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  • CLASSES

    Varicose Therapy, Systemic

    DEA CLASS

    Rx

    DESCRIPTION

    IV sclerosing agent
    Injectable solution approved for uncomplicated spider veins or reticular veins in the lower extremity; injectable foam approved for treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee
    Requires monitoring for anaphylaxis post-injection.

    COMMON BRAND NAMES

    Varithena

    HOW SUPPLIED

    Varithena Intravenous Inj Emulsion: 18mL, 180mg

    DOSAGE & INDICATIONS

    For the treatment of varicose veins.
    For the treatment of uncomplicated spider veins in the lower extremity (varicose veins <= 1 mm in diameter).
    Intravenous dosage [injectable solution (Asclera)]
    Adults

    Insert the needle tangentially into the affected vein; then, with the needle still in the vein, slowly inject 0.1 to 0.3 mL of polidocanol 0.5% solution. Multiple injections may be necessary; however, do not inject more than 10 mL per session. After the needle has been removed, cover the injection site and apply compression in the form of a stocking or bandage. Encourage patients to walk for 15 to 20 minutes after each treatment session. Keep the patient under observation during this time to observe any allergic or anaphylactic reaction. Maintain compression for 2 to 3 days after treatment. Longer compression with compression bandages or a gradient compression stocking of a higher class may be necessary for more extensive varicosities. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. Repeat treatments may be necessary if the varicose vein requires more than 10 mL. Separate treatments by 1 to 2 weeks. If small intravaricose blood clots (thrombi) develop, they may be removed by stab incision and thrombus expression (thrombectomy).

    For the treatment of uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter).
    NOTE: Asclera has not been studied in varicose veins > 3 mm in diameter.
    Intravenous dosage [injectable solution (Asclera)]
    Adults

    Insert the needle tangentially into the affected vein; then, with the needle still in the vein, slowly inject 0.1 to 0.3 mL of polidocanol 1% solution. Multiple injections may be necessary; however, do not inject more than 10 mL per session. After the needle has been removed, cover the injection site and apply compression in the form of a stocking or bandage. Encourage patients to walk for 15 to 20 minutes after each treatment session. Keep the patient under observation during this time to observe any allergic or anaphylactic reaction. Maintain compression for 2 to 3 days after treatment. Longer compression with compression bandages or a gradient compression stocking of a higher class may be necessary for more extensive varicosities. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis. Repeat treatments may be necessary if the varicose vein requires more than 10 mL. Separate treatments by 1 to 2 weeks. If small intravaricose blood clots (thrombi) develop, they may be removed by stab incision and thrombus expression (thrombectomy).

    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.
    Intravenous dosage [injectable foam (Varithena)]
    Adults

    Using ultrasound guidance, inject up to 5 mL of polidocanol 1% foam into affected vein or varicosity slowly (approximately 1 mL/second in the GSV and 0.5 mL/second in accessory veins or varicosities). Confirm venospasm of the treated vein using ultrasound. Multiple injections may be necessary; however, do not inject more than 15 mL per session. Cannulate the vein to be treated using ultrasound guidance to confirm venous access. Local anesthetic may be administered prior to cannula insertion but neither tumescent anesthesia nor patient sedation is required. Administer polidocanol via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. When treating the proximal GSV, stop the injection when polidocanol is 3 to 5 cm distal to the saphenofemoral junction. 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 polidocanol. Separate treatment sessions by a minimum of 5 days. Retained coagulum may be removed by aspiration (microthrombectomy) to improve comfort and reduce skin staining.

    MAXIMUM DOSAGE

    Adults

    0.3 ml per injection and 10 ml per treatment session for injectable solution; 5 ml per injection and 15 ml per treatment session for injectable foam.

    Geriatric

    0.3 ml per injection and 10 ml per treatment session for injectable solution; 5 ml per injection and 15 ml per treatment session for injectable foam.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Injectable Administration

    Administer as an intravenous injection.
    Visually inspect parenteral products for particular matter and discoloration prior to administration whenever solution and container permit.

    Intravenous Administration

    Injectable solution:
    Use a fine needle syringe (typically 26- or 30-gauge).
    Insert the needle tangentially into the vein and inject 0.1—0.3 ml of the solution slowly. Apply only gentle pressure during injection to prevent vein rupture.
    After the needle has been removed and the injection site covered, apply compression in the form of a bandage or stocking.
    After the treatment session, encourage the patient to walk for 15—20 minutes. Keep the patient under direct observation for allergic or anaphylactic reaction.
    Maintain compression for 2—3 days for spider veins and 5—7 days for reticular veins. Extensive varicosities may require longer or more intense compression.
    Do not inject more than 10 ml of polidocanol solution per treatment session.
    Injectable foam:
    Activate product using the oxygen canister and polidocanol canister as described in the Instructions for Use accompanying the product. Do not shake canisters.
    With the supplied transfer unit 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.
    Local anesthetic may be administered prior to insertion of cannula; however, tumescent anesthesia or patient sedation is not required.
    To confirm venous access, cannulate the vein using ultrasound guidance.
    Inject foam slowly (1 ml/second in the great saphenous vein and 0.5 ml/second in accessory veins or varicosities). Use ultrasound to confirm venospasm of treated vein.
    When injecting into the great saphenous vein, stop injection when polidocanol foam is 3—5 cm distal to the saphenofemoral junction.
    Use a new sterile syringe for each injection; only use supplied low-silicone syringes. Use a new transfer unit for each treatment session.
    Following the injection, 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.
    Keep the patient under direct observation for at least 10 minutes following the injection for allergic or anaphylactic reaction; be prepared to treat anaphylaxis appropriately.
    Do not inject more than 15 ml of polidocanol foam per treatment session. Separate treatment sessions by a minimum of 5 days.
    Retained coagulum may be removed by aspiration to improve patient comfort and reduce skin staining.

    STORAGE

    Varithena:
    - Do not use more than 30 days after opening

    CONTRAINDICATIONS / PRECAUTIONS

    Thromboembolic disease

    Polidocanol is contraindicated for use in patients with acute thromboembolic disease. There is a small risk for the development of thrombosis in patients after they receive polidocanol. Patients at increased risk for developing thrombosis include those with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization or pregnant females. The mechanism of action of polidocanol in the treatment of varicose veins involves the destruction of the endothelial lining of target vessels. This destruction induces subsequent endovascular fibrosis and occlusion. In addition, polidocanol appears to increase the apparent activity of clotting factors VIII, IX, XI, and XII.

    Extravasation

    Severe allergic reactions, including anaphylactic reactions, have occurred with polidocanol use. Some of these reactions have been fatal. Polidocanol is contraindicated for use in patients with a known allergy or anaphylactic reaction to polidocanol. Severe reactions occur more frequently with the use of larger volumes of polidocanol (> 3 ml). The minimum effective dose of polidocanol should be used, and clinicians should be prepared to treat anaphylaxis appropriately. In addition, severe local adverse effects including tissue necrosis may occur after polidocanol extravasation. Use caution when placing the intravenous needle and administer the smallest effective volume at each injection site. After the injection session is completed, apply compression with a stocking or bandage for 15—20 minutes. Keep the patient under observation for allergic reaction during this time.

    Accidental exposure, arteriosclerosis, intraarterial administration, thromboangiitis obliterans (Buerger's disease)

    Intraarterial administration may cause severe necrosis, ischemia, or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's disease) may be at increased risk for tissue ischemia. If polidocanol is administered intraarterially consult a vascular surgeon immediately. In addition, accidental exposure of polidocanol after inadvertent perivascular injection may cause pain. Severe pain may require the injection of a local anesthetic (without epinephrine).

    Pregnancy

    Polidocanol is classified as FDA pregnancy risk category C. The manufacturer recommends that the drug not be used during pregnancy. There are no adequate and well-controlled studies in pregnant women, and its ability to cause fetal harm or affect reproductive capacity is unknown. In animal studies, doses approximately equal to the recommended human dose (based on body surface area) resulted in embryocidal effects. However, in one case report, polidocanol was administered as an intravasal injection for the treatment of variceal hemorrhage to a woman in mid-pregnancy. No adverse effects were reported in the infant. In another case report, polidocanol was administered as an in utero treatment to two fetuses in the third trimester for congenital cystic adenomatoid malformation of the lung. No treatment-related adverse effects were observed in the infants.

    Breast-feeding

    Data are limited regarding use of polidocanol during breast-feeding, and its excretion in human milk is unknown. Because of the risk for serious reactions in a nursing infant, the manufacturer recommends avoiding treatment in women who are breast-feeding.

    Children, infants, neonates

    The safety and efficacy of polidocanol has not been established in children, infants, or neonates.

    ADVERSE REACTIONS

    Severe

    anaphylactic shock / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    thrombosis / Delayed / Incidence not known
    vasculitis / Delayed / Incidence not known
    cardiac arrest / Early / Incidence not known
    pulmonary embolism / Delayed / Incidence not known
    stroke / Early / Incidence not known

    Moderate

    palpitations / Early / Incidence not known
    migraine / Early / Incidence not known
    confusion / Early / Incidence not known
    dyspnea / Early / Incidence not known

    Mild

    skin discoloration / Delayed / 1.1-38.0
    pruritus / Rapid / 19.0-19.0
    skin hyperpigmentation / Delayed / Incidence not known
    injection site reaction / Rapid / Incidence not known
    hypertrichosis / Delayed / Incidence not known
    urticaria / Rapid / Incidence not known
    syncope / Early / Incidence not known
    dizziness / Early / Incidence not known
    paresthesias / Delayed / Incidence not known
    flushing / Rapid / Incidence not known
    fever / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Polidocanol products.

    PREGNANCY AND LACTATION

    Pregnancy

    Polidocanol is classified as FDA pregnancy risk category C. The manufacturer recommends that the drug not be used during pregnancy. There are no adequate and well-controlled studies in pregnant women, and its ability to cause fetal harm or affect reproductive capacity is unknown. In animal studies, doses approximately equal to the recommended human dose (based on body surface area) resulted in embryocidal effects. However, in one case report, polidocanol was administered as an intravasal injection for the treatment of variceal hemorrhage to a woman in mid-pregnancy. No adverse effects were reported in the infant. In another case report, polidocanol was administered as an in utero treatment to two fetuses in the third trimester for congenital cystic adenomatoid malformation of the lung. No treatment-related adverse effects were observed in the infants.

    Data are limited regarding use of polidocanol during breast-feeding, and its excretion in human milk is unknown. Because of the risk for serious reactions in a nursing infant, the manufacturer recommends avoiding treatment in women who are breast-feeding.

    MECHANISM OF ACTION

    Polidocanol is an injectable sclerosing agent. When administered intravenously, polidocanol locally damages the endothelium of blood vessels. As a result of this damage, platelets aggregate at the site of damage and adhere to the venous wall. Platelets, cellular debris, and fibrin subsequently occlude the vessel.  The occluded vein is then replaced with connective fibrous tissue. In addition, polidocanol appears to increase the apparent activities of clotting factors VIII, IX, XI, and XII and decrease the activity of protein C and protein S. Polidocanol induced endothelial damage is concentration and volume dependent. 

    PHARMACOKINETICS

    Polidocanol is administered intravenously for the treatment of varicose veins. Polidocanol exerts its therapeutic effect by inducing local endothelial damage at the site of injection. Low systemic concentrations of polidocanol were observed in some of a subgroup of 22 patients enrolled in a clinical trial of polidocanol. The mean elimination of half-life of polidocanol was 1.5 hours, as observed in 4 evaluable patients receiving 4.5—18 mg.