Cabergoline for men & women: Dostinex (Know Your Medicine)

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Symptomatic hypotension can occur with cabergoline administration for any indication. Care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure. Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia. The pharmacokinetics of cabergoline seem to be dose-independent both in healthy volunteers (doses of 0.5-1.5 mg) and parkinsonian patients (steady state of daily doses up to 7 mg/day).

There were maternotoxic effects but no teratogenic effects in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis. The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon. Due to the long half-life of the drug and limited data on in utero exposure, women planning to become pregnant should discontinue cabergoline one month before intended conception. If conception occurs during therapy, treatment should be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug. Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London. Patients should be evaluated during dose escalation to determine the lowest dosage that produces the therapeutic response. Monitoring of serum prolactin levels at monthly intervals is advised since, once the effective therapeutic dosage regimen has been reached, serum prolactin normalisation is usually observed within two to four weeks.Cabergoline should only be used during pregnancy if clearly indicated and after an accurate benefit/risk evaluation. (See section 4.4). Certain medicines used for reducing blood pressure and certain medicinal products (e.g. phenothiazines, butyrophenones, thioxanthene) used for the treatment of psychological illnesses (schizophrenia or psychoses), if taken at the same time as Cabergoline, can interfere with the effects of cabergoline. The treating doctor should therefore be aware of such concomitant medication.

Before administration of cabergoline, pregnancy should be excluded. Because clinical experience is still limited and the product has a long half-life, as a precautionary measure it is recommended that once regular ovulatory cycles have been achieved women seeking pregnancy discontinue cabergoline one month before intended conception. Should pregnancy occur during treatment, cabergoline is to be discontinued. As a precautionary measure, women who become pregnant should be monitored to detect signs of pituitary enlargement since expansion of pre-existing pituitary tumours may occur during gestation.Because pregnancy might occur prior to reinitiation of menses, a pregnancy test is recommended at least every four weeks during the amenorrhoeic period and, once menses are reinitiated, every time a menstrual period is delayed by more than three days. Women who wish to avoid pregnancy should be advised to use mechanical contraception during treatment with cabergoline and after discontinuation of cabergoline until recurrence of anovulation. As a precautionary measure, women who become pregnant should be monitored to detect signs of pituitary enlargement since expansion of pre-existing pituitary tumours may occur during gestation. Valvulopathy has been associated with cumulative doses, therefore, patients should be treated with the lowest effective dose. At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline. You should not take cabergoline with erythromycin or clarithromycin (these are types of antibiotics), as they increase the cabergoline level in the blood, increasing the risk of sideeffects. You should also avoid domperidone and metoclopramide (sometimes used to treat nausea or vomiting), as they counter-act the effect of the cabergoline. Are there alternatives to cabergoline treatment? The dose is determined by your doctor who adjusts it individually for you. The recommended dose at the start of treatment is 0.5 –1 mg cabergoline daily. The dose is then increased gradually as directed by the doctor up to a suitable maintenance dose. Cabergoline should only be used during pregnancy if clearly indicated and after an accurate benefit/risk evaluation.

Before cabergoline administration, pregnancy should be excluded and after treatment pregnancy should be prevented for at least one month. Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Dostinex (see section 4.4). If you are a woman, you may want to discuss what forms of contraception are suitable for you. Hormonal forms of contraception (such as 'the pill') may not be suitable while you are taking cabergoline. You should avoid becoming pregnant during treatment with cabergoline and for one month after stopping.For inhibition of lactation cabergoline should be administered during the first day post-partum. The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as a single dose. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. In controlled clinical trials, cabergoline given as a single 1 mg administration during the first day post-partum, was effective in inhibiting milk secretion, as well as breast engorgement and pain in 70 - 90% of the women. Less than 5% of women experienced rebound breast symptomatology during the third post-partum week (which was usually mild in severity). As cabergoline suppresses milk production, you should not take it whilst breast feeding. It is often helpful to see whether your periods start again when you have stopped breast feeding, and reassess your prolactin levels, before deciding whether or not to resume cabergoline treatment. Sometimes microprolactinomas resolve after a pregnancy. Rarely, women with large macroprolactinomas will be advised to continue cabergoline treatment and not to breast feed. Your endocrinologist will discuss these decisions with you. Are there any medicines I should avoid when taking cabergoline?