Mallinckrodt Tc 99m Sestamibi—a choice for nuclear medicine professionals that provides imaging quality and economic value in a single product offering.
Full US prescribing information
EquivalenceTc 99m Sestamibi is fully substitutable for branded product.
TrustMallinckrodt is an experienced manufacturer of generic pharmaceuticals with a strong history in the radiopharmaceutical industry.
ConfidenceTc 99m Sestamibi delivers a high degree of diagnostic accuracy.1,2
ValueMallinckrodt seeks to provide value to nuclear medicine professionals.
INDICATIONS AND USAGE
Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).
It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.
Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.
Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.
IMPORTANT RISK INFORMATION WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
1. Klocke FJ, Baird MG, Bateman TM, et al. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2003:10-11.2. Kit for the Preparation of Technetium Tc 99m Sestamibi Injection package insert. Hazelwood, MO: Mallinckrodt Inc; 2006.
Mallinckrodt, the “M” brand mark, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2015 Mallinckrodt.
Mallinckrodt Pharmaceuticals is a registered business name of Mallinckrodt plc, which is registered in Ireland as a public limited company with registration number 522227 and has its registered office at Damastown, Mulhuddart, Dublin 15, Ireland.