Tetrofosmin

FDA label, Medi-Physics Inc. dba GE Healthcare, intravenous, effective 2024-01-10. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Table 1 Estimated Radiation Absorbed Dose (Technetium Tc99m Tetrofosmin Injection)
Radiation absorbed dose per unit activity injected intravenously
ExerciseRest
Target organrad/mCimicroGy/MBqrad/mCimicroGy/MBq
Gall bladder wall0.10270.1336
Upper large intestine0.074200.1027
Lower large intestine0.055150.07420
Bladder wall0.052140.06317
Small intestine0.041110.05615
Kidney0.037100.04813
Salivary glands0.0308.00.04312
Ovaries0.0297.70.0338.8
Uterus0.0267.00.0297.8
Bone surface0.0236.30.0215.8
Thyroid0.0174.70.0205.5
Pancreas0.0195.00.0184.9
Heart wall0.0195.20.0174.7
Stomach0.0174.60.0174.5
Adrenals0.0164.40.0164.2
Liver0.0123.30.0154.0
Spleen0.0154.10.0143.9
Red marrow0.0143.90.0143.8
Muscle0.0133.50.0123.3
Testes0.0133.40.0113.1
Thymus0.0123.30.0102.8
Esophagus0.0123.30.0102.8
Lungs0.0123.20.0102.8
Brain0.0102.70.00852.3
Skin0.00812.20.00742.0
Breasts0.00852.30.00742.0
Remaining organs0.0143.80.0143.8
Effective dose per unit activity0.026 rem/mCi6.9 microSv/MBq0.030 rem/mCi8.0 microSv/MBq

Preparation and administration

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Your numbers for tetrofosmin. Take vial strength, diluent, and limits from the label below.

Basis

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Administration Instructions Use aseptic technique for all drug preparation and handling. Measure the dose in a suitable radioactivity calibration system immediately prior to intravenous administration. Visually inspect the drug for particulate matter and discoloration prior to administration. Do not use or administer the drug if there is evidence of particulate matter or discoloration.

Instruct patients to remain hydrated and void frequently following administration to decrease radiation exposure [ see Warnings and Precautions ].

Instructions for Preparation The technetium Tc99m labeling reaction involved in the preparation of MYOVIEW Injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m used may adversely affect the quality of the preparation. Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product.

Elute the technetium generator with sodium chloride injection, USP. Insert a venting needle (standard 18 to 26 gauge needle, not provided) through the rubber septum of the shielded vial containing the lyophilized powder. Inject no more than 89 GBq (

Contraindications

None. None ( 4 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for tetrofosmin. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary There are no data with technetium Tc99m tetrafosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc99m tetrafosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

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