BTG plc: FDA Approves Varithena™ (Polidocanol Injectable Foam) for the Treatment of Patients with Varicose Veins

INDICATIONS

Varithena™ (polidocanol injectable foam) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee. Varithena™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

IMPORTANT SAFETY INFORMATION

For intravenous use only. Varithena™ is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. 

Physicians administering Varithena™ must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena™.

Contraindications

The use of Varithena™ is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Warnings and Precautions

Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.

Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Varithena™ can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.

Adverse Reactions

In clinical trials, the most common related adverse events (occurring in ?3% of patients treated with Varithena™) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.

Use in Specific Populations

Pregnancy Category C. Do not use Varithena™ in pregnant women.

See Full Prescribing Information for Varithena™ online at Varithena.com.

References:

1. Varithena™ prescribing information. BTG International Inc. November 2013.
2. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(5 Suppl):2S-48S.

About BTG

BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at http://www.btgplc.com.

For further information please contact:

BTG
Andy Burrows, Director of Investor Relations
+44(0)20-7575-1741; Mobile: +44(0)7990-530605

Rolf Soderstrom, Chief Financial Officer
+44(0)20-7575-0000

FTI Consulting
Ben Atwell
+44(0)20-7831-3113

SOURCE BTG plc