Varithena® in clinical tests for varicose veins

Varithena® safety profile established in clinical trials1,2

Safety evaluated in 1333 patients in 12 clinical trials

  • No clinically important neurologic or visual AEs suggestive of cerebral gas embolism
    • The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group* and 4.0% in the placebo groups
    • Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician-compounded foam sclerosants
  • No anaphylaxis or life-threatening hypersensitivity reactions reportedSevere 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
  • No pulmonary emboli reported. Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena®. Approximately half (49%) of patients with thrombi received treatment with anticoagulantsVarithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment
  • Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group* and 0.7% of the placebo group in placebo-controlled studies
  • No treatment-related life-threatening serious adverse events

For more information on adverse events, see the Full Prescribing Information.

Note: Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice.

*Pooled Varithena® group includes Varithena® 0.125%, 0.5%, 1.0%, and 2.0%
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INDICATIONS

Varithena®  (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena®  improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

IMPORTANT SAFETY INFORMATION

The use of Varithena®  is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

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. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial 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. 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. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis.

Physicians administering Varithena®  must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena® .

See Full Prescribing Information for Varithena®.

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