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Varithena Generic Name & Formulations
Legal Class
Rx
General Description
Polidocanol 1% (1.3mg/mL); foam for IV inj after activation.
Pharmacological Class
Sclerosing agent.
How Supplied
Convenience box—1 (w. canisters, transfer units, administration boxes); Bi-canister—1; Administration pack—1 (transfer unit, components)
Manufacturer
Generic Availability
NO
Varithena Indications
Indications
Treatment of incompetent great saphenous veins (GSV), accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.
Varithena Dosage and Administration
Adult
See full labeling. For IV inj using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct inj into varicosities. Inject foam slowly (approx. 1mL/sec in the GSV and 0.5mL/sec in accessory veins or varicosities). Give up to 5mL per inj; max 15mL per treatment session. Repeat if necessary; separate sessions by a minimum of 5 days. Apply compression bandage or stocking. Have the patient walk for at least 10mins after treatment; monitor. Maintain compression for 2 weeks post-treatment.
Children
Not established.
Varithena Contraindications
Contraindications
Acute thromboembolic diseases.
Varithena Boxed Warnings
Not Applicable
Varithena Warnings/Precautions
Warnings/Precautions
Do not inject intra-arterially. Must be experienced in venous procedures. Monitor for at least 10mins post-inj for anaphylaxis; treat appropriately if occurs. Increased risk of tissue ischemia in peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease). Monitor for venous thrombosis post-treatment. Increased risk of thrombosis in patients with reduced mobility, history of DVT/PE, pregnancy, major surgery within 3mos, prolonged hospitalization. Pregnancy. Nursing mothers: consider interrupting breastfeeding up to 8hrs after dose.
Varithena Pharmacokinetics
See Literature
Varithena Interactions
Not Applicable
Varithena Adverse Reactions
Adverse Reactions
Pain/discomfort in extremity, infusion site thrombosis (retained coagulum), inj site hematoma or pain, thrombophlebitis superficial, extravasation; anaphylaxis (may be fatal).
Varithena Clinical Trials
See Literature
Varithena Note
Not Applicable
Varithena Patient Counseling
See Literature
