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