ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Technetium Tc-99m sulfur colloid: Drug information

Technetium Tc-99m sulfur colloid: Drug information
For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Breast cancer lymph node localization

Breast cancer lymph node localization: SubQ: 0.1 to 1 mCi (3.7 to 37 MBq) in volumes ranging from 0.1 to 1 mL

Malignant melanoma lymph node localization

Malignant melanoma lymph node localization: SubQ: 0.1 to 1 mCi (3.7 to 37 MBq) in volumes ranging from 0.1 to 1 mL

Peritoneo-venous shunt patency evaluation

Peritoneo-venous (LeVeen) shunt patency evaluation:

Intraperitoneal injection: 1 to 3 mCi (37 to 111 MBq)

Percutaneous transtubal (efferent limb) injection: 0.3 to 1 mCi (12 to 37 MBq) in a maximum volume of 0.5 mL

Reticuloendothelial cell imaging

Reticuloendothelial cell imaging:

Bone marrow: IV: 3 to 12 mCi (111 to 444 MBq)

Liver/spleen: IV: 1 to 8 mCi (37 to 296 MBq)

Esophageal transit studies, gastroesophageal reflux scintigraphy, pulmonary aspiration imaging

Esophageal transit studies, gastroesophageal reflux scintigraphy, pulmonary aspiration imaging:

Gastroesophageal studies: Oral: 0.15 to 0.3 mCi (5.55 to 11.1 MBq)

Pulmonary aspiration studies: Oral: 0.3 to 0.5 mCi (11.1 to 18.5 MBq)

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Reticuloendothelial cell imaging

Reticuloendothelial cell imaging:

Bone marrow: Pediatrics: IV: 0.03 to 0.15 mCi/kg (1.11 to 5.55 MBq/kg)

Liver/spleen:

Newborn Infants: IV: 0.2 to 0.5 mCi (7.4 to 18.5 MBq)

Children and Adolescents: IV: 0.015 to 0.075 mCi/kg (0.56 to 2.78 MBq/kg)

Esophageal transit studies, gastroesophageal reflux scintigraphy, pulmonary aspiration imaging

Esophageal transit studies, gastroesophageal reflux scintigraphy, pulmonary aspiration imaging: Gastroesophageal studies or pulmonary aspiration studies: Pediatrics: Oral or nasogastric tube: 0.1 to 0.3 mCi (3.7 to 11.1 MBq)

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Cardiorespiratory arrest, flushing, hypotension, localized blanching

Central nervous system: Chills, dizziness, numbness, seizure

Dermatologic: Diaphoresis, pruritus, scarring (injection site), skin rash, skin sclerosis (injection site), urticaria

Gastrointestinal: Abdominal pain, nausea, vomiting

Hypersensitivity: Anaphylactic shock, anaphylaxis, hypersensitivity reaction

Local: Burning sensation at injection site, erythema at injection site, swelling at injection site, tissue necrosis at injection site (eschar)

Respiratory: Bronchospasm, dyspnea

Miscellaneous: Fever

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Anaphylactic reactions (bronchospasm, hypotension, urticarial), with rare fatalities have occurred. Medications, equipment, and personnel for management of hypersensitivity reactions should be available during administration.

• Malignancy: Radiation-emitting products may increase the risk for cancer, particularly in children. Use the smallest dose necessary and ensure safe handling to protect patients and healthcare workers.

• Pulmonary accumulation: Technetium Tc 99m sulfur colloid is physically unstable; particles may settle with exposure/time. Following IV administration, larger particles may be trapped by the pulmonary capillary bed, resulting in uneven distribution of radioactivity. Agitate vial adequately prior to administration to avoid particle aggregation and nonuniform distribution.

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Note: Contents of kit are not radioactive; however, adequate shielding is required after addition of radioactive material.

Other warnings/precautions:

• Gastroesophageal imaging: May consider administering via nasogastric tube to facilitate imaging for gastroesophageal reflux.

• Lymph node localization: Tracers are intended to supplement palpation, visual inspection, and other traditional lymph node localization procedures. Node localization is dependent on underlying lymphatic system patency and structure, reticuloendothelial cell function within nodes, and the radiopharmaceutical injection technique. Distortion by prior surgery, radiation therapy, or metastatic disease may result in failure to localize nodes. Technetium Tc 99m sulfur colloid, like other tracers, may not localize all nodes; tracers may differ in extent of lymph node localization.

• Peritoneal clearance: Following intraperitoneal administration, tracer mixes with peritoneal fluid; clearance from peritoneal cavity (into systemic circulation) varies depending on shunt patency; concentrates in the liver following transfer to systemic circulation. Obtain serial images of shunt and liver. An adequate evaluation of complete versus partial shunt blockage may not be possible. Transperitoneal absorption may occur, although it would be slow. The most definitive evaluation of both shunt and liver/spleen is generally obtained within 3 hours after intraperitoneal injection.

• Reticuloendothelial cell imaging: Altered biodistribution with lung and soft tissue uptake (instead of reticuloendothelial system) has been observed after IV administration. Biodistribution and reticuloendothelial uptake may be determined by particle size and physical-chemical properties formed during preparation. Diseases affecting the reticuloendothelial system may also affect uptake.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Injection:

Generic: Contents to be combined with Technetium Tc 99m pertechnetate sodium (not included)]

Generic Equivalent Available: US

Yes

Administration: Adult

Route of administration varies by indication. Agitate the vial/syringe (carefully) immediately prior to administration to avoid particle aggregation and to assure uniform radioactivity distribution.

Breast cancer or malignant melanoma, lymph node localization: Administer SubQ; used in conjunction with a handheld gamma counter to identify nodes

Peritoneo-venous (LaVeen) shunt patency evaluation: Administer either by intraperitoneal injection or by percutaneous transtubal (efferent limb; maximum volume of 0.5 mL) injection. Consider patient repositioning or other measures to help assure uniform radiopharmaceutical mixing with the peritoneal fluid.

Reticuloendothelial cell imaging: Administer IV

Gastroesophageal imaging studies and pulmonary aspiration studies: Administer orally. To facilitate GI reflux imaging, consider administering by nasogastric tube.

Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.

Administration: Pediatric

Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding, including syringe shields, when handling.

IV, oral, nasogastric: Contents of vials are not for direct administration; only reconstituted technetium Tc 99m sulfur colloid may be administered to patients. Carefully agitate the shielded syringe immediately prior to administration to avoid particle aggregation and to uniformly distribute radioactivity. Route of administration varies by indication.

Reticuloendothelial cell imaging: Administer by IV injection.

Gastroesophageal imaging studies and pulmonary aspiration studies: May be administered either orally or by nasogastric tube. To facilitate GI reflux imaging, consider administering by nasogastric tube.

Oral administration: Combine with a milk feeding.

Nasogastric administration: Administer into the stomach, then instill a normal volume of dextrose or milk feeding.

Use: Labeled Indications

Imaging agent: Localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma (when used with a handheld gamma counter); reticuloendothelial cell function imaging agent (liver, spleen, bone marrow); evaluation of peritoneo-venous (LeVeen) shunt patency; esophageal transit studies, gastroesophageal reflux scintigraphy, detection of pulmonary aspiration of gastric contents

Medication Safety Issues
Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Pregnancy status should be evaluated prior to use in women of reproductive potential (SNM 2010).

Pregnancy Considerations

Unbound technetium crosses the placenta. Technetium Tc 99m can be detected in fetal tissue; the amount depends upon the specific formulation, route of administration, and stage of pregnancy (Adelstein 1999). Information related to maternal use of Technetium Tc 99m in pregnancy is limited.

In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose absorbed by the fetus and the stage of pregnancy. High doses of radiopharmaceuticals used for therapeutic procedures are more likely to result in fetal harm. A medically required diagnostic procedure can usually be modified to decrease fetal risk. Elective diagnostic procedures should be delayed until after delivery (Adelstein 1999; ICRP 2000; SNM 2010).

Breastfeeding Considerations

Technetium Tc 99m is present in breast milk.

According to the manufacturer, the decision to breastfeed following imaging should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Available guidelines recommend lactating women interrupt breastfeeding for a period of 4 hours after receiving technetium Tc 99m sulfur colloid for liver scans (IAEA 2018). During the period of breastfeeding interruption, the manufacturer recommends substituting formula for breast milk. Alternatively, women can pump and store breast milk prior to the procedure, which can be bottle-fed (Harding 1995). Following higher dose (>370 MBq) procedures, the manufacturer recommends avoiding close contact with infants for 6 hours.

Elective diagnostic procedures should be delayed until breastfeeding has stopped (SNM 2010). Women who are breastfeeding and caring for individuals undergoing nuclear medicine procedures do not need any additional precautions (ABM [Mitchell 2019]).

Monitoring Parameters

Pregnancy status should be evaluated prior to use in women of reproductive potential (Parker 2010). Monitor for signs/symptoms of hypersensitivity reactions.

Mechanism of Action

Radioactive diagnostic agent which decays by isomeric transition to emit a photon that can be detected by imaging.

Pharmacokinetics (Adult Data Unless Noted)

Distribution:

Intraperitoneal: Distributed to the peritoneal fluid

IV: Distributed to the reticuloendothelial system

Oral: Distributed through the gastrointestinal tract

SubQ: Distributed to lymphatic capillaries and then to the lymph nodes

Half-life elimination: Half-life, nominal: IV: ~2.5 minutes; Half-life, physical: 6 hours

Excretion: Oral: Feces (primarily)

  1. Adelstein SJ. Administered radionuclides in pregnancy. Teratology, 1999, 59(4):236-9. [PubMed 10331526]
  2. International Atomic Energy Agency. IAEA Safety Standards for Protecting People and the Environment: Radiation Protection and Safety in Medical Uses of Ionizing Radiation. Specific Safety Guide No. SSG-46. IAEA; 2018. https://www​.iaea.org​/publications/11102/radiation-protection-and-safety-in-medical-uses-of-ionizing-radiation.
  3. International Commission on Radiological Protection (ICRP). Pregnancy and medical radiation. Ann ICRP. 2000;30(1):iii-viii, 1-43. [PubMed 11108925]
  4. Mitchell KB, Fleming MM, Anderson PO, Giesbrandt JG; Academy of Breastfeeding Medicine. ABM Clinical Protocol #31: radiology and nuclear medicine studies in lactating women. Breastfeed Med. 2019;14(5):290‐294. doi:10.1089/bfm.2019.29128.kbm [PubMed 31107104]
  5. Society of Nuclear medicine (SNM). Society of Nuclear Medicine procedure guideline for general imaging. Version 6.0. Revised 2010. http://s3.amazonaws.com/rdcms-snmmi/files/production/public/docs/General_Imaging_Version_6.0.pdf. Accessed July 22, 2019.
  6. Technetium Tc 99m Sulfur Colloid Kit [prescribing information]. Billerica, MA: Pharmalucence Inc; October 2019.
Topic 91064 Version 56.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟