Included as part of the PRECAUTIONS section.
Risks Associated With Exercise Or Pharmacologic Stress
Patients 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.
Technetium 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 [see DOSAGE AND ADMINISTRATION].
Hypersensitivity 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
Carcinogenesis, Mutagenesis, Impairment Of Fertility
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.
Use In Specific Populations
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.
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 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
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 Tc 99m tetrofosmin administration.
Safety and effectiveness in pediatric patients have not
Of 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.