Kit for the Preparation of Technetium Tc 99m Sulfur Colloid

Technetium Tc 99m Sulfur Colloid Kit · Kit

Prescription (Rx)

Uses

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

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 nasogastric tube administration, administer the radiopharmaceutical into the stomach then instill a normal volume of dextrose or milk feeding. 2.2 Drug Preparation and Administration The contents of the two Solution vials, the Solution A vial containing the appropriate acidic solution and the Solution B vial containing the appropriate buffer solution, are intended only for use in the preparation of the Technetium Tc 99m Sulfur Colloid Injection and are not to be directly administered to the patient. Do not use Sodium Pertechnetate Tc 99m containing oxidants to reconstitute this kit. The contents of the kit are not radioactive. However, after the Sodium Pertechnetate Tc 99m is added, maintain adequate shielding of the final preparation. Wear waterproof gloves during the preparation procedure. Do not use Sodium Pertechnetate Tc 99m containing more than 10 micrograms per mL of aluminum ion because a flocculent precipitate may occur and such a precipitate may localize in the lung. The contents of the kit are sterile and non-pyrogenic. This preparation contains no bacteriostatic preservative (preservative-free). Follow the directions carefully and adhere strictly to aseptic procedures during preparation. Prepare Technetium Tc 99m Sulfur Colloid Injection by the following aseptic procedure: Remove the dark brown plastic cap from the Sulfur Colloid Multi-Dose Reaction Vial and swab the top of the vial closure with alcohol to sterilize the surface. Complete the radiation label and affix to the vial. Place the vial in an appropriate lead-capped radiation shield labeled and identified. With a sterile shielded syringe, aseptically obtain 1 to 3 mL of a suitable, oxidant-free sterile and non-pyrogenic Sodium Pertechnetate Tc 99m, each milliliter containing a maximum activity of 18,500 MBq (500 mCi). Aseptically add the Sodium Pertechnetate Tc 99m to the vial. Place a lead cover on the vial shield and dissolve the reagent by gentle swirling. Just before use, remove the red cap from the Solution A vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution A from the vial. Aseptically inject 1.5 mL Solution A into the Multi-Dose Reaction Vial and swirl again. Transfer the Multi-Dose Reaction Vial from vial shield and place in a vigorously boiling water bath (water bath should be shielded with 1/8” to 1/4” lead) deep enough to cover the entire liquid contents of the vial. Keep the vial in the water bath for five minutes. Remove the Multi-Dose Reaction Vial from the water bath and place in the lead shield and allow to cool for three minutes. Swab the vial closure again with an antiseptic. Just before use, remove the blue cap from the Solution B vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution B from the vial. Aseptically inject 1.5 mL Solution B into the Multi-Dose Reaction Vial and swirl again.

Dosage forms and strengths

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied in a package that contains 5 kits. All components of a kit are sterile and non-pyrogenic. Each kit contains three vials: one 10 mL Multi-Dose Reaction Vial, a Solution A vial and a Solution B vial. The vials contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection. 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; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial 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. The Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection is supplied as a package that contains 5 kits. Each kit contains three vials: one 10 mL Multi-Dose Reaction Vial, a Solution A vial and a Solution B vial. The vials contain the sterile non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Sulfur Colloid Injection. (3)

Contraindications

None None ( 4 )

Warnings and precautions

Anaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Have resuscitation equipment and personnel immediately available. (5.1) 5.1 Anaphylactic Reactions Anaphylactic reactions with bronchospasm, hypotension, urticaria and rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid Injection. Have emergency resuscitation equipment and personnel immediately available. 5.2 Radiation Risks Radiation-emitting products, including Technetium Tc 99m Sulfur Colloid Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker. [see Dosage and Administration (2.3)] 5.3 Altered Distribution, Accumulation of Tracer in the Lungs Technetium Tc 99m Sulfur Colloid Injection is physically unstable, and the particles will settle with time or with exposure to polyvalent cations. These larger particles are likely to be trapped by the pulmonary capillary bed following intravenous injection and result in non-uniform distribution of radioactivity. Agitate the vial adequately before administration of sulfur colloid to avoid particle aggregation and non-uniform distribution of radioactivity. Discard unused drug after 6 hours from the time of formulation. [see Dosage and Administration (2.2)]

Side effects

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

Specific drug-drug interactions have not been studied.

Use in specific populations

Lactation: Advise a lactating woman to pump and discard breast milk for 24 hours and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection. (8.2) 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. 8.2 Lactation Risk Summary Technetium Tc 99m is excreted in human milk during lactation. Exposure of Technetium Tc 99m Sulfur Colloid Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Technetium Tc 99m Sulfur Colloid Injection and any potential adverse effects on the breastfed child from Technetium Tc 99m Sulfur Colloid Injection or from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection. Following higher dose procedures [greater than 370 MBq (10 mCi)], patients should minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection. 8.4 Pediatric Use The safety and efficacy of Technetium Tc 99m Sulfur Colloid kit in pediatric patients has been shown for the following indications: liver, spleen, and bone marrow imaging, and gastroesophageal and pulmonary aspiration studies. 8.5 Geriatric Use Clinical studies of Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Pregnancy

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.

Pediatric use

8.4 Pediatric Use The safety and efficacy of Technetium Tc 99m Sulfur Colloid kit in pediatric patients has been shown for the following indications: liver, spleen, and bone marrow imaging, and gastroesophageal and pulmonary aspiration studies.

Geriatric use

8.5 Geriatric Use Clinical studies of Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Overdosage

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

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 attenuate the radiation emitted by a factor of about 1,000. Table 8. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 9. Table 9. Physical Decay Chart: Tc 99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time 1.000 6 0.501 1 0.891 7 0.447 2 0.794 8 0.398 3 0.708 9 0.355 4 0.631 10 0.316 5 0.562 11 0.282 - - 12 0.251

Mechanism of action

12.1 Mechanism of Action Technetium Tc 99m decays by isomeric transition, emitting a photon that can be detected for imaging purposes. [see Description (11.1)] Following subcutaneous injection, Technetium Tc 99m Sulfur Colloid enters the lymphatic capillaries and is transported with lymph to lymph nodes. However, when there is massive nodal metastatic involvement, the normal transport to lymph nodes is lost because few normal cells remain in the node. [see Dosage and Administration (2.4)] Following intraperitoneal injection, Technetium Tc 99m Sulfur Colloid mixes with the peritoneal fluid; rate of clearance from the cavity allows assessment of the patency of the shunt. Clearance varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent. Following intravenous injection, Technetium Tc 99m Sulfur Colloid is taken up by the reticuloendothelial system (RES), allowing RES rich structures to be imaged. With oral administration, Technetium Tc 99m Sulfur Colloid is not absorbed accounting for its function in esophageal transit studies, gastroesophageal reflux scintigraphy, and for the detection of pulmonary aspiration of gastric contents.

How supplied

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.

Patient information

Inform patients they may experience a burning sensation at the injection site. Inform lactating woman to pump and discard breast milk for 24 hours after administration of Technetium Tc 99m Sulfur Colloid Injection and minimize close contact with infants for 6 hours after receiving a Technetium Tc 99m Sulfur Colloid Injection ( 8.2 ). Manufactured for: Jubilant DraxImage Inc., dba Jubilant Radiopharma TM 16 751 TransCanada Highway Kirkland, Quebec H9H 4J4 Canada 1-888-633-5343 www.jubilantradiopharma.com Revised: December 2020 Art Rev.: 1.0 50000003096 Jubilant Radiopharma TM is a trademark used under license by Jubilant DraxImage Inc. logo

Label text from the FDA structured product label by Jubilant DraxImage Inc., dba Jubilant Radiopharma (revised Dec 5, 2023). Long sections are shortened; the complete label is on DailyMed.

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid NDC products (1)

NDC	Strength & form	Labeler	Type
65174-179	Kit	Jubilant DraxImage Inc., dba Jubilant Radiopharma	ANDA

Frequently asked questions

What is Kit for the Preparation of Technetium Tc 99m Sulfur Colloid used for?

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Who makes Kit for the Preparation of Technetium Tc 99m Sulfur Colloid?

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid is listed by 1 labeler in the FDA NDC directory, including Jubilant DraxImage Inc., dba Jubilant Radiopharma.