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Polidocanol: Drug information

Polidocanol: Drug information
(For additional information see "Polidocanol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Asclera;
  • Varithena
Brand Names: Canada
  • Varithena
Pharmacologic Category
  • Sclerosing Agent
Dosing: Adult
Varicose veins

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Foam, Intravenous:

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

Solution, Intravenous:

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

Solution, Intravenous [preservative free]:

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

Generic Equivalent Available: US

No

Dosage Forms: Canada

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

Foam, Intravenous:

Varithena: 1% (45 mL) [contains alcohol, usp]

Administration: Adult

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: Do not shake canister. 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, posttreatment bandages should stay dry and in place for 48 hours. Apply compression in the form of a stocking or bandage (maintain for 2 weeks) and have patient walk for ≥10 minutes while under observation. Advise patient to walk at least 10 minutes daily, avoid heavy exercise for 1 week, and avoid extended periods of inactivity for 1 month.

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.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>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

Contraindications

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

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

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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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

Breastfeeding Considerations

It is not known if polidocanol is present in breast milk.

Lactating women can consider expressing and discarding milk for up to 8 hours following polidocanol administration to minimize potential exposure to a breastfed infant.

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.

Mechanism of Action

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

Pharmacokinetics

Distribution: Varithena: Vd: 35 to 82 L

Half-life elimination: Asclera: 90 minutes; Varithena: 102 to 153 minutes

Pricing: US

Foam (Varithena Intravenous)

180 mg/18 mL (per mL): $85.20

Solution (Asclera Intravenous)

0.5% (per mL): $11.82

1% (per mL): $13.56

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • AET (AR);
  • Aethoxyscerol (BE, CZ);
  • Aethoxyskerol (DE);
  • Aethoxysklerol (AT, AU, CH, CN, CU, DK, FI, GR, LB, LU, NL, PY, RU, SE, SK, TH, TR);
  • Aethoxysklreol (SI);
  • Aetoxisclerol (FR);
  • Aetoxysklerol (AR);
  • Asklerol (IN);
  • Atossisclerol (IT);
  • Etoxisclerol (ES, PT, VE);
  • Polidocasklerol (JP);
  • Recessan (PY);
  • Redessan (DE);
  • Sclerovein (SE, UA);
  • Sensinol (AR);
  • Venodenol (ID);
  • Venoscler (UY)


For country code abbreviations (show table)
  1. Asclera (polidocanol) [prescribing information]. Coral Springs, FL: Methapharm Inc; February 2022.
  2. Reich-Schupke S, Leiste A, Moritz R, Altmeyer P, Stücker M. Sclerotherapy in an undetected pregnancy - a catastrophe? Vasa. 2012;41(4):243-247. doi: 10.1024/0301-1526/a000199. [PubMed 22825857]
  3. Varithena (polidocanol) [prescribing information]. West Conshohocken, PA: Biocompatibles Inc; November 2021.
  4. Varithena (polidocanol) [Canadian product monograph]. London, United Kingdom: Provensis Ltd; October 2017.
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