Administration Procedure for SIR-Spheres Y-90 resin microspheres

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This video series has been created by Sirtex Medical to serve as an educational resource that provides a narrative look at Selective Internal Radiation Therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres.
SIRT, also known as radioembolization, is a proven technology for inoperable liver cancer that delivers doses of radiation directly to the site of tumors. In a minimally invasive treatment, millions of radioactive SIR-Spheres Y-90 resin microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.
Clinical studies have confirmed that patients with metastatic colorectal cancer treated with SIR-Spheres Y-90 resin microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.
Learn more at www.sirtex.com
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. SIR-Spheres Y-90 resin microspheres may only be distributed to a duly licensed or accredited facility capable of handling therapeutic medical isotopes. This product is radioactive and should thus be handled in accordance with all applicable standards and regulations.
Intended Use / Indications For Use: SIR-Spheres Y-90 resin microspheres are approved for use in Argentina, Australia, Brazil, the European Union (CE Mark), Switzerland, Turkey, and several countries in Asia for the treatment of unresectable liver tumors. In the US, SIR-Spheres Y-90 resin microspheres have a Pre-Market Approval (PMA) from the FDA and are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).
Warnings / Precautions: Inadvertent delivery of the microspheres to locations other than the intended hepatic tumor may result in local radiation damage. Due to the radioactivity and the significant consequences of misplacing the microspheres in situ, this product must be implanted by physicians who have completed the Sirtex TEC training program. A SPECT scan of the upper abdomen immediately after implantation is recommended. Patients may experience abdominal pain immediately after administration and pain relief may be required. H-2 blocking agents may be administered the day before implantation and continued as needed to reduce gastric complications.
Side Effects: Common side effects are fever, transient decrease of hemoglobin, mild to moderate abnormality of liver function tests, abdominal pain, nausea, vomiting, and diarrhea. Potential serious effects due to exposure to high radiation include acute pancreatitis, radiation pneumonitis, acute gastritis, radiation hepatitis, and acute cholecystitis.
Contraindications: SIR-Spheres Y-90 resin microspheres should not be implanted in patients who have either had previous external beam radiation therapy to the liver, ascites, or are in clinical liver failure. This device is contraindicated in patients with markedly abnormal synthetic and excretory liver function tests, greater than 20% lung shunting of the hepatic artery blood flow, disseminated extra-hepatic malignant disease, and portal vein thrombosis. This device should not be implanted in patients determined via angiogram to have an abnormal vascular anatomy that would result in significant reflux of the hepatic arterial blood flow to the stomach, pancreas or bowel.
Reference the Package Insert (www.sirtex.com) for a complete listing of indications, contraindications, side effects, warnings, and precautions.
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd.
Sirtex Medical Inc., 300 Unicorn Park Drive, Woburn, MA 01801
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©2016 Sirtex Medical Inc.
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