pharmacopeia
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/api/v1/drug/polidocanol

Mechanism of action

Sourced from openFDA

The active ingredient of Asclera is polidocanol. Polidocanol is a sclerosing agent that locally damages the endothelium of blood vessels.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • Asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases. Known allergies to polidocanol.contraindicated

Dosage & administration

Sourced from openFDA

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 (5.3) ] . 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.

Warnings & precautions

Sourced from openFDA

Be prepared to treat anaphylaxis. ( 5.1 ) Venous Thrombosis and Pulmonary Embolism. ( 5.2 ) Arterial Embolism. ( 5.3 ) Tissue ischemia and necrosis: Do not inject intra-arterially. ( 5.4 ) 5.1 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). Minimize the dose of polidocanol. Be prepared to treat anaphylaxis appropriately. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection. 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 Venous Thrombosis and Pulmonary Embolism Asclera can cause venous thrombosis and subsequent pulmonary embolism or other thrombotic events. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization or pregnancy are at increased risk for developing thrombosis.

Adverse reactions

Sourced from openFDA

The most common adverse reactions occurring at least 3% more frequently than on placebo are mild local reactions at the site of injection. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or medinfo@methapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 [see Clinical Studies (14) ] . All of these were injection site reactions and most were mild.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary The available data from case reports on use of polidocanol-containing products, including ASCLERA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although none of these risks have been identified, there is minimal benefit in treating uncomplicated spider veins and reticular veins in the lower extremity during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. The animal reproduction studies were conducted in a manner to achieve systemic exposure, while the intended clinical use is local exposure at the injection site with minimal to no systemic exposure; therefore, these data are not relevant to the intended clinical use (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration.

Pharmacokinetics

Sourced from openFDA
Metabolism
During the major effectiveness study (EASI-trial), scheduled blood samples were taken from a sub-group of 22 patients to measure plasma levels of polidocanol after Asclera treatment of spider and reticular veins. Low systemic blood levels of polidocanol were seen in some patients.

Overdosage

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Mar 30, 2010NDANDA021201Chemisch Fbrk Krsslr
  • Nov 25, 2013NDANDA205098Provensis

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,358 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Deep Vein Thrombosis33725%
  2. 2No Adverse Event936.8%
  3. 3Pain856.3%
  4. 4Pain In Extremity685.0%
  5. 5Product Quality Issue654.8%
  6. 6Wrong Technique In Product Usage Process634.6%
  7. 7Off Label Use624.6%
  8. 8Erythema523.8%
  9. 9Skin Discolouration513.8%
  10. 10Drug Ineffective433.2%
  11. 11Pruritus433.2%
  12. 12Rash433.2%
  13. 13Peripheral Swelling402.9%
  14. 14Swelling392.9%
  15. 15Dizziness372.7%

Literature

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Recent PubMed references pinned to Polidocanol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 77 ClinicalTrials.gov registrations naming Polidocanol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Polidocanol work?
The active ingredient of Asclera is polidocanol. Polidocanol is a sclerosing agent that locally damages the endothelium of blood vessels.
What is Polidocanol used for?
According to FDA labeling, Polidocanol carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Polidocanol?
Polidocanol is classified as Sclerosing agents for local injection, Sclerosing Agent, Sclerosing Activity, Hemostasis Alteration, Vascular Sclerosing Activity.
What are the brand names for Polidocanol?
Polidocanol is marketed under brand names including Asclera, Varithena.
What are the contraindications for Polidocanol?
Polidocanol labeling lists contraindications including: Asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases. Known allergies to polidocanol.. Always consult the full prescribing information and a clinician.
Note. Data for polidocanol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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