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Clinical Trials Experience
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.
A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena™ at dose concentrations of 0.125%, 0.5%, 1.0%, or 2.0%, including 437 patients treated with Varithena™ in placebo-controlled clinical trials.
Adverse reactions occurring in 3% more patients receiving Varithena™ 1% than receiving placebo are shown in Table 1.
Table 1: Treatment-emergent adverse reactions (3% more on Varithena™ 1% than on placebo) through Week 8 (n=588)
|Adverse Reaction|| Placebo
| Varithena™ 1.0%
| Pooleda Varithena™ |
|Pain in extremity||14 (9.3)||25 (16.8)||65 (14.9)|
|Infusion site thrombosisb||0||24 (16.1)||46 (10.5)|
|Contusion/injection site hematoma||9 (6.0)||23 (15.4)||38 (8.7)|
|Limb discomfort||5 (3.3)||18 (12.1)||32 (7.3)|
|Tenderness/injection site pain||5 (3.3)||16 (10.7)||30 (6.9)|
|Venous thrombosis limbc||0||12 (8.1)||24 (5.5)|
|Thrombophlebitis superficial||2 (1.3)||8 (5.4)||40 (9.2)|
|Deep vein thrombosis||0||7 (4.7)||10 (2.3)|
| a Includes Varithena™ 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials. |
b Retained coagulum.
c Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).
In Varithena™-treated patients, 80% of pain events in the treated extremity resolved within 1 week.
In the 1333 patients treated with Varithena™, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius, and soleal vein thrombosis (1.4%).
Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena™. Approximately half (49%) of patients with thrombi received treatment with anticoagulants.
Since Varithena™ induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena™.
Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena™ trials experienced clinically important neurological or visual adverse events 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.
Skin discoloration adverse events were reported in 1.1% of the pooled Varithena™ group and 0.7% of the placebo group in the placebo-controlled studies.
Read the Varithena (polidocanol injectable foam) Side Effects Center for a complete guide to possible side effects
No specific drug interaction studies have been performed. There are no known drug interactions with Varithena™.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/4/2015
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