INDICATIONS

Varithena^® (polidocanol injectable foam) is a prescription medicine used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg's GSV system. Varithena^® improves symptoms related to or caused by varicose veins, and the appearance of varicose veins.

IMPORTANT SAFETY INFORMATION

You should not be treated with Varithena^® if you are allergic to polidocanol or have clots in your blood vessels.

Severe allergic reactions have been reported in people treated with liquid forms of polidocanol and some patients have died from these reactions. Varithena^® is a foam made from polidocanol. A healthcare professional will observe you for signs of allergic reactions for at least 10 minutes after you are treated with Varithena^®.

Tell your doctor about all of your medical conditions, including if you

 

• have arterial disease (a disease of the blood vessels)
• have reduced mobility
• have a history of blood clots in the veins or lungs
• have had major surgery in the past 3 months
• have recently had a long hospital stay
• are pregnant or have recently been pregnant

 

The most common side effects seen with Varithena^® are leg pain or discomfort, injection site bruising or pain, and potentially serious blood clots in the leg veins. These are not all of the possible side effects of Varithena^®. Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.

Varithena^® is administered by your doctor. Doctors using Varithena^® must be experienced in vein procedures and trained in using Varithena^®.

See Full Prescribing Information for Varithena^®.

References

¹ Lammer J, Malagari K, Vogl T et al. Cardiovasc Intervent Radiol 33 (2010): 41-52.
² Internal analysis of Pubmed Search June 2014 updated March 2015
³ Hong K, Khwaja A, Liapi E et al. Clin Cancer Res 12 (2006): 2563-7.
⁴ Varela M, Real MI, Burrel M et al. J Hepatol 46 (2007): 474-81.
⁵ Data on File
⁶ A Lewis, C Adams, W Busby et al. J Mater Sci Mater Med 12 (2006): 1193-204.
⁷ K Hidaka, L Moine, G Collin et al. J Mech Behav Biomed Mater 8 (2011): 2161-7
⁸ Salem R, Thurston KG. J Vasc Interv Radiol 2006;17:1251-1278.
⁹ Rhee TK, Lewandowski RJ, Liu DM, et al. Annals of Surgery 2008;247:1029–1035.
¹⁰ American Society of Clinical Oncology (ASCO). Cancerprogress.net. 2014. Timeline: Major Milestones Against Cancer. Available at: www.cancerprogress.net/timeline/major-milestones-against-cancer.
¹¹ United States Regulatory Commission (U.S. NRC). Measuring Radiation. http://www.nrc.gov/about-nrc/radiation/health-effects/measuring-radiation.html. Updated Friday, June 28, 2013; accessed July 22, 2014.
¹² McGhee S, Data on file, July 18, 2014.
¹³ Adapted from Brateman L, 1999. Brateman L. Radiation safety considerations for diagnostic radiology personnel. Radiographics. 1999 Jul-Aug;19(4):1037-55.
¹⁴ Package Insert – TheraSphere^® Yttrium-90 Glass Microspheres Rev.12  ALARA = As Low As Reasonably Achievable
¹⁵ Package Insert – TheraSphere^® Yttrium-90 Glass Microspheres – Rev. 12. Biocompatibles UK Ltd, a BTG International group company

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Noteworthy News articles are selected from information communicated on websites external to BTG and are selected because the information relates to BTG products available in various countries. The information is not being shared to advocate use of a product outside of its locally approved indication for use.

Not all products and/or indications are available in your territory. LC Bead^™ and Varithena^™ are not available outside the US for commercial distribution. DC Bead, LC Bead and Bead Block are trademarks and/or registered trademarks of Biocompatibles UK Ltd. EKOS, the EKOS logo and EkoSonic are trademarks and/or registered trademarks of EKOS Corporation. TheraSphere^™ is manufactured by Nordion (Canada) Inc. for Biocompatibles UK Ltd. TheraSphere is a trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. TheraSphere is a registered trademark in the US, EU and certain other territories. Varithena is a trademark of Provensis Ltd and is a registered trademark in the US and certain other territories. PneumRx and RePneu Coils are trademarks of PneumRx. PneumRx is a registered trademark in the US and certain other territories. ‘See more. Reach further. Treat smarter’, ‘Imagine where we can go’, BTG and the BTG roundel logo are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks in the US, EU and certain other territories. Biocompatibles UK Ltd, EKOS Corporation, Provensis Ltd and PneumRx Corporation are BTG International group companies. For full prescribing information please click here Bead Block^™, DC Bead^™, EKOS^™, LC Bead^™, TheraSphere^™, PneumRx^™, and Varithena^™ © Copyright 2017 BTG International Ltd.