Rapid cardiac imaging
Diagnostic information in as soon as 15 minutes for stress MPI1
Image quality
Myoview patients require fewer repeat scans due to extra cardiac activity2
Flexible 1 or 2-day protocols
Help to optimize department scheduling
Minimize radiation exposure
Lower, approved injected dose ranges may help minimize radiation exposure1
The shorter image-to-acquisition time of Myoview may assist physicians in improving patient management related to identification and definition of ischemia³. In a subset of patients, earlier (15-minute) image acquisition with Myoview permitted more rapid and accurate identification of severe myocardial ischemia³.
In a prospective study by Ravizzini,
Safety data for Myoview
The frequencies of the undesirable effects are defined as follows:
Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000) and not known (cannot be determined with the data available). Adverse drug reactions following administration of tetrofosmin (99mTc) are very rare (less than 1 in 10,000).
The following undesirable effects are recognised for Myoview:
- Immune system disorders: Face oedema, hypersensitivity reaction, allergic reaction, anaphylactic reaction
-Nervous system disorders: Headache, dizziness, taste metallic, disturbances of smell and taste
-Vascular disorders: Flushing, hypotension
-Respiratory, thoracic and mediastinal disorders: Dyspnoea
-Gastrointestinal disorders: Vomiting, nausea, burning mouth
-Skin and subcutaneous tissue disorder: Urticaria, itching, erythematous rash
-General disorders and administration site condition: Feeling of warmth
Investigations
White blood cell count increased.
Some reactions were delayed by several hours following administration of tetrofosmin (99mTc). Isolated cases of serious reactions have been reported, including anaphylactic reaction (less than 1 in 100,000) and severe allergic reaction (single report). Since the administered substance quantity is very low, the major risk is caused by the radiation. Exposure to ionising radiation is linked with cancer induction and a potential for developing hereditary defects. As the effective dose is 8.5 mSv when the maximal recommended activity of 1200 MBq is administered these adverse reactions are expected to occur with a low probability.
Preparing Myoview
Method of preparation:
Use aseptic technique throughout.
1. Place the vial in a suitable shielding container and sanitize the rubber septum with the swab provided.
2. Insert a sterile needle (the venting needle, see Note a) through the rubber septum. Using a shielded, 10 mL sterile syringe, inject the required activity of Sodium Pertechnetate (99mTc) Injection Ph.Eur. (appropriately diluted with 0.9% Sodium Chloride Injection BP) into the shielded vial (see Notes b to d). Before removing the syringe from the vial, withdraw 5 mL of gas from above the solution (see Note e). Remove the venting needle. Shake the vial to ensure complete dissolution of the powder.
3. Incubate at room temperature for 15 minutes.
4. During this time assay the total activity, complete the user label provided and attach it to the vial.
5. Store the reconstituted injection below 25°C and do not freeze. Use within 12 hours of preparation. Dispose of any unused material and its container via an authorized route.
Notes:
a. A needle of size 19G to 26G may be used.
b. The Sodium Pertechnetate (99mTc) Injection Ph.Eur. used for reconstitution should contain less than 5ppm aluminium.
c. The volume of diluted Sodium Pertechnetate (99mTc) Injection Ph.Eur. added to the vial must be in the range 4-8 ml.
d. The radioactive concentration of the diluted Sodium Pertechnetate (99mTc) Injection Ph.Eur. must not exceed 1.5 GBq/mL when it is added to the vial.
e. For preparation volumes of more than 6 mL, the remaining vial headspace is less than the 5 mL added air volume. In these cases, the withdrawal of a 5 mL volume of gas ensures that all of the vial headspace is replaced by air.
1. Myoview [prescribing information]. Arlington Heights, IL: GE HealthCare; 2022.
2. Vermeltfoort IA, van Dijk AB, de Jong JA, et al. A randomized study of the effect of carbonated water prior to myocardial SPECT. Ann Nucl Med. 2014:7:669-673.
3. Giorgettii A, Rossi N, Stanislao M, et al. Feasibility and diagnostic accuracy of a gated SPECT early-imaging protocol: a multicenter study of the Myoview Imaging Optimization Group. J Nucl Med. 2007;48:1670-1675.
4. Ravizzini GC,Hanson MW, Shaw LK, et al. Efficiency comparison between 99m Tc-tetrofosmin and 99m Tc-sestamibi myocardial perfusion studies. Nucl Med Comm. 2002;23:203-208.
5. Port SC. Imaging guidelines for nuclear cardiology procedures. J Nucl Cardiol. 1999;6:G47-G84.
6. Higley B, Smith FW, Smith T, et al. Technetium-99m-1,2-bis[bis(2-ethoxyethyl) phosphino]ethane: human biodistribution, dosimetry and safety of a new myocardial perfusion imaging agent. J Nucl Med. 1993;34:30-38.
[Ratio Image References]
*Myocardial Perfusion Imaging (MPI)
**Coronary Artery Disease (CAD)
MYOVIEWTM (Kit for the Preparation of Technetium Tc99m Tetrofosmin 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.
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 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 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
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
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Technetium Tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). There are no data available regarding the effects of technetium Tc99m 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 Product Indications and Important Safety Information – Myoview breastfed child from MYOVIEW or from the underlying maternal condition. To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard for 60 hours (10 half-lives) after technetium Tc99m tetrofosmin administration. Prior to MYOVIEW administration, please read the full Prescribing Information for additional Important Safety Information. To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
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 patients and younger patients, but greater sensitivity regarding some older individuals cannot be ruled out
Prior to MYOVIEW administration, please read the full Prescribing Information for additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
MYOVIEWTM (Kit for the Preparation of Technetium Tc99m Tetrofosmin 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.
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 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 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
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
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Technetium Tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). There are no data available regarding the effects of technetium Tc99m 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 Product Indications and Important Safety Information – Myoview breastfed child from MYOVIEW or from the underlying maternal condition. To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard for 60 hours (10 half-lives) after technetium Tc99m tetrofosmin administration. Prior to MYOVIEW administration, please read the full Prescribing Information for additional Important Safety Information. To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
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 patients and younger patients, but greater sensitivity regarding some older individuals cannot be ruled out
Prior to MYOVIEW administration, please read the full Prescribing Information for additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
