Polidocanol (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 above and below the knees. This medicine helps improve the symptoms and appearance of varicose veins. It belongs to a group of medicines known as sclerosing agents.

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 taking the medicine compared to the benefits it will provide. For this medicine, consider 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 if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how polidocanol injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to 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

Some medicines should not be taken at or around mealtime or with certain foods due to possible 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 conditions may affect how this medicine works. Be sure to tell your doctor if you have any other medical problems, especially:

• Blood clots or
• Blood clotting disorders, acute—Should not be used in patients with these conditions.

• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or
• Major surgery, recent (within 3 months) or
• Prolonged immobilization—May increase risk for blood clotting problems.

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

Along with its intended effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Bleeding, blistering, burning, coldness, changes in skin color, 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
• Blood collection under the skin at 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 sensations
• Chest pain or tightness
• Cough
• Darkening of the skin
• Difficulty or labored breathing
• Trouble 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 skin sloughing at the injection site
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness, soreness, or itching of the skin
• Seizures
• Severe or sudden headache
• Skin rash
• Slurred speech
• Sores, welts, or blisters
• Cardiac arrest
• Temporary blindness
• Trouble breathing
• Unusual tiredness or weakness
• Sudden and severe weakness in the arm or leg on one side of the body

Get emergency help immediately if you experience any of the following signs of overdose:

Symptoms of overdose

• Break in the skin, especially if it is accompanied by blue-black discoloration, swelling, or fluid drainage

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Additionally, your healthcare professional may have suggestions to help prevent or lessen some of these side effects. Talk to your healthcare professional if any of the following side effects persist, become bothersome, or if you have any questions about them:

Incidence not known

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

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

Call your doctor for medical advice about side effects. You can 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.