Kit for the preparation of Technetium Tc 99m

Sulfur Colloid Injection

For Subcutaneous, Intraperitoneal, intravenous and Oral Use
For Diagnostic Use by Prescription Only

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.

Sulfur Colloid is available only by prescription, ask your Healthcare Professional if Sulfur Colloid is right for you.

(1) American Society of Clinical Oncology Guideline Recommendations for Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer, Published in Journal of Clinical Oncology.
(2) Sentinel Lymph Node Biopsy for Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Joint Clinical Practice Guideline, March 2012.
(3) Society of Nuclear Medicine Procedure Guideline for Lymphoscintigraphy and the Use of Intraoperative Gamma Probe for Sentinel Lymph Node Localization in Melanoma of Intermediate Thickness, June 2002.

Why Sulfur Colloid?

In lymph node localization procedures, for breast cancer using Sulfur Colloid and blue dye, SCI effectively localized in at least one lymph node in 94% of all studies performed, while blue dye was shown to localize only 85%(4). In malignant melanoma patient studies, SCI affectively localized in at least one lymph node in 96% of all studies performed, while blue dye was shown to localize in only 84%(5)

(4) In 9,213 procedures using both Sulfur Colloid and blue dye, as cited in FDA approved product labeling for Sulfur Colloid (July 2011).
(5) In 249 patients using both Sulfur Colloid and blue dye, as cited in FDA approved product labeling for Sulfur Colloid (August 2012).

Lymph node localization studies performed with Sulfur Colloid are the established standard of care in breast cancer and melanoma patient management. (6,7,8,9) More than 100,000 patients are studied with Sulfur Colloid each year as part of their breast cancer management. (10)

(6) Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer, American Society of Clinical Oncology Clinical Practice Guideline Update, Vol 32 No13 (May1), 2014; 1365-1383
(7) Sentinel Lymph Node Biopsy for Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Joint Clinical Practice Guideline, August 2012.
(8) Society of Nuclear Medicine Procedure Guideline for Lymphoscintigraphy and the Use of Intraoperative Gamma Probe for Sentinel Lymph Node Localization in Melanoma of Intermediate Thickness, June 2002.
(9) The EANM and SNMI practice guideline for lymphoscintigraphy and sentinel node localization in breast cancer, August 2013.
(10) Data complied by Braid-Forbes Health Research LLC, Silver Spring, MD, 2012.

In 8,730 patients studied in 13 clinical publications evaluated for patient safety in lymph node localization in either breast cancer or melanoma patients, there were no adverse events reported attributed with the use of Sulfur Colloid. However, 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. Local injection site reactions, including burning, blanching, erythema, sclerosis, swelling, eschar, and scarring, have also been reported.(11) 

(11) Pharmalucence Sulfur Colloid s-NDA submissions to FDA (approved 2011 and 2012) 

IMPORTANT SAFETY INFORMATION

WARNINGS AND GENERAL PRECAUTIONS

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.

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.

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.

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.

Please See Full Prescribing Information Above

The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Kit for the preparation of Technetium Tc 99m Sulfur Colloid as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.