No information provided.
None.
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW 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 and 253 women) 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 MYOVIEW.
After MYOVIEW 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.
Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of MYOVIEW. 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.
Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease.
Ventricular Function ImagingMYOVIEW is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.
The relationship between Tc99m tetrofosmin plasma concentrations and successful imaging has not been explored in clinical trials.
Uptake in the myocardium is dependent on coronary flow and reaches a maximum of 1.2% of the injected dose (i.d.) at 5 minutes and 1% of the i.d. at 2 hours, respectively. Background activities in the blood, liver and lung were less than 5% of the administered activity in whole blood at 10 minutes post-injection, less than 4.5% i.d., after 60 minutes, and less than 2% i.d. after 30 minutes.
EliminationApproximately 66% of the injected activity is excreted within 48 hours post-injection, with approximately 40% excreted in the urine and 26% in the feces.
There are no data with technetium Tc 99m tetrafosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc 99m 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 Tc 99m 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.
Kit for the preparation of technetium Tc 99m tetrofosmin injection: 10 mL multiple-dose, clear, glass vial with a white sterile, non-pyrogenic, lyophilized powder of 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 disodium sulphosalicylate, 1 mg sodium D-gluconate and 1.8 mg sodium hydrogen carbonate.
Following reconstitution with the Tc99m eluate, MYOVIEW is a clear solution not exceeding 1110 MBq/mL (30mCi/mL) of Tc99m.
Five (5) multiple-dose kits, each containing a 10 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, 1.8 mg sodium hydrogen carbonate.
NDC 17156-024-05
The radionuclide is not part of the kit. Before reconstitution and radiolabeling with Tc 99m, the contents of the kit are not radioactive.
Storage And HandlingStore the kit at 2°-8°C (36°-46°F). Protect the kit from light.
This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc 99m tetrofosmin in accordance with these regulations.
Manufactured by: GE Healthcare AS, Oslo, Norway, Patent No. 5,045,302 (r). Distributed by: GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL 60004. Revised: Apr 2017
Included as part of the PRECAUTIONS section.
PRECAUTIONS Risks Associated With Exercise Or Pharmacologic StressPatients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular reactions such as headache, paraesthesias, convulsions, somnolence and cerebrovascular accident, including hemorrhage. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information.
Radiation RisksTechnetium Tc99m contributes to a patient's overall long-term cumulative radiation exposure. Longterm cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure. Encourage adequate hydration; instruct patients to void when the examination is completed and as often thereafter as possible.
Hypersensitivity ReactionsHypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, throat tightness, coughing, tachycardia, chest pain, hypotension, abdominal pain, and cutaneous reactions (rash, urticaria, pruritus, erythema, and swelling or angioedema) have been observed after the administration of MYOVIEW. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of FertilityStudies 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.
Use In Specific Populations Pregnancy Risk SummaryThere are no data with technetium Tc 99m tetrafosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc 99m 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 Tc 99m 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.
Lactation Risk SummaryTechnetium Tc99m tetrofosmin is present in human milk in small amounts ( < 1% of maternal dose). There are no data available regarding the effects of technetium Tc 99m 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 MYOVIEW and any potential adverse effects on the breastfed child from MYOVIEW or from the underlying maternal condition.
Clinical ConsiderationsTo 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 Tc 99m tetrofosmin administration.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.
Geriatric UseOf 2300 subjects in clinical studies of MYOVIEW, 1053 (46%) were 65 or older and 270 (12%) were 75 or older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Technetium Tc99m tetrofosmin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration.
Instructions For PreparationObtain the following materials:
Perform the following:
| % Tc99m tetrofosmin = | Activity of Center Piece (B) | X 100 |
| Total Activity of Three Pieces (A+B+C) |
Radiation absorbed dose per unit activity of the agent injected intravenously in an adult of average weight (74 kg) is estimated in Table 1 for exercise and resting conditions. The values listed correspond to a 3.5-hour voiding period for excretion from the urinary bladder.
Table 1 : Estimated Radiation Absorbed Dose
(Technetium Tc99m Tetrofosmin Injection)
| Target organ | Radiation absorbed dose per unit activity injected intravenously | |||
| Exercise | Rest | |||
| rad/mCi | microGy/MBq | rad/mCi | microGy/MBq | |
| Gall bladder wall | 0.10 | 27 | 0.13 | 36 |
| Upper large intestine | 0.074 | 20 | 0.10 | 27 |
| Lower large intestine | 0.055 | 15 | 0.074 | 20 |
| Bladder wall | 0.052 | 14 | 0.063 | 17 |
| Small intestine | 0.041 | 11 | 0.056 | 15 |
| Kidney | 0.037 | 10 | 0.048 | 13 |
| Salivary glands | 0.030 | 8.0 | 0.043 | 12 |
| Ovaries | 0.029 | 7.7 | 0.033 | 8.8 |
| Uterus | 0.026 | 7.0 | 0.029 | 7.8 |
| Bone surface | 0.023 | 6.3 | 0.021 | 5.8 |
| Thyroid | 0.017 | 4.7 | 0.020 | 5.5 |
| Pancreas | 0.019 | 5.0 | 0.018 | 4.9 |
| Heart wall | 0.019 | 5.2 | 0.017 | 4.7 |
| Stomach | 0.017 | 4.6 | 0.017 | 4.5 |
| Adrenals | 0.016 | 4.4 | 0.016 | 4.2 |
| Liver | 0.012 | 3.3 | 0.015 | 4.0 |
| Spleen | 0.015 | 4.1 | 0.014 | 3.9 |
| Red marrow | 0.014 | 3.9 | 0.014 | 3.8 |
| Muscle | 0.013 | 3.5 | 0.012 | 3.3 |
| Testes | 0.013 | 3.4 | 0.011 | 3.1 |
| Thymus | 0.012 | 3.3 | 0.010 | 2.8 |
| Esophagus | 0.012 | 3.3 | 0.010 | 2.8 |
| Lungs | 0.012 | 3.2 | 0.010 | 2.8 |
| Brain | 0.010 | 2.7 | 0.0085 | 2.3 |
| Skin | 0.0081 | 2.2 | 0.0074 | 2.0 |
| Breasts | 0.0085 | 2.3 | 0.0074 | 2.0 |
| Remaining organs | 0.014 | 3.8 | 0.014 | 3.8 |
| Effective dose per unit activity | 0.026 rem/mCi | 6.9 microSv/MBq | 0.030 rem/mCi | 8.0 microSv/MBq |
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW 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 and 253 women) 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 MYOVIEW.
After MYOVIEW 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.
Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of MYOVIEW. 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.
DRUG INTERACTIONSNo information provided.
