Kit for the Preparation of Technetium Tc 99m Pentetate Injection (commonly known as DTPA)

Kit for the Preparation of Technetium Tc 99m Pentetate Injection

CONTRAINDICATIONS

Hypersensitivity to the active ingredient or to any component of the product.

WARNINGS AND PRECAUTIONS

• Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions and have access to cardiopulmonary resuscitation equipment and personnel.
• Image Interpretation Risks in Lung Ventilation Studies: In patients with obstructive pulmonary disease there may be deposition of particles in the proximal airways influencing image quality and interfering with diagnostic interpretation, therefore to ensure diagnostic quality, careful use of the nebulizer to assure optimal particle delivery is essential. If interfering particle deposition occurs, consider additional diagnostic options.
• Radiation Exposure Risk: Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Use the lowest dose of Technetium Tc 99m pentetate necessary for imaging. Encourage patients to drink fluids and void as frequently as possible after intravenous administration.

Radiation risks associated with the use of Technetium Tc 99m pentetate are greater in pediatric patients than in adults due to greater radiosensitivity and longer life expectancy.

• Bronchospasm in Lung Ventilation Studies: As with other inhaled medications, inhalation of Technetium Tc 99m pentetate solution may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity, such as patients with asthma or other lung or allergic disorders. Monitor all patients for bronchoconstriction.

ADVERSE REACTIONS

Adverse reactions are presented in decreasing order of reported frequency:

• Immune system disorders: allergic reaction, anaphylactic reaction, angioedema.
• Skin and subcutaneous tissue disorders: rash, itching, hives, erythema.
• Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing.
• Vascular disorders: hypotension, hypertension.
• Nervous system disorders: headache, fainting, dizziness.
• General disorders and administration site conditions: chills.
• Gastrointestinal disorders: nausea, vomiting.
• Cardiac disorders: cyanosis, tachycardia.

USE IN SPECIFIC POPULATIONS

Pregnancy: Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta. No animal reproductive studies have been conducted with Technetium Tc 99m pentetate. 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 pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc 99m pentetate and the gestational timing of exposure.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S., general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

Lactation: There are limited data available in scientific literature on the presence of Technetium Tc 99m pentetate in human milk. There are no data available on the effects of Technetium Tc 99m pentetate on the breastfed infant or the effects on milk production. Based on the United States Nuclear Regulatory Commission guidelines for breastfeeding interruption after exposure to radiopharmaceuticals, breastfeeding interruption is not recommended for Technetium 99m pentetate, at levels less than 1000 MBq (30 mCi). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technetium Tc 99m pentetate, any potential adverse effects on the breastfed child from Technetium Tc 99m pentetate or from the underlying maternal condition.

Pediatric Use: Technetium Tc 99m pentetate is indicated for lung ventilation and evaluation of pulmonary embolism when paired with perfusion imaging and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in pediatric patients ages birth to less than 17 years of age.

Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience.

The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults.

Geriatric Use: No formal studies of Technetium Tc 99m pentetate in the elderly were performed to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

To report suspected adverse reactions, contact CURIUM US LLC at 1-866-789-2211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information.