polidocanol (Rx)

>10%

Asclera

• Injection site hematoma (42%)
• Injection site irritation (41%)
• Injection site discoloration (38%)
• Injection site pain (24%)
• Injection site pruritus (19%)
• Injection site warmth (16%)

Varithena

• Pain in extremity (16.8%)
• Infusion site thrombosis (16.1%)
• Contusion/injection site hematoma (15.4%)
• Limb discomfort (12.1%)
• Injection site pain/tenderness (10.7%)

1-10%

Asclera

• Neovascularization (8%)
• Injection site thrombosis (6%)

Varithena

• Venous thrombosis limb (8.1%)
• Superficial thrombophlebitis (5.4%)
• Deep vein thrombosis (4.7%)

Contraindications

Hypersensitivity to product or components

Acute thromboembolic disease

Cautions

Severe allergic reactions reported; administer in facility with ability to treat anaphylaxis; observe patient for at least 10 min after injection

IV use only, do not inject intra-arterially; inadvertent intra-arterial injection or extravasation may cause severe necrosis, ischemia, or gangrene; consult vascular surgeon immediately if this occurs

Stroke, TIA, MI, and impaired cardiac function 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

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 (see Administration for posttreatment compression instructions)

Pregnancy

There are no adequate and well-controlled studies in pregnant women

Few published case reports with use of polidocanol-containing products, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; although no risks identified, there is minimal benefit in treating lower extremity varicosities during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum

Polidocanol reported to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose; this effect may have been secondary to maternal toxicity

Developmental reproductive toxicity testing was performed in rats and rabbits with IV administration

Lactation

There are no data on presence of polidocanol in human milk, effects on breastfed infant, or on milk production; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk up to 8 hours after administration in order to minimize exposure to a breastfed infant

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Sclerosing agent; induces local damage to endothelium of blood vessels; platelets then aggregate at site of damage and attache to venous wall that eventually occludes the vessel; finally the occluded vein is replaced with connective fibrous tissue

Pharmacokinetics

Asclera

• Half-life: 1.5 hr (dose range 4.5-18 mg)

Varithena

• Half-life: 102-153 min
• Peak plasma concentration: 15 min (1st dose); 5 min (2nd dose)
• Vd: 35-82 L
• Systemic clearance: 0.2-0.4 L/min

IV Administration

For IV use only with ultrasound guidance

Asclera

• Use a syringe with a fine needle (26- or 30-gauge)
• Insert the needle tangentially into the vein and inject the solution slowly while the needle is still in the vein; apply only gentle pressure during injection to prevent vein rupture
• After needle removed and the injection site has been covered, apply compression in the form of a stocking or bandage
• After treatment session, encourage patient to walk for 15-20 minutes; keep patient under observation to detect any anaphylactic or allergic reaction
• Maintain compression for 2-3 days after treatment of spider veins and for 5-7 days for reticular veins
• For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended
• Repeat treatments may be necessary if extent of varicose veins requires more than 10 mL; these treatments should be separated by 1-2 wk

Varithena

• Administer, using ultrasound guidance, via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities
• Physicians 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 oxygen canister and polidocanol canister (see prescribing information)
• Once a Varithena transfer unit is in place, foam can be generated and transferred to a syringe (use a new syringe and transfer set for each injection)
• 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 cannula insertion but neither tumescent anesthesia nor patient sedation is required
• Inject freshly generated Varithena slowly (~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
• 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
• May repeat treatment if the size and extent of the veins to be treated require >15 mL; separate treatment session by a minimum of 5 days
• Retained coagulum may be removed by aspiration (microthrombectomy) to improve comfort and reduce skin staining

Storage

Asclera

• Each ampule is intended for immediate use in a single patient
• Each unopened ampule is stable up to 3 yr
• Store at 15-30°C (59-86°F)

Varithena

• Do not shake canisters Store the bicanister or convenience box at 68-77°F (20-25°C); excursions are permitted to between 59-86°F (15-30°C)
• Do not refrigerate or freeze
• Unused, nonactivated 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 must be used within 30 days
• Store activated canisters upright, with the transfer unit attached, under the same temperature conditions as the convenience box
• Use a new transfer unit for each treatment session
• Discard aerosol canisters after use in accordance with state and local requirements