FIBROVEIN Solution for injection Ref.[7675] Active ingredients: Sodium tetradecyl sulfate

General precautions

Fibrovein should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique.

Emergency resuscitation equipment should be immediately available. 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.

Before treatment, healthcare professional should investigate patient’s risk factors and inform them about the risks of the technique.

As a reminder, sclerotherapy is contraindicated in patients with high risk of thromboembolic events, but should also be avoided in most situations at lower risk. Sclerotherapy is notably not recommended in patients with a history of thromboembolic events

Nevertheless, if sclerotherapy is judged necessary, preventive anticoagulation can be initiated.

Patent foramen ovale (PFO)

Due to the risk of circulation of product, bubbles or particulates in the right heart, the presence of a PFO may enhance the occurrence of serious arterial adverse events. In patients with history of migraine with aura, serious cerebrovascular events or pulmonary hypertension, it is recommended to search for PFO before sclerotherapy.

In patients with asymptomatic but known PFO, it is recommended to use smaller volumes and avoid Valsalva manoeuvre in the minutes after injection.

Patients with a PFO have been shown to be more likely to suffer from adverse events such as temporary neurological events, visual disturbances and migraine. A symptomatic PFO is a contraindication for use of Fibrovein as a foam (see section 4.3)

Migraine

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, particularly following injections with foamed sclerosant.

Use smaller volumes in patients with history of migraine.

Truncular varicosities

For the treatment of truncular varicosities, there should be a minimal distance of 8 to 10 cm between the site of foam injection and the saphenofemoral junction.

Lymphoedema

If venous insufficiency is associated with lymphoedema, the sclerosant injection may worsen local pain and inflammation for days or several weeks. Patients should be informed of this expected phase, which does not compromise efficacy.

Extravasation

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. Pigmentation may be more likely to result if blood is extravasated at the injection site (particularly when treating smaller surface veins) and compression is not used.

Intra-arterial injection

Sclerosants must never be injected into an artery as this can cause extended tissue necrosis and may result in loss of the extremity. Injection under duplex ultrasound is recommended in order to avoid extravasations and arterial injection.

Healthcare professional should monitor the patient during and after the administration of Fibrovein. Symptoms of hypersensitivity (redness, pruritus, cough) or neurological symptoms (scotoma, amaurosis, migraine with aura, paraesthesia, focal deficit) may happen.

Respiratory disease

Special care should be taken in patients with laboured breathing (bronchial asthma) or a strong predisposition to allergies (see section 4.2).

Pre-injection evaluation

Because of the danger of thrombosis extension into the deep venous system, thorough pre-injection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by non-invasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.

Follow-up

Healthcare professional should see the patient again after 1 month for a control of treatment efficacy and safety, by clinical and ultrasound evaluation.

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.

Underlying arterial disease

Extreme caution in use is required in patients with underlying arterial disease such as severe peripheral atherosclerosis or thromboangiitis obliterans (Buerger’s disease).

Foot and malleolar area

Special care is required when injecting the foot and malleolar area where the risk of inadvertent injection into an artery may be increased.

Excipients

This medicinal product contains:

• less than 1 mmol sodium (23 mg) per vial/ampoule, i.e. essentially ‘sodium-free’.
• less than 1 mmol potassium (39 mg) per vial/ampoule, i.e. essentially ‘potassium-free’.

No interaction studies have been performed.

Pregnancy

Safety for use in pregnancy has not been established. There are no or limited amount of data from the use of sodium tetradecyl sulfate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Treatment should be postponed until after childbirth.

Fibrovein should be used only when clearly needed for symptomatic relief and when the potential benefits outweigh the potential hazards to the fetus.

Breast-feeding

It is not known whether sodium tetradecyl sulfate is excreted in human milk. Caution should be exercised when used in nursing mothers.

Fertility

It is not known whether sodium tetradecyl sulfate affects fertility.

Fibrovein has no or negligible direct influence on the ability to drive and use machines. However, a bandage and/or compression stockings may be added after treatment. This could affect the ability to drive.

The most commonly reported side effects are pain on injection urticaria, superficial thrombophlebitis and temporary skin pigmentation after treatment. Very rarely a permanent discoloration may remain along the path of the sclerosed vein segment. Ulceration may occur following extravasation of the drug. It is important to use the lowest strength that will sclerose the vein as many of the common side effects are caused by using a concentration that is too high.

Intra-arterial injection although very rare has been reported resulting in significant tissue necrosis including loss of the extremity.

The most serious side effects are anaphylactic shock and pulmonary embolism and deaths have been reported in patients receiving sodium tetradecyl sulfate.

Adverse events are listed below by system organ class and estimated frequency from published clinical data. Frequencies are defined using the following convention:

Very common: ≥1/10
Common: ≥1/100 to <1/10
Uncommon: ≥1/1,000 to <1/100
Rare: ≥1/10,000 to <1/1,000
Very rare: (includes isolated reports) <1/10,000

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This medicinal product is not compatible with heparin.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.