Laser Vein Therapy:  Sclerotherapy  –  About Asclera  –  Asclera Warnings  –  Before & After

 

Indication:

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 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.

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.


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