Polidocanol

Polidocanol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Polidocanol is a sclerosing agent that is FDA approved for the treatment of uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Common adverse reactions include mild local reactions at the site of injection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Asclera® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.

Dosage

• For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter is seen or if the contents of the vial are discolored or if the vial is damaged in any way.

For spider veins (varicose veins ≤1 mm in diameter), use Asclera 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%. Use 0.1 to 0.3 mL per injection and no more than 10 mL per session.

Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge). Insert the needle tangentially into the vein and inject the solution slowly while the needle is still in the vein. Apply only 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. After the treatment session, encourage the patient to walk for 15 to 20 minutes. Keep the patient under observation to detect any anaphylactic or allergic reaction (see WARNINGS AND PRECAUTIONS [5]).

Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

Repeat treatments may be necessary if the extent of the varicose veins requires more than 10 mL. These treatments should be separated by 1 to 2 weeks.

Small intravaricose blood clots (thrombi) that develop may be removed by stab incision and thrombus expression (microthrombectomy).

DOSAGE FORMS AND STRENGTHS

• Asclera is available as a 0.5% and 1% solution in 2 mL glass ampules.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Polidocanol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Polidocanol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Polidocanol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Polidocanol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Polidocanol in pediatric patients.

Contraindications

• Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

Warnings

• Anaphylaxis

Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used.

After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction (see DOSAGE AND ADMINISTRATION [2]).

5.2 Accidental Intra-arterial Injection Intra-arterial injection can cause severe necrosis, ischemia or gangrene. If this occurs consult a vascular surgeon immediately.

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

Adverse Reactions

Clinical Trials Experience

Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old. The patient population was predominately female and consisted of Caucasian and Asian patients.

Table 1 shows adverse events more common with Asclera or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo- controlled EASI study. All of these were injection site reactions and most were mild.

• Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.

Postmarketing Experience

Post-marketing Safety Experience The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma

Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness

Cardiac disorders: Cardiac arrest, palpitations

Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis

Respiratory, thoracic and mediastinal disorders: Dyspnea

Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy)

General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush

Injury, poisoning and procedural complications: Nerve injury

Drug Interactions

• No drug-drug interactions have been studied with Asclera.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Asclera should not be used during pregnancy.

Animal Studies

Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg.

Human Studies

There are no adequate and well-controlled studies on the use of Asclera in pregnant women.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Polidocanol in women who are pregnant.

Labor and Delivery

• The effects of Asclera on labor and delivery in pregnant women are unknown.

Nursing Mothers

• It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman.

Pediatric Use

• The safety and effectiveness of Asclera in pediatric patients have not been established.

Geriatic Use

• Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Gender

There is no FDA guidance on the use of Polidocanol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Polidocanol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Polidocanol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Polidocanol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Polidocanol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Polidocanol in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Polidocanol in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Polidocanol in the drug label.

Overdosage

• Overdose may result in a higher incidence of localized reactions such as necrosis.

Pharmacology

There is limited information regarding Polidocanol Pharmacology in the drug label.

Mechanism of Action

Structure

File:Polidocanol01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Polidocanol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Polidocanol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Polidocanol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Polidocanol in the drug label.

How Supplied

Storage

There is limited information regarding Polidocanol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Polidocanol in the drug label.

Precautions with Alcohol

• Alcohol-Polidocanol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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