Technescan PYP
Generic: TECHNETIUM TC 99M PYROPHOSPHATE
Basic Information
Manufacturer
Curium US LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
304b63f4-a32e-4700-805d-5bc9f27e7d6a
Indications & Usage
INDICATIONS AND USAGE Technescan PYP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for: • Skeletal imaging to demonstrate areas of altered osteogenesis in adults • Cardiac imaging as an adjunct in the diagnosis of acute myocardial infarction in adults (See WARNINGS ) Technescan PYP, in conjunction with sodium pertechnetate Tc 99m injection for red blood cell (RBC) labeling, is indicated for gated cardiac blood pool imaging and for the detection of gastrointestinal bleeding sites in adults.
Warnings
WARNINGS Image interpretation errors can occur.
As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the estimate of false negative image interpretations was 6%.
False negative image interpretations can occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase.
In a study involving 22 patients in whom ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the estimates of false negative and false positive image interpretations were 23% and 9%, respectively.
False positive image interpretations have been reported following coronary artery bypass graft surgery and in unstable angina pectoris, old myocardial infarcts, and cardiac contusions.
Technetium Tc 99m pyrophosphate may impair brain imaging with sodium pertechnetate Tc 99m and result in false positive or false negative image interpretation.
It is recommended, where feasible, that brain imaging precede skeletal imaging procedures.
Gated cardiac blood pool and gastrointestinal bleed imaging may be impaired in patients receiving sodium heparin for anticoagulant therapy.
This is characterized by a reduction in the amount of injected radioactivity remaining in the blood pool.
Avoid heparinized catheter systems for administration of Technescan PYP.
The biodistribution of technetium Tc 99m pyrophosphate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum).
This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality.
High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.).
Most cases are observed after iron infusion.
(See PRECAUTIONS, Drug Interactions .)
As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the estimate of false negative image interpretations was 6%.
False negative image interpretations can occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase.
In a study involving 22 patients in whom ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the estimates of false negative and false positive image interpretations were 23% and 9%, respectively.
False positive image interpretations have been reported following coronary artery bypass graft surgery and in unstable angina pectoris, old myocardial infarcts, and cardiac contusions.
Technetium Tc 99m pyrophosphate may impair brain imaging with sodium pertechnetate Tc 99m and result in false positive or false negative image interpretation.
It is recommended, where feasible, that brain imaging precede skeletal imaging procedures.
Gated cardiac blood pool and gastrointestinal bleed imaging may be impaired in patients receiving sodium heparin for anticoagulant therapy.
This is characterized by a reduction in the amount of injected radioactivity remaining in the blood pool.
Avoid heparinized catheter systems for administration of Technescan PYP.
The biodistribution of technetium Tc 99m pyrophosphate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum).
This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality.
High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.).
Most cases are observed after iron infusion.
(See PRECAUTIONS, Drug Interactions .)
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions associated with the use of Technescan PYP have been reported: flushing, hypotension, fever, chills, nausea, vomiting, and dizziness, as well as hypersensitivity reactions such as itching and various skin rashes.