Cardiolite

Generic name: Technetium Tc 99m Sestamibi
Drug class: Radiologic conjugating agents

Medically reviewed by  A Ras MD.

What is Cardiolite?

Cardiolite is used with a special imaging test.

Before taking Cardiolite, tell your doctor:

• If you are allergic to Cardiolite; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cardiolite with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Description

Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:

• Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1.0 mg
• Sodium Citrate Dihydrate – 2.6 mg
• L-Cysteine Hydrochloride Monohydrate – 1.0 mg
• Mannitol – 20 mg
• Stannous Chloride, Dihydrate, minimum (SnCl2∙2H2O) – 0.025 mg
• Stannous Chloride, Dihydrate, (SnCl2∙2H2O) – 0.075 mg
• Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl2∙2H2O) – 0.086 mg

Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen.

This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0 – 6.0). No bacteriostatic preservative is present.

The precise structure of the technetium complex is Tc99m[MIBI]6+ where MIBI is 2-methoxy isobutyl isonitrile.

Mechanism of Action

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 clinical relevance of these findings has not been determined.

The mechanism of Tc99m Sestamibi localization in various types of breast tissue (e.g., benign, inflammatory, malignant, fibrous) has not been established.

What are some things I need to know or do while I take Cardiolite?

• Tell all of your health care providers that you take Cardiolite. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is radioactive. You will need to follow what the doctor has told you to lessen being exposed to Cardiolite.
• Patients who have or may have heart disease: Rarely, deaths have happened 4 to 24 hours after using Cardiolite in people with heart disease. Most of the time, these have happened with exercise stress tests.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Cardiolite best taken?

Use Cardiolite as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Cardiolite that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Chest pain or pressure.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Shortness of breath.
• Feeling very tired or weak.

What are some other side effects of Cardiolite?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Change in taste.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Cardiolite?

• If you need to store Cardiolite at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 5 VIAL BOX

• Lantheus
  Medical Imaging®
• Cardiolite®
• Kit for the Preparation of Technetium Tc99m Sestamibi for Injection
• CONTENTS AND STORAGE CONDITIONS:
  1 Package Insert, 12 Radiation Labels and 5 Vials, each containing:
  Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1.0 mg
  Stannous Chloride Dihydrate – 0.075 mg; L-Cysteine Hydrochloride
  Monohydrate – 1.0 mg; Sodium Citrate Dihydrate – 2.6 mg; Mannitol – 20 mg
  Store at 15-25°C (59-77°F).
• CONTAINS NO PRESERVATIVE. See Package Insert for dosage information.
  Reconstitute with additive-free Tc99m and store at 15-25°C (59-77°F).
  Use within 6 hours of reconstitution.

SRC: NLM .