Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ .
Adverse events should also be reported to GE HealthCare at
gpv.drugsafety@gehealthcare.com
Fast and efficient protocol
15-minute injection-to-image delay time1 and shorter total examination time vs sestamibi1
Image quality
Fewer repeated scans vs sestamibi, due to fewer suboptimal images resulting from liver/bowel activity2
Flexible one- or two-day protocols
Help to optimize department scheduling
Minimise radiation
Lower radiation dose vs sestamibi may help minimize patient radiation exposure3
Myoview helps clinicians improve the workflow efficiency of their department and the image quality of the SPECT scans.
Myoview allows for a 15-minute injection-to-image acquisition time, enabling efficient protocol for stress and rest imaging as well as a reduction in patient waiting time. In a prospective study by Ravizzini, Myoview demonstrated significantly shorter completion time compared to sestamibi for both rest studies and total study time.1
Myoview also required fewer repeated scans compared with sestamibi, due to fewer suboptimal images resulting from liver/bowel activity.2 Earlier imaging with Myoview is equivalent to later imaging with sestamibi when assessing subjective image quality.2 Flexible one- or two-day protocols with Myoview can help optimize department scheduling.
Preparing Myoview is a 15-minute preparation procedure without boiling or extra dilution.
Myoview demonstrated high sensitivity, specificity and diagnostic accuracy.4,5,6 Clearance of Myoview from the lungs and the liver is faster than that of sestamibi, improving the resolution of early cardiac images.7
Earlier imaging with Myoview is equivalent to later imaging with sestamibi when assessing subjective image quality.2 Myoview produced a favourable heart-to-liver ratio compared with sestamibi, when imaged 30-60 minutes post-injection.2,8
The recommended effective dose of technetium (99mTc) tetrofosmin (Myoview) per administered unit of activity to adults is 0.0058 under stress and 0.0063 at rest. In comparison, The recommended effective dose of technetium (99mTc) sestamibi (mSv/MB1) per administered unit of activity to adults is 0.0066 under stress and 0.0070 at rest.3
The quality of images that you get very rarely requires any repeat images simply because there is limited spill over from the liver or gastric activity
If you acquire after 15 minutes, you can reduce the patient’s hospital stay time.
Myoview enables acquisitions 15 minutes before MIBI so therefore Myoview can
transform your clinical efficiency by shortening total time examination
Myoview can improve your image quality and workflow efficiency when localising myocardial ischaemia and infarction and assessing left ventricular function. Learn more about supporting resources available for Myoview.
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
Withdrawals should be performed under aseptic conditions. The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorized automated application system. If the integrity of this vial is compromised, the product should not be used.
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. Ravizzini GC et al. Nucl Med Comm 2002; 23: 203–208.
2. Duvall et al. J Nucl Cardiol 2020; 27: 254–265
3. Verberne HJ et al. Eur J Nucl Med Mol Imaging 2015; 42: 1929–1940
4. Jain D. Semin Nucl Med 1999; 29: 221–236
5. Kapur A et al. Eur J Nucl Med 2002; 29: 1608–1616
6. Underwood S et al. Eur J Nucl Med Mol Imaging 2004; 31: 261–291
7. Acampa W et al. J Nucl Cardiol 2000; 7: 701–707.
8. Münch G et al. J Nucl Med 1997; 38: 428–432
9. Technescan MIBI (Technetium [99mTc] sestamibi) Summary of Product Characteristics (UK), Curium Pharma, August 2021.