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Varithena

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Varithena

Varithena Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Varithena (polidocanol) Injectable Foam is a sclerosing agent used to treat incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee. Common side effects include pain or discomfort in the extremities, or injection site reactions such as pain or tenderness.

Varithena is for intravenous use under ultrasound guidance only. A dose of up to 5 ml per injection and 15 ml per treatment session is used. Treatment sessions should be separated by a minimum of 5 days. Varithena may interact with other drugs. Tell your doctor all medications and supplements you use. Varithena is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Varithena (polidocanol) Injectable Foam Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Varithena FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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)
aIncludes Varithena™ 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials.
bRetained coagulum.
cCommon 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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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.


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