Varithena

Avoid heavy or strenuous exercise for 2 or 3 days after your treatment. Also avoid sitting for long periods of time, such as long-distance travel in a car or on an airplane.

Also avoid exposure to sunlight, tanning beds, hot tubs, or saunas for 2 or 3 days after your treatment.

Do not use ice or a heating pad on your treated leg without your doctor's advice.

It is not likely that other drugs you take orally or inject will have an effect on laureth-9 used to treat varicose veins. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

• Asclera

• Sotradecol

© Varithena Patient Information is supplied by Cerner Multum, Inc. and Varithena Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

In the U.S.

• Varithena

Available Dosage Forms:

• Solution
• Foam

Therapeutic Class: Sclerosing Agent

Polidocanol injection is used to treat small varicose veins of the lower legs. This medicine is also used to treat incompetent great saphenous veins, accessory saphenous veins, and visible varicose veins above and below the knees. It is a type of medicine called a sclerosing agent.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Wear compression stockings or support hose on the treated legs continuously for 2 to 3 days or for 5 to 7 days, and for 2 to 3 weeks during daytime. This would help prevent formation of blood clots.

It is recommended for you to walk for 10 to 20 minutes immediately after the treatment and daily for the next few days, unless your doctor tells you otherwise.

This medicine may cause a permanent depression (necrosis) under the skin at the injection site. Contact your doctor right away if you notice any of these side effects at the injection site: depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

Avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna for 2 to 3 days after receiving this medicine.

• Tell all of your health care providers that you take Varithena. This includes your doctors, nurses, pharmacists, and dentists.
• You may need to avoid things like sunbathing, hot baths, and saunas. Talk with your doctor.
• Very bad and sometimes deadly allergic side effects have happened during infusion of this medicine. You will be watched closely during and after the infusion. Tell your doctor right away if you have a cough, skin redness, tightness in the throat, itching, flushing, blue skin, very bad dizziness or passing out, rash, shortness of breath, chest pain, upset stomach or throwing up, or stomach pain during the infusion.
• Blood clots have happened with Varithena. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• After treatment, keep bandages dry and in place for as long as you have been told by the doctor.
• After treatment, you will need to wear compression stockings on the treated legs and walk around every day for some time. You will also need to avoid heavy exercise and avoid long amounts of time not doing anything for some time. Closely follow what the doctor has told you.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

The use of Varithena is contraindicated in patients with:

• known allergy to polidocanol [see Warnings and Precautions (5.1)]
• acute thromboembolic disease

Anaphylaxis

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.

Tissue Ischemia and Necrosis

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.

Venous Thrombosis

Varithena can cause venous thrombosis [see Adverse Reactions (6)]. 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.

Clinical Trials Experience

Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice.

A total of 1333 patients with GSVI in 12 clinical trials were evaluated for safety when treated with Varithena at dose concentrations of 0.125%, 0.5%, 1.0%, or 2.0%, including 437 patients treated with Varithena in placebo-controlled clinical trials.

Adverse reactions occurring in 3% more patients receiving Varithena 1% than receiving placebo are shown in Table 1.

In Varithena-treated patients, 80% of pain events in the treated extremity resolved within 1 week.

In the 1333 patients treated with Varithena, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius, and soleal vein thrombosis (1.4%).

Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena. Approximately half (49%) of patients with thrombi received treatment with anticoagulants.

Since Varithena induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena.

Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena trials experienced clinically important neurological or visual adverse events suggestive of cerebral gas embolism. The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena group and 4.0% in the placebo groups.

Skin discoloration adverse events were reported in 1.1% of the pooled Varithena group and 0.7% of the placebo group in the placebo-controlled studies.