Important Safety Information | 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 PATIENTS:
For intravenous use only.
CONTRAINDICATIONS: 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 be the smallest dose that is effective. Please notify your healthcare provider if you have a known history of severe allergies or allergy to polidocanol.
Venous Thrombosis and Pulmonary Embolism: Asclera can cause venous thrombosis and subsequent pulmonary embolism or other thrombotic events. Your physician should 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: 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.
Accidental injection into an artery can cause severe necrosis, ischemia or gangrene.
Care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used. If injection of polidocanol into an artery occurs, consult a vascular surgeon immediately.
After the injection session is completed, apply compression with a stocking or bandage, and walk for 15- 20 minutes. Your healthcare provider will provide monitoring during this period to treat any possible anaphylactic or allergic reactions.
Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 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.
ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera® and were more common with Asclera® than placebo: injection site hematoma, injection site irritation, injection site discoloration, injection site pain, injection site itching, injection site warmth, neovascularization, injection site clotting.
You are encouraged to report any suspected adverse events. To report SUSPECTED ADVERSE REACTIONS, contact your Healthcare Provider, Merz North America at 1-866-862-1211, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.