Varithena® (polidocanol) Injectable Foam

We are happy to announce the addition of Varithena® to our treatment armamentarium in the management of Varicose veins, venous insufficiency and chronic venous disease. We have successfully treated multiple patients with Varithena® since September 26th 2018. This procedure is minimally invasive and involves injection of a non-compounded foam (Varithena®) to treat the diseased refluxing superficial vein and eliminate the reflux in that vein which results in significant improvement in symptoms and in severe cases help heal venous ulcers in addition to the cosmetic improvement in the appearance of varicose veins.

INDICATIONS for Varithena®

Polidocanol injectable foam is a prescription medicine used to treat varicose veins caused by problems with the incompetent great saphenous veins (GSV), accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. Varithena® improves symptoms related to or caused by varicose veins, and the appearance of varicose veins.

Common side effects of Varithena Injectable Foam include:

Varithena is for intravenous use under ultrasound guidance only. A dose of up to 5 ml per injection and 15 ml per treatment session is used. Treatment sessions should be separated by a minimum of 5 days. Varithena may interact with other drugs. Tell your doctor about all medications and supplements you use. Varithena is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk.

Mechanism of Action

Varithena® (polidocanol injectable foam) is a non-ionic surfactant sclerosing agent. The hydrophobic pole of the polidocanol molecule attaches to the lipid cell membrane of the venous endothelium, resulting in disruption of the osmotic barrier, destruction of the venous endothelium, and vasospasm. Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic, which leads to thrombus formation and venous occlusion. The occluded vein is eventually replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood, thus limiting the sclerosant action to the endothelium near the site of injection.

Common Patient Questions about Treatment with Varithena®

1. What are varicose veins?

2. What is Varithena®?

3. What results might I expect with Varithena®?

4. How does Varithena® work?

5. What happens to Varithena® after it’s injected?

6. How long does treatment take?

7. Are there side effects to treatment with Varithena®?

8. How many treatments might I need?

9. How soon can I get back to normal activities?

10. How long do I have to wear my compression stockings after the procedure?

11. Do I need to wear my compression stockings while I shower or bathe?

12. Is Varithena® covered by my insurance carrier?

IMPORTANT SAFETY INFORMATION

You should not be treated with Varithena® if you are allergic to polidocanol or have clots in your blood vessels. See back side for additional safety information. See Full Prescribing Information for Varithena® at VarithenaProfessional.com.
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® at VarithenaProfessional.com © 2014 Biocompatibles, Inc., a BTG International group company All rights reserved US-VAR-2014-0134(1) 08/14 Varithena and HASTI are trademarks of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd