Asclera
(Polidocanol)Dosage & Administration
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
Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with polidocanol administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism. The safety and efficacy of polidocanol foamed with room air has not been established and its use should be avoided.
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 thrombi that develop may be removed by microthrombectomy.
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Asclera Prescribing Information
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.
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
Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with polidocanol administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism. The safety and efficacy of polidocanol foamed with room air has not been established and its use should be avoided.
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 thrombi that develop may be removed by microthrombectomy.
Asclera (polidocanol) is an injection for intravenous use and is available as follows:
• 0.5% [10 mg/2 mL (5 mg/mL)] solution in 2 mL single-dose glass ampule
• 1% [20 mg/2 mL (10 mg/mL)] solution in 2 mL single-dose glass ampule
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
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.
These 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.
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.
Asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases.
- Be prepared to treat anaphylaxis. ()
5.1 AnaphylaxisSevere 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)]. - Venous Thrombosis and Pulmonary Embolism. ()
5.2 Venous Thrombosis and Pulmonary EmbolismAsclera 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.
- Arterial Embolism. ()
5.3 Arterial EmbolismStroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with polidocanol administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism. The safety and efficacy of polidocanol foamed with room air has not been established and its use should be avoided.
- Tissue ischemia and necrosis: Do not inject intra-arterially. ()
5.4 Tissue Ischemia and NecrosisIntra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Take care in intravenous needle placement and use the smallest effective volume at each injection site. After the injection session is completed, apply compression with a stocking or bandage and have patients walk for 15-20 minutes. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.