Fluorodopa F 18
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Fluorodopa F 18 is a Radiopharmaceutical Diagnostic Agent that is FDA approved for the {{{indicationType}}} of indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS).. Common adverse reactions include Injection site pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Fluorodopa F 18 is indicated for use in PET imaging to visualize dopaminergic nerve terminals in the striatum for evaluating adult patients with suspected Parkinsonian syndromes. The recommended adult dose is 185 megabecquerels (MBq) [5 millicuries (mCi)] administered as an intravenous injection infused over 1 minute.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fluorodopa F 18 in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluorodopa F 18 in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Fluorodopa F 18 FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fluorodopa F 18 in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluorodopa F 18 in pediatric patients.
Contraindications
There are no known contraindications for Fluorodopa F 18.
Warnings
Fluorodopa F 18 contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure. Use the smallest dose necessary for imaging and employ appropriate safety measures, including waterproof gloves and effective shielding.
Adverse Reactions
Clinical Trials Experience
Pain at the injection site.
Postmarketing Experience
There is limited information regarding Fluorodopa F 18 Postmarketing Experience in the drug label.
Drug Interactions
Carbidopa: Administering carbidopa prior to Fluorodopa F 18 increases its uptake in the brain by inhibiting peripheral decarboxylation.
Anti-Parkinsonian Medications: Instruct patients to discontinue medications for the treatment of Parkinson's disease 12 hours prior to administration of Fluorodopa F 18 to avoid potential interactions.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Fluorodopa F 18 in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluorodopa F 18 in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fluorodopa F 18 during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Fluorodopa F 18 in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Fluorodopa F 18 in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Fluorodopa F 18 in geriatric settings.
Gender
There is no FDA guidance on the use of Fluorodopa F 18 with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fluorodopa F 18 with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fluorodopa F 18 in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fluorodopa F 18 in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fluorodopa F 18 in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fluorodopa F 18 in patients who are immunocompromised.
Administration and Monitoring
Administration
Administer 185 MBq (5 mCi) of Fluorodopa F 18 intravenously over 1 minute.
Hydration: Patients must have nothing to eat or drink, except water, for 4 hours before administration. To minimize radiation absorbed dose to the bladder, instruct patients to hydrate before and after the study and to void 70 minutes after administration and frequently thereafter for the next 12 hours. Premedication: Administer 150 mg of carbidopa orally at least 60 minutes (and no longer than 120 minutes) prior to the administration of Fluorodopa F 18 to increase uptake in the brain. Medication Withdrawal: Instruct patients to discontinue medications for the treatment of Parkinson's disease 12 hours prior to administration of Fluorodopa F 18.
Monitoring
Instruct patients to void immediately before imaging. Start imaging at approximately 80 minutes post-administration (with a 9-second CT scan for attenuation correction), followed by a 3D PET scan from 80 to 100 minutes.
IV Compatibility
There is limited information regarding the compatibility of Fluorodopa F 18 and IV administrations.
Overdosage
There is limited information regarding Fluorodopa F 18 overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Fluorodopa F 18 Pharmacology in the drug label.
Mechanism of Action
Fluorodopa F 18 is a radiolabeled analog of L-DOPA. After intravenous administration, it crosses the blood-brain barrier and is taken up by dopaminergic neurons in the striatum, where it undergoes decarboxylation to form fluorodopamine. This process allows for visualization of dopaminergic nerve terminals during PET imaging.
Structure
There is limited information regarding Fluorodopa F 18 Structure in the drug label.
Pharmacodynamics
Fluorodopa F 18 PET imaging reflects the density and integrity of dopaminergic neurons in the striatum, aiding in the evaluation of Parkinsonian syndromes.
Pharmacokinetics
Distribution: Following intravenous injection, Fluorodopa F 18 distributes to the brain, with uptake in the striatum peaking at approximately 80 minutes post-administration.
Elimination: Fluorodopa F 18 has a physical half-life of approximately 110 minutes.
Nonclinical Toxicology
There is limited information regarding Fluorodopa F 18 Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Fluorodopa F 18 Clinical Studies in the drug label.
How Supplied
Fluorodopa F 18 Injection is supplied as a clear, colorless solution in a multiple-dose glass vial containing 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL) of Fluorodopa F 18.
Storage
Store Fluorodopa F 18 Injection at controlled room temperature, 20°C to 25°C (68°F to 77°F). The product should be used within 8 hours from the end of synthesis. Store the product in radiation shielding to protect from radiation exposure.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Fluorodopa F 18 Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Fluorodopa F 18 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Fluorodopa F 18 is marketed under the name "Fluorodopa F 18 Injection."
Look-Alike Drug Names
There is limited information regarding Fluorodopa F 18 Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.