Consumer medicine information

Technescan Sestamibi

Technetium (99mTc) sestamibi

BRAND INFORMATION

Brand name

Technescan Sestamibi

Active ingredient

Technetium (99mTc) sestamibi

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Technescan Sestamibi.

What is in this leaflet

This leaflet answers some of the common questions about TECHNESCAN®SESTAMIBI. It does not contain all of the available information about TECHNESCAN®SESTAMIBI. It does not replace talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you or your child receiving TECHNESCAN®SESTAMIBI against the benefits he or she expects it will have.

If you have any concerns about having this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What is TECHNESCAN®SESTAMIBI

TECHNESCAN®SESTAMIBI is a kit for radiopharmaceutical preparation.

This kit contains an active ingredient (non-radionuclide) called tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate to which a solution containing another ingredient called a radionuclide is added to give the final radiopharmaceutical preparation, TECHNETIUM [99mTc] SESTAMIBI INJECTION. The radiopharmaceutical preparation is administered to you as an injection.

A radionuclide is radioactive. The radionuclide in TECHNETIUM [99mTc] SESTAMIBI INJECTION is called pertechnetate (99mTc).

What is TECHNESCAN®SESTAMIBI used for

TECHNESCAN®SESTAMIBI is used to show the blood flow inside your heart during exercise and rest. It can be used to show the presence and size of any breast cancer.

Your doctor may have prescribed TECHNESCAN®SESTAMIBI for another purpose. Ask your doctor if you have any questions about why TECHNESCAN®SESTAMIBI has been prescribed for you. If you have any concerns, you should discuss these with your doctor.

This medicine is only available with a doctors prescription.

Before you are given TECHNESCAN®SESTAMIBI

Before you are given TECHNESCAN®SESTAMIBI your doctor will explain to you the procedure you are about to undergo, and the radioactive medicine you will be given. You must discuss any concerns you have with your doctor. TECHNESCAN®SESTAMIBI is not recommended for patients less than 18 years of age. If your doctor believes it is necessary to give TECHNESCAN®SESTAMIBI to a patient under 18, he or she will discuss the benefits and risks with you.

You must tell your doctor if you have allergies to:

  • any other medicines
  • any other substances such as foods, preservatives or dyes

Tell your doctor if you are or plan to become pregnant. Like most medicines TECHNESCAN®SESTAMIBI is not recommended for use during pregnancy. If there is a need to consider TECHNESCAN®SESTAMIBI during your pregnancy, your doctor will discuss the benefits and risks of giving it to you.

Tell your doctor if you are breastfeeding or plan to breastfeed. Like most medicines TECHNESCAN®SESTAMIBI is not recommended while you are breastfeeding. However if you are breastfeeding, formula feedings should be substituted for breastfeeding for 24 hours following the administration of radiopharmaceutical preparation. Breast milk produced within that time should be discarded.

Tell your doctor if you have any other medical conditions especially if you suffer from heart disease.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

How TECHNESCAN®SESTAMIBI is given

How much is given

Your doctor will decide how much you will be given. This depends on your condition and other factors, such as weight.

If you are being given TECHNESCAN®SESTAMIBI for heart imaging you may be given two injections, one at rest and one with exercise. You may be asked to fast for 4 hours before the procedure, and may be given a light meal after the injection.

If you are being given TECHNESCAN®SESTAMIBI for breast imaging you will be given one injection.

How it is given

TECHNESCAN®SESTAMIBI is a kit for the preparation of Technetium [99mTc] Sestamibi Injection. Once preparation of Technetium [99mTc] Sestamibi Injection is complete it is administered by injection into a vein. It should only be given by a doctor or a nurse.

When you are given TECHNESCAN®SESTAMIBI

Things you must do

After the procedure you must drink about 2 litres of fluid and urinate immediately and frequently. This will remove as much radioactivity as possible from your bladder.

Things you must not do

Do not take any other medicines unless advised by your doctor.

Things to be careful of

Do not drive or operate machinery until you know how this medicine affects you. The radiopharmaceutical preparation Technetium [99mTc] Sestamibi Injection may cause dizziness in some people. Make sure you know how you react to this medicine before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Side Effects

Tell your doctor as soon as possible if you do not feel well after being given TECHNESCAN®SESTAMIBI.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.

Tell your doctor if you experience any of the following and they worry you

  • headache
  • nausea
  • things taste different
  • sleep disorders (such as nightmares, sleep terror or sleepwalking)
  • breast pain (women having breast imaging)
  • transient arthritis
  • flushing
  • oedema
  • injection site inflammation
  • dry mouth
  • fatigue

These side effects are usually mild.

Tell your doctor or a nurse immediately if you notice any of the following:

  • chest pain or a feeling of tightness, pressure or heaviness in the chest
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • changes in your heart rate
  • feeling faint
  • vomiting
  • abdominal pain
  • rash, itching or hives (itchy swellings on the skin)
  • allergic reaction – shortness of breath or difficulty breathing, slow heart rate, dizziness or light-headedness, feeling unusually tired or weak
  • fever

These are serious side effects for which you may need urgent medical treatment.

Do not be alarmed by this list of side effects. You may not experience any of them.

Product Description

What it looks like

TECHNESCAN®SESTAMIBI is a white powder supplied in a clear glass vial.

Ingredients

The active ingredient in TECHNESCAN®SESTAMIBI is tetrakis (2-methylisobutylisonitrile) copper (I) tetrafluoroborate. The other ingredients are stannous chloride dihydrate, sodium citrate, cysteine hydrochloride and mannitol. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.

Sodium Pertechnetate [99mTc] Injection is the radioactive solution added to TECHNESCAN®SESTAMIBI to give the final radiopharmaceutical preparation for injection. The solution for injection is clear and colourless.

Sponsor

Landauer Radiopharmaceuticals Pty Ltd
Level 3/69 Phillip Street
Parramatta NSW 2150
Australia

Registration Number: AUST R 170503

Date of Preparation:

November 2015.


Published by MIMS October 2017

BRAND INFORMATION

Brand name

Technescan Sestamibi

Active ingredient

Technetium (99mTc) sestamibi

Schedule

Unscheduled

 

1 Name of Medicine

Tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate.
The abbreviated notation is [Cu(MIBI)4]BF4 (where MIBI is 2-methoxyisobutylisonitrile).

2 Qualitative and Quantitative Composition

Technescan Sestamibi is a kit for radiopharmaceutical preparation of technetium (99mTc) sestamibi injection. Each vial contains 1 mg of tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate.
Technescan Sestamibi is a sterile, nonpyrogenic, lyophilised white powder. After reconstitution of the radiopharmaceutical kit with sterile, non-pyrogenic, oxidant free sodium pertechnetate (99mTc) injection, the solution for injection is clear and colourless and a complex of the MIBI and technetium-99m forms yielding Technetium [99mTc] Sestamibi ([Tc-99m (MIBI)6]+Cl-).
The pH of the reconstituted product is 5.5 (5.0 to 6.0). No bacteriostatic preservative is present. The contents of the vial are stored under nitrogen.
For the full list of excipients, see Section 6.1 List of Excipients.
Physical characteristics. Technetium (99mTc) decays by isomeric transition with a physical half-life of 6 hours. Photons associated with this transition which are useful for detection and imaging studies are listed (see Tables 1 and 2).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHSE01.gif https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHSE02.gif External radiation. The specific gamma ray constant for 99mTc is 0.19 milligray (mGy) per MBq-h at 1 cm. The first half value thickness of lead (Pb) for 99mTc is 0.2 mm. Attenuation by lead is given in Table 3.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHSE03.gif

3 Pharmaceutical Form

Powder for Injection.
Technescan Sestamibi is a white to almost white lyophilised powder or pellets in a glass vial for intravenous injection. To be reconstituted with sodium pertechnetate (99mTc) solution for injection.

4 Clinical Particulars

4.9 Overdose

In the event of administration of a radiation overdose with technetium [99mTc] sestamibi the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defaecation.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No long-term animal studies have been performed to evaluate carcinogenic potential or whether technetium [99mTc] sestamibi affects fertility in males or females. Several mutagenicity studies indicate that [Cu(MIBI)4]BF4 is not likely to induce mutagenic changes. However, in an in vitro study on human lymphocytes, [Cu(MIBI)4]BF4 resulted in chromosomal aberrations.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTECHSE.gif The molecular formula is C24H44N4O4BF4Cu and the molecular weight is 602.98.
CAS number. The CAS number is 103694-84-4.

7 Medicine Schedule (Poisons Standard)

Not considered for scheduling.

Summary Table of Changes

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