Varithena
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Varithena™ (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
History
There is currently no drug history available for this drug.
Other Information
Varithena™ injectable foam contains the sclerosant, polidocanol. It is intended for intravenous use only.
Chemically, polidocanol is polyoxyl lauryl ether. The structural formula is represented below:
Polidocanol has the molecular formula CH3(CH2)11(OCH2CH)nOH and a molecular weight of 582.9 when the average ethylene glycol moieties is nine (n=9). Polidocanol is a white to almost white, waxy, hygroscopic solid that is soluble in water and alcohol and melts at temperatures above 20°C.
Varithena™ is a sterile, injectable foam of an aqueous polidocanol solution (1%) containing the following inactive ingredients: ethanol (4.2% w/w), disodium hydrogen phosphate dihydrate (0.24% w/w), and potassium dihydrogen phosphate (0.085% w/w) with pH adjustment using 0.1 M sodium hydroxide solution and 0.1 M hydrochloric acid solution to achieve a pH of 6.0-7.5.
Activate the Varithena™ canister to enable foam generation from the polidocanol solution (180 mg/18 mL (10 mg/mL)). Once activated, Varithena™ is a white, injectable foam delivering a 1% polidocanol solution. Each mL of Varithena™ injectable foam contains 1.3 mg of polidocanol. An activated canister of Varithena™ generates 90 mL of injectable foam, which following purging instructions contained in the IFU, is sufficient to yield 45 mL of usable injectable foam for intravenous injection. The polidocanol solution is stored under a carbon dioxide atmosphere in an aluminum canister prior to use.
The injectable foam is generated after activation of the polidocanol canister with oxygen from a second aluminum canister, resulting in a final gas mixture of oxygen:carbon dioxide in a ratio of 65:35 with low (<0.8%) nitrogen content. At the time of use, Varithena™ is generated as an injectable foam of controlled density and bubble size. The foam is then transferred to a syringe through the Varithena™ transfer unit. The injectable foam has a liquid to gas ratio of approximately 1:7 by volume. The median bubble diameter is less than 100 µm and no bubbles are greater than 500 µm.
Sources
Varithena Manufacturers
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Biocompatibles, Inc.
![Varithena (Polidocanol) Kit [Biocompatibles, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Varithena | Biocompatibles, Inc.
For intravenous use only.
Varithena™ is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Use up to 5 mL per injection and no more than 15 mL per session.
Physicians administering Varithena™ must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena™.
Activate Varithena™ using the Varithena™ oxygen canister and polidocanol canister (see Instructions for Use). Once a Varithena™ transfer unit is in place, foam can be generated and transferred to a syringe. Discard the syringe contents if there are any visible bubbles. Administer the injectable foam within 75 seconds of extraction from the canister to maintain injectable foam properties. Use a new sterile syringe after each injection. Use a new Varithena™ transfer unit for each treatment session.
Local anesthetic may be administered prior to cannula insertion but neither tumescent anesthesia nor patient sedation is required. Cannulate the vein to be treated using ultrasound guidance to confirm venous access.
Inject freshly generated Varithena™ injectable foam slowly (approximately 1 mL/second in the GSV and 0.5 mL/second in accessory veins or varicosities) while monitoring using ultrasound. Confirm venospasm of the treated vein using ultrasound.
When treating the proximal GSV, stop the injection when Varithena™ is 3-5 cm distal to the saphenofemoral junction (SFJ).
Apply compression bandaging and stockings and have the patient walk for at least 10 minutes, while being monitored. Maintain compression for 2 weeks after treatment.
Repeat treatment may be necessary if the size and extent of the veins to be treated require more than 15 mL of Varithena™. Separate treatment sessions by a minimum of 5 days.
Retained coagulum may be removed by aspiration (microthrombectomy) to improve comfort and reduce skin staining.
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