Distributed by Merz North America
Merz North America at 1-866-862-1211
FDA at 1-800-FDA-1088
What is sclerotherapy?
Sclerotherapy is a minimally invasive procedure done by your healthcare provider to treat uncomplicated spider veins and uncomplicated reticular veins. The treatment involves the injection of a solution into the affected veins.
What are varicose veins?
Varicose veins are large blue, dark purple veins. They protrude from the skin and many times they have a cord-like appearance and may twist or bulge. Varicose veins are found most frequently on the legs.
What are spider veins?
Spider veins are very small and very fine red or blue veins. They are closer to the surface of the skin than varicose veins. They can look like a thin red line, tree branches or spider webs. Spider veins can be found on the legs and face and may cover a small or large area.
What are reticular veins?
Reticular veins can also be known as feeder veins. They are the blue and green veins beneath the surface of the skin.
Reticular veins enlarge because of increased pressure in the vein. They can be caused by heredity. You may have reticular veins alone but you may also have spider veins at the same time.
What causes spider and reticular veins?
Spider and reticular veins can be caused by many factors.
Heredity. Having a family member with prominent veins may increase the risk of you developing them. Approximately half of the people who get varicose veins have a family history of them.
Age. The normal wear and tear of aging may cause valves in the veins to weaken and not work as well.
Gender. Women are two to three times more likely to develop varicose veins than men. Up to half of American women have varicose veins. Changes in hormones due to puberty, pregnancy, menopause, or taking birth control pills may increase a woman’s risk of developing varicose veins.
Pregnancy. During pregnancy, the growth of the fetus increases the pressure on the veins in the legs. Varicose veins that occur during pregnancy usually improve within 3 to 12 months following delivery.
Overweight and obesity. Having extra weight on the body can put additional pressure on the veins.
Prolonged standing or sitting. This is particularly true with legs bent or crossed. When standing or sitting with legs bent or crossed, the veins have to work harder to pump the blood up to the heart.
Other possible causes for varicose veins are race, posture, occupation, hormones such as estrogen and progesterone, primary valvular incompetence, and incompetent perforating veins.
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.