Breast Imaging: MIRALUMA^®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 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.

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

Myocardial Imaging: CARDIOLITE^®, Kit for the Preparation of Technetium Tc99m Sestamibi for 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. CARDIOLITE^® 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.

For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA^® is a single dose of 740-1110 MBq (20 - 30 mCi).

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).

Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view.

For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence:

Beginning five minutes after the injection of Technetium Tc99m Sestamibi:

ten-minute lateral image of breast with abnormality ten-minute lateral image of contralateral breast ten-minute anterior image of both breasts

RADIATION DOSIMETRY: The radiation doses to organs and tissues of an average patient (70 kg) per 1110 MBq (30mCi) of Technetium Tc99m Sestamibi injected intravenously are shown in Table 10.

Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Istitute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117, (865) 576-3448.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Store at 15-25^o C before and after reconstitution.

Preparation of the Technetium Tc99m Sestamibi from the Kit for the Preparation of Technetium Tc99m Sestamibi is done by the following aseptic procedure:

General Procedure

a. Prior to adding the Sodium Pertechnetate Tc99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found.

Tear off a radiation symbol and attach it to the neck of the vial.

b. Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize the surface.

c. Place the vial in a suitable radiation shield with a fitted radiation cap.

d. With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc99m Injection [925-5550 MBq, (25-150 mCi)] in approximately 1 to 3 mL.

e. Aseptically add the Sodium Pertechnetate Tc99m Injection to the vial in the lead shield.

Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial.

f. Shake vigorously, about 5 to 10 quick upward-downward motions.

g. Remove the vial from the lead shield and place upright in an appropriately shielded and contained boiling water bath, such that the vial is suspended above the bottom of the bath, and boil for 10 minutes. Timing for 10 minutes is begun as soon as the water begins to boil again. Do not allow the boiling water to come in contact with the aluminum crimp.

h. Remove the vial from the water bath, place in the lead shield and allow to cool for fifteen minutes.

c. Place the vial in the thermal cycler radiation shield.

d. With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc99m Injection [925-5550 MBq, (25-150 mCi)] in approximately 1 to 3 mL.

e. Aseptically add the Sodium Pertechnetate Tc99m Injection to the vial in the lead shield.

Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial.

f. Shake vigorously, about 5 to 10 quick upward-downward motions.

g. Place shield on sample block. While slightly pressing downward, give the shield a quarter turn to make certain there is a firm fit between the shield and the sample block.

h. Press the proceed button to initiate the program (the thermal cycler automatically heats & cools the vial and contents). Please see the Recon-o-Stat Instruction Manual for further details.

General Procedure (cont.)

i. Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration.

j. Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc99m concentration, total volume, assay time and date, expiration time and lot number on the vial shield label and affix the label to the shield.

k. Store the reaction vial containing the Technetium Tc99m Sestamibi at 15^° to 25^°C until use; at such time the product should be aseptically withdrawn. Technetium Tc99m Sestamibi should be used within six hours of preparation. The vial contains no preservative.

Note: Adherence to the above product reconstitution instructions is recommended.

The potential for cracking and significant contamination exists whenever vials containing radioactive material are heated.

Product should be used within 6 hours after preparation.

Final product with radiochemical purity of at least 90% was used in the clinical trials that established safety and effectiveness. The radiochemical purity was determined by the following method.

1. Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5cm x 7.5cm.

2. Dry the plate or plates at 100^°C for 1 hour and store in a desiccator. Remove pre-dried plate from the desiccator just prior to use.

3. Apply 1 drop of ethanol* using a 1 mL syringe with a 22-26 gauge needle, 1.5 cm from the bottom of the plate. THE SPOT SHOULD NOT BE ALLOWED TO DRY.

4. Add 2 drops of Technetium Tc99m Sestamibi solution, side by side on top of the ethanol* spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes).

5. The TLC tank is prepared by pouring ethanol* to a depth of 3-4 mm. Cover the tank and let it equilibrate for ~10 minutes.

6. Develop the plate in the covered TLC Tank in ethanol* for a distance of 5 cm from the point of application.

7. Cut the TLC plate 4cm from the bottom and measure the Tc99m activity in each piece by appropriate radiation detector.

8. Calculate the % Tc99m Sestamibi as:

*The ethanol used in this procedure should be 95% or greater. Absolute ethanol (99%) should remain at > 95% ethanol content for one week after opening if stored tightly capped, in a cool dry place.

Bristol-Myers Squibb Medical Imaging, Inc. MIRALUMA^®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is supplied as a 5ml vial in kits of two (2) (NDC # 11994-001-02) and five (5) (NDC # 11994-001-05), sterile and non-pyrogenic.

Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25^°C before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each two (2) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels.

This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.533 or under equivalent licenses of the Nuclear Regulatory Commission, Agreement States or Licensing States.

Distributed by: Bristol-Myers Squibb Medical Imaging, Inc., 331 Treble Cove Road N. Billerica, Massachusetts 01862 USA, For Ordering Tel: Toll Free 800-225-1572 All Other Business: 800-362-2668 (For Massachusetts and International, call 978-667-9531) Printed in the U.S.A.

Revised Nov 12, 2003

Bookmark this page: