Kit for the preparation of Technetium Tc 99m

Sulfur Colloid Injection

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

PATIENT INFORMATION

The resources below are provided to help you learn more about the management of Breast Cancer or Malignant Melanoma and the role of lymph node localization in diagnosis and treatment.

The American Society of Clinical Oncology Guideline Recommendations for Sentinel Lymph Node Biopsy in Early – Stage Breast Cancer
www.asco.org

Sentinel Lymph Node Biopsy for Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Joint Clinical Practice Guideline, March 2012.
www.asco.org

From the National Cancer Institute, understanding Sentinel Lymph Node Biopsy
www.cancer.gov

The EANM and SNMMI practice guideline for lymphoscintigraphy and sentinel node localization in breast cancer
www.snmmi.org

EANM practice guidelines for lymphoscintigraphy and sentinel lymph node biopsy in melanoma
www.snmmi.org

Additional Breast Cancer information
breastcancercourse.org

 

VIDEOS

What is Cancer? (produced by Cancerquest, a cancer education and outreach program at Emory University)

What is Sentinel Lymph Node Biopsy? (produced by Cancerquest, a cancer education and outreach program at Emory University)

NOTE: These resources are not associated with Pharmalucence.com. By clicking on the links above, you will leave the Pharmalucence.com website. Pharmalucence accepts no responsibility for the content of the linked sites.

What is Sulfur Colloid?
Sulfur Colloid is a prescription diagnostic imaging agent used in a variety of FDA approved indications. When prepared with technetium 99m, a common radionuclide used in many nuclear medicine procedures, it forms a chemical complex used to image and evaluate: 

  • Lymph nodes that drain a primary tumor in breast cancer or malignant melanoma patients 
  • Reticuloendothelial cells in the liver, spleen and bone marrow 
  • Esophageal transit and gastroesophageal reflux 

What is Sulfur Colloid’s role in the evaluation of breast cancer or malignant melanoma tumors?
Sulfur Colloid received FDA approvals in 2011 and 2012 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. Sulfur Colloid helps cancer surgeons locate lymph nodes draining a primary tumor so they can be removed and analyzed to determine the presence or absence of tumor cells. When no tumor cells are present in the target node, the surgeon may be able to avoid additional surgery or other invasive procedures. 

How does Sulfur Colloid help patients with breast cancer or malignant melanoma?
In patients with early onset of disease, lymph node localization with Sulfur Colloid has been an accepted strategy in breast cancer or malignant melanoma patient management for over a decade with hundreds of thousands (1) of cancer patients benefitting from less invasive surgical procedures during the treatment of their disease. Lymph node localization with Sulfur Colloid, with or without blue dye injection, has evolved into the standard of care in clinical practice (2,3,4). This practice is the product of extensive research documented by voluminous peer reviewed professional publications.Ask your healthcare professional if Sulfur Colloid is right for you in your management of Breast Cancer or Malignant Melanoma. 

How is Sulfur Colloid used in a lymph node localization procedure?
During a lymph node localization procedure, Sulfur Colloid is injected in the skin near the site of a primary tumor. Sulfur colloid will enter the lymphatics and follow the drainage path of the tumor to the nearest lymph node or nodes. A gamma detection probe is used to scan the known regions of drainage with the intent of finding a signal associated with the accumulation of the radioactive sulfur colloid within a lymph node. Once a lymph node is identified, it can be surgically removed for examination by a pathologist for malignancy.How long has Sulfur Colloid been used as a radiopharmaceutical in nuclear medicine procedures?Sulfur Colloid was first approved for clinical use in 1978 for use as a liver and spleen cell imaging agent. Its use has expanded greatly since then to numerous FDA approved clinically indicated uses. It can be administered by subcutaneous, intraperitoneal, intravenous and oral routes. 

Is Sulfur Colloid safe?
With a clinical history spanning over thirty years and millions of administrations, Sulfur Colloid has an excellent safety profile. This is supported by zero reports of adverse events attributed to the use of Sulfur Colloid in studies supporting all lymph lode localization indications. See product package insert for full prescribing and safety information. 

(1) As projected from CMS Medicare claims data, over 100,000 patients received Sulfur Colloid as part of their breast cancer evaluation and management in 2010 alone. Data compiled by Braid-Forbes Health Research LLC, Silver Spring, MD, 2012.

(2) American Society of Clinical Oncology Guideline Recommendations for Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer, Published in Journal of Clinical Oncology, Vol 23, No 30 (October 20), 2005: pp. 7703-7720.

(3) Sentinel Lymph Node Biopsy for Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Joint Clinical Practice Guideline, March 2012.

(4) 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. 

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.