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Polidocanol

Medically reviewed by Drugs.com. Last updated on Aug 12, 2020.

Pronunciation

(pol i DOE kuh nol)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Foam, Intravenous:

Varithena: 180 mg/18 mL (45 mL) [contains alcohol, usp]

Solution, Intravenous [preservative free]:

Asclera: 0.5% (2 mL); 1% (2 mL) [contains alcohol, usp]

Brand Names: U.S.

  • Asclera
  • Varithena

Pharmacologic Category

  • Sclerosing Agent

Pharmacology

Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein

Distribution

Varithena: Vd: 35 to 82 L

Half-Life Elimination

Asclera: 90 minutes

Varithena: 102 to 153 minutes

Use: Labeled Indications

Varicose veins:

Asclera: Treatment of uncomplicated spider veins (varicose veins 1 mm or less in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.

Varithena: Treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.

Contraindications

Hypersensitivity to polidocanol or any component of the formulation; acute thromboembolic diseases

Canadian labeling: Additional contraindications (not in the US labeling): Thrombophilia; pregnancy

Dosing: Adult

Varicose veins: IV:

Asclera:

Reticular veins (1 to 3 mm diameter): 0.1 to 0.3 mL of 1% solution per injection (maximum: 10 mL per session); may repeat in 7 to 14 days

Spider veins (≤1 mm diameter): 0.1 to 0.3 mL of 0.5% solution per injection (maximum: 10 mL per session); may repeat in 7 to 14 days

Varithena: Great saphenous veins and accessory saphenous veins: Up to 5 mL of 1% solution per injection (maximum: 5 mL per injection; 15 mL per session); may repeat in ≥5 days

Dosing: Geriatric

Refer to adult dosing.

Administration

IV: For intravenous use only. Avoid extravasation and intra-arterial injection.

Asclera: Administer using a syringe with 26 or 30-gauge needle. Insert the needle tangentially into the vein and inject slowly while the needle is still in the vein; apply gentle pressure during injection to prevent vein rupture. After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage (maintain for 2 to 3 days [spider veins] and 5 to 7 days [reticular veins]); longer compression is recommended for extensive varicosities. After applying compression, patient should walk for 15 to 20 minutes and be observed for anaphylactic or allergic reaction.

Varithena: Administer via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into the varicosities within 75 seconds of extraction from canister; use a new sterile syringe after each injection. Do not use syringe if visible bubbles present. A local anesthetic may be administered prior to cannula insertion. Inject slowly (~1 mL/second in great saphenous vein and 0.5 mL/second in accessory veins or varicosities) using ultrasound guidance. Confirm venospasm of the treated vein. When treating the proximal great saphenous vein, stop the injection when polidocanol is 3 to 5 cm distal to the saphenofemoral junction. After injection, apply compression in the form of a stocking or bandage (maintain for 2 weeks) and have patient walk for ≥10 minutes while under observation.

Storage

Asclera: Store between 15°C and 30°C (59°F and 86°F).

Varithena: Store at 20°C to 25°C (68°F and 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Once activated, the canister must be used within 30 days. Contains gas under pressure and pressurized oxygen; keep away from heat and combustible materials; store in well-ventilated area.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%: Local: Hematoma at injection site (42%), irritation at injection site (41%), local discoloration (38%), pain at injection site (24%), local pruritus (19%), warm sensation at injection site (16%)

1% to 10%: Local: Venous thrombosis at injection site (6%)

<1%, postmarketing, and/or case reports: Allergic dermatitis, anaphylactic shock, angioedema, asthma, cerebrovascular accident, circulatory shock, confusion, deep vein thrombosis, dizziness, dyspnea, fever, flushing, hypertrichosis, loss of consciousness, migraine, neurologic injury, palpitations, paresthesia, pulmonary embolism, skin hyperpigmentation, tissue necrosis at injection site, urticaria, vasculitis, vasodepressor syncope

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reaction: Severe allergic reactions, including anaphylaxis and fatal anaphylactoid reactions have been reported with polidocanol. More frequent with larger volumes (>3 mL), therefore, dose should be minimized. Observe 10 to 20 minutes following injection to monitor for hypersensitivity/anaphylactic reaction; emergency resuscitation equipment should be available.

• Arterial embolism: Stroke, TIA, MI, and impaired cardiac function have been reported with IV solution. May be caused by air embolism, when using polidocanol IV solution foamed with room air, or thromboembolism. Avoid using polidocanol IV solution foamed with room air; safety and efficacy has not been established.

• Thromboembolism: Thrombosis and subsequent pulmonary embolism or other thrombotic events can occur. Use with caution in patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, recent (≤3 months of age) major surgery, or prolonged hospitalization; increased risk for thrombosis.

Other warnings/precautions:

• Appropriate use: Check for proper needle placement; the smallest effective volume should be used at each injection site. After injection is complete, apply compression with stocking or bandage, and have patient walk for 15 to 20 minutes. Small intravaricose blood clots (thrombi) can develop; may be removed by stab incision and thrombus expression (microthrombectomy).

• Tissue ischemia/necrosis: Intra-arterial injection or extravasation can cause severe necrosis, ischemia, or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans may be at increased risk for tissue ischemia. Consult a vascular surgeon immediately if intra-arterial injection occurs.

Monitoring Parameters

Monitor patient for anaphylactic or allergic reaction for at least 10 to 20 minutes after injection, and for signs/symptoms of DVT or PE.

Pregnancy Considerations

Information related to inadvertent use of polidocanol in pregnancy for the treatment of varicose veins is limited (Reich-Schupke 2012).

Patient Education

What is this drug used for?

• It is used to treat varicose veins.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bruising

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Severe injection site pain, burning, swelling, blistering, or irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.