Pharmalucence Generic Sestamibi
Kit for the Preparation of TechnetiumTc99m Sestamibi Injection
Product Information and Features
Competitively priced 5 vial kits (SES05) and 30 vial packs (SES30).
Significant quantity based purchase discounts are available, please contact Customer Service for details.
No reporting requirements, no fee per dose pricing, no licensing.
Direct vial sale with no strings attached.
The FDA has determined that Pharmalucence Sestamibi is bioequivalent and therapeutically equivalent to the Referenced Listed Drug (RLD)*.
*The Referenced Listed Drug (RLD) for the generic Pharmalucence Technetium Tc99m Sestamibi Kit is Cardiolite®, a registered trademark of Lantheus Medical Imaging, Inc.
Indications and Usage
Technetium Tc 99m Sestamibi, is a myocardial perfusion agent indicated for:
Detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects).
Evaluating myocardial function and developing information for use in patient management decisions.
During these times of diminished reimbursement, greater emphasis on cost control and increasing technetium prices, Pharmalucence generic sestamibi provides you the means to realize significant radiopharmaceutical cost savings.
IMPORTANT SAFETY INFORMATION
WARNINGS AND GENERAL PRECAUTIONS
Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.
Technetium Tc 99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Technetium Tc 99m Sestamibi imaging.
Caution should be exercised and emergency equipment should be available when administering Technetium Tc 99m Sestamibi. Before administering Technetium Tc 99m Sestamibi patient should be asked about the possibility of allergic reactions to either drug.
The contents of the vial are intended only for use in the preparation of Technetium Tc 99m Sestamibi and are not to be administrated directly to the patient without first undergoing the preparative procedure.
In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Infrequently, death has occurred 4 to 24 hours after Tc 99m Sestamibi and is usually associated with exercise stress testing.
The following adverse reactions have been reported in > 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc 99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent.
Please See Full Prescribing Information Above
The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Technetium Tc 99m Sestamibi Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.