Varithena (Intravenous)

Polidocanol injection is used to treat small varicose veins in the lower legs. It is also used to treat incompetent great saphenous veins, accessory saphenous veins, and visible varicose veins both above and below the knees. This medicine helps improve the symptoms and appearance of varicose veins. It is a type of medicine known as a sclerosing agent.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests will be needed to check for unwanted effects.

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

Wear compression stockings or a support hose on the treated leg(s) 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 that you walk for 10 to 20 minutes for Varithena® or 15 to 20 minutes for Asclera® 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.

This medicine may increase your risk of having blood clots in the brain, heart, blood vessels, or lungs, which may lead to stroke, heart attack, deep vein thrombosis, or pulmonary embolism. Check with your doctor right away if you have difficulty with speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, pain, redness, or swelling in the arm or leg, trouble breathing, or dizziness or lightheadedness.

Avoid heavy exercise, sunbathing, long plane flights, and hot baths or saunas for 2 to 3 days for Asclera® or 1 week for Varithena® after you receive this medicine. Do not spend long periods of time being inactive (including long car rides) for 1 month after Varithena® treatment.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. For this medicine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been any appropriate studies on how polidocanol injection affects children. Its safety and effectiveness have not been established for the pediatric population.

Geriatric

Current studies have not shown any specific problems related to aging that would limit the usefulness of polidocanol injection in older adults.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other health issues, especially:

• Blood clots or
• Blood clotting disorders, acute—This medicine should not be used if you have these conditions.

• History of blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism) or
• Recent major surgery (within 3 months) or
• Prolonged immobilization—These may increase your risk for blood clotting problems.

• Blood vessel disease (e.g., peripheral arteriosclerosis, thromboangiitis obliterans)—This may increase your risk for tissue ischemia.

Along with its needed effects, Varithena (Intravenous) may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they might need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Collection of blood under the skin of the injection site
• Deep, dark purple bruise at the injection site
• Pain, discomfort, redness, or swelling in the arm or leg

Incidence not known

• Anxiety
• Blue-green to black skin discoloration
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chest pain or tightness
• Cough
• Darkening of the skin
• Difficult or labored breathing
• Difficulty with swallowing
• Dizziness or lightheadedness
• Fainting
• Fast, irregular, pounding, or racing heartbeat or pulse
• Fever
• Inability to speak
• Increased hair growth in the treatment area
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of consciousness
• Nerve injury
• No blood pressure or pulse
• Noisy breathing
• Pain, redness, or sloughing of the skin at the injection site
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness, soreness, or itching skin
• Seizures
• Severe or sudden headache
• Skin rash
• Slurred speech
• Sores, welts, or blisters
• Stopping of the heart
• Temporary blindness
• Trouble breathing
• Unusual tiredness or weakness
• Weakness in the arm or leg on one side of the body, sudden and severe

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Varithena (Intravenous). Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Confusion
• Feeling of warmth
• Redness of the face, neck, arms, and occasionally, upper chest
• Sudden sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Varithena

Available Dosage Forms:

• Foam
• Solution

Therapeutic Class: Sclerosing Agent

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins.