Polidocanol

Asclera ® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. Asclera (polidocanol) is a sclerosing agent indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3mm in diameter. ( 1 )

• For intravenous use only
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
• Do not use if particulate matter is seen or if the contents of the vial are discolored or if the vial is damaged in any way
• For spider veins (varicose veins ≤1 mm in diameter), use Asclera 0.5%
• For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%
• Use 0.1 to 0.3 mL per injection and no more than 10 mL per session
• Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge)
• Insert the needle tangentially into the vein and inject the solution slowly while the needle is still in the vein
• Apply only gentle pressure during injection to prevent vein rupture
• After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage
• After the treatment session, encourage the patient to walk for 15 to 20 minutes
• Keep the patient under observation to detect any anaphylactic or allergic reaction [see Warnings and Precautions ]
• 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

Asclera (polidocanol) is an injection for intravenous use and is available as follows: • 0.5% [10 mg/2 mL (5 mg/mL)] solution in 2 mL single-dose glass ampule • 1% [20 mg/2 mL (10 mg/mL)] solution in 2 mL single-dose glass ampule 0.5% and 1% solution in 2 mL glass ampules. ( 3 )

• The safety and effectiveness of Asclera
• In pediatric patients have not been established

Clinical studies of Asclera did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

• Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime
• Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage
• Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days
• For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna
• Distributed by: Methapharm, Inc
• Boca Raton, FL 33433 Tel: 1-833-766-8346 www.asclera.com Manufactured by: Chemische Fabrik Kreussler & Co. …

• Asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases
• Known allergies to polidocanol
• Patients with acute thromboembolic diseases

No drug-drug interactions have been studied with Asclera.

Be prepared to treat anaphylaxis. ( 5.1 ) Venous Thrombosis and Pulmonary Embolism. ( 5.2 ) Arterial Embolism. ( 5.3 ) Tissue ischemia and necrosis: Do not inject intra-arterially. ( 5.4 ) 5.1 Anaphylaxis Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (> 3 mL). Minimize the dose of polidocanol. 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 use the smallest effective volume at each injection. …

The most common adverse reactions occurring at least 3% more frequently than on placebo are mild local reactions at the site of injection. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or medinfo@methapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary The available data from case reports on use of polidocanol-containing products, including ASCLERA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. …

Overdose may result in a higher incidence of localized reactions such as necrosis.

Store at 15°C to 30°C; (59°F to 86°F).

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.