Asclera

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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.

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