Chemical formula: C₁₈H₄₀O₄P₂Tc Molecular mass: 898.86 g/mol PubChem compound: 131704316
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 2-4% and 15-20%, respectively.
Technetium Tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). There are no data available regarding the effects of technetium Tc99m tetrofosmin on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for technetium Tc99m tetrofosmin and any potential adverse effects on the breastfed child from technetium Tc99m tetrofosmin or from the underlying maternal condition.
To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium Tc99m tetrofosmin administration.
Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. Tetrofosmin sulphosalicylate was not mutagenic in vitro in the Ames test, mouse lymphoma, or human lymphocyte tests, nor was it clastogenic in vivo in the mouse micronucleus test.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of technetium Tc99m tetrofosmin cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions were evaluated in clinical studies (using an exercise/rest protocol) of 764 adults (511 men) with a mean age of 58.7 years (range 29-94 years). The subjects received a mean dose of 285 MBq (7.7 mCi) on the first injection and 829 MBq (22.4 mCi) on the second injection of technetium Tc99m tetrofosmin.
After technetium Tc99m tetrofosmin injection, angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject.
The following reactions were noted in less than 1% of subjects:
Cardiovascular: angina, hypertension, torsades de pointes.
Gastrointestinal: vomiting, abdominal discomfort.
Hypersensitivity: cutaneous allergy, hypotension, dyspnea.
Special Senses: metallic taste, burning of the mouth, smell alteration.
In four studies,438 adults (232 men and 205 women: gender was not recorded for one subject) with a mean age of 65 years (range 27-97 years) received a single pharmacologic stress agent. The subjects received a mean dose of 7-8 mCi on the rest/first injection and 22-34 mCi on the stress/second injection. Among the 438 subjects, 319 subjects (73%) experienced an adverse reaction. Reactions occurring in ≥1% of the subjects included angina (39%), flushing (36%), dyspnea (28%), headache (14%), abdominal pain (11%), dizziness (7%), palpitations (2%), nausea (2%), hypotension (1%) and pain (1%). Events occurring in <1% include cough, arrhythmia, bronchospasm, ECG abnormalities, hypertension, vomiting and asthenia.
The following adverse reactions have been identified during post approval use of technetium Tc99m tetrofosmin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions reported included: rash, urticaria, abnormal vision, hypersensitivity reactions, and fever.
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