Polidocanol Injectable Foam
Name: Polidocanol Injectable Foam
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.
Side effects
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 with GSVI 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 (N=151) | VARITHENA 1.0% (N=149) | Pooleda VARITHENA (N=437) |
| 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 entire FDA prescribing information for Varithena (Polidocanol Injectable Foam)
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