polidocanol

REMS

Asclera

Uncomplicated spider veins (varicose veins≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in legs.

Varithena

Incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Known allergy;
History of venous thromboembolism, reduced mobility, major surgery in previous 3 mo, or recent prolonged hospitalization (↑ risk of venous thromboembolism);
OB: Pregnancy (may cause fetal harm).

Use Cautiously in:

Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established.

Adv. Reactions/Side Effects ⬆ ⬇

CV: DEEP VEIN THROMBOSIS, MI, STROKE, TRANSIENT ISCHEMIC ATTACK

Local: mild injection site reactions, tissue ischemia/necrosis/gangrene

Resp: PULMONARY EMBOLISM

Misc: ANAPHYLAXISALLERGIC REACTIONS INCLUDING

Interactions ⬆ ⬇

Drug-drug:

None noted.

Availability ⬆ ⬇

Solution for injection (contains ethanol) (Asclera): 0.5%; 1%
Foam for injection (Varithena): 10 mg/mL

Route/Dosage ⬆ ⬇

Asclera

LocalIV (Adults ): Spider veins: 0.1–0.3 mL of 0.5% solution for each injection into each varicose vein; Reticular veins: 0.1–0.3 mL of 1% solution for each injection into each varicose vein. Not to exceed 10 mL/treatment session.

Varithena

LocalIV (Adults ): Up to 5 mL per injection. Not to exceed 15 mL/treatment session.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Causes local endothelial damage following intravenous administration, followed by platelet aggregation and attachment to the venous wall, resulting in a dense network of platelets, cellular debris, and fibrin, which occludes the vein. This is followed by replacement with connective fibrous tissue.

Therapeutic effects:

Improved appearance of spider/reticular veins and incompetent veins and visible varicosities.

Classifications ⬆ ⬇

Therapeutic Classification: sclerosing agents

Pharmacokinetics ⬆ ⬇

Absorption: Local IV administration results in low systemic blood levels.

Distribution: Action is primarily local.

Metabolism/Excretion: Unknown.

Half-Life: 1.5 hr.

Time/Action Profile ⬆ ⬇

(vessel occlusion)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	3–6 wk	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to keep bandages dry and in place for 48 hrs and to wear compression stockings or support hose on treated legs continuously for 2 wks after Varithena and for 2–3 days and for 2–3 wks during daytime after Asclera. Compression stockings or support hose should be thigh high or knee high depending on area treated.
Advise patient to walk for 15–20 min immediately after procedure and daily for next few days.
Advise patient to notify health care professional if signs or symptoms of DVT or PE develop.
Advise patient to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna for 2–3 days following treatment.
Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

52919- Siegfried Hameln GmbH
- 52919-021-
  - 52919-021-14- 525 AMPULE in 1 CARTON (52919-021-14) / 2 mL in 1 AMPULE (52919-021-01)

52919- Siegfried Hameln GmbH
- 52919-022-
  - 52919-022-14- 525 AMPULE in 1 CARTON (52919-022-14) / 2 mL in 1 AMPULE (52919-022-01)

52919- Siegfried Hameln GmbH
- 52919-024-
  - 52919-024-14- 525 AMPULE in 1 CARTON (52919-024-14) / 2 mL in 1 AMPULE (52919-024-01)

57821- Agno Pharma Jiangsu
- 57821-011-
  57821-011-01- 1 CANISTER in 1 BAG (57821-011-01) / 4.5 kg in 1 CANISTER

60635- Biocompatibles, Inc.
- 60635-118- Varithena
  60635-118-01- 1 POUCH in 1 CARTON (60635-118-01) / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER

60635- Biocompatibles, Inc.
- 60635-133- Varithena
  - 60635-133-01- 1 CARTON in 1 PACKAGE (60635-133-01) / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER

67850- Methapharm, Inc
- 67850-140- Asclera
  - 67850-140-05- 2 mL in 1 AMPULE (67850-140-05)

67850- Methapharm, Inc
- 67850-141- Asclera
  - 67850-141-05- 2 mL in 1 AMPULE (67850-141-05)

section name header

Indications ⬇