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
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®.
1 Hilgard P, Hamami M, Fouly AE, et al. Hepatology 2010;52(5):1741-9
2 Mazzaferro V, Sposito C, Bhoori S, et al. Hepatology 2013;57(5):1826-37.
3 Mueller PR and Adams A (editors). Interventional Oncology: A Practical Guide for the Interventional Radiologist, Chapter 7, Principles of Embolization. Springer Science + Business Media, LLC 2012.
4 Varithena® (polidocanol injectable foam) [prescribing information]. London, England; Provensis Ltd, a BTG International group company; 2013
5 Data on file
6 American Society of Clinical Oncology (ASCO). Cancerprogress.net. 2014. Timeline: Major Milestones Against Cancer. Available at: www.cancerprogress.net/timeline/major-milestones-against-cancer.
7 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.
8 McGhee S, Data on file, July 18, 2014.
9 Adapted from Brateman L, 1999. Brateman L. Radiation safety considerations for diagnostic radiology personnel. Radiographics. 1999 Jul-Aug;19(4):1037-55.
10 Package Insert – TheraSphere® Yttrium-90 Glass Microspheres Rev.12 ALARA = As Low As Reasonably Achievable
11 Data on file. Provensis Ltd, a BTG International group company; 2013
12 A Lewis, C Adams, W Busby et al. J Mater Sci Mater Med 12 (2006): 1193-204.
13 K Hidaka, L Moine, G Collin et al. J Mech Behav Biomed Mater 8 (2011): 2161-7
14 Package Insert – TheraSphere® Yttrium-90 Glass Microspheres – Rev. 12. Biocompatibles UK Ltd, a BTG International group company
15TheraSphere® is authorized by Federal Law (USA) for use as a humanitarian device 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.
Corporate and Regional Press Releases
Corporate press releases are selected from information communicated on www.btgplc.com 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.
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 the US and certain other territories. LC Bead and Bead Block are trademarks and/or registered trademarks of Biocompatibles UK Ltd. EKOS, the EKOS logo, Acoustic Pulse Thrombolysis and EkoSonic are trademarks and/or registered trademarks of EKOS Corporation. TheraSphere® is manufactured for Biocompatibles UK Ltd. TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. Varithena is a registered trademark of Provensis Ltd. PneumRx and RePneu are trademarks of PneumRx. PneumRx is a registered trademark in the US and certain other territories. The RePneu Coils are not approved for commercial sale in the United States, and are restricted by US law to investigational use only in the U.S. ‘See more. Reach further. Treat smarter’ and ‘Imagine where we can go’ are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. Biocompatibles UK Ltd, EKOS Corporation, Provensis Ltd and PneumRx Corporation are BTG International group companies. For full prescribing information please click here Bead BlockTM, EKOS®, LC Bead®, TheraSphere®, Varithena®, PneumRx © Copyright 2015 BTG International Ltd. All rights reserved.”