Asclera

Asclera® (polidocanol) Injection is a prescription medicine that is used in a procedure called sclerotherapy to remove unwanted veins on your legs. It is administered by a healthcare provider to treat two types of veins:

*Uncomplicated spider veins (very small varicose veins ≤ 1 mm in diameter)

*Uncomplicated small varicose veins (1 to 3 mm in diameter) known as reticular veins

Asclera® has not been studied in varicose veins more than 3 mm in diameter.

IMPORTANT SAFETY INFORMATION FOR HEALTHCARE PROVIDERS:

For intravenous use only.

CONTRAINDICATIONS: Asclera® (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic 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. Be prepared to treat anaphylaxis appropriately.

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

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

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care 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.

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.

ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera® and were more common with Asclera® than placebo: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, neovascularization, injection site thrombosis.