Polidocanol
Generic Name: polidocanol
Brand Names:
Varithena
11 DESCRIPTION VARITHENA injectable foam contains the sclerosant, polidocanol. It is intended for intravenous use only. Chemically, polidocanol is polyoxyl lauryl ether. The structural formula is represented below: Polidocanol has the molecular formula CH 3 (CH 2 ) 11 (OCH 2 CH 2 ) n OH and a molecular weight of 582.9 when the average ethylene glycol moieties is nine (n=9).
Overview
11 DESCRIPTION VARITHENA injectable foam contains the sclerosant, polidocanol. It is intended for intravenous use only. Chemically, polidocanol is polyoxyl lauryl ether. The structural formula is represented below: Polidocanol has the molecular formula CH 3 (CH 2 ) 11 (OCH 2 CH 2 ) n OH and a molecular weight of 582.9 when the average ethylene glycol moieties is nine (n=9).
Uses
1 INDICATIONS AND USAGE VARITHENA (polidocanol injectable foam) is indicated 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. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. VARITHENA (polidocanol injectable foam) is a sclerosing agent indicated 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. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION For intravenous use only. VARITHENA is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Use up to 5 mL per injection and no more than 15 mL per session. Physicians administering VARITHENA must be experienced with venous procedures and be trained in the administration of VARITHENA. Activate VARITHENA using the VARITHENA oxygen canister and polidocanol canister ( see Instructions for Use ). Once a VARITHENA transfer unit is in place, foam can be generated and transferred to a syringe. Discard the syringe contents if there are any visible bubbles.
Side Effects
6 ADVERSE REACTIONS In clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with VARITHENA) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocompatibles, Inc. at 1-855-971-VEIN (1-855-971-8346) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of VARITHENA cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS No specific drug interaction studies have been performed. There are no known drug interactions with VARITHENA. There are no known drug interactions with VARITHENA. ( 7 )
Warnings
5 WARNINGS AND PRECAUTIONS Be prepared to treat anaphylaxis. ( 5.1 ) Tissue ischemia and necrosis: do not inject intra-arterially. ( 5.2 ) Venous Thrombosis. ( 5.3 ) 5.1 Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. 5.2 Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can 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. 4 CONTRAINDICATIONS The use of VARITHENA is contraindicated in patients with: known allergy to polidocanol [see Warnings and Precautions ( 5.1 )] acute thromboembolic disease Known allergy to polidocanol ( 4 ) Acute thromboembolic disease ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Few published case reports with use of polidocanol-containing products, including VARITHENA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although no risks have been 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.
Storage
16.2 Storage and Handling Do not shake VARITHENA canisters. Avoid contact with eyes. Store the VARITHENA Bi-Canister or convenience box at or below 86°F (30°C); Do not refrigerate or freeze. Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place.
Frequently Asked Questions
What is Polidocanol used for?▼
1 INDICATIONS AND USAGE VARITHENA (polidocanol injectable foam) is indicated 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. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. VARITHENA (polidocanol injectable foam) is a sclerosing agent indicated 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. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. ( 1 ).
What are the side effects of Polidocanol?▼
6 ADVERSE REACTIONS In clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with VARITHENA) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocompatibles, Inc. at 1-855-971-VEIN (1-855-971-8346) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of VARITHENA cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice.
Can I take Polidocanol during pregnancy?▼
8.1 Pregnancy Risk Summary Few published case reports with use of polidocanol-containing products, including VARITHENA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although no risks have been 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.
What are the important warnings for Polidocanol?▼
5 WARNINGS AND PRECAUTIONS Be prepared to treat anaphylaxis. ( 5.1 ) Tissue ischemia and necrosis: do not inject intra-arterially. ( 5.2 ) Venous Thrombosis. ( 5.3 ) 5.1 Anaphylaxis Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. 5.2 Tissue Ischemia and Necrosis Intra-arterial injection or extravasation of polidocanol can 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. 4 CONTRAINDICATIONS The use of VARITHENA is contraindicated in patients with: known allergy to polidocanol [see Warnings and Precautions ( 5.1 )] acute thromboembolic disease Known allergy to polidocanol ( 4 ) Acute thromboembolic disease ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.