Asclera

Name: Asclera

Adverse Effects

>10%

Asclera

  • Injection site hematoma (42%)
  • Injection site irritation (41%)
  • Injection site discoloration (38%)
  • Injection site pain (24%)
  • Injection site pruritus (19%)
  • Injection site warmth (16%)

Varithena

  • Pain in extremity (16.8%)
  • Infusion site thrombosis (16.1%)
  • Contusion/injection site hematoma (15.4%)
  • Limb discomfort (12.1%)
  • Injection site pain/tenderness (10.7%)

1-10%

Asclera

  • Neovascularization (8%)
  • Injection site thrombosis (6%)

Varithena

  • Venous thrombosis limb (8.1%)
  • Superficial thrombophlebitis (5.4%)
  • Deep vein thrombosis (4.7%)

Asclera Overview

Asclera is a brand name medication included in a group of medications called Sclerosing agents for local injection. For more information about Asclera see its generic Polidocanol

Asclera Dosage and Administration

Administration

IV Administration

Administer only by IV injection.1 Avoid extravasation.1 (See Administration Precautions under Cautions.)

Commercially available as 0.5 or 1% solution in single-use ampuls (containing a total of 10 or 20 mg, respectively, in each 2-mL ampul).1 Has been administered as an endovenous foam or microfoam;2 3 6 8 9 11 12 13 these preparations not commercially available in US and extemporaneous preparation of polidocanol foam not approved by FDA.

Administration Procedure

Use a syringe (glass or plastic) with a fine needle (typically, 26- or 30-gauge).1 Insert needle tangentially into target vein and inject solution slowly while needle is still in vein.1 To prevent vein rupture, only apply gentle pressure during injection.1

After removing needle from target vein and covering injection site, apply compression in the form of a stocking or bandage.1 After treatment session, have patient walk for 15–20 minutes and observe patient to detect any anaphylactic or allergic reaction.1 (See Sensitivity Reactions under Cautions.)

Advise patient to maintain compression (stocking or bandage) for 2–3 days after treatment of spider veins or 5–7 days after treatment of reticular veins.1 For extensive varicosities, longer compression treatment with compression bandages or gradient compression stocking of a higher compression class is recommended.1

If small intravaricose blood clots (thrombi) develop, they may be removed by stab incision and thrombus expression (microthrombectomy).1

Dosage

Adults

Sclerotherapy Uncomplicated Varicose Veins in Lower Extremity IV

Concentration of polidocanol solution (0.5 or 1%) and injection volume depend on type and size of varicose veins.1 2 After polidocanol treatment, compression is necessary to reduce risk of deep vein thrombosis.1 (See IV Administration under Dosage and Administration.)

Spider veins (varicose veins ≤1 mm in diameter): 0.1–0.3 mL (0.5–1.5 mg) of 0.5% solution for each injection.1 Do not exceed 10 mL (50 mg) per treatment session.1

Reticular veins (varicose veins 1–3 mm in diameter): 0.1–0.3 mL (1–3 mg) of 1% solution for each injection.1 Do not exceed 10 mL (100 mg) per treatment session.1

Repeat treatments may be necessary if extent of varicose veins requires >10 mL of solution.1 Separate treatment sessions by 1–2 weeks.1

Prescribing Limits

Adults

Sclerotherapy Uncomplicated Varicose Veins in Lower Extremity IV

Maximum 0.3 mL of 0.5 or 1% solution (1.5 or 3 mg, respectively) per injection site; maximum 10 mL per treatment session.1

Actions

  • A nonionic detergent consisting of 2 components: a polar hydrophilic (dodecyl alcohol) chain and an apolar hydrophobic (polyethylene oxide) chain.1 Used as a sclerosing agent.1

  • Has a concentration- and volume-dependent damaging effect on blood vessel endothelium.1

  • Following IV injection, induces local endothelial damage in target vein.1 Platelets then aggregate at site of damage and attach to the venous wall; eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel.1 Finally, the occluded vein is replaced with connective fibrous tissue.1

  • Effect on the vein is permanent.10

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Coughing up blood.
  • Chest pain or pressure.
  • Shortness of breath.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

Adverse Reactions

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old. The patient population was predominately female and consisted of Caucasian and Asian patients.

Table 1 shows adverse events more common with Asclera or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo- controlled EASI study (see Clinical Studies [14]). All of these were injection site reactions and most were mild.

Table 1: Adverse Reactions in EASI-study
Asclera (180 patients) STS 1% (105 patients) Placebo (53 patients)
Injection site haematoma 42% 65% 19%
Injection site irritation 41% 73% 30%
Injection site discoloration 38% 74% 4%
Injection site pain 24% 31% 9%
Injection site pruritus 19% 27% 4%
Injection site warmth 16% 21% 6%
Neovascularisation 8% 20% 4%
Injection site thrombosis 6% 1% 0%

Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.

Post-marketing Safety Experience

The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma

Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness

Cardiac disorders: Cardiac arrest, palpitations

Vascular disorders: Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis

Respiratory, thoracic and mediastinal disorders: Dyspnea

Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy)

General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush

Injury, poisoning and procedural complications: Nerve injury

Overdosage

Overdose may result in a higher incidence of localized reactions such as necrosis.

PRINCIPAL DISPLAY PANEL - 10 mg Ampule 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 North America, Inc (028147846)
Establishment
Name Address ID/FEI Operations
Chemische Fabrik Kreussler & Co. GmbH 315568337 MANUFACTURE(46783-221, 46783-121)
Revised: 07/2014   Merz North America, Inc
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