Chemical formula: C₁₁H₂₁NO₃ Molecular mass: 215.293 g/mol PubChem compound: 6433083
Hexaminolevulinate interacts in the following cases:
There is an increased risk of false fluorescence in the resection area in patients who recently have undergone surgical procedures of the bladder.
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. As a precautionary measure, it is preferable to avoid the use of hexaminolevulinate during pregnancy.
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 hexaminolevulinate.
Animal studies do not indicate effects on female fertility. 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).
| System Organ Class (MedDRA) | Frequency | Adverse reaction |
|---|---|---|
| Infections and infestations | Uncommon | Cystitis, sepsis, urinary tract infection |
| Blood and lymphatic system disorders | Uncommon | White blood cell count increased, anaemia |
| Immune system disorders | Not known | Anaphylactoid shock |
| Metabolism and nutrition disorders | Uncommon | Gout |
| Psychiatric disorders | Uncommon | Insomnia |
| Nervous system disorders | Uncommon | Headache |
| Gastrointestinal disorders | Common | Nausea, vomiting, constipation, diarrhoea |
| Hepatobiliary disorders | Uncommon | Increased serum bilirubin, hepatic enzyme increased |
| Skin and subcutaneous tissue disorders | Uncommon | Rash, pruritus |
| Musculoskeletal and connective tissue disorders | Uncommon | Back pain |
| Renal and urinary bladder disorders | Common | Bladder spasm, bladder pain, dysuria, urinary retention, haematuria |
| Uncommon | Urethral pain, pollakuria, micturition urgency, urinary tract disorder | |
| Reproductive system and breast disorders | Uncommon | Balanitis |
| General disorders and administration site conditions | Common | Pyrexia |
| Injury, poisoning and procedural complications | Common | Post procedural pain |
| Uncommon | Post-operative fever |
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