Technetium Tc 99M Sulfur Colloid Kit

FDA Drug Information • Also known as: Kit For The Preparation Of Technetium Tc 99M Sulfur Colloid

Brand Names: Kit For The Preparation Of Technetium Tc 99M Sulfur Colloid
Dosage Form: KIT
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection contains a Multi-Dose Reaction Vial, a Solution A vial and a Solution B vial which contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection for diagnostic use by subcutaneous, intraperitoneal, or intravenous injection or by oral administration. Each 10 mL Multi-Dose Reaction Vial contains, in lyophilized form 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; a Solution A vial contains 1.8 mL of 0.148 N hydrochloric acid solution and a Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. When a solution of sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection in isotonic saline is mixed with these components, following the instructions provided with the kit, Technetium Tc 99m Sulfur Colloid Injection is formed. The product is intended for subcutaneous, intraperitoneal, or intravenous injection or for oral administration. The precise structure of Technetium Tc 99m Sulfur Colloid Injection is not known at this time. 11.1 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours 4 . The principal photon that is useful for detection and imaging studies is listed in Table 7. Table 7. Principal Radiation Emission Data 4 Radiation Mean Percent Per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 4 Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981. 11.2 External Radiation The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 8. For example, the use of a 0.25 cm thickness of Pb will...

What Is Technetium Tc 99M Sulfur Colloid Kit Used For?

1 INDICATIONS AND USAGE Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: Localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. Evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: Areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. Studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated: (1) In adults, to assist in the: Localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. Evaluation of peritoneo-venous (LeVeen) shunt patency in adults. In adults and pediatric patients for: Imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. Studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Technetium Tc 99m Sulfur Colloid Injection emits radiation. Use procedures to minimize radiation exposure. Measure patient dose by a suitable radioactivity calibration system immediately before administration. Minimize Tc 99m Sulfur Colloid radiation exposure and measure patient doses immediately before administration. Breast cancer or malignant melanoma setting: by subcutaneous injection, 3.7 to 37 MBq (0.1 to 1 mCi in volumes ranging from 0.1 to 1 mL) ( 2.1 ) Peritoneo-venous (LeVeen) shunt setting in adults: (2.1) By intraperitoneal injection: 37 to 111 MBq (1 to 3 mCi); By percutaneous transtubal injection: 12 to 37 MBq (0.3 to 1 mCi) in a volume not to exceed 0.5 mL. Imaging areas of functioning reticuloendothelial cells by intravenous injection: (2.1) In adults: Liver/spleen imaging: 37 to 296 MBq (1 to 8 mCi); Bone marrow imaging: 111 to 444 MBq (3 to 12 mCi); In pediatric patients: Liver/spleen imaging in newborns: 7.4 to 18.5 MBq (0.2 to 0.5 mCi); Liver/spleen imaging in children: 0.56 to 2.78 MBq (0.015 to 0.075 mCi) per kg of body weight (BW); Bone marrow imaging: 1.11 to 5.55 MBq (0.03 to 0.15 mCi) per kg of BW. Gastroesophageal and pulmonary aspiration studies by oral route: (2.1) In adults: Gastroesophageal studies: 5.55 to 11.1 MBq (0.15 to 0.3 mCi); Pulmonary aspiration studies: 11.1 to 18.5 MBq (0.3 to 0.5 mCi). In pediatric patients: 3.7 to 11.1 MBq (0.1 to 0.3 mCi). 2.1 Recommended Doses Breast cancer or malignant melanoma setting in adults: 3.7 to 37 MBq (0.1 to 1 mCi) in volumes ranging from 0.1 to 1 mL by subcutaneous injection. Peritoneo-venous (LeVeen) shunt setting in adults: 37 to 111 MBq (1 to 3 mCi) by intraperitoneal injection, or 12 to 37 MBq (0.3 to 1 mCi) in a volume not to exceed 0.5 mL by percutaneous transtubal (efferent limb) injection. Patient repositioning or other measures may be used to help assure uniform mixing of the radiopharmaceutical with peritoneal fluid. Imaging areas of functioning reticuloendothelial cells: In adults: Liver/spleen imaging: 37 to 296 MBq (1 to 8 mCi) by intravenous injection; Bone marrow imaging: 111 to 444 MBq (3 to 12 mCi) by intravenous injection. In pediatric patients: Liver/spleen imaging in children: 0.56 to 2.78 MBq (0.015 to 0.075 mCi) per kg of body weight (BW) by intravenous injection; Liver/spleen imaging in newborns: 7.4 to 18.5 MBq (0.2 to 0.5 mCi) by intravenous injection; Bone marrow imaging: 1.11 to 5.55 MBq (0.03 to 0.15 mCi) per kg of BW by intravenous injection Gastroesophageal and pulmonary aspiration imaging studies: In adults: Gastroesophageal studies: 5.55 to 11.1 MBq (0.15 to 0.3 mCi) by oral administration; Pulmonary aspiration studies: 11.1 to 18.5 MBq (0.3 to 0.5 mCi) by oral administration. In pediatric patients: Gastroesophageal and pulmonary aspiration studies: 3.7 to 11.1 MBq (0.1 to 0.3 mCi) by oral or nasogastric tube administration. For oral administration, combine the radiopharmaceutical with a milk feeding. For...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The most frequently reported adverse reactions, across all categories of use and routes of administration, include rash, allergic reaction, urticaria, anaphylaxis/anaphylactic shock, and hypotension. Less frequently reported adverse reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, and dizziness. Local injection site reactions, including burning, blanching, erythema, sclerosis, swelling, eschar, and scarring, have also been reported. The most frequently reported adverse reactions include rash, urticaria, anaphylactic shock, and hypotension. (6) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc., dba Jubilant Radiopharma TM at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

7 DRUG INTERACTIONS Specific drug-drug interactions have not been studied.

Contraindications

4 CONTRAINDICATIONS None None ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sulfur Colloid Injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium Tc 99m crosses the placenta [see Data] . Animal reproduction studies have not been conducted with Technetium Tc 99m Sulfur Colloid Injection. All radiopharmaceuticals, including Technetium Tc 99m Sulfur Colloid Injection, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Technetium Tc 99m Sulfur Colloid Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug 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 is 2 to 4% and 15 to 20%, respectively. Data Human Data Among 14 infants born to pregnant patients exposed to Technetium Tc 99m Sulfur Colloid Injection for lymph node localization, no birth defects were reported following drug exposure.

Overdosage

10 OVERDOSAGE The clinical consequences of overdosing with Technetium Tc 99m Sulfur Colloid Injection are not known.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits (NDC 65174-179-05). All kit components are sterile and non-pyrogenic. Each 10 mL Multi-Dose Reaction Vial (NDC 65174-131-01) contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; each Solution A vial (NDC 65174-046-01) contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial (NDC 65174-047-01) contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Included in each 5-kit package are one package insert and 10 radiation labels. Store the kit at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] as packaged and after reconstitution. Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection must comport with the product labeling and is approved for distribution to facilities and persons licensed by the U.S. Nuclear Regulatory Commission or under an equivalent license issued by an Agreement State.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.