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ALARA and Radiation

Safety

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What is TheraSphere® ?

TheraSphere® is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment.3

TheraSphere®:

› Consists of insoluble glass microspheres where yttrium-90 (90Y) is an integral constituent of the glass3

› Has a mean microsphere diameter of 20 to 30 μm3

› Is a pure beta emitter with an average energy of 0.9367 MeV and physical half-life of 64.1 hours (2.67 days)3

› Is calibrated to U.S. National Institute of Standards and Technology (NIST) standards9

The recommended dose for TheraSphere® administered to the liver is between 80–150 Gy (8000–15,000 rad).3,*

TheraSphere® dose vial

* Please refer the TheraSphere® Package Insert for complete dosing calculations and administration instructions.

Radiation exposure to the healthcare professional during TheraSphere® treatment is well below the amount of exposure from a US coast-to-coast flight.10,11

Reducing exposure time reduces radiation risk.

1. TIME

Shielding material absorbs radiation between the source and the individual.

3. SHIELDING

Doubling the distance reduces radiation exposure four-fold.

2. DISTANCE

As Low As Reasonably Achievable

The use of radiation for beneficial purposes in medical procedures is a major contributor to improved human health. However, the benefits of treatment need to be balanced with the risks of radiation exposure.

ALARA is a radiation safety principle of keeping unneccessary radiation exposure and release of radioactive materials to the environment as low as can be achieved by employing all reasonable methods.1

ALARA is also a regulatory requirement for all radiation safety programs.

ALARA is based on the assumption that exposure to radiation of any dose increases the probability of detrimental biological effects such as genetic mutations and cancer.

ALARA can be achieved using three key factors:

What is ALARA?

Adapted from Brateman L, 1999.2

ALARA = As Low As Reasonably Achievable

Power Where You Need It

TheraSphere® was designed with ALARA in mind to reduce radiation exposure to both healthcare professionals and patients to ‘As Low As Reasonably Achievable’ levels.

› Dose vials are ready to use3

• Both the shipping vial and the administration vial are ONE AND THE SAME

• NO dose preparation or manipulation is required

› Rapid infusion means that delivery is quick, with an infusion time of less than 5 minutes4

› NO continuous fluoroscopy or contrast is needed during administration4

› Preparation (priming) of the administration system tubing is performed independent of the dose vial3

› Protection is provided by acrylic and lead shielding around the dose vial during shipping AND patient treatment3

• Acrylic shield blocks 100% of the beta radiation3

• Lead pot reduces Bremsstrahlung radiation exposure to 1/7th of levels without lead shielding3,5

› NO significant amount of free 90Y present in the treatment vial5

Minimizing radiation exposure to patients and others:

› NO significant amount of 90Y leaches from the glass matrix5

› Secondary radiation exposure to others is well below regulatory limits5

› Body fluid radioactivity is NOT an issue for TheraSphere® patients5

• There is NO need for special precautions regarding body fluids (urine, stool, blood, or vomit)

• Patient hygiene instructions are NOT necessary

› High delivery efficiency means less 90Y in waste materials that need to be handled after patient treatment4

How Does the TheraSphere® Dose Vial Conform to ALARA?

90Y = yttrium-90; ALARA = As Low As Reasonably Achievable

The TheraSphere® Administration Accessory Kit is designed and constructed to SHIELD healthcare professionals and patients from radiation exposure to ‘As Low As Reasonably Achievable’ levels.

TheraSphere® Administration Accessory Kit:

› Provides 100% beta shielding to the user through the acrylic shield3,6

› Is supplied with a 2 L waste jar with beta shield for handling and storing post-treatment waste3

› Is designed to contain any potential leaks from the dose vial (although leaks are exceedingly rare)7

How Does the Administration Accessory Kit Conform to ALARA?

Acrylic shieldDosimeter

2 L waste jar with beta shield

Lead pot containing dose vial

ALARA = As Low As Reasonably AchievableAdapted from the TheraSphere® website: www.therasphere.com.8

Administration Accessory Kit

Power Where You Need It

Humanitarian Device.TheraSphere® is authorized by Federal Law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated.3

Common adverse effects include fatigue, pain, and nausea. The majority of adverse effects are mild to moderate in severity and are manageable or resolve over time. For details on rare or more severe adverse effects, please refer to the TheraSphere® Package Insert at www.therasphere.com.3,12,13

TheraSphere® is manufactured for Biocompatibles UK Ltd, a BTG International group company. TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. ‘Power Where You Need It’ and ‘Power You Can Trust’ are trademarks of Biocompatibles UK Ltd. ‘Imagine where we can go’ is a trademark of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. All rights reserved.

© 2015 BTG International Canada Inc. US-USTHSP-2014-0958

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References: 1. Canadian Nuclear Safety Commission. Regulatory Guide: Keeping Radiation Exposures and Doses “As Low as Reasonably Achievable (ALARA)”. G-129, Revision 1, October 2004. 2. Brateman L. Radiographics 1999;19(4):1037–55. 3. Package Insert – TheraSphere® Yttrium-90 Glass Microspheres – Rev. 12. Biocompatibles UK Ltd, a BTG International group company. Available at: http://www.therasphere.com/physicians-package-insert/TS_PackageInsert_USA_v12.pdf. 4. Salem R, Thurston KG. J Vasc Interv Radiol 2006;17:1251–78. 5. U.S.A. TheraSphere® Reference Manual (PCCS 550A). 6. McGhee S, Data on file, July 11, 2014. 7. McGhee S, Data on file, July 3, 2014. 8. BTG International Canada Inc. http://www.therasphere.com. Accessed July 14, 2014. 9. Cessna JT, Email communication, April 8, 2014. 10. United States Nuclear Regulatory Commission (U.S. NRC). Measuring Radiation. http://www.nrc.gov/about-nrc/radiation/health-effects/measuring-radiation.html. Updated June 28, 2013; accessed July 22, 2014. 11. McGhee S, Data on file, July 18, 2014. 12. Hilgard P, Hamami M, Fouly AE, et al. Hepatology 2010;52(5):1741–9. 13. Mazzaferro V, Sposito C, Bhoori S, et al. Hepatology 2013;57(5):1826–37.

Indication for UseAuthorized by Federal Law under a humanitarian device exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated.3

Important Safety Information

CautionFederal (USA) law restricts this device to sale by or on the order of a physician with appropriate training and experience.3

WarningsA retrospective study of 121 patients from five clinical trials has shown that the following five Pre-treatment High Risk Factors have been associated with at least 48% of all serious adverse events that were possibly related to use of the device and with 11 of the 12 deaths that were possibly related to use of the device:• Infiltrative tumor type• “Bulk disease” (tumor volume >70% of the

target liver volume, or tumor nodules too numerous to count)

The physician should always take the above-noted Pre-treatment High Risk Factors into consider-ation for each patient when making decisions regarding the use of TheraSphere® for treatment.3

Additional Product Information

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Contraindications The use of TheraSphere® is contraindicated in patients:3

• whose Tc-99m MAA hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques

• who show shunting of blood to the lungs that could result in delivery of greater than 16.5 mCi of yttrium-90 to the lungs. Radiation pneumonitis has been seen

in patients receiving doses to the lungs greater than 30 Gy in a single treatment

• in whom hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis

• who have severe liver dysfunction or pulmonary insufficiency

• who are pregnant

Adverse EventsThe most common adverse events (≥5%) include elevated bilirubin (23.1%), ascites (8.3%), abdominal pain (6.6%), and elevated AST/ALT (5.8%).3

Please see the full TheraSphere® Package Insert available at www.TheraSphere.com for complete important safety information, including BOXED WARNINGS.

ALT = alanine aminotransferase; AST = aspartate aminotransferase; Tc-99m MAA = technetium-99m macroaggregated albumin; ULN = upper limit of normal

• AST or ALT >5 × ULN• Bilirubin >2 mg/dL• Tumor volume >50% combined with

an albumin <3 g/dL