HEXVIX Powder and solvent for intravesical solution Ref.[9504] Active ingredients: Hexaminolevulinate

The possibility of hypersensitivity including serious anaphylactic/anaphylactoid reactions should always be considered (see section 4.8). Advanced life support facilities should be readily available.

Hexaminolevulinate should not be used in patients at high risk of bladder inflammation, e.g. after BCG therapy, or in moderate to severe leucocytouria. Widespread inflammation of the bladder should be excluded by cystoscopy before the product is administered. Inflammation may lead to increased porphyrin build up and increased risk of local toxicity upon illumination,and false fluorescence.

If a wide-spread inflammation in the bladder becomes evident during white light inspection, the blue light inspection should be avoided.

There is an increased risk of false fluorescence in the resection area in patients who recently have undergone surgical procedures of the bladder.

No specific interaction studies have been performed with hexaminolevulinate.

Pregnancy

There are no or limited data on the use of hexaminolevulinate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to the reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Hexvix during pregnancy.

Breast-feeding

It is unknown whether hexaminolevulinate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during the treatment with Hexvix.

Fertility

Animal studies do not indicate effects on female fertility (see section 5.3). Male fertility has not been investigated in animals.

No studies on the effects on the ability to drive and use machines have been performed.

Most of the reported adverse reactions were transient and mild or moderate in intensity. The most frequently reported adverse reactions from clinical studies were bladder spasm, reported by 2.0% of the patients, dysuria by 1.6%, bladder pain by 1.4% and haematuria by 1.5%, of the patients. The adverse reactions that were observed were expected, based on previous experience with standard cystoscopy and transurethral resection of the bladder (TURB) procedures.

The table below includes adverse reactions from clinical trials and spontaneous reporting. The adverse reactions are classified by System Organ Class and frequency, 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 (<1/10,000), Not known (cannot be estimated from the available data).

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 HPRA Pharmacovigilance, Website: www.hpra.ie.

This medicinal product must not be mixed with other medicinal products.