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Varithena

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Varithena

Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Dosage Forms And Strengths

Polidocanol Solution, 180 mg/18 mL (10 mg/mL) must be activated before use.

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.

Varithena™ (polidocanol injectable foam) product is supplied as two components:

  • Varithena™ Bi-Canister (NDC 60635-118-01)
    • A Tyvek® pouch containing two sterile, connected 303 mL aluminum alloy canisters: one containing polidocanol solution, 180 mg/18 mL (10 mg/mL), under a carbon dioxide atmosphere, the second containing pressurized oxygen at approximately 5.4 bar absolute. The connector joins the two canisters and allows activation of the product. Once activated, Varithena™ injectable foam delivers a 1% polidocanol solution. Each mL of Varithena™ injectable foam contains 1.3 mg of polidocanol. One canister of Varithena™ generates 90 mL of foam which, following purging instructions in the IFU, is sufficient to yield 45 mL of usable foam for injection.
    • Prescribing Information
    • Instructions for Use
  • Varithena™ Administration Pack (NDC 60635-123-01)
    • One Varithena™ Transfer Unit to generate and dispense foam.
    • Instructions for Use
    • Patient ancillary components:
      • Three 10 mL silicone-free Luer syringes;
      • A 20 inch manometer tube;
      • Two compression pads.

Varithena™ is also supplied in a Convenience Box (NDC 60635-133-01 ) that contains:

  • A Tyvek® pouch containing two sterile, connected 303 mL aluminum alloy canisters: one containing polidocanol solution, 180 mg/18 mL (10 mg/mL), under a carbon dioxide atmosphere, the second containing pressurized oxygen at approximately 5.4 bar absolute. The connector joins the two canisters and allows activation of the product. Once activated, Varithena™ injectable foam delivers a 1% polidocanol solution. Each mL of Varithena™ injectable foam contains 1.3 mg of polidocanol. One canister of Varithena™ generates 90 mL of foam which, following purging instructions in the IFU, is sufficient to yield 45 mL of usable foam for injection.
  • Three Varithena™ Transfer Units to dispense injectable foam;
  • Three administration boxes each containing:
    • Three 10 mL silicone-free Luer syringes;
    • A 20-inch manometer tube;
    • Two compression pads.

Storage And Handling

Do not shake Varithena™ canisters.

Avoid contact with eyes.

Store the Varithena™ convenience box at 68° to 77°F (15° to 25°C); excursions are permitted to between 59° to 86°F (15° 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 seven (7) 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.

Manufactured for Provensis Ltd by: Biocompatibles UK Ltd Chapman House, Weydon Lane, Farnham, UK, GU9 8QL. Distributed by: Biocompatibles, Inc. 115 Hurley Road, Building 3, Oxford, CT 06478. Revised: June 2014

Last reviewed on RxList: 7/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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