Technetium (99mTc) sestamibi

What is Technetium (99mTc) sestamibi?

• Technetium (99mTc) sestamibi (Cardiolite) is a myocardial perfusion agent is a pharmaceutical agent used in nuclear medicine imaging.
• The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six (sesta=6) methoxyisobutylisonitrile (MIBI) ligands.
• The anion is not defined.
• A scan of a patient using MIBI is commonly known as a MIBI scan.

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99mTc-Sestamibi

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Tc99 sestamibi 3D

What are the uses of this medicine?

Technetium (99mTc) sestamibi (Cardiolite) is used 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

Miraluma, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is used 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. Limitations of use:

• Miraluma is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

• Additionally, sestamibi is frequently used in the noninvasive intraoperative localization of hyperfunctioning parathyroid tissues and adenomas in patients with primary hyperparathyroidism.

How does this medicine work?

• Technetium Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201.
• Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with thallous chloride Tl-201 in normal and abnormal myocardial tissue.
• Animal studies have shown that myocardial uptake is not blocked when the sodium pump mechanism is inhibited.
• Although studies of subcellular fractionation and electron micrographic analysis of heart cell aggregates suggest that Tc99m Sestamibi cellular retention occurs specifically within the mitochondria as a result of electrostatic interactions.
• The mechanism of Tc99m Sestamibi localization in various types of breast tissue (e.g., benign, inflammatory, malignant, fibrous) has not been established.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• pregnant or known allergies or hypersensitivity to mouse proteins.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Specific drug-drug interactions have not been studied.

Is this medicine FDA approved?

• Initial U.S. Approval: December, 1990
• The generic drug became available late September 2008.

How should this medicine be used?

Recommended dosage: 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).

• In preparation for parathyroid surgery, a dose of 740 to 925 megabecquerel of sestamibi is injected intravenously approximately 2.5 to 3 hours before the surgery to localize the adenoma to be removed.

Administration:

• Sestamibi is introduced intravenously, using aseptic technique, in small amounts.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.

This medicine is available in fallowing brand namesː Cardiolite; Miraluma

What side effects can this medication cause?

The most common side effects of this medicine include:

• seizure occurring shortly after administration of the agent
• transient arthritis
• angioedema
• arrythmia
• dizziness
• syncope
• abdominal pain
• vomiting
• severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia
• vomiting within two hours after a second injection of Technetium Tc99m Sestamibi.
• flushing
• edema
• injection site inflammation
• dry mouth
• fever
• pruritis
• rash
• urticaria
• fatigue

What special precautions should I follow?

• Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.
• Cardiolite® 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 Cardiolite® imaging.
• Caution should be exercised and emergency equipment should be available when administering Cardiolite®.
• Before administering Cardiolite® patients 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 Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
• Cardiolite® and Miraluma® are different names for the same drug. Patients should be advised to inform their health care provider if they had an allergic reaction to either drug or if they had an imaging study with either drug.
• Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary, however, a lactating woman should be advised to consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• The clinical consequences of overdosing with Cardiolite® are not known.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• If considering Technetium Tc99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc99m Sestamibi and the gestational timing of exposure.

Can this medicine be used in children?

• Safety and effectiveness in the pediatric population have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

Inactive ingredients:

• TRISODIUM CITRATE DIHYDRATE
• CYSTEINE HYDROCHLORIDE
• MANNITOL
• STANNOUS CHLORIDE

Who manufactures and distributes this medicine?

Distributed by:

• Lantheus Medical Imaging®
• 331 Treble Cove Road
• N. Billerica, Massachusetts USA

What should I know about storage and disposal of this medication?

• The contents of the vial are lyophilized and stored under nitrogen.
• Store at 15-25°C (59-77° F) before and after reconstitution.
• Technetium Tc99m Sestamibi contains no preservatives.

• Dailymed label info on Technetium (99mTc) sestamibi
• FDA Technetium (99mTc) sestamibi

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