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VARITHENA
Miscellaneous dermatological conditions
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Drug Name:

VARITHENA Rx

Generic Name and Formulations:
Polidocanol 1% (1.3mg/mL); foam for IV inj after activation.

Company:
BTG International

Therapeutic Use:

Indications for VARITHENA:

Treatment of incompetent great saphenous veins (GSV), accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.

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. Use up to 5mL per injection and max 15mL per treatment session. Inject foam slowly (approx. 1mL/sec in the GSV and 0.5mL/sec in accessory veins or varicosities). Repeat if necessary; separate treatment sessions by a minimum of 5 days. Apply compression bandaging and stockings and have the patient walk for at least 10mins; monitor. Maintain compression for 2 weeks post-treatment.

Children:

Not established.

Contraindications:

Acute thromboembolic disease.

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, major surgery within 3 months, prolonged hospitalization, pregnancy. Labor & delivery. Pregnancy (Cat.C), nursing mothers: not recommended.

Pharmacological Class:

Sclerosing agent.

Adverse Reactions:

Pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, extravasation; anaphylaxis (may be fatal).

Generic Availability:

NO

How Supplied:

Convenience box—1 (w. canisters, transfer units, administration boxes); Bi-canister—1; Administration pack—1 (transfer unit, components)

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