As we get older, many of us develop varicose and spider veins on our legs, face, arms, and other parts of our body.
The appearance of these prominent, unattractive veins are not only a nuisance, but in severe cases can be quite painful.
Spider veins, which more commonly appear on the face and legs, are purple or red in color and are smaller than varicose veins. They crop up close to the skin’s surface and are said to form in a web-like pattern, giving them their name. Spider veins are usually not painful and thus are considered strictly an aesthetic issue.
Varicose veins are larger and much more noticeable than spider veins. They are also red, purple or blue in color, and they most often develop in patients’ legs. Varicose veins can resemble long, bulging cords underneath the skin’s surface, sometimes in a slightly rippled pattern, and stand out from the skin in an obvious manner. Varicose veins can be painful, as well as cause aching and itching for patients who experience them.
Asclera® is an injectable vein treatment, effective for both spider veins and small varicose veins. The treatment solution or sclerosing agent, once injected into problem veins, irritates the blood vessel’s lining and causes the vein to clot. Soon after, the vein turns to scar tissue and quickly diminishes in appearance. Asclera® is better suited to treating medium-sized veins in the body; fine veins in the face usually aren’t large enough to accommodate Asclera® injections.
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For intravenous use only.
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.
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 of Asclera® 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- 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 Aesthetics at 1-866-862-1211, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.