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Technetium Tc 99m Sulfur Colloid (Systemic)

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VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): AN-Sulfur Colloid; Frosstimage Sulfur Colloid; TSC; TechneColl; TechneScan Sulfur Colloid.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (hepatic disease; hematological disease; spleen disease; gastroesophageal disorders; gastrointestinal disorders)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Liver imaging, radionuclide—Technetium Tc 99m sulfur colloid, administered intravenously, is indicated for imaging the functioning reticuloendothelial cells of the liver in the evaluation of metastatic disease, primary liver tumors, abscesses, and other focal hepatic lesions; and in the evaluation of patients with cirrhosis, hepatitis, and other hepatic disorders. {05} {08} {09} {10} {13} {14} {21} {25} {34}

Spleen imaging, radionuclide—Technetium Tc 99m sulfur colloid, administered intravenously, is indicated for imaging the functioning reticuloendothelial cells of the spleen, thus serving to demonstrate clinically significant splenomegaly, and in the evaluation of splenic infarct, other local splenic lesions, or splenic rupture. {05} {08} {09} {10} {14} {25} {27} {34}

Bone marrow imaging, radionuclide—Technetium Tc 99m sulfur colloid, administered intravenously, is indicated for imaging the functioning reticuloendothelial cells of the bone marrow to complement other hematological studies for the evaluation of hematopoiesis in hematological diseases, such as leukemia, polycythemia, anemias, and myelofibrosis. {03} {05} {08} {09} {14}

Esophageal imaging, radionuclide1—Technetium Tc 99m sulfur colloid, administered orally, is indicated in adults and children for esophageal transit studies, gastroesophageal reflux scintigraphy, and the detection of pulmonary aspiration of gastric contents. {01} {02} {03} {08} {14} {17} {20} {22} {29} {31} {32} {33}

LeVeen peritoneovenous shunt patency assessment1—Intraperitoneal technetium Tc 99m sulfur colloid is indicated in adults to determine the patency of a peritoneovenous shunt in patients with ascites. {01} {22}

[Bleeding, gastrointestinal (diagnosis)]1—Technetium Tc 99m sulfur colloid, administered intravenously, is used to detect and locate the site of bleeding in the gastrointestinal tract. {18} {19} {34}

[Gastric emptying studies]1—Technetium Tc 99m sulfur colloid is used orally in studies to evaluate gastric function in patients with suspected anatomical or functional obstruction, or hypomotility (e.g., gastroparesis). {01} {03} {05} {14} {16}

1 Not included in Canadian product labeling.



Physical Properties

Nuclear data {01} {08} {09}:



Radionuclide
(half-life)
Decay
constant
Mode
of
decay
Principal
photon
emissions
(keV)
Mean
number of
emissions/
disintegration
(³0.01)
Tc 99m
(6.0 hr)
0.1151 h -1
Isomeric
transition to
Tc 99
18
0.062
140.5
0.891


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Diagnostic aid (hepatic disease; hematological disease; spleen disease)—Radioactive colloids are phagocytized by the reticuloendothelial system of the liver, spleen, and bone marrow, and remain there long enough for scintillation scans of their distribution to be obtained. {13}

Diagnostic aid (gastroesophageal disorders)—Esophageal transit of technetium Tc 99m sulfur colloid after oral administration is depicted scintigraphically and quantified by computer assistance. {03} {17}

Diagnostic aid (gastrointestinal disorders)—Gastrointestinal bleeding: After intravenous injection, technetium Tc 99m sulfur colloid circulates in the blood until it is cleared by the cells of the reticuloendothelial system. If active gastrointestinal bleeding is occurring during this period, there will be accumulation of the tracer in the lumen of the gastrointestinal tract at the site of bleeding, thus permitting scintigraphic detection and localization. {05} {18} {34}

Absorption:

Rapidly phagocytized by the reticuloendothelial system after intravenous administration. {05} {13} {14} {22} {23}

Distribution:


Parenteral:

Distribution dependent on relative blood flow and functional capacity of phagocytic cells; technetium Tc 99m sulfur colloid is selectively concentrated in reticuloendothelial system of the liver, spleen, and bone marrow. About 80 to 90% of the injected colloidal particles are phagocytized by the Kupffer cells of the liver, 5 to 10% by the spleen, and the balance by the bone marrow. {01} {04} {09} {14}

Uptake may be decreased in the liver and increased in the spleen and bone marrow of patients with impaired portal circulation or Kupffer cell dysfunction. {04}

Several cases of uptake in the lungs and other soft tissues have been reported in the presence of a wide variety of disorders, usually inflammatory or neoplastic. {01} {14}


Half-life:

Elimination from the blood pool—2.5 minutes. {04} {23} {34}

Time to radioactivity visualization


With intravenous administration:

Liver and spleen imaging: 10 to 15 minutes. {14}

Note: Onset of hepatic visualization may be delayed in patients with severe hepatic disease because of slower blood clearance of the radiopharmaceutical, with an overall result of decreased liver uptake and increased spleen and marrow uptake. {14} {34}
Bone marrow imaging: 15 minutes. {14}




With oral administration:

Esophageal imaging: Immediate; usually as the patient swallows, in a single swallow, the water containing technetium Tc 99m sulfur colloid. {14}


Radiation dosimetry:
{27}

Organ
Estimated absorbed radiation dose*
With normal
hepatic function
With parenchymal
liver disease
(intermediate/advanced)

mGy/
MBq
rad/
mCi
mGy/
MBq
rad/
mCi
Spleen
0.077
0.29
0.14
0.52
Liver
0.074
0.27
0.042
0.16
Pancreas
0.012
0.044
0.018
0.066
Red marrow
0.011
0.041
0.023
0.085
Adrenals
0.010
0.037
0.0098
0.036
Kidneys
0.0097
0.036
0.011
0.041
Bone surfaces
0.0064
0.024
0.012
0.044
Stomach wall
0.0062
0.023
0.0098
0.036
Large intestine
wall (upper)

0.0056

0.021

0.0049

0.018
Lungs
0.0055
0.20
0.0048
0.018
Small intestine
0.0043
0.016
0.0046
0.017
Breast
0.0027
0.010
0.0024
0.0089
Ovaries
0.0022
0.0081
0.0033
0.012
Uterus
0.0019
0.0070
0.0028
0.010
Large intestine
wall (lower)

0.0018

0.0067

0.0031

0.011
Bladder wall
0.0011
0.0041
0.0016
0.0059
Thyroid
0.00079
0.0029
0.0011
0.0041
Testes
0.00062
0.0023
0.00095
0.0035
Other tissue
0.0028
0.010
0.0031
0.011


Radionuclide
Effective dose*
With normal
hepatic function
With parenchymal
liver disease
(intermediate/advanced)

mSv/
MBq
rem/
mCi
mSv/
MBq
rem/
mCi
Tc 99m
0.014
0.052
0.017
0.063
* For adults; intravenous injection of technetium Tc 99m–labeled large colloids. Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation dose to patients from radiopharmaceuticals. {27}

Elimination:
    Renal, about 3% of the administered activity eliminated within 48 hours after intravenous administration. {04}


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of technetium Tc 99m sulfur colloid have not been performed. {22}

Pregnancy/Reproduction

Pregnancy—
Tc 99m (as free pertechnetate) crosses the placenta. However, studies with technetium Tc 99m sulfur colloid have not been done in humans.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist where the benefit to the patient and fetus, based on information derived from radiopharmaceutical use, outweighs the risks from fetal exposure to radiation. In these situations, the physician should use discretion and reduce the radiopharmaceutical dose to the lowest possible amount. {12}

Studies have not been done in animals. {08} {14}

FDA Pregnancy Category C. {08} {22}

Breast-feeding

Although it is not known whether technetium Tc 99m sulfur colloid is distributed into breast milk, it is known that Tc 99m as free pertechnetate is distributed into breast milk. Based on the assumption that the Tc 99m in breast milk is in the form of pertechnetate and based on the effective half-life of the radionuclide in breast milk, the daily volume of milk, a dose factor relating the radionuclide to its critical organ (thyroid) in the nursing infant, and the maximum permissible dose to that organ, a guideline has been proposed. According to this guideline, it has been calculated that nursing can be safely resumed when the concentration in breast milk reaches 30.3 × 10 -4 megabecquerels (8.2 × 10 -2 microcuries) per mL. This level of activity is probably reached, in the majority of patients, within 12 to 24 hours after administration of technetium Tc 99m–labeled radiopharmaceuticals. {11} {14} {24}

Pediatrics

Diagnostic studies performed to date using technetium Tc 99 sulfur colloid have not demonstrated pediatrics-specific problems that would limit the usefulness of technetium Tc 99m sulfur colloid in children. However, when this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. {12} {15} {30}


Geriatrics


Appropriate studies on the relationship of age to the effects of technetium Tc 99m sulfur colloid have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
See Diagnostic interference. {01}

Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of this test

Due to other medications
Anesthetics, inhalation, such as halothane{06}{14}    (recent administration of general anesthetics may increase splenic uptake of technetium Tc 99m sulfur colloid, probably because the reduced hepatic flow and hepatotoxicity associated with general anesthetics may alter the hepatic radiocolloid extraction efficiency, resulting in a reversal of the normal liver-spleen colloid distribution pattern {06} {14})


Antacids, aluminum-containing, high doses or long-term use or{06}{09}{14}{23}
Magnesium sulfate, parenteral or{09}{23}
Polyvalent cations{06}{23}    (reticuloendothelial cell imaging may be impaired by polyvalent cations, which cause agglomeration of the individual colloidal particles leading to trapping by the pulmonary capillary bed rather than the reticuloendothelial cells of the liver, spleen, and bone marrow {06} {23})


Chemotherapy, especially with nitrosoureas    (use of technetium Tc 99m sulfur colloid in patients who are undergoing or have recently undergone chemotherapy, may result in inhomogeneous or irregular hepatic uptake, shift of activity from the liver to the bone marrow and spleen, and hepatomegaly; irregular hepatic distribution of radiopharmaceutical may be misinterpreted as malignancy; thus, it is recommended that liver and/or spleen imaging be done prior to initiating chemotherapy with these agents or several weeks after discontinuing therapy {06} {14} {26})


Reticuloendothelial system stimulators, such as:
Dextrose{26}
Heparin{26}
Steroid hormones (including estrogen){06}{14}{26}
Thyroid hormones{26}
Vitamin B 12{26}    (use of technetium Tc 99m sulfur colloid in patients receiving these medicines may result in lung uptake of technetium Tc 99m sulfur colloid, probably due to a drug-induced increase in number of free intravascular macrophages, which may migrate to pulmonary capillary bed and phagocytize colloidal particles there {05} {06})


Due to medical problems or conditions
Malaria    (diffuse lung uptake of technetium Tc 99m sulfur colloid may occur, probably related to increased reticuloendothelial system activity due to malaria-induced increase in the pulmonary macrophages {28} {34})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to the radiopharmaceutical preparation, especially gelatin-containing preparations{09}{14}


Side/Adverse Effects

Note: Cardiopulmonary arrest has been reported rarely with the administration of technetium Tc 99m sulfur colloid. {01} {08}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Allergic reaction (coughing or choking; flushing or redness of face; skin rash, hives, or itching; swelling of throat, hands, or feet; wheezing, tightness in chest, or troubled breathing)
    
bronchospasm with or without pulmonary edema (severe wheezing or troubled breathing)
    
fever
    
hypotension (severe tiredness or weakness)
    
pain or burning sensation at injection site
    
seizures
    
slow or irregular heartbeat{08}{09}{14}{22}
Note: The allergic reaction may be the initial manifestation of a more severe anaphylactic reaction.
Allergic reactions and fever may be caused by the colloid stabilizer (i.e., gelatin) used in the preparation. {09} {14}





Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
    
Dizziness
    
nausea or vomiting{08}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use

Action in the body
Accumulation of radioactive colloid particles in liver, spleen, and bone marrow

Esophageal and gastric transit of radiocolloid
Retention of radioactivity in these organs allows visualization; or transit of radioactivity through mouth/esophagus/stomach allows visualization

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:
Sensitivity to radiopharmaceutical preparation

Pregnancy—Technetium Tc 99m (as free pertechnetate) crosses placenta; risk to fetus from radiation exposure as opposed to benefit derived from use should be considered





Breast-feeding—Not known if technetium Tc 99m sulfur colloid is distributed into breast milk, but Tc 99m as free pertechnetate is distributed into breast milk; temporary discontinuation of nursing may be recommended because of risk to infant from radiation exposure





Use in children—Risk of radiation exposure as opposed to benefit derived from use should be considered


Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance (fasting required for esophageal imaging and gastric emptying studies)

Precautions after having this test
No special precautions


Side/adverse effects
Signs of potential side effects, especially allergic reaction, fever, hypotension, pain or burning sensation at injection site, seizures, slow or irregular heartbeat, or respiratory distress


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency, if required, or, outside the U.S., the appropriate authority. {09} {13}

Epinephrine, antihistamines, and corticosteroids should be available during the administration of technetium Tc 99m sulfur colloid because of the possibility of allergic reactions. {09} {14}

Safety considerations for handling this radiopharmaceutical
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals.


Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

TECHNETIUM Tc 99m SULFUR COLLOID INJECTION USP

Usual adult and adolescent administered activity
Liver and/or spleen imaging
Intravenous, 37 to 296 megabecquerels (1 to 8 millicuries). {08} {22}

Bone marrow imaging
Intravenous, 111 to 444 megabecquerels (3 to 12 millicuries). {08} {14} {22}

Esophageal imaging1
Gastroesophageal studies: Oral, 5.55 to 11.1 megabecquerels (150 to 300 microcuries). {08} {20} {22}

Pulmonary aspiration studies: Oral, 11.1 to 18.5 megabecquerels (300 to 500 microcuries). {08} {22}

LeVeen shunt patency1
Intraperitoneal, 37 to 111 megabecquerels (1 to 3 millicuries). {01} {22}

Percutaneous transtubal, 12 to 37 megabecquerels (0.3 to 1 millicurie) in a volume not to exceed 0.5 mL. {01} {22}

[Diagnosis of gastrointestinal bleeding]1
Intravenous or intra-arterial, 370 megabecquerels (10 millicuries). {18} {19}

[Gastric emptying studies]1
Oral, 9.2 to 37 megabecquerels (0.25 to 1 millicurie). {27}

Note: For gastric emptying studies, the dosage may be given in a liquid or incorporated into food such as scrambled eggs.



Usual pediatric administered activity
Liver and/or spleen imaging
Intravenous, 0.55 to 2.75 megabecquerels (15 to 75 microcuries) per kg of body weight. {08} {14} {22}

Note: In newborns the total administered activity should be 7.4 to 18.5 megabecquerels (200 to 500 microcuries), since a minimum administered activity of 7.4 megabecquerels (200 microcuries) is required for this procedure. {08}


Bone marrow imaging
Intravenous, 1.11 to 5.55 megabecquerels (30 to 150 microcuries) per kg of body weight. {08} {22}

Note: In newborns a maximum total administered activity of 22.2 megabecquerels (600 microcuries) is recommended, since this is the minimum administered activity required for this procedure. {08}


Esophageal imaging1
Gastroesophageal and pulmonary aspiration studies: Oral, 3.7 to 11.1 megabecquerels (100 to 300 microcuries). {08} {14} {17}

Note: Oral dosage may be incorporated into milk feeding. However, to avoid preliminary contamination of the esophagus, the oral dosage may be instilled directly into the stomach by intubation, followed by a dextrose or milk meal. {08} {34}



Usual geriatric administered activity
See Usual adult and adolescent administered activity .

Strength(s) usually available
U.S.—


2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium, and 18.1 mg gelatin, per 10-mL multidose reaction vial; 1.5 mL of 0.148 N hydrochloric acid solution per syringe A; and 1.5 mL aqueous solution of 38.8 mg sodium biphosphate anhydrous and 11.1 mg sodium hydroxide, per syringe B (Rx) [AN-Sulfur Colloid] [TechneScan Sulfur Colloid{22}{23}]


50 mg phosphoric acid per mL or reaction mixture vial; 12 mg gelatin and 9 mg sodium chloride per mL in one compartment, and 12 mg sodium thiosulfate per mL in the other compartment of syringe I; 36 mg gelatin and 9 mg sodium chloride per mL in one compartment, and 544 mg sodium acetate and 4 mg edetate disodium per mL in the other compartment of syringe II (Rx) [TechneColl]


0.5 mL of 1.0 N hydrochloric acid per reaction vial; and two syringes, one containing a 1.1 mL aqueous solution of 1.9 mg sodium thiosulfate anhydrous and the other containing 5.3 mg gelatin in 2.1 mL of an aqueous buffer solution containing 177 mg sodium acetate (Rx) [TSC]

Canada—


3 mg sodium thiosulfate, 4.25 mg gelatin, 0.65 mg potassium perrhenate, per mL of reaction vial A; 1 N hydrochloric acid solution per vial B; alkaline buffer solution per vial C (Rx) [Frosstimage Sulfur Colloid{09}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {01} {09} {22} {23}

Preparation of dosage form:
To prepare injection, an oxidant-free sodium pertechnetate Tc 99m solution is used. See manufacturer's package insert for instructions.

Stability:
Preparations containing a flocculent precipitate should not be used. {01} {22} {23}

Injection should be administered within 6 hours after preparation, since particles tend to agglomerate with aging. {22} {23}

Incompatibilities:
Polyvalent cations may decrease the stability of the colloidal preparation. Solutions of sodium pertechnetate Tc 99m containing more than 10 mcg per mL of aluminum ion should not be used since a flocculent precipitate may form. These larger particles may become lodged in the pulmonary capillary bed rather than in the reticuloendothelial system. {09}

If oxidants such as peroxides and hypochlorites are present in the sodium pertechnetate Tc 99m used for labeling, the final preparation may be adversely affected and it should be discarded.

Note: Caution—Radioactive material.
Shake well. {22} {23}




Revised: 06/23/1994



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