Asclera® (polidocanol) Injection

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Asclera® (polidocanol) Injection is a prescription medicine that is used in a procedure called sclerotherapy to remove unwanted veins on your legs. It is administered by a healthcare provider to treat two types of veins:

  • Uncomplicated spider veins (very small varicose veins ≤ 1 mm in diameter)
  • Uncomplicated small varicose veins (1 to 3 mm in diameter) known as reticular veins

Asclera® has not been studied in varicose veins more than 3 mm in diameter.

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IMPORTANT SAFETY INFORMATION FOR PATIENTS:

For intravenous use only.

CONTRAINDICATIONS: Asclera® (polidocanol) Injection is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute vein and blood clotting diseases.

WARNINGS AND PRECAUTIONS:
Anaphylaxis: Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should be the smallest dose that is effective. Please notify your healthcare provider if you have a known history of severe allergies or allergy to polidocanol.

Venous Thrombosis and Pulmonary Embolism: Asclera can cause venous thrombosis and subsequent pulmonary embolism or other thrombotic events. Your physician should follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization or pregnancy are at increased risk for developing thrombosis.

Arterial Embolism: Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with polidocanol administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism. The safety and efficacy of polidocanol foamed with room air has not been established and its use should be avoided.

Accidental injection into an artery can cause severe necrosis, ischemia or gangrene.

Care should be taken in intravenous needle placement and the smallest effective volume at each injection site should be used. If injection of polidocanol into an artery occurs, consult a vascular surgeon immediately.

After the injection session is completed, apply compression with a stocking or bandage, and walk for 15- 20 minutes. Your healthcare provider will provide monitoring during this period to treat any possible anaphylactic or allergic reactions.

Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins, or as directed by your Healthcare Provider. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.

ADVERSE REACTIONS: In clinical studies, the following adverse reactions were observed after using Asclera® and were more common with Asclera® than placebo: injection site hematoma, injection site irritation, injection site discoloration, injection site pain, injection site itching, injection site warmth, neovascularization, injection site clotting.

You are encouraged to report any suspected adverse events. To report SUSPECTED ADVERSE REACTIONS, contact your Healthcare Provider, Methapharm Medical Information at 1-866-701-4636, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For all other Asclera inquiries please call 1-833-766-8346 (VEIN).


Ask your provider about Asclera® for Treatment of Spider Veins

If you’re one of the estimated 30 million Americans1 with venous disease, you’re not alone.

The good news is that thanks to Asclera® (pronounced uh-SKLAIR-uh), you may no longer need to feel self-conscious about showing your legs due to spider veins. Asclera® is an FDA-approved treatment used in a procedure called sclerotherapy. It’s administered in-office by a healthcare provider to treat two types of veins in the lower extremities:

  • Uncomplicated spider veins (very small varicose veins ≤ 1 mm in diameter)
  • Uncomplicated small varicose veins (1 to 3 mm in diameter) known as reticular veins

The Asclera® procedure

1) Your provider or vascular specialist injects Asclera® into the vein.
2) Over a period of weeks, the treated veins collapse and become less visible.
3) Over time, the body naturally resorbs the treated vein.


 Asclera ImageAsclera® At-A-Glance

  •  NON-SURGICAL:Administered in a provider’s office
  •  RELIABLE:FDA-approved in the U.S. since 2010
  •  CONVENIENT:Each session typically lasts 15 to 45 minutes
  •  SATISFIED PATIENTS:88% of clinical study patients were satisfied or very satisfied with treatment after 12 weeks2,3
  •  SIDE EFFECTS:In a clinical study, the most common side effect was temporary bruising (hematoma) at the injection site2,3. These are not all the potential side effects. 

Why should I ask for Asclera® by name?

The Asclera® difference is in the quality and consistency of the medicine. When your provider uses FDA-approved Asclera®, you can be assured that the drug was created using strict quality controls. In addition, Asclera has been studied in patients and has been evaluated for its safety and effectiveness.

Conversely, compounded medications like non-Asclera® polidocanol are not approved by the FDA. They have not been evaluated or verified for safety or effectiveness. In some cases, the drug may have even been created in unsanitary conditions. Recent FDA investigations1 have shown that poor compounding practices can result in serious drug quality problems, such as:

  • contamination
  • too much or too little of the active ingredient
  • additional ingredients that you may not be aware of

Be sure to ask your provider for FDA-approved Asclera® for treatment of your spider veins in your legs.

FDA has said: “Our goal will be to make sure that patients do not receive compounded drugs unnecessarily when an FDA-approved drug is appropriate to meet their medical needs.”


How often do I need treatment to see results?

The number and frequency of treatments depends on the size of the vessels and their location. Ask your provider about an individualized treatment approach that is right for you.

How does Asclera® work?

Asclera® is a sclerosing agent that is injected into the vein. It works by damaging the endothelium, the inside lining of blood vessels. This causes blood platelets and cellular debris to attach to the lining of the vessels. Eventually, cellular debris and platelets cause the blood vessel to clot. Over time, the clotted vein will be replaced with tissue.

How satisfied are patients who use Asclera®?

88% of clinical study patients were satisfied or very satisfied with their Asclera® treatment after 12 weeks.2,3

How long is each Asclera® session?

A typical session lasts 15 to 45 minutes. Generally, 1 to 3 injections may be necessary to treat a given spider or reticular vein. Repeat treatment sessions may be necessary. Any additional treatment sessions are usually separated by 1 to 2 weeks.

What should I expect after being treated with Asclera®?

Following treatment, you’ll need to wear compression stockings day and night for 2 to 3 days, then for 2 to 3 weeks during the daytime, as directed by your provider. Compression stockings are designed to apply pressure to your lower legs, helping to maintain blood flow, and reduce discomfort and swelling. Compression helps your legs heal and is necessary to reduce the risk of deep vein thrombosis.

You should also walk 15 to 20 minutes immediately after treatment and daily for a few days.

Are there activities I should avoid after receiving an Asclera® Injection?

For 2 to 3 days following the treatment, avoid:

  • Heavy exercise
  • Sunbathing
  • Long plane flights
  • Hot baths, hot tubs, or saunas

Be sure to ask your healthcare provider if you are uncertain about any activities you should avoid post-procedure.

Are there any possible side effects to Asclera® treatments?

Temporary side effects may occur at the site of the injection, including:

  • Bruising
  • Raised red areas
  • Small skin sores
  • Darkened skin in the form of lines or spots
  • Multiple tiny red blood vessels

These side effects usually go away within a few days to several weeks. Some side effects may take months or years to resolve.

Although rare, some individuals may experience serious side effects, which may require treatment. These can include:

  • An allergic reaction. Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are most frequent with use of larger volumes (> 3 mL). The dose of polidocanol should therefore be minimized. A provider should be prepared to treat anaphylaxis appropriately
  • In rare cases, formation of small “burns” or ulcers form, usually due to leakage of Asclera® into the skin. These will heal in time but may leave a scar
  • Inadvertent perivascular injection of Asclera® can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected

Is there any reason I should not be treated with Asclera®?

You should not be treated with Asclera® if you:

  • Have a known allergy to polidocanol
  • Have an acute vein or blood clotting (thromboembolic) disease
  • Are pregnant or nursing

Be sure to tell your provider about all the medicines you are taking, including prescription and nonprescription medicines, vitamins and herbal products.

 


Before & After Photos

RESULTS AT 26 WEEKS AFTER LAST TREATMENT

 

 

 

 

 

Uncomplicated reticular vein treatment*(1 to 3 mm) actual patient treated with 1%

*Individual results may vary depending on varicose.

 

 

 

 

 

 

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  • Store Name: Merz
  • Address: 6501 Six Forks Road Raleigh, NC
    27615
    United States (US)
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