FIBROVEIN

What it is

FIBROVEIN is a solution for injection containing sodium tetradecyl sulfate, available in 0.5%, 1.0% and 3% strengths. It is a clear, colourless, sterile solution free from visible particles. FIBROVEIN is a sclerosing agent for local injections used as a vasoprotective.

Approved indications

— Treatment of uncomplicated varicose veins of the leg by compression sclerotherapy.

Dosing overview

The strength of FIBROVEIN selected depends on the size of the veins to be treated. Dosing varies by strength and vein size:

FIBROVEIN should only be administered by medical practitioners experienced in injection sclerotherapy. Compression should be applied immediately to the site of injection and must be maintained for 6 weeks after the last chosen site is injected.

Key safety warnings

Allergic reactions, including anaphylaxis have been reported. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately. The treatment of varicose veins with FIBROVEIN should not be undertaken in settings where the emergency treatment of anaphylaxis is not immediately available. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Sclerosants must never be injected into an artery as this can cause extended tissue necrosis and may result in loss of the extremity. The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis. Previous migraine sufferers should be treated with care. Patients with previous migraine have been shown to be more likely to suffer from visual disturbances and migraine. Use smaller volumes in patients with history of migraine.

Contraindications

FIBROVEIN is not recommended for treatment when patients are hypersensitive to the active substance or any excipients, or are unable to walk due to any cause or bedridden. Treatment is not advisable if the patient cannot walk at least 5 km each day. FIBROVEIN is contraindicated in patients at high risk of thrombosis, including those with congenital predisposition to blood clots or multiple risk factors such as hormonal contraception or hormone replacement therapy, significant obesity, smoking or extended periods of immobility. Recent acute superficial thrombophlebitis, deep vein thrombosis or pulmonary embolism are contraindications, as are recent surgery and varicosities caused by pelvic or abdominal tumours unless the tumour has been removed. FIBROVEIN is also contraindicated in uncontrolled systemic disease such as diabetes mellitus, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases, as well as in evolutive cancer, significant valvular or deep vein incompetence, occlusive arterial disease, huge superficial veins with wide open communications to deeper veins, phlebitis migrans, acute cellulitis and acute infections.

Regulatory history

The 3% strength (ampoule and vial formulations) was first listed on the ARTG on 25 October 1991. The 1% and 0.5% strengths were first listed on the ARTG on 4 September 2000. The product was first approved on 1 June 2000.