Fluorodopa F18
Generic: FLUORODOPA F18
Basic Information
Manufacturer
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
37f8c405-ccb6-4fcd-8513-108956bb1674
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.
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.
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 Conditions: Pain
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 Conditions: Pain
( 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 Conditions: Pain
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 Conditions: Pain