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Myoview


IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: None known. WARNINGS and PRECAUTIONSRisks Associated With Exercise or Pharmacologic Stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, and bronchoconstriction, as well as cerebrovascular reactions such as headache, paraesthesias, convulsions, somnolence and cerebrovascular accident, including hemorrhage. Perform stress testing in a 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.

Please see Indications and additional Important Safety Information below.


Image earlier with Myoview
Myoview is the only FDA-approved myocardial perfusion imaging agent that can begin gathering diagnostic information about your patient’s heart in as soon as 15 minutes1

Experience the potential benefits of Myoview

For Healthcare Providers: Diagnostic Confidence and Practice Efficiencies

  • High-quality imaging done fast (as early as 15 minutes post-injection , per package insert)1
  • Higher patient throughput and flexibility, which may ultimately support increased departmental productivity & efficiency3
  • Myoview may reduce the need for rescans3

For Patients: Enhanced Experience

  • Lower dose range helps minimize patient radiation exposure
        o Myoview offers an approved dose range with the lowest dose (5-12 mCi and 15-33 mCi) available for MPI agents2 (See Full Prescribing Information for Myoview for the recommended dosing)
  • Patient friendly 
        o Myoview’s 15-minute start time to image acquisition enables efficient protocol for stress and rest imaging, and reduces patient waiting time

References:
1. Myoview [prescribing information]. Arlington Heights, IL: GE Healthcare; 2017.
2. NIH-NHLBI/NCI, National Institutes of Health-National Heart, Lung, and Blood Institute/National Cancer Institute. https://www.nih.gov/.
Accessed February 13, 2018.
3. Ravizzini GC, Hanson MW, Shaw LK, et al. Efficiency comparison between 99mTc-tetrofosmin and 99mTc-sestamibi myocardial perfusion studies. Nucl Med Comm. 2002;23(3):203-208.

Indications

Myoview gated SPECT imaging produces high-quality, images for:1

  • Detection of myocardial ischemia
        - Delineation of heart regions of reversible myocardial ischemia with or without infarcted myocardium
  • Evaluation of patients with known or suspected coronary artery disease
        - Identification of changes in perfusion induced by pharmacologic stress and/or under resting conditions
  • Evaluation of heart disease through assessment of left ventricular function
        - Measurement of left ventricular ejection fraction (LVEF) and wall motion
  • Indication: Myoview 30 mL is a myocardial perfusion imaging (MPI) agent indicated for MPI 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. Myoview is also indicated for the assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.

Important Safety Information

PRODUCT INDICATIONS: Myoview 30 mL (Kit for the Preparation of Technetium Tc-99m Tetrofosmin for Injection) is indicated for 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. Myoview is also indicated for the assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.

Important Risk and Safety Information About MyoviewTM (Kit for the Preparation of Technetium Tc-99m Tetrofosmin for Injection)

CONTRAINDICATIONS: None known. WARNINGS and PRECAUTIONS — 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, and bronchoconstriction, as well as cerebrovascular reactions such as headache, paraesthesias, convulsions, somnolence and cerebrovascular accident, including hemorrhage. Perform stress testing in a 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. Radiation Risks: Technetium Tc-99m 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 reconstitution procedures to protect patients and healthcare workers from unintentional radiation exposure. Encourage adequate hydration; instruct patients to void when the examination is completed and as often thereafter as possible. Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, dyspnea, bronchospasm, throat tightness, coughing, tachycardia, chest pain, hypotension, abdominal pain, and cutaneous reactions (rash, urticuria, pruritus, erythema, and swelling or angiodema) have been observed after the administration of Myoview. Always have cardiopulmonary resuscitation equipment and personnel available, and monitor all patients for hypersensitivity reactions. Nursing Mothers: Technetium Tc-99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). There are no data available regarding the effects of technetium Tc-99m tetrofosmin on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Myoview and any other potential adverse effects on the breastfed child from Myoview or from the underlying maternal condition. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No overall differences in safety were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity regarding some older individuals cannot be ruled out. ADVERSE REACTIONS: Serious episodes of angina, ventricular tachycardia, and respiratory arrest were reported. Other events included angina, hypertension, torsades de pointes, vomiting, abdominal discomfort, cutaneous allergy, hypotension, dyspnea, metallic taste, burning of the mouth, and smell alteration. The following were reported when used with pharmacological stress: Angina, flushing, dyspnea, headache, abdominal pain, dizziness, palpitations, nausea, hypotension, pain, cough, arrhythmia, bronchospasm, ECG (electrocardiogram) abnormalities, hypertension, vomiting, and asthenia. Postmarketing adverse reactions included rash, urticaria, abnormal vision, hypersensitivity reactions, and fever.

Prior to Myoview administration, please read the full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.