Polidocanol (Local) (Monograph)

Brand name: Asclera
Drug class: Sclerosing Agents

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Sclerosing agent; nonionic detergent.

Uses for Polidocanol (Local)

Sclerotherapy

Treatment of uncomplicated spider veins (varicose veins ≤1 mm in diameter) in lower extremity.

Treatment of uncomplicated reticular veins (varicose veins 1–3 mm in diameter) in lower extremity.

Not studied in varicose veins >3 mm in diameter.

Polidocanol (Local) Dosage and Administration

Administration

IV Administration

Administer only by IV injection. Avoid extravasation. (See Administration Precautions under Cautions.)

Commercially available as 0.5 or 1% solution in single-use ampuls (containing a total of 10 or 20 mg, respectively, in each 2-mL ampul). Has been administered as an endovenous foam or microfoam; these preparations not commercially available in US and extemporaneous preparation of polidocanol foam not approved by FDA.

Administration Procedure

Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge). Insert needle tangentially into target vein and inject solution slowly while needle is still in vein. To prevent vein rupture, only apply gentle pressure during injection.

After removing needle from target vein and covering injection site, apply compression in the form of a stocking or bandage. After treatment session, have patient walk for 15–20 minutes and observe patient to detect any anaphylactic or allergic reaction. (See Sensitivity Reactions under Cautions.)

Advise patient to maintain compression (stocking or bandage) for 2–3 days after treatment of spider veins or 5–7 days after treatment of reticular veins. For extensive varicosities, longer compression treatment with compression bandages or gradient compression stocking of a higher compression class is recommended.

If small intravaricose blood clots (thrombi) develop, they may be removed by stab incision and thrombus expression (microthrombectomy).

Dosage

Adults

Sclerotherapy

Uncomplicated Varicose Veins in Lower Extremity

Concentration of polidocanol solution (0.5 or 1%) and injection volume depend on type and size of varicose veins. After polidocanol treatment, compression is necessary to reduce risk of deep vein thrombosis. (See IV Administration under Dosage and Administration.)

Spider veins (varicose veins ≤1 mm in diameter): 0.1–0.3 mL (0.5–1.5 mg) of 0.5% solution for each injection. Do not exceed 10 mL (50 mg) per treatment session.

Reticular veins (varicose veins 1–3 mm in diameter): 0.1–0.3 mL (1–3 mg) of 1% solution for each injection. Do not exceed 10 mL (100 mg) per treatment session.

Repeat treatments may be necessary if extent of varicose veins requires >10 mL of solution. Separate treatment sessions by 1–2 weeks.

Prescribing Limits

Adults

Sclerotherapy

Uncomplicated Varicose Veins in Lower Extremity

Maximum 0.3 mL of 0.5 or 1% solution (1.5 or 3 mg, respectively) per injection site; maximum 10 mL per treatment session.

Cautions for Polidocanol (Local)

Contraindications

Known allergy (anaphylaxis) to polidocanol. (See Sensitivity Reactions under Cautions.)
Acute thromboembolic diseases.

Warnings/Precautions

Sensitivity Reactions

Severe allergic reactions (e.g., anaphylactic reactions), including some fatalities, reported. Severe reactions more frequent with larger volumes (>3 mL). Use minimal required dose.

Postmarketing reports of allergic dermatitis, angioedema, generalized urticaria, and asthma.

Observe patient for 15–20 minutes after polidocanol treatment session in case an anaphylactic or allergic reaction occurs. Clinicians should be prepared to provide appropriate treatment of anaphylaxis.

Administration Precautions

Extravasation may result in severe adverse local effects, including tissue necrosis. Carefully place IV needle into target vein; use smallest effective volume of solution at each injection site. Overdosage may result in higher incidence of localized reactions such as necrosis.

After polidocanol treatment session, apply compression to treatment area with a stocking or bandage and have patient walk for 15–20 minutes. (See IV Administration under Dosage and Administration.) Supervise patient during this period in case an anaphylactic or allergic reaction occurs. (See Sensitivity Reactions under Cautions.)

Accidental Intra-arterial Injection

Accidental intra-arterial injection may cause severe necrosis, ischemia, or gangrene. Immediately consult vascular surgeon if occurs.

Inadvertent Perivascular Injection

Inadvertent perivascular injection can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.

Specific Populations

Pregnancy

Category C.

Do not use during pregnancy.

Labor and Delivery

Effects on labor and delivery unknown.

Lactation

Not known whether distributed into human milk. Potential for serious adverse reactions in nursing infants; avoid use in nursing women.

Pediatric Use

Safety and efficacy not established in pediatric patients.

Geriatric Use

Insufficient experience in patients ≥65 years to determine whether geriatric patients respond differently than younger adults.

Common Adverse Effects

Injection site reactions including hematoma, irritation, discoloration, pain, pruritus, warmth, neovascularization, thrombosis.

Drug Interactions

No drug interaction studies.

Polidocanol (Local) Pharmacokinetics

Absorption

Onset

Rapid onset and offset of local sclerosing effect.

Plasma Concentrations

Following IV injection of 4.5–18 mg in 4 adults, low systemic plasma concentrations were observed. Peak concentrations occurred 5 minutes after IV injection.

Elimination

Metabolism

Not known.

Elimination Route

Not known.

Half-life

Mean apparent terminal half-life is 1.5 hours.

Stability

Storage

Parenteral

Solution for IV Injection

15–30°C. Use immediately after opening ampul; does not contain a preservative.

Actions

A nonionic detergent consisting of 2 components: a polar hydrophilic (dodecyl alcohol) chain and an apolar hydrophobic (polyethylene oxide) chain. Used as a sclerosing agent.
Has a concentration- and volume-dependent damaging effect on blood vessel endothelium.
Following IV injection, induces local endothelial damage in target vein. Platelets then aggregate at site of damage and attach to the venous wall; eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel. Finally, the occluded vein is replaced with connective fibrous tissue.
Effect on the vein is permanent.

Advice to Patients

Advise patients that compression will be applied in the form of a stocking or bandage immediately after polidocanol treatment to reduce the risk of deep vein thrombosis.
Importance of walking for 15–20 minutes immediately after polidocanol treatment and then daily for next few days.
Importance of wearing compression stockings or support hose on the treated legs continuously for 2–3 days after treatment of spider veins or for 5–7 days after treatment of reticular veins. After this initial period, importance of wearing compression stockings or support hose during daytime for an additional 2–3 weeks. Depending on area treated, compression stockings or support hose should be thigh or knee high to provide adequate coverage.
Advise patients to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna for 2–3 days after polidocanol treatment.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.