Fluorodopa F18 40 mCi/mL
Fluorodopa F18 · INJECTION · THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Fluorodopa F18 is a injection containing fluorodopa f18 at 40 mCi/mL, taken intravenous. Manufactured by THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH.
Key Facts
- Brand Name
- Fluorodopa F18
- Generic Name
- Fluorodopa F18
- NDC Code (Product)
13267-346- Manufacturer
- THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
- Strength
- 40 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA200655
- Marketing Start
- 10/10/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fluorodopa F 18 Injection is 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). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations. Fluorodopa F 18 Injection is a radioactive diagnostic agent 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). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • The recommended adult dose is 185 megabecquerels (MBq) [5 millicuries (mCi)] by intravenous injection infused over 1 minute. ( 2.2 ) • Use aseptic techniques and radiation shielding to maintain sterility during all operations involved in the manipulation and administration of Fluorodopa F 18 Injection. ( 2.1 , 2.2 ) • Instruct patients to void immediately before imaging and start imaging at approximately 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. ( 2.5 ) • See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety - Drug Handling • Handle Fluorodopa F 18 Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.1 )] . Use waterproof gloves, effective shielding and appropriate safety measures to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. 2.2 Recommended Dosage and Administration Recommended Dose • The recommended dose for adults is 185 meg…
Contraindications
4 CONTRAINDICATIONS None None
Drug Interactions
7 DRUG INTERACTIONS 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 )] .
Adverse Reactions
6 ADVERSE REACTIONS Injection site pain occurred with administration based on a review of the published literature. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact The Feinstein Institutes for Medical Research at 516-562-1052 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. No adverse reactions have been reported for Fluorodopa F 18 Injection based on an open-label clinical trial in 68 patients [see Clinical Studies ( 14 ) ] and additional clinical experience in 53 patients. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval of use of Fluorodopa F 18 Injection outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General Disorders and Administration Site Con…
Frequently Asked Questions
What is Fluorodopa F18 used for?
Fluorodopa F18 contains Fluorodopa F18. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Fluorodopa F18 a controlled substance?
Fluorodopa F18 is not classified as a controlled substance by the DEA.
What is the generic name for Fluorodopa F18?
The generic name for Fluorodopa F18 is Fluorodopa F18. There are no other listed brand versions of Fluorodopa F18.
What is the NDC code for Fluorodopa F18 40 mCi/mL?
The NDC (National Drug Code) for Fluorodopa F18 40 mCi/mL is 13267-346, listed by THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH.
Other Fluorodopa F18 Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)