Technetium Tc 99m Mertiatide

Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is a radioactive diagnostic agent indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. ( 1 )

Kit for the Preparation of Technetium Tc 99m Mertiatide Injection contains 1 mg betiatide supplied as a white lyophilized powder packaged in 10 mL glass multiple-dose vials. Radiolabeling with sodium pertechnetate Tc 99m injection provides a clear, colorless solution containing up to 3,700 MBq (100 mCi) technetium Tc 99m mertiatide in approximately 10 mL volume at calibration time.. Kit for the Preparation of Technetium Tc 99m Mertiatide Injection: 1 mg betiatide as a lyophilized powder in 10 ml glass multiple-dose vial. Upon radiolabeling with technetium-99m, it contains up to 3,700 MBq (100 mCi) technetium Tc 99m mertiatide in approximately 10 mL volume at calibration time.

None. None. (4)

Radiation risks: Ensure safe handling to minimize radiation exposure to patients and healthcare providers. ( 5.1 )

5.1 Radiation Risks Technetium Tc 99m Mertiatide Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [ see Dosage and Administration ( 2.2 ) ] .

The following adverse reactions associated with the use of Technetium Tc 99m Mertiatide Injection were identified in clinical studies or postmarketing reports. Because some of these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders : tachycardia. Gastrointestinal disorders : nausea, vomiting. General disorders and administration site conditions : shaking chills, fever. Nervous system disorders : seizure. Respiratory, thoracic and mediastinal disorders : wheezing, dyspnea. Skin and subcutaneous tissue disorders : itching, rash. Vascular disorders : elevation in blood pressure. Reported adverse reactions are: tachycardia, nausea, vomiting, shaking chills, fever, seizure, wheezing, dyspnea, itching, rash, and elevation in blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for at least 24 hours after Technetium Tc99m Mertiatide administration. ( 8.2 )

8.1 Pregnancy Risk Summary There are no data with technetium Tc 99m mertiatide use in pregnant women to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproductive studies have been conducted with technetium Tc 99m mertiatide. Although all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose, the radiation exposure to the fetus from technetium Tc 99m mertiatide is expected to be low (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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 are 2% to 4% and 15% to 20%, respectively. Data Human Data No adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.

8.2 Lactation Risk Summary There are no data on the presence of technetium Tc 99m mertiatide in breast milk, however, published case reports describe the presence of technetium Tc 99m in breast milk. There are no data on the effects of technetium Tc 99m mertiatide on the breastfed infant or the effects on milk production. Based on clinical guidelines, exposure of technetium Tc 99m mertiatide to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of 24 hours after administration of Technetium Tc 99m Mertiatide Injection. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Technetium Tc 99m Mertiatide Injection and any potential adverse effects on the breastfed child from technetium Tc 99m mertiatide or from the underlying maternal condition.

8.4 Pediatric Use Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in pediatric patients aged 30 days and older. The safety and effectiveness of Kit for the Preparation of Technetium Tc 99m Mertiatide Injection have not been established in pediatric patients younger than 30 days old.

8.5 Geriatric Use No formal studies of Technetium Tc 99m Mertiatide Injection in subjects aged 65 and over were performed to determine whether they respond differently than younger adult subjects.

Following intravenous administration for renal imaging, Technetium Tc 99m Mertiatide is rapidly cleared from the blood. It is cleared by the kidneys and excreted in the urine.