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Varithena

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Overview

What is Varithena?

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 CH(CH)(OCHCH)OH 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. Once activated, VARITHENA is a white, injectable foam delivering the polidocanol solution:

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 (



What does Varithena look like?



What are the available doses of Varithena?

VARITHENA is supplied as polidocanol solution (10 mg/mL) in 18 mL; and must be activated before use. ()

Once activated, VARITHENA is a white, injectable foam delivering the polidocanol solution. ()

Each mL of VARITHENA injectable foam contains 1.3 mg of polidocanol.

What should I talk to my health care provider before I take Varithena?

Do not use VARITHENA in pregnant women. ()

How should I use Varithena?

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.

For intravenous use only.

The specific VARITHENA dose should be used as directed for the venous disease to be treated.

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. Those physicians administering VARITHENA 1% for the treatment of GSV must possess a working knowledge of the use of duplex ultrasound in venous disease.

Physicians administering VARITHENA must be experienced with venous procedures and be trained in the administration of VARITHENA.

Activate VARITHENA using the VARITHENA oxygen canister and polidocanol canister (). 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.


What interacts with Varithena?

Sorry No Records found


What are the warnings of Varithena?

Sorry No Records found


What are the precautions of Varithena?

Sorry No Records found


What are the side effects of Varithena?

Sorry No records found


What should I look out for while using Varithena?

The use of VARITHENA is contraindicated in patients with:


What might happen if I take too much Varithena?

There are no known cases of overdosage with VARITHENA. In clinical studies, total volumes of up to 60 mL of VARITHENA per treatment session have been administered.


How should I store and handle Varithena?

Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.Do not shake VARITHENA canisters.Avoid contact with eyes.Store the VARITHENA Bi-Canister or convenience box at 68°F to 77°F (20°C to 25°C); excursions are permitted to between 59°F to 86°F (15°C and 30°C). Do not refrigerate or freeze.Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions.Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials.Once activated, the canister of VARITHENA must be used within thirty (30) days.Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA convenience box. Use a new VARITHENA transfer unit for each treatment session.Discard aerosol canisters after use in accordance with state and local requirements.For more information, please refer to the IFU.NDC:50436-6608-1 30 TABLET in a BOTTLENDC:50436-6608-2 60 TABLET in a BOTTLENDC:50436-6608-1 30 TABLET in a BOTTLENDC:50436-6608-2 60 TABLET in a BOTTLE


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Clinical Information

Chemical Structure

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Clinical Pharmacology

VARITHENA is a drug/device combination product that generates injectable foam. The injectable foam is composed of a liquid and gas phase, both of which are necessary to have its therapeutic effect. VARITHENA is intended to act as follows: (1) the foam displaces blood from the vein to be treated, and (2) the polidocanol then scleroses the endothelium.

The active pharmaceutical ingredient of VARITHENA is polidocanol, a non-ionic surfactant sclerosing agent. The hydrophobic pole of the polidocanol molecule attaches to the lipid cell membrane of the venous endothelium, resulting in disruption of the osmotic barrier, destruction of the venous endothelium, and vasospasm. Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic, which leads to thrombus formation and venous occlusion. The occluded vein is eventually replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood, thus limiting the sclerosant action to the endothelium near the site of injection.

Non-Clinical Toxicology
The use of VARITHENA is contraindicated in patients with:

See Table 1 for clinically significant drug interactions with naproxen.

Table 1: Clinically Significant Drug Interactions with naproxen

Drug/Laboratory Test Interactions

Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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