Data from FDA - Curated by EPG Health - Last updated 19 December 2016

Indication(s)

INDICATIONS Tetrofosmin is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium and is also used to assess ventricular function.

PHYSICAL HALF-LIFE & TARGET ORGANS The physical half-life of technetium, Tc99 m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 KeV.

Estimated Absorbed Radiation Dose (Technetium Tc99 m Tetrofosmin Injection) Absorbed radiation dose Exercise Rest Target organ rad/mCi µGy/MBq rad/mCi µGy/MBq Gall bladder wall 0.123 33.2 0.180 48.6 Upper large intestine 0.075 20.1 0.113 30.4 Bladder wall 0.058 15.6 0.071 19.3 Lower large intestine 0.057 15.3 0.082 22.2 Small intestine 0.045 12.1 0.063 17.0 Kidney 0.039 10.4 0.046 12.5 Salivary glands 0.030 8.04 0.043 11.6 Ovaries 0.029 7.88 0.035 9.55 Uterus 0.027 7.34 0.031 8.36 Bone surface 0.023 6.23 0.021 5.58 Pancreas 0.019 5.00 0.018 4.98 Stomach 0.017 4.60 0.017 4.63 Thyroid 0.016 4.34 0.022 5.83 Adrenals 0.016 4.32 0.015 4.11 Heart wall 0.015 4.14 0.015 3.93 Red marrow 0.015 4.14 0.015 3.97 Spleen 0.015 4.12 0.014 3.82 Muscle 0.013 3.52 0.012 3.32 Testes 0.013 3.41 0.011 3.05 Liver 0.012 3.22 0.015 4.15

Thymus 0.012 3.11 0.009 2.54 Brain 0.010 2.72 0.008 2.15 Lungs 0.008 2.27 0.008 2.08 Skin 0.008 2.22 0.007 1.91 Breasts 0.008 2.22 0.007 1.83 Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No. 1 (rev), Society of Nuclear Medicine, 1976). Effective dose equivalents (EDE) were calculated in accordance with ICRP 53 (Ann. ICRP 18 (1-4), 1988) and gave values of 8.61? 10-3 mSV/MBq and 1.12? 10-2 mSV/MBq after exercise and rest, respectively.

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Advisory information

contraindications
CONTRAINDICATIONS There are no known contraindications for this preparation.

Usage information

Dosing and administration

DOSE AND ROUTE OF ADMINISTRATION Depending on the protocol for rest/stress imaging, doses of 10 to 30 mCi (370 to 1110 MBq) are given intravenously PREPARATION Snap off the plastic lid and place in appropriate lead shielding.

Wipe the septum with 70 % isopropyl alcohol and allow it to dry.

Using a 10 mL syringe, dilute up to 360 mCi of Tc99 m with saline and add to vial.

The total volume should be between 6 mL - 12 mL and the Tc99 m concentration should not exceed 30 mCi/mL (360 mCi/12 mL).

After adding the Tc99 m, insert a 0.22 µm filtered vent needle and, using a separate syringe, withdraw 3 mL of gas from the vial, allowing sterile filtered air into the vial.

Remove vent needle and syringe.

Mix gently and invert several times for 10 seconds.

Let stand for 15 minutes at room temperature as the complexes form.

Inspect vial through a lead glass shield for particulate matter.

Do not use if the solution is not clear.

Store at 2°- 8°C (36°- 46°F) and use within 12 hours after mixing.

Radiochemical purity should be at least 90 % prior to administration QC info: Solvent - Ethyl Acetate, Strip - Whatman CHR% Tag = top counts/total counts X 100 % STORAGE The preparation should be stored in the refrigerator at 2- 8 (C (36 - 46 (F) and protected from light.

More information

Category Value
Orphan designation No
Product NDC 51808-223
Date Last Revised 23-05-2012
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder AnazaoHealth Corporation