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SIR-Spheres® Y-90 Resin Microspheres

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SIR-Spheres® Y-90 Resin Microspheres Manufacturer: US Sales Office: Sirtex Medical Limited Sirtex Medical Inc Level 33, 101 Miller Street, 300 Unicorn Park Drive, North Sydney NSW 2060, Australia Woburn MA 01801, USA Tel: +61 2 9964 8400 Tel: 1 888 474 7839 www.sirtex.com 4 Warnings • Some patients may experience gastric problems following treatment but H-2 blocking agents may 4.1 Non-Target Delivery of SIR-Spheres be used the day before implantation of SIR- microspheres Spheres microspheres and continued as needed to reduce gastric complications. Inadvertent delivery of SIR-Spheres microspheres to extra-hepatic structures such as the esophagus, • Many patients may experience abdominal pain SIR-Spheres® Y-90 resin stomach, duodenum, gallbladder or pancreas may immediately after administration of SIR-Spheres result in radiation injury to these structures. microspheres and pain relief may be required. microspheres Meticulous angiographic technique must be • SIR-Spheres microspheres demonstrated a mild (Yttrium-90 microspheres) employed to prevent the non-target delivery of SIR- sensitization potential when tested dermally in an Spheres microspheres to any extra-hepatic animal model. structures. 1 Description 4.2 Radioembolization Induced Liver 6 Clinical Trial Results SIR-Spheres microspheres consist of biocompatible microspheres containing yttrium-90 with a size Disease (REILD) In a randomized, controlled clinical trial, a total of 70 patients were studied in two arms, 34 patients with between 20 and 60 microns in diameter. Yttrium-90 Delivery of excessive radiation to the normal liver FUDR chemotherapy (control group), and 36 is a high-energy pure beta-emitting isotope with no parenchyma may result in REILD – see description patients with FUDR plus SIR-Spheres microspheres. primary gamma emission. The maximum energy of in Section 7. The results are shown in the following tables. the beta particles is 2.27 MeV with a mean of 0.93 MeV. The maximum range of emissions in The risk of REILD may also be increased in patients Table 1 – Tumor Response by Volume tissue is 11 mm with a mean of 2.5 mm. The half-life with pre-existing liver disease. Consideration should is 64.1 hours. In therapeutic use, requiring the be given to reducing the prescribed activity of SIR- Response CR PR NC PD Others FUDR only isotope to decay to infinity, 94% of the radiation is Spheres microspheres in the following clinical 1 7 12 9 5 delivered in 11 days. The average number of settings1: (N = 34) 6 particles implanted is 30 – 60 x 10 . SIR-Spheres • Reduced liver functional reserve due to steatosis, FUDR + SIR-Spheres microspheres are a permanent implant. 2 16 10 5 3 steatohepatitis, hepatitis or cirrhosis microspheres (N = 36)* SIR-Spheres microspheres are implanted into a • Elevated baseline bilirubin level hepatic tumor by injection into either the common • Small tumor burden (< 5% liver involvement) *(P = 0.033) hepatic artery or the right or left hepatic artery via the • Small liver volume (< 1.5 L) Tumor response was measured by two consecutive chemotherapy catheter port. The SIR-Spheres • Prior hepatic resection microspheres distribute non-uniformly in the liver, CT scans in a 3 month interval period. primarily due to the unique physiological • Prior liver directed therapy characteristics of the hepatic arterial flow, the tumor • Extensive prior treatment with systemic CR = Complete Response, PR = Partial Response, to normal liver ratio of the tissue vascularity, and the chemotherapy and/or biologic therapies NC = No Change, PD = Progressive Disease, Others size of the tumor. The tumor usually gets higher = No follow-up or unmeasurable density per unit distribution of SIR-Spheres 4.3 Radiation Pneumonitis Table 1 indicates that there is a statistically microspheres than the normal liver. The density of High levels of implanted radiation and/or excessive SIR-Spheres microspheres in the tumor can be as significant improvement of the tumor response rates shunting to the lung may lead to radiation (CR+PR) in the group treated with FUDR plus SIR- high as 5 to 6 times of the normal liver tissue. Once pneumonitis. The lung radiation dose must be limited SIR-Spheres microspheres are implanted into the Spheres microspheres, when compared with the to ≤ 30 Gy. group treated with FUDR only. liver, they are not metabolized or excreted and they stay permanently in the liver. Each device is for single patient use. 5 Precautions Table 2 – Time to First Progressive Disease in the Liver FUDR + • For determining the prescribed activity of SIR- FUDR Only SIR-Spheres 2 Indications for Use Spheres microspheres to administer, the Body microspheres Surface Area (BSA) method is recommended. Number of SIR-Spheres microspheres are indicated for the The Empirical method is not recommended. 34 36 treatment of unresectable metastatic liver tumors Patients For some patients, the Empirical method may Mean Time in 312 Days 510 Days from primary colorectal cancer with adjuvant intra- result in excessive activity being prescribed. hepatic artery chemotherapy (IHAC) of FUDR Days +/- SD* +/- 330 +/- 516 For further information on the BSA method, refer Median Time in (Floxuridine). 233 Days 366 Days to Appendix III: Calculation of Individual Dose. Days* • No studies have been done on the safety and *(P = 0.05) 3 Contraindications effectiveness of this device in pregnant women, nursing mothers or children. SIR-Spheres microspheres are contraindicated in Progressive Disease was defined as more than 25% patients who have: • Due to the radioactivity of this device and the increase of tumor volume, or development of new lesion(s) in the follow up CT scan, when compared • had previous external beam radiation therapy to significant consequences of misplacing the microspheres in situ, this product must be to the pre-treatment CT scan. the liver implanted by doctors with adequate training in the • ascites or are in clinical liver failure handling and implantation technique for this Table 2 indicates that there is a statistically • markedly abnormal synthetic and excretory liver device. significant delay of time to progression of the function tests (LFTs), such as total bilirubin • Sirtex recommends a SPECT scan of the upper disease in the group treated with FUDR plus SIR- > 2.0 mg/dL or albumin < 3.0 g/dL abdomen be performed immediately after Spheres microspheres, when compared with the • > 20% lung shunting of the hepatic artery blood implantation of SIR-Spheres microspheres. The group treated with FUDR only. flow, or > 30 Gy radiation absorbed dose to the SPECT scan will detect the Bremsstrahlung lungs, as estimated by the 99mTc MAA scan radiation from the yttrium-90 to confirm placement 7 Adverse Events • pre assessment angiogram that demonstrates of the microspheres in the liver. When the patient is treated with proper technique, abnormal vascular anatomy that would result in • This product is radioactive. The use of this device without excessive radiation to any organ, the significant reflux of hepatic arterial blood to the is regulated under Title 10 of the Code of Federal common adverse events after receiving the SIR- stomach, pancreas or bowel Regulations Part 35. These regulations must be Spheres microspheres are fever, transient decrease followed when handling this device. • disseminated extra-hepatic malignant disease of hemoglobin, mild to moderate abnormality of liver • been treated with capecitabine within the two • All persons handling, dispensing and implanting function tests (mild increase in SGOT, alkaline previous months, or who will be treated with this device must be familiar with and abide by all phosphatase, bilirubin), abdominal pain, nausea, capecitabine at any time following treatment with Local, State and Federal regulatory requirements vomiting, and diarrhea. SIR-Spheres microspheres governing therapeutic radioactive materials. • portal vein thrombosis Accepted radiation protection techniques should In the Phase III randomized controlled clinical trial be used to protect staff when handling both the with 70 patients, there was a minimal increase of isotope and the patient. Grade 1 and 2 events, mostly transient abnormal ® SIR-Spheres is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd 1 Gil-Alzugaray et al. Hepatology, Vol 57, No. 3, 2013. SSL-US-13 Date of Issue: February 2017 (CR2189) Page 1 of 3 LFTs and nausea and vomiting in the patients who • Tumor invasion of the hepatic confluence where 10 How Supplied received SIR-Spheres microspheres. There was no the three hepatic veins enter the IVC such that difference in the number of patients who developed none of the hepatic veins could be preserved if the SIR-Spheres microspheres are provided in a vial Grade 3 and 4 adverse events between the two metastases were resected. with water for injection. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc groups. No patient died due to the adverse events • Tumor invasion of the porta hepatis such that directly related to SIR-Spheres microspheres. water for injection. Each vial contains 40 – 80 million neither origin of the right or left portal veins could microspheres. The vial is shipped within a 6.4 mm be preserved if resection were undertaken. Table 3 – Adverse Events minimum thickness lead pot. The package consists • Widespread metastases such that resection would of a crimp-sealed SIR-Spheres microspheres glass Grade 1 and 2 Grade 3 and 4 require removal of more liver than is necessary to vial within a lead pot, and a package insert within Events FUDR + SIR- FUDR + SIR- maintain life. Type-A packing bucket. FUDR Spheres FUDR Spheres microspheres microspheres Resectability may be evaluated via imaging with a The vial and its contents should be stored inside its Hemoglobin 4 5 1 0 triple phase contrast angio-portal CAT scan or MRI. transportation container at room temperature Bilirubin 7 2 0 1 Patient Tests Before Treatment with SIR-Spheres (15-25 °C, 59-77 °F).
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