Pronunciation:

pol-ee-doe-KAY-nol

Brand Names:

• Varithena

Dosage Forms:

• Foam
• Solution

Classifications:

Therapeutic—

Sclerosing Agent

Uses of This Medicine:

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. This medicine improves the symptoms and appearance of varicose veins. 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of polidocanol injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of polidocanol injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you 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 (eg, 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 (eg, peripheral arteriosclerosis, thromboangiitis obliterans)—May increase risk for tissue ischemia.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may 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 the medicine. 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.