Technetium Tc-99m Tetrofosmin Kit is a medicine sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Myoview (application NDA020372). Other technetium tc-99m tetrofosmin kit products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 MBq (5 to 33 mCi) by intravenous administration for rest and stress imaging. When rest…
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) 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None ( 4 )