Varithena™ - Polidocanol
Manufacturer: Biocompatibles UK Ltd.
FDA Approval Date: November 26, 2013
Varithena™ - Polidocanol
Clinical Application
• Indications:
• Incompetent great saphenous veins,
accessory saphenous veins, and visible
varicosities of the great saphenous vein
system above and below the knee
• Place in therapy:
• For those with varicose veins whose
symptoms disrupt quality of life
Varithena™ - Polidocanol
Clinical Application
• Contraindications:
• Known allergy to polidocanol
• Acute thromboembolic disease
• Warnings and Precautions
• Anaphylaxis
• Tissue ischemia and necrosis
• Venous thrombosis
Varithena™ - Polidocanol
Clinical Application
• Pregnancy:
• Category C
• Lactation:
• Excretion into breast milk is unknown; use
is not recommended
Varithena™ - Polidocanol
Drug Facts
• Pharmacology:
• Sclerosing agent
• Displaces blood from vein to be treated
• Scleroses local endothelium
Varithena™ - Polidocanol
Drug Facts
Pharmacokinetics
A
D
M
E
Cmax: 15 minutes after 1st injection;
5 minutes after 2nd injection
Vd: 59 L (range: 35L- 82L)
N/A
Half-life: 1.5 hours
Varithena™ - Polidocanol
Drug Interactions
• Drug Interactions – Object Drugs:
• No known drug interactions
• Drug Interactions – Precipitant Drugs:
• No known drug interactions
Varithena™ - Polidocanol
Adverse Effects
(polidocanol %)[placebo %]
Pain in extremity
(16.8%)[9.3%]
Injection site pain
(10.7%)[3.3%]
Infusion site thrombosis
(16.1%) [0%]
Injection site hematoma
(15.4%)[6%]
Venous thrombosis limb
(8.1%)[0%]
Thrombophlebitis
(5.4%)[1.3%]
Limb discomfort
(12.1%)[3.3%]
Deep vein thrombosis
(4.7%)[0%]
Varithena™ - Polidocanol
Monitoring Parameters
• Efficacy Monitoring:
• Symptom improvement
• Improved appearance of visible varicosities
• Toxicity Monitoring:
• None recommended
Varithena™ - Polidocanol
Prescription Information
• Dosing: Up to 5 ml per injection with a
maximum of 15 ml per session
• Under ultrasound guidance only
• Use compression therapy for 2 weeks
• Cost: Unavailable at present
• Will be commercially available in first half
of 2014
Varithena™ - Polidocanol
Literature Review
• A randomized, blinded, multicenter,
placebo-controlled, phase 3 study
• [0.5%][1.0%][placebo]
• Primary Endpoint
• Patient-reported improvement in symptoms
as indicated by VVSymQ™ score
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Literature Review
• Secondary Endpoints
• Patient-reported improvement in
appearance of visible varicosities
• Physician-assessed improvement in
appearance of visible varicosities
• Tertiary Endpoint
• Response to treatment based on duplex
ultrasound, VCSS, and VEINES-QOL
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Literature Review
• N = 232*
• Mean age: 50 years
• Eligibility: Incompetence as evidenced by
reflux of great and/or accessory saphenous
veins
• Exclusion: History of DVT or PE, reduced
mobility, major surgery, pregnancy or
prolonged hospitalization within 3 months
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Literature Review
Primary Endpoint: VVSymQ™ Score
Placebo
(n = 54)
Varithena™ 0.5%
(n = 60)
Varithena™ 1%
(n = 57)
Mean Baseline
Score
9.26
9.48
7.82
Adjusted Mean
Change at Week 8
-2.00
-6.01
-5.06
Improvement in Sx
at Week 8
21.2%
83.1%
77.8%
<0.0001
<0.0001
P value
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Literature Review
Secondary Endpoints: IPR-V3 Score
Placebo
(n = 56)
Varithena™ 0.5%
(n = 60)
Varithena™ 1%
(n = 57)
Mean Baseline
Score
2.18
2.20
2.02
Adjusted Mean
Change at Week 8
-0.07
-0.89
-0.83
Improvement in Sx
at Week 8
0
75.1%
70.7%
<0.0001
<0.0001
P value
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Literature Review
Secondary Endpoint: PA-V3 Score
Placebo
(n = 56)
Varithena™ 0.5%
(n = 60)
Varithena™ 1%
(n = 57)
Mean Baseline
Score
3.30
3.58
3.49
Adjusted Mean
Change at Week 8
-0.32
-1.86
-1.79
Improvement in Sx
at Week 8
7.1%
80.2%
69.0%
<0.0001
<0.0001
P value
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Literature Review
Tertiary Endpoint: Duplex Ultrasound
Placebo
(n = 56)
Responders
P-Value
1.8%
Varithena™ 0.5% Varithena™ 1%
(n = 60)
(n = 57)
83.3%
87.9%
0.0043
0.0004
Todd et al. Phlebology. 2013; 0(0):1-11
Varithena™ - Polidocanol
Summary
 Varithena™, polidocanol, 1% is indicated for the
treatment of incompetent saphenous veins and
visible varicosities of the lower extremities
 Usual dosing is typically up to 5 ml per injection
with a maximum of 15 ml per session followed by
2 weeks of compression therapy
 Pain is the most common side effect
 Monitor for anaphylaxis, tissue ischemia, and
venous thrombosis
Varithena™ - Polidocanol
References
1.
2.
3.
http://www.varithena.com
Varithena [package insert]. Farnham, UK: Biocompatibles UK
Ltd.; November 2013.
Todd KL, et al. The VANISH-2 study: a randomized, blinded,
multicenter study to evaluate the efficacy and safety
of polidocanol endovenous microfoam 0.5% and 1.0%
compared with placebo for the treatment of saphenofemoral
junction incompetence. Phlebology. 2013;0(0): 1-11