Asclera Injection

Name: Asclera Injection

Indications and Usage for Asclera Injection

Asclera® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.

Contraindications

Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.

Clinical Studies

Asclera was evaluated in a multicenter, randomized, double-blind, placebo- and comparator-controlled trial (EASI-study) in patients with spider or reticular varicose veins. A total of 338 patients were treated with Asclera [0.5% for spider veins (n=94), 1% for reticular veins (n=86)], sodium tetradecyl sulfate (STS) 1% (n=105), or placebo (0.9% isotonic saline solution) (n=53) for either spider or reticular veins. Patients were predominately female, ranging in age from 19 to 70 years. All of them received an intravenous injection in the first treatment session; repeat injections were given three and six weeks later if the previous injection was evaluated as unsuccessful (defined as 1, 2 or 3 on a 5-point scale, see below). Patients returned at 12 and 26 weeks after the last injection for final assessments.

The primary effectiveness endpoint was improvement of veins judged by a blinded panel. Digital images of the selected treatment area were taken prior to injection, compared with those taken at 12 weeks post-treatment, and rated on a 5-point scale (1 = worse than before, 2 = same as before, 3 = moderate improvement, 4 = good improvement, 5 = complete treatment success); results are shown in Table 2.

Table 2: Improvement of veins in digital photographs after 12 weeks and 26 weeks
Treatment Group Polidocanol (n=155) STS (n=105) Placebo (n=53)
* p <0.0001 compared to placebo (Wilcoxon-Mann-Whitney test)
Digital Photograph Scores at 12 weeks
Mean ± SD 4.5* ± 0.7 4.5*± 0.7 2.2 ± 0.7
Digital Photograph Scores at 26 weeks
Mean ± SD 4.5* ± 0.7 4.5*± 0.8 2.2 ± 0.7

The secondary efficacy criterion was the rate of treatment success, pre-defined as a score of 4 or 5 with patients scoring 1, 2, or 3 considered treatment failures; results are shown in Table 3.

Table 3: Treatment success rates at 12 weeks and 26 weeks
Treatment success?* Polidocanol (n=155) STS (n=105) Placebo (n=53)
* Treatment success: Yes= Grade 4 to 5, No= Grade 1 to 3; derived from median of evaluation; † p<0.0001 compared to placebo.
At 12 weeks (Visit 4)
Yes 95%† 92%† 8%
No 5% 8% 92%
Missing 0.6% 0% 0%
At 26 weeks (Visit 5)
Yes 95%† 91%† 6%
No 5% 9% 94%

At 12 and 26 weeks, patients' judgement of the results was assessed by showing them the digital images of their treatment area taken at baseline and asking them to rate their satisfaction with their treatment using a verbal rating scale (1 = very unsatisfied; 2 = somewhat unsatisfied; 3 = slightly satisfied; 4 = satisfied and 5 = very satisfied); results are shown in Table 4.

Table 4: Patient satisfaction after 12 weeks and 26 weeks
Polidocanol (N=155) STS (N=105) Placebo (N=53)
* p <0.0001 compared to STS and placebo
Patient satisfaction with treatment after 12 weeks (Visit 4)
Satisfied or very satisfied 87%* 64% 14%
Patient satisfaction with treatment after 26 weeks (Visit 5)
Satisfied or very satisfied 84%* 63% 16%

Patient Counseling Information

Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage.

Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days.

For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna.

Distributed by:
Merz Aesthetics, Inc.
4133 Courtney Road, Suite #10 Franksville, WI 53126

Manufactured by:
Chemische Fabrik Kreussler & Co. GmbH 65203 Wiesbaden GERMANY

Asclera is a registered trademark of Chemische Fabrik Kreussler & Co. GmbH, 65203 Wiesbaden, GERMANY

PRINCIPAL DISPLAY PANEL - 20 mg Carton

NDC 46783-221-52

ASCLERA®
(polidocanol) Injection

20 mg per 2 mL
(10 mg per mL)

1%

For Intravenous Use Only
Rx Only
Single use: Discard unused portion
Contains:
5 ampules each containing 20 mg per 2 mL

PRINCIPAL DISPLAY PANEL - 10 mg Carton

NDC 46783-121-52

ASCLERA®
(polidocanol) Injection

10 mg per 2 mL
(5 mg per mL)

0.5%

For Intravenous Use Only
Rx Only
Single use: Discard unused portion
Contains:
5 ampules each containing 10 mg per 2 mL

ASCLERA  
polidocanol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:46783-221
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLIDOCANOL (POLIDOCANOL) POLIDOCANOL 0.01000 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 0.04200 g  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.00085 g  in 1 mL
SODIUM PHOSPHATE, DIBASIC 0.00240 g  in 1 mL
WATER 0.93875 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:46783-221-52 2 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021201 06/01/2010
ASCLERA  
polidocanol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:46783-121
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLIDOCANOL (POLIDOCANOL) POLIDOCANOL 0.00500 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 0.04200 g  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.00043 g  in 1 mL
SODIUM PHOSPHATE, DIBASIC 0.00120 g  in 1 mL
WATER 0.94437 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:46783-121-52 2 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021201 06/01/2010
Labeler - Merz Aesthetics, Inc. (137113929)
Establishment
Name Address ID/FEI Operations
Chemische Fabrik Kreussler & Co. GmbH 315568337 MANUFACTURE
Revised: 09/2011   Merz Aesthetics, Inc.
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