Cabergoline

SCOPE: this entry publishes the page's primary indication - hyperprolactinaemic disorders / prolactinoma - by the page's only route, oral. THE SPC's OTHER CEILING SENTENCE, reproduced verbatim for traceability and deliberately kept out of the maximum-dose field: immediately after the 4.5 mg per week sentence, UK SPC 4.2 states "The maximum dose should not exceed 3mg per day." That is a PER-DAY figure printed inside a section whose entire dosing scheme is weekly (initial 0.5 mg per week, usual 1 mg per week, range 0.25-2 mg per week); 3 mg per day would be 21 mg per week, roughly ten times the top of the SPC's own therapeutic range. It is a long-standing quirk of this SPC's wording and must NOT be read as authorising daily dosing for hyperprolactinaemia - hence the maximum field carries the weekly figure. TITRATION: "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." TOLERABILITY: UK SPC 4.8 - adverse events are generally dose related; in patients known to be intolerant to dopaminergic drugs the likelihood of adverse events may be lessened by starting at reduced doses, "e.g. 0.25 mg once a week, with subsequent gradual increase until the therapeutic dosage is reached"; if persistent or severe adverse events occur, temporary dose reduction followed by a more gradual increase, "e.g. increments of 0.25 mg/week every two weeks", may increase tolerability. WITHDRAWAL: "After cabergoline withdrawal, recurrence of hyperprolactinaemia is usually observed. However, persistent suppression of prolactin levels has been observed for several months in some patients." US LABEL, same indication, for comparison: "The recommended dosage of Cabergoline Tablets, USP for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level"; dosage increases should not occur more rapidly than every 4 weeks; after a normal serum prolactin level has been maintained for 6 months cabergoline may be discontinued with periodic prolactin monitoring; "The durability of efficacy beyond 24 months of therapy with cabergoline has not been established." OTHER LICENSED INDICATION IN THE SAME UK SPC, quoted for completeness and NOT this page's primary indication: inhibition of physiological lactation - administer during the first day post-partum, "The recommended therapeutic dose is 1 mg (two 0.5 mg tablets) given as a single dose"; suppression of established lactation - "0.25 mg (one-half 0.5 mg tablet) every 12 hours for two days (1 mg total dose)", a regimen demonstrated to be better tolerated than the single-dose regimen with a lower incidence of adverse events, in particular hypotensive symptoms. ELDERLY: "As a consequence of the indications for which cabergoline is presently proposed, the experience in elderly is very limited. Available data do not indicate a special risk." INTERACTIONS (US label; UK section 4.5 was not fetched into this bundle and must be checked): "Cabergoline should not be administered concurrently with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide." UK SPC 4.4 adds that care should be exercised when giving cabergoline with other drugs known to lower blood pressure, and that particular care should be taken when patients are taking concomitant psychoactive medication.