Tetrofosmin

Technetium (99mTc) tetrofosmin is a lipophilic, cationic complex which diffuses passively through the cell membrane and is locally retained actively due to the presence of intact mitochondria reflecting the presence of viable cells. After intravenous injection, it is distributed within the myocardium according to myocardial perfusion and viability.

• MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease ( 1.1 ) Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease ( 1.2 ) 1.1 Myocardial Perfusion Imaging Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease.

• None.contraindicated

Use appropriate radiation safety measures and aseptic technique during preparation and handling ( 2.1 , 2.3 ) The recommended dose range for MYOVIEW for rest or stress imaging is 185 to 1,221 megabecquerels (MBq) [5 to 33 millicuries (mCi)] by intravenous administration ( 2.2 ) When rest and stress injections are administered on the same day, the first dose should be 185 to 444 MBq (5 to 12 mCi) followed by the second dose of 555 to 1,221 MBq (15 to 33 mCi) given approximately 1 to 4 hours later ( 2.2 ) The recommended dose range for MYOVIEW for ventricular function assessment is 185 to 1,221 MBq (5 to 33 mCi) as an intravenous injection ( 2.2 ) See Full Prescribing Information for instructions for preparation and determination of radiochemical purity ( 2.4 , 2.5 ) Imaging may begin 15 minutes following administration of the agent ( 2.6 ) 2.1 Radiation Safety – Drug Handling Technetium Tc99m tetrofosmin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc99m tetrofosmin injection. 2.2 Recommended Dosage The recommended dose range for MYOVIEW is 185 to 1,221 megabecquerels (MBq) (5 to 33 millicuries (mCi) by intravenous administration for rest and stress imaging.

Risk with exercise or pharmacologic stress: Continuous cardiac monitoring should be performed in studying patients with known or suspected coronary artery disease ( 5.1 ) When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information ( 5.1 ) Appropriate safety measures should be used to minimize radiation exposure to clinical personnel and to the patient consistent with proper patient management ( 2.1 , 5.2 ) 5.1 Risks Associated with Exercise or Pharmacologic Stress Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular reactions such as headache, paraesthesias, convulsions, somnolence and cerebrovascular accident, including hemorrhage. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information. 5.2 Radiation Risks Technetium Tc99m contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation radiolabeling procedures to protect patients and health care workers from unintentional radiation exposure.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence < 1%) after MYOVIEW injection: Cardiovascular: angina, hypertension, torsades de pointes. Gastrointestinal: vomiting, abdominal discomfort. Hypersensitivity: cutaneous allergy, hypotension, dyspnea. Special Senses: metallic taste, burning of the mouth, smell alteration. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 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 MYOVIEW cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions were evaluated in clinical studies (using an exercise/rest protocol) of 764 adults (511 men and 253 women) with a mean age of 58.7 years (range 29 to 94 years). The subjects received a mean dose of 285 MBq (7.7 mCi) on the first injection and 829 MBq (22.4 mCi) on the second injection of MYOVIEW. After MYOVIEW injection, angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject. The following reactions were noted in less than 1% of subjects: Cardiovascular: angina, hypertension, torsades de pointes. Gastrointestinal: vomiting, abdominal discomfort. Hypersensitivity: cutaneous allergy, hypotension, dyspnea.

Advise the pregnant woman of the potential risk to the fetus based on the radiation dose from technetium Tc99m and the gestational timing of exposure ( 8.1 ) Lactation - A lactating woman should pump and discard breastmilk for 60 hours after technetium Tc99m tetrofosmin administration ( 8.2 ) 8.1 Pregnancy Risk Summary There are no data with technetium Tc99m tetrofosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc99m tetrofosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary Technetium Tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose).

Metabolism

Uptake in the myocardium is dependent on coronary flow and reaches a maximum of 1.2% of the injected dose (i.d.) at 5 minutes and 1% of the i.d. at 2 hours, respectively.

• Feb 9, 1996NDANDA020372Medi-physics

1. 1No Adverse Event33054%
2. 2Radioisotope Scan Abnormal19632%
3. 3Drug Ineffective14925%
4. 4Product Quality Issue294.8%
5. 5Dizziness213.5%
6. 6Headache203.3%
7. 7Nausea193.1%
8. 8Hypersensitivity162.6%
9. 9Scan Myocardial Perfusion Abnormal162.6%
10. 10Urticaria162.6%
11. 11Vomiting162.6%
12. 12Dyspnoea152.5%
13. 13Pruritus152.5%
14. 14Hyperhidrosis122.0%
15. 15Diarrhoea111.8%

The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Tetrofosmin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluation of the Diagnostic Performance of Dynamic Myocardial Perfusion Scintigraphy in Comparison With Invasive Intracoronary FFR Measurement, in the Assessment of Significant Residual Coronary Stenosis After Acute Coronary Syndrome: Dyna-MI Pilot Study.
  Active not recruiting · Interventional · 60 enrolled · Nantes University Hospital
  NCT05940285updated 2026-04-08
• Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
  Completed · Observational · 35 enrolled · Ottawa Heart Institute Research Corporation
  NCT03427749updated 2025-04-10
• Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)
  Completed · Interventional · 66 enrolled · Ottawa Heart Institute Research Corporation
  NCT02280941updated 2025-04-06
• A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)
  Completed · Phase 2 · Interventional · 124 enrolled · Astellas Pharma Inc
  NCT01334918updated 2024-12-04
• Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
  Completed · Phase 3 · Interventional · 347 enrolled · Astellas Pharma Inc
  NCT00826280updated 2024-12-03
• Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction
  Completed · Interventional · 105 enrolled · Cedars-Sinai Medical Center
  NCT01568177updated 2024-09-19
• A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
  Completed · Phase 3 · Interventional · 795 enrolled · Lantheus Medical Imaging
  NCT01347710updated 2020-11-24
• Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma
  Completed · Phase 2 · Interventional · 32 enrolled · Proactina S.A.
  NCT02971319updated 2018-01-26
• Anti-gravity Treadmill Exercise in Stress Myocardial Perfusion Imaging
  Completed · Interventional · 49 enrolled · University of Cincinnati
  NCT02628002updated 2017-05-09
• Prognostic Value of Stress SPECT Myocardial Perfusion Imaging With Half Dose 99mTc-Tetrofosmin
  Completed · Observational · 4,000 enrolled · Ottawa Heart Institute Research Corporation
  NCT02019212updated 2017-04-13

Frequently asked questions

How does Tetrofosmin work?

Technetium (99mTc) tetrofosmin is a lipophilic, cationic complex which diffuses passively through the cell membrane and is locally retained actively due to the presence of intact mitochondria reflecting the presence of viable cells. After intravenous injection, it is distributed within the myocardium according to myocardial perfusion and viability.

What is Tetrofosmin used for?

According to FDA labeling, Tetrofosmin carries indications including: MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease ( 1.1 ) Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease ( 1.2 ) 1.1 Myocardial Perfusion Imaging Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Tetrofosmin?

Tetrofosmin labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.