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Polidocanol

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: To treat 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: To treat 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

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: 5 mL of 1% solution per injection (maximum: 15 mL per session); may repeat in ≥5 days

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Administration

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 2-3 days [spider veins] and 5-7 days [reticular veins]); longer compression is recommended for extensive varicosities. After applying compression, patient should walk for 15-20 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 3-5 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 7 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 (42%), irritation (41%), discoloration (38%), pain (24%), pruritus (19%), warmth (16%)

1% to 10%: Local: Neovascularization (8%), injection site thrombosis (6%)

Postmarketing and/or case reports: Allergic dermatitis, anaphylactic shock , angioedema, asthma, cardiac arrest, cerebrovascular accident, circulatory collapse, confusion, deep vein thrombosis, dizziness, dyspnea, hot flush, hypertrichosis, injection site necrosis, loss of consciousness, migraine, nerve injury, palpitation, paresthesia, pulmonary embolism, pyrexia, skin hyperpigmentation, syncope (vasovagal), urticaria, vasculitis

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.

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

Other warnings/precautions:

• Appropriate use: After injection is complete, apply compression/bandage, and have patient walk for 10 to 20 minutes. Small intravaricose blood clots (thrombi) can develop; may be removed by stab incision and thrombus expression (microthrombectomy).

• Extravasation: Pain may occur with inadvertent perivascular injection and may be resolved with a local anesthetic (without epinephrine).

• 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 10-20 minutes after injection, and for signs/symptoms of DVT or PE.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Do not use polidocanol during pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience ecchymosis. Have patient report immediately to prescriber hemoptysis, angina, dyspnea, edema of extremities, extremity discoloration, painful extremities, or injection site pain or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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