Mercaptamine Other names: Cysteamine

No data on the effect of mercaptamine on human fertility are available. Studies in animals have shown a reduction on fertility.

The recommended total daily ocular dose of mercaptamine is no more than approximately 0.4% of the highest recommended dose of oral mercaptamine in any age group. Systemic exposure of mercaptamine following ocular administration is therefore lower than following oral administration. Although no effects during pregnancy are anticipated, since systemic exposure to mercaptamine is negligible, precautions should be taken with concomitant treatment with oral mercaptamine.

There are no adequate data from the use of mercaptamine in pregnant women. Studies in animals have shown reproductive toxicity, including teratogenesis. The potential risk for humans is unknown. The effect on pregnancy of untreated cystinosis is also unknown.

Therefore, oral mercaptamine should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.

If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of mercaptamine.

The recommended total daily ocular dose of mercaptamine is no more than approximately 0.4% of the highest recommended dose of oral mercaptamine in any age group. Systemic exposure of mercaptamine following ocular administration is therefore lower than following oral administration. Although no effects during breast-feeding are anticipated, since systemic exposure to mercaptamine is negligible, precautions should be taken with concomitant treatment with oral mercaptamine.

Mercaptamine excretion in human’s milk is unknown. However, due to the results of animal studies in breast-feeding mothers and neonates, women taking oral mercaptamine should not breast-feed.

Fertility

No data on the effect of mercaptamine on human fertility are available. Studies in animals have shown a reduction on fertility.

Mercaptamine may have a minor influence on the ability to drive and use machines.

Temporary (in average less than 1 minute) blurred vision or other visual disturbances may affect the ability to drive or use machines.

If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.

Summary of the safety profile

The most common adverse reactions are eye pain, ocular hyperaemia, eye pruritus, lacrimation increased, blurred vision or eye irritation. The majority of these adverse reactions are transient and most are mild or moderate.

List of adverse reactions

The following adverse reactions were reported during clinical trials and the French NPU programme with mercaptamine. Reported adverse reactions are listed below, by system organ class and by frequency (by patient).

Frequencies are defined as: 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).

Eye disorders

Very common: eye pain, vision blurred, eye irritation, ocular hyperaemia, eye pruritus, lacrimation increased, deposit eye

Common: abnormal sensation in eye, dry eye, foreign body sensation in eye, eyelid oedema, eyelid irritation, visual impairment, hordeolum

General disorders and administration site conditions

Very common: instillation site discomfort (mainly sticky eyes and sticky eyelashes)

Common: instillation site pain

Paediatric population

Frequency, type and severity of adverse reactions in children are the same as in adults. 69 paediatric patients were followed through clinical trials and the French NPU programme. 19 patients were under 6 years old, 21 between 6 and 12 years old and 29 between 12 and 18 years old.