Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Foam, Intravenous:
Varithena: 180 mg/18 mL (45 mL) [contains alcohol, usp]
Solution, Intravenous [preservative free]:
Asclera: 0.5% (2 mL); 1% (2 mL) [contains alcohol, usp]
Pharmacology
Mechanism of Action
Acts by irritation of the vein intimal endothelium and causes thrombosis formation leading to occlusion of the injected vein
Pharmacokinetics/Pharmacodynamics
Distribution
Varithena: Vd: 35 to 82 L
Half-Life Elimination
Asclera: 90 minutes
Varithena: 102 to 153 minutes
Use: Labeled Indications
Varicose veins:
Asclera: Treatment of uncomplicated spider veins (varicose veins 1 mm or less in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.
Varithena: Treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.
Contraindications
Hypersensitivity to polidocanol or any component of the formulation; acute thromboembolic diseases
Canadian labeling: Additional contraindications (not in the US labeling): Thrombophilia; pregnancy
Dosage and Administration
Dosing: Adult
Varicose veins: IV:
Asclera:
Reticular veins (1 to 3 mm diameter): 0.1 to 0.3 mL of 1% solution per injection (maximum: 10 mL per session); may repeat in 7 to 14 days
Spider veins (≤1 mm diameter): 0.1 to 0.3 mL of 0.5% solution per injection (maximum: 10 mL per session); may repeat in 7 to 14 days
Varithena: Great saphenous veins and accessory saphenous veins: Up to 5 mL of 1% solution per injection (maximum: 5 mL per injection; 15 mL per session); may repeat in ≥5 days
Dosing: Geriatric
Refer to adult dosing.
Administration
IV: For intravenous use only. Avoid extravasation and intra-arterial injection.
Asclera: Administer using a syringe with 26 or 30-gauge needle. Insert the needle tangentially into the vein and inject slowly while the needle is still in the vein; apply gentle pressure during injection to prevent vein rupture. After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage (maintain for 2 to 3 days [spider veins] and 5 to 7 days [reticular veins]); longer compression is recommended for extensive varicosities. After applying compression, patient should walk for 15 to 20 minutes and be observed for anaphylactic or allergic reaction.
Varithena: Administer via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into the varicosities within 75 seconds of extraction from canister; use a new sterile syringe after each injection. Do not use syringe if visible bubbles present. A local anesthetic may be administered prior to cannula insertion. Inject slowly (~1 mL/second in great saphenous vein and 0.5 mL/second in accessory veins or varicosities) using ultrasound guidance. Confirm venospasm of the treated vein. When treating the proximal great saphenous vein, stop the injection when polidocanol is 3 to 5 cm distal to the saphenofemoral junction. After injection, apply compression in the form of a stocking or bandage (maintain for 2 weeks) and have patient walk for ≥10 minutes while under observation.
Storage
Asclera: Store between 15°C and 30°C (59°F and 86°F).
Varithena: Store at 20°C to 25°C (68°F and 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Once activated, the canister must be used within 30 days. Contains gas under pressure and pressurized oxygen; keep away from heat and combustible materials; store in well-ventilated area.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>10%: Local: Hematoma at injection site (42%), irritation at injection site (41%), local discoloration (38%), pain at injection site (24%), local pruritus (19%), warm sensation at injection site (16%)
1% to 10%: Local: Venous thrombosis at injection site (6%)
<1%, postmarketing, and/or case reports: Allergic dermatitis, anaphylactic shock, angioedema, asthma, cerebrovascular accident, circulatory shock, confusion, deep vein thrombosis, dizziness, dyspnea, fever, flushing, hypertrichosis, loss of consciousness, migraine, neurologic injury, palpitations, paresthesia, pulmonary embolism, skin hyperpigmentation, tissue necrosis at injection site, urticaria, vasculitis, vasodepressor syncope
Warnings/Precautions
Concerns related to adverse effects:
- Anaphylaxis/hypersensitivity reaction: Severe allergic reactions, including anaphylaxis and fatal anaphylactoid reactions have been reported with polidocanol. More frequent with larger volumes (>3 mL), therefore, dose should be minimized. Observe 10 to 20 minutes following injection to monitor for hypersensitivity/anaphylactic reaction; emergency resuscitation equipment should be available.
- Arterial embolism: Stroke, TIA, MI, and impaired cardiac function have been reported with IV solution. May be caused by air embolism, when using polidocanol IV solution foamed with room air, or thromboembolism. Avoid using polidocanol IV solution foamed with room air; safety and efficacy has not been established.
- Thromboembolism: Thrombosis and subsequent pulmonary embolism or other thrombotic events can occur. Use with caution in patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, recent (≤3 months of age) major surgery, or prolonged hospitalization; increased risk for thrombosis.
Other warnings/precautions:
- Appropriate use: Check for proper needle placement; the smallest effective volume should be used at each injection site. After injection is complete, apply compression with stocking or bandage, and have patient walk for 15 to 20 minutes. Small intravaricose blood clots (thrombi) can develop; may be removed by stab incision and thrombus expression (microthrombectomy).
- Tissue ischemia/necrosis: Intra-arterial injection or extravasation can cause severe necrosis, ischemia, or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans may be at increased risk for tissue ischemia. Consult a vascular surgeon immediately if intra-arterial injection occurs.
Monitoring Parameters
Monitor patient for anaphylactic or allergic reaction for at least 10 to 20 minutes after injection, and for signs/symptoms of DVT or PE.
Pregnancy
Pregnancy Considerations
Information related to inadvertent use of polidocanol in pregnancy for the treatment of varicose veins is limited (Reich-Schupke 2012).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience bruising. Have patient report immediately to prescriber signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood), severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), or severe injection site pain, burning, edema, blistering, or irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
