SIR-Spheres® Y-90 resin microspheres are indicated for the treatment of patients with inoperable liver tumours.

Contraindications

SIR-Spheres Y-90 resin microspheres are contraindicated in patients who have:

  • had previous external beam radiation therapy to the liver;
  • ascites or are in clinical liver failure;
  • markedly abnormal synthetic and excretory liver function tests (LFTs);
  • greater than 20% lung shunting of the hepatic artery blood flow determined by Technetium-99m macroaggregated human albumin (99mTc-MAA)  scan;
  • pre-assessment angiogram that demonstrates abnormal vascular anatomy that would result in significant reflux of hepatic arterial blood to the stomach, pancreas or bowel;
  • disseminated extra-hepatic malignant disease;
  • been treated with capecitabine within the two previous months, or who will be treated with capecitabine at any time following treatment with SIR-Spheres Y-90 resin microspheres.

Warnings

  • Inadvertent delivery of SIR-Spheres Y-90 resin microspheres to the gastrointestinal tract or pancreas will cause acute abdominal pain, acute pancreatitis or peptic ulceration. 
  • High levels of implanted radiation and/or excessive shunting to the lung may lead to radiation pneumonitis.
  • Excessive radiation to the normal liver parenchyma may result in radiation hepatitis.
  • Inadvertent delivery of SIR-Spheres Y-90 resin microspheres to the gallbladder may result in cholecystitis.

Precautions

  • Safety and effectiveness of this device in pregnant women, nursing mothers or children have not been established.
  • A SPECT scan of the upper abdomen may be performed immediately after implantation of SIR-Spheres Y-90 resin microspheres. The SPECT scan will detect the Bremsstrahlung radiation from the yttrium-90 to confirm placement of the microspheres in the liver.
  • This product is radioactive. Local regulations must be followed when handling this device.
  • Some patients may develop gastritis following treatment. Gastric acid blocking drugs may be used the day before implantation of SIR-Spheres Y-90 resin microspheres and continued as needed to reduce gastric complications.
  • Many patients may experience abdominal pain immediately after administration of SIR-Spheres Y-90 resin microspheres and pain relief may be required.
  • SIR-Spheres Y-90 resin microspheres demonstrated a mild sensitisation potential when tested dermally in an animal model.


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