Technetium Tc-99m Sestamibi 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 Cardiolite (application NDA019785). Other technetium tc-99m sestamibi kit products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® in a single dose to be employed in the average patient (70 Kg) is 370 - 1110 MBq (10 - 30 mCi). For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi). For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® in a single dose to be employed in the average patient (70 Kg) is 370 - 1110 MBq (10 - 30 mCi). For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi). 2.1 Image Acquisition Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view. For complete study, sets of images should be…
Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patient's genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred (see Section 5 ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: Table 2.0 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose gender was not recorded. Body System Breast Studies Cardiac Studies Women n = 673 Women n = 685 Men n = 2361 Total n = 3046 Body as a Whole 21 (3.1%) 6 (0.9%) 17 (0.7%) 23 (0.8%) Headache 11 (1.6%) 2 (0.3%) 4 (0.2%) 6 (0.2%) Cardiovascular 9 (1.3%) 24 (3.5%) 75 (3.2%) 99 (3.3%) Chest Pain/Angina 0 (0%) 18 (2.6%) 46 (1.9%) 64 (2.1%) ST segment changes 0 (0%) 11 (1.6%) 29 (1.2%) 40 (1.3%) Digestive System 8 (1.2%) 4 (0.6%) 9 (0.4%) 13 (0.4%) Nausea 4 (0.6%) 1 (0.1%) 2 (0.1%) 3 (0.1%) Special Senses 132 (19.6%) 62 (9.1%) 160 (6.8%) 222 (7.3%) Taste Perversion 129 (19.2%) 60 (8.8%) 157 (6.6%) 217 (7.1%) Parosmia 8 (1.2%) 6 (0.9%) 10 (0.4%) 16 (0.5%) In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) 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 known. None known.
Specific drug-drug interactions have not been studied. Specific drug-drug interactions have not been studied.