do not use the drug if the solution contains particulate matter or is discolored.

Measure the patient dose immediately prior to administration in a dose calibrator.

Dispose of unused drug in compliance with applicable regulations.

Patient Preparation Hydration

Patients must have nothing to eat or drink, except water for 4 hours before administration

To minimize the radiation absorbed dose to the bladder, instruct patient to: o hydrate 4 hours prior to the administration of Fluorodopa F 18 Injection and continue hydration after the study. o void 70 minutes after administration of Fluorodopa F 18 Injection and as frequently thereafter as possible for the next 12 hours.

Pre-medication and Medication Withdrawal

Carbidopa blocks systemic/peripheral decarboxylation of Fluorodopa F 18 Injection to increase uptake in the brain. Administer 150 mg of Carbidopa orally at least 60 minutes (and no longer than 120 minutes) prior to the administration of Fluorodopa F 18 Injection.

Instruct the patient to discontinue medications for the treatment of Parkinson’s disease 12 hours prior to administration of Fluorodopa F 18 Injection [see Drug Interactions] .

Imaging Guidelines

Instruct the patient to void immediately before imaging, 70 minutes post administration.

Start imaging at about 80 minutes post administration (with a 9 second CT scan for attenuation correction) followed by 3D PET scan from 80 to 100 minutes post administration.

Recommended Dosage and Administration Recommended Dose

The recommended dose for adults is 185 megabecquerels (MBq) [5 millicuries (mCi)] administered as an intravenous injection infused over 1 minute.

Minimize the dose of Fluorodopa F 18 Injection consistent with the objectives of the procedure and the nature of the imaging cameras employed. Administration

Use aseptic techniques and radiation shielding during all operations involved in the manipulation and administration of Fluorodopa F 18 Injection.

Calculate the necessary volume to administer based on calibration time and dose.

Inspect Fluorodopa F 18 Injection visually and do not use the drug if the solution contains particulate matter or is discolored.

Measure the patient dose immediately prior to administration in a dose calibrator.

Dispose of unused drug in compliance with applicable regulations.

Patient Preparation Hydration

Patients must have nothing to eat or drink, except water for 4 hours before administration

To minimize the radiation absorbed dose to the bladder, instruct patient to: o hydrate 4 hours prior to the administration of Fluorodopa F 18 Injection and continue hydration after the study. o void 70 minutes after administration of Fluorodopa F 18 Injection and as frequently thereafter as possible for the next 12 hours.

Pre-medication and Medication Withdrawal

Carbidopa blocks systemic/peripheral decarboxylation of Fluorodopa F 18 Injection to increase uptake in the brain. Administer 150 mg of Carbidopa orally at least 60 minutes (and no longer than 120 minutes) prior to the administration of Fluorodopa F 18 Injection.

Instruct the patient to discontinue medications for the treatment of Parkinson’s disease 12 hours prior to administration of Fluorodopa F 18 Injection [see Drug Interactions] .

Drug interactions

Check fluorodopa f-18 against a medication list
Label text (3 paragraphs)

Aromatic L-amino acid decarboxylase (AADC) inhibitors Prior to Fluorodopa F 18 Injection administration, use of AADC inhibitors (e.g. carbidopa, benserazide etc.) may increase Fluorodopa F 18 bioavailability to the brain by inhibiting peripheral decarboxylase activity and restricting peripheral Fluorodopa F 18 metabolism [see Dosage and Administration ( 2.3 )] .

Dopamine agonists, dopamine reuptake inhibitors, dopamine releasing agents (DRAs), peripheral catechol-O-methyltransferase (COMT) inhibitors, and monoamine oxidase (MAO) inhibitors Therapy for Parkinson’s syndromes includes dopamine agonists, dopamine reuptake inhibitors, dopamine releasing agents (DRAs) such as psychostimulants of the amphetamine class, peripheral catechol-O-methyltransferase (COMT) inhibitors, and monoamine oxidase (MAO) inhibitors.

Whether discontinuation of these drugs prior to Fluorodopa F 18 administration may minimize the interference with a Fluorodopa F 18 image is not fully known; however, if use of these drugs can be safely suspended, discontinue use 12 hours before administration of Fluorodopa F18 Injection [see Dosage and Administration ( 2.3 )] .

Contraindications

None None

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for fluorodopa f-18. Check the label's hepatic warnings.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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