Asclera (generic name polidocanol) is a prescription medicine injected into the veins during sclerotherapy. The treatment aims to remove or reduce the appearance of two types of unwanted veins: reticular veins (diameter between 1 and 3 mm) and uncomplicated spider veins (diameter ≤ 1 mm).
The safety and effectiveness of Asclera on varicose veins with diameters ≤ 3 mm has not been studied.
Important Safety Information for Patients
For intravenous use only.
Asclera (polidocanol) injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute vein and blood clotting diseases.
Warnings and Precautions
- Anaphylaxis. Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. Please notify your healthcare provider if you have a known history of severe allergies or allergy to polidocanol.
- Accidental injection into an artery can cause severe necrosis, ischemia, or gangrene. If this occurs, consult your healthcare provider or a vascular surgeon immediately.
- Unintentional injection outside of the vein can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected by your healthcare provider.
Severe adverse local effects, including tissue necrosis, may occur following flow of the product outside of the vein; therefore, 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 walk for 15 to 20 minutes. Your healthcare provider will provide monitoring during this period to treat any possible anaphylactic or allergic reactions.
Maintain compression for two to three days after treatment of spider veins and for five to seven days for reticular veins, or as directed by your Healthcare Provider. 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.
In clinical studies, the following adverse reactions at the injection site were observed after using Asclera and were more common with Asclera than placebo: hematoma, irritation, discoloration, pain, itching, warmth and clotting.
You are encouraged to report any suspected adverse events to your healthcare provider or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
To learn more about sclerotherapy and Asclera, visit these sites: