Asclera

Asclera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Asclera (polidocanol injection) is a sclerosing agent used to treat small uncomplicated spider veins and varicose veins in the legs. It will not treat varicose veins that are larger than 3 millimeters (about one-eighth of an inch) in diameter. Asclera is not a cure for varicose veins and the effects of this medication may not be permanent. Common side effects include mild numbness or tingling, headache, dizziness, increased hair growth on the treated leg, or injection site reactions including pain, warmth, itching, or bruising.

The dose of Asclera for spider veins (varicose veins ≤ 1 mm in diameter), is 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%. Use 0.1 to 0.3 mL per injection and no more than 10 mL per session. Asclera may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Asclera should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Asclera (polidocanol injection) 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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Asclera in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • severe pain, burning, or other irritation in your leg;
  • discoloration or skin changes where an injection was given;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • severe numbness that does not go away;
  • pain, swelling, warmth, or redness in one or both legs;
  • trouble breathing, pounding heartbeats or fluttering in your chest; or
  • confusion, feeling like you might pass out.

Less serious side effects may include:

  • mild numbness or tingling;
  • mild headache, dizziness;
  • increased hair growth on the treated leg; or
  • mild pain or warmth, mild itching, or slight bruising where an injection was given.

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.

Read the entire detailed patient monograph for Asclera (Polidocanol Injection) »

What is Prescribing information?

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

Asclera FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 (polidocanol injection) 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 (polidocanol injection) or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo- controlled EASI study (see Clinical Studies). 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

Read the entire FDA prescribing information for Asclera (Polidocanol Injection) »

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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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