Drug: Asclera

Asclera (polidocanol injection) is a sterile, nonpyrogenic, and colorless to faintly greenish-yellow solution of polidocanol for intravenous use as a sclerosing agent. The active ingredient, polidocanol is a non-ionic detergent, consisting of two components, a polar hydrophilic (dodecyl alcohol) and an apolar hydrophobic (polyethylene oxide) chain. Polidocanol has the following structural formula:
C12H25(OCH2CH2)nOH      Polyethylene glycol monododecyl ether Mean extent of polymerization (n) : Approximately 9
Mean molecular weight : Approximately 600 Each mL contains 5 mg (0.5%) or 10 mg (1.0%) polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate are added for pH adjustment.

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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. In 5 controlled randomized clinical trials, Asclera (polidocanol injection) has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old. The patient population was predominately female and consisted of Caucasian and Asian patients. Table 1 shows adverse events more common with Asclera (polidocanol injection) or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo- controlled EASI study (see Clinical Studies). All of these were injection site reactions and most were mild. Table 1: Adverse Reactions in EASI-study
  ASCLERA
(180 patients) STS 1%
(105 patients) Placebo
(53 patients) Injection site haematoma 42% 65% 19% Injection site irritation 41% 73% 30% Injection site discoloration 38% 74% 4% Injection site pain 24% 31% 9% Injection site pruritus 19% 27% 4% Injection site warmth 16% 21% 6% Neovascularisation 8% 20% 4% Injection site thrombosis 6% 1% 0% Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group. Post-marketing Safety Experience The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness Cardiac disorders: Cardiac arrest, palpitations Vascular disorders. Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis Respiratory, thoracic and mediastinal disorders: Dyspnea Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy) General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush Injury, poisoning and procedural complications: Nerve injury Read the Asclera (polidocanol injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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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 (polidocanol injection) 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera (polidocanol injection) 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. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. Repeat treatments may be necessary if the extent of the varicose veins requires more than 10 ml. These treatments should be separated by 1 to 2 weeks. Small intravaricose blood clots (thrombi) that develop may be removed by stab incision and thrombus expression (microthrombectomy).

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No drug-drug interactions have been studied with Asclera (polidocanol injection) .Last reviewed on RxList: 4/16/2010
This monograph has been modified to include the generic and brand name in many instances.

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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 (polidocanol injection) has not been studied in varicose veins more than 3 mm in diameter.

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Asclera (polidocanol injection) is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases. Last reviewed on RxList: 4/16/2010
This monograph has been modified to include the generic and brand name in many instances.

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

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Dosage Forms And Strengths Asclera (polidocanol injection) is available as a 0.5% and 1% solution in 2 mL glass ampules. Storage And Handling Asclera (polidocanol injection) is supplied in single-use, preservative free ampules in the following packages: NDC XXXXX-XXX-XX Five 0.5% ampules (2 mL)
NDC XXXXX-XXX-XX Five 1.0% ampules (2 mL) Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years. Store at 15-30°C; (59-86°F). Distributed by: BioForm Medical, Inc. 4133 Courtney Road, Suite #10, Franksville, WI 53126. Manufactured by: Chemische Fabrik Kreussler & Co. GmbH 65203 Wiesbaden GERMANY.Last reviewed on RxList: 4/16/2010
This monograph has been modified to include the generic and brand name in many instances.

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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). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, care should be taken 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 (see DOSAGE AND ADMINISTRATION). Accidental Intra-arterial Injection Intra-arterial injection can cause severe necrosis, ischemia or gangrene. If this occurs consult a vascular surgeon immediately. Inadvertent Perivascular Injection Inadvertent perivascular injection of Asclera (polidocanol injection) can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate carcinogenic potential have not been conducted with polidocanol. Polidocanol was negative in bacterial reverse mutation assays in Salmonella and E. coli, and in a micronucleus assay conducted in mice. Polidocanol induced numerical chromosomal aberrations in cultured newborn Chinese hamster lung fibroblasts in the absence of metabolic activation. Polidocanol did not affect reproductive performance (fertility) of rats when administered intermittently at dosages up to 10 mg/kg (approximately equal to the maximum human dose on the basis of body surface area). Use In Specific Populations Pregnancy Pregnancy Category C Polidocanol has been shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose. This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Asclera (polidocanol injection) should not be used during pregnancy. Animal Studies Developmental reproductive toxicity testing was performed in rats and rabbits with intravenous administration. Polidocanol induced maternal and fetal toxicity in rabbits, including reduced mean fetal weight and reduced fetal survival, when administered during gestation days 6-20 at doses of 4 and 10 mg/kg, but it did not cause skeletal or visceral abnormalities. No adverse maternal or fetal effects were observed in rabbits at a dose of 2 mg/kg. No evidence of teratogenicity or fetal toxicity was observed in rats dosed during gestation days 6-17 with doses up to 10 mg/kg. Polidocanol did not affect the ability of rats to deliver and rear pups when administered intermittently by intravenous injection from gestation day 17 to post-partum day 21 at doses up to 10 mg/kg. Human Studies There are no adequate and well-controlled studies on the use of Asclera (polidocanol injection) in pregnant women. Labor and Delivery The effects of Asclera (polidocanol injection) on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether polidocanol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, avoid administering to a nursing woman. Pediatric Use The safety and effectiveness of Asclera (polidocanol injection) in pediatric patients have not been established. Geriatric Use Clinical studies of Asclera (polidocanol injection) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.Last reviewed on RxList: 4/19/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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