Phone: (866) 862-1211 Asclera™ Now Approved in the U.S.

Important Safety Information

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

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.

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, should one occur.

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.

In clinical studies, the following adverse reactions were observed after using Asclera: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, revascularization, injection site thrombosis.