Polidocanol

Polidocanol is a prescription medication used to treat varicose veins in the lower extremity. Polidocanol belongs to a group of drugs called sclerosing agents. These work by inducing local damage and reconstruction of the lining of blood vessels.

This medication comes in solution and foam forms. These are injected directly into the varicose vein by a healthcare professional. Repeat treatment may be necessary.

Common side effects of polidocanol include mild local reactions at the site of injection.

Polidocanol is a prescription medication used to treat varicose veins. Asclera (polidocanol) is indicated for the treatment of uncomplicated spider veins (varicose veins ≤ 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 – 3 mm in diameter) in the lower extremity. Polidocanol is also indicated for the treatment of incompetent great saphenous veins, accessary saphenous veins, and visible variscosities of the great saphenous vein system above and below the knee.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Polidocanol may be found in some form under the following brand names:

• Asclera

• Varithena

Serious side effects have been reported with polidocanol. See the “Polidocanol Precautions” section.

Common side effects of polidocanol include the following:

• mild local reactions at the site of the injection
• tissue ischemia and necrosis
• venous thrombosis
• anaphylaxis

This is not a complete list of polidocanol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No polidocanol drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with poidocanol including the following:

• Severe allergic reaction. Tell your healthcare provider right away if you have some or all of the following symptoms of a severe allergic reaction:
  • difficulty breathing or tightness in the throat or chest
  • decreased heart rate, chest pain, or lightheadedness
  • hives, swelling, or rash
  • confusion, headache, slurred speech
• Polidocanol can cause dizziness. Do not drive or operate heavy machinery until you know how polidocanol affects you.

Do not take polidocanol if you: 

• are allergic to polidocanol or to any of its ingredients
• have acute thromboembolic disease

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of polidocanol, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking polidocanol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to polidocanol or to any of its ingredients
• have or have had thromboembolic disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Polidocanol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if polidocanol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using polidocanol.

Take polidocanol exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Use polidocanol exactly as prescribed by your doctor.

The polidocanol dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of polidocanol for the treatment of varicose veins is 0.1 – 0.3 mL injected into each vein. The maximum recommended volume per treatment session is 10 mL.

The recommended dose of polidocanol for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities, of the great saphenous vein (GSV) system, is up to 5 mL injected into each vein. The maximum recommended volume per treatment session is 15 mL.

If polidocanol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store polidocanol at room temperature between 59° and 86°F (15° - 30° C).
• Varithena (polidocanol) contains gas under pressure and may explode if heated. Store in a well-ventilated place, away from sources of heat.
• Keep this and all medicines out of the reach of children.