lauromacrogol-400: clinical use

Prescribing considerations

• Restrict administration to clinicians experienced in sclerotherapy and microfoam preparation.
• Assess vein anatomy and valvular competence, arterial circulation, mobility, thrombotic risk, allergies, asthma and relevant systemic disease.
• Use caution with moderate hepatic or renal impairment; the product is not recommended in severe impairment.
• Microfoam requires additional assessment for right-to-left cardiac shunts and previous neurological or visual symptoms after foam treatment.
• The formulation contains ethanol and should not be mixed with other medicinal products.

Contraindications and cautions

• Hypersensitivity to lauromacrogol-400 or an excipient
• Uncontrolled systemic disease
• Immobility
• Severe arterial occlusive disease
• Current thromboembolic disease or high thrombosis risk
• For microfoam: a known symptomatic right-to-left shunt

Monitoring

• Confirm intravenous needle placement and monitor for extravasation or accidental arterial injection.
• Ensure emergency treatment for anaphylaxis and cardiovascular reactions is immediately available.
• Arrange follow-up for efficacy, local tissue injury and development of deep-vein thrombosis.
• Promptly assess chest pain, respiratory or neurological symptoms, or visual disturbance during or after treatment.

Clinical pharmacology

Lauromacrogol-400 is a locally acting detergent sclerosant with local-anaesthetic properties. Membrane disruption damages venous endothelium in a concentration- and exposure-dependent manner, promoting closure and fibrous transformation of the treated vein.

Formulation and product differences

• The selected product is a sterile, single-use solution for intravenous injection.
• It may be administered as liquid or converted immediately before use into homogeneous, fine-bubbled microfoam by an appropriately trained clinician.
• Microfoam has additional contraindications and precautions; visual or neurological adverse effects occur more often than with liquid treatment.
• The solution contains ethanol, phosphate salts and water for injections, with only small amounts of sodium and potassium.

Injection

Route: Parenteral

Strengths: 2.5 mg/mL, 5 mg/mL, 10 mg/mL, 20 mg/mL, 30 mg/mL