"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.
Tissue Ischemia and Necrosis
Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.
Varithena™ can cause venous thrombosis [see ADVERSE REACTIONS]. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential of Varithena™. No mutagenic activity was observed in the in vitro bacterial reverse mutation assay at non-toxic concentrations. No mutagenic activity was observed in the in vitro mouse lymphoma assay in the absence of S9 mix and was weakly mutagenic in the presence of S9 close to the limit of acceptance for
the accompanying level of toxicity. No micronucleus induction was detected in the in vivo assay on mouse bone marrow cells up to the maximum tolerated dose of 80 mg/kg.
No specific drug interaction studies have been performed. There are no known drug interactions with Varithena™.
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled studies of Varithena™ in pregnant women. Do not use Varithena™ during pregnancy.
Developmental reproductive toxicity testing was performed in rats and rabbits using intravenous administration of polidocanol solution. In rabbits, dose levels up to and including 10 mg/kg/day (approximately 12 times the proposed maximum human dose of 15 mL of 1% Varithena™ based on body surface area) did not produce any indication of adverse effects on embryo-fetal mortality, fetal weight, or the incidences of fetal abnormalities and variants. In rats administered 27 mg/kg/day of polidocanol solution (approximately 13.5 times the human dose based on body surface area), there were no adverse effects on pregnancy performance or fetal development. In a peri-natal and post-natal study in rats, dose levels of polidocanol up to 9 mg/kg/day (approximately 4.5 times the human dose based on body surface area) were without effects on the development of the conceptus and offspring, and at a dose level of 27 mg/kg/day of polidocanol solution (approximately 13.5 times the human dose based on body surface area), effects were confined to an equivocal reduction in body weights of first-generation males, and an associated equivocal delay in the age of preputial separation.
Labor and Delivery
The effects of Varithena™ on labor and delivery in pregnant women are unknown.
It is not known whether polidocanol, the active pharmaceutical ingredient in Varithena™, 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 Varithena™ to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Of the 1333 subjects in clinical studies treated with Varithena™, 9.1% (n=121) were >65 years of age. No clinically important differences in safety or efficacy were observed between older and younger patients in all studies.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/4/2015
Additional Varithena Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.