Asclera Generic Name & Formulations
Legal Class
Rx
General Description
Polidocanol 0.5%, 1%; soln for IV inj; preservative-free.
Pharmacological Class
Sclerosing agent.
How Supplied
Single-use ampules (2mL)—5
Manufacturer
Generic Availability
NO
Asclera Indications
Indications
To sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1–3mm in diameter) in the lower extremity.
Asclera Dosage and Administration
Adult
For IV use only. Spider veins: use 0.5%. Reticular veins: use 1%. Inject soln slowly. Give 0.1–0.3mL per inj; max: 10mL per treatment session. Repeat if necessary; separate sessions by 1–2 weeks. Cover inj site; apply compression bandage or stocking. Have patient walk for 15–20mins after treatment; monitor. Maintain compression (spider veins): 2–3 days; (reticular veins): 5–7 days.
Children
Not established.
Asclera Contraindications
Contraindications
Acute thromboembolic diseases.
Asclera Boxed Warnings
Not Applicable
Asclera Warnings/Precautions
Warnings/Precautions
Not studied in varicose veins >3mm in diameter. Do not inject intra-arterially. Monitor for 15–20mins post-inj for anaphylaxis; treat appropriately if occurs. Monitor for venous thrombosis posttreatment. Increased risk of thrombosis in patients with reduced mobility, history of DVT/PE, pregnancy, major surgery within 3mos, prolonged hospitalization. Arterial embolism. Avoid polidocanol foamed with room air. Advise to avoid heavy exercise, sunbathing, long plane flights, hot baths/sauna 2–3 days posttreatment. Pregnancy. Nursing mothers: consider interrupting breastfeeding up to 8hrs after dose.
Asclera Pharmacokinetics
See Literature
Asclera Interactions
Not Applicable
Asclera Adverse Reactions
Adverse Reactions
Mild local reactions at inj site; anaphylaxis (may be fatal).
Asclera Clinical Trials
See Literature
Asclera Note
Not Applicable
Asclera Patient Counseling
See Literature