Quinagolide

The tolerability of quinagolide may be reduced by alcohol.

Quinagolide has been associated with somnolence. Other dopamine agonists can be associated with sudden sleep onset episodes, particularly in patients with Parkinson’s disease. Patients must be informed of this and advised to exercise caution whilst driving or operating machines during treatment with quinagolide. Patients who have experienced somnolence must not drive or operate machines. Furthermore, a reduction of dosage or termination of therapy may be considered.

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including quinagolide. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

Animal data provide no evidence that quinagolide has any embryotoxic or teratogenic potential, but experience in pregnant women is still limited. In patients wishing to conceive, quinagolide should be discontinued when pregnancy is confirmed, unless there is a medical reason for continuing therapy. No increased incidence of abortion has been observed following withdrawal of the drug at this point.

If pregnancy occurs in the presence of a pituitary adenoma and quinagolide treatment has been stopped, close supervision throughout pregnancy is essential.

Breast-feeding is usually not possible since quinagolide suppresses lactation. If lactation should continue during treatment, breast-feeding cannot be recommended because it is not known whether quinagolide passes into human breast milk.

Since, especially during the first days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, patients should be cautious when driving a vehicle or operating machinery.

Patients being treated with quinagolide and presenting with somnolence must be advised not to drive or engage in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) unless patients have overcome such experiences of somnolence.

Frequency estimate: very common ≥10%, common ≥1% to <10%, uncommon≥0.1% to <1%, rare ≥0.01% to <0.1%, very rare <0.01%.

The adverse reactions reported with the use of quinagolide are characteristic for dopamine receptor agonist therapy. They are usually not sufficiently serious to require discontinuation of treatment and tend to disappear when treatment is continued.

Very common undesirable effects are nausea, vomiting, headache, dizziness and fatigue. They occur predominantly during the first few days of the initial treatment or, as a mostly transient event, following dosage increase. If necessary, nausea and vomiting may be prevented by the intake of a peripheral dopaminergic antagonist, such as domperidone, for a few days, at least 1 hour before ingestion of quinagolide.

Common undesirable effects include anorexia, abdominal pain, constipation or diarrhoea, insomnia, oedema, flushing, nasal congestion and hypotension. Orthostatic hypotension may result in faintness or syncope.

Rarely quinagolide has been associated with somnolence.

In very rare cases, treatment with quinagolide has been associated with the occurrence of acute psychosis, reversible upon discontinuation.

Impulse control disorders

Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including quinagolide.