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Amber with Guidance= To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care where deemed appropriate. Drug name: Cabergoline for hyperprolactinaemic disorders Background Information Cabergoline is indicated for the treatment of hyperprolactinaemic disorders. Cabergoline is a dopaminergic ergoline derivative endowed with a potent and longlasting prolactin-lowering activity. It acts by direct stimulation of the D 2-dopamine receptors on pituitary lactotrophs, thus inhibiting prolactin secretion. BNF therapeutic class Indication 6.7 Other Endocrine Drugs Dosage and administration Initial dose: 500micrograms (orally) weekly (either as a stat dose or 250micrograms on two separate days) Hyperprolactinaemic disorders, acromegaly, Cushing and pituitary tumours Maintenance dose: Increase at monthly intervals in steps of 500 micrograms until optimal therapeutic response is achieved – usual maintenance dose is 0.25-2 milligrams weekly If doses above 1mg to be used weekly, give in divided doses If intolerance is suspected, reduce dose and increase more gradually Cautions and Contraindication Cautioned use in: History of peptic ulcers (withdraw cabergoline if GI bleed occurs) Raynaud's syndrome Cardiovascular disease Concomitant use with psychoactive medication and /or history of mental health disorders Acute Porphyria Concomitant use with antihypertensives due to risk of postural hypotension post dose Contraindication: Hypersensitivity to cabergoline or any ergot alkaloid Patients with cardiac valvulopathy History of pulmonary, pericardial and retroperitoneal fibrotic disorders Avoid in pre-eclampsia History of puerperal psychosis in women Adverse Drug Reactions Very Common: nausea, abdominal and gastric pain constipation and headache Reported: Hypotension, drowsiness, dyskinesia, impulse control disorders, leg cramps Dyspepsia, gastritis and vomiting Angina, syncope and depression Peripheral oedema Pleuritis and pleural effusion signs of impulse control disorders i.e pathological gambling, increased libido, hyper sexuality, compulsive spending or buying, binge and compulsive eating Cabergoline Guidance Rarely: Paraesthesia, palpitations, epistaxis, digital vasospasm, transient hemianopia Page 1 of 2 Date Prepared: October 2015 Review Date: October 2017 Amber with Guidance= To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care where deemed appropriate. Monitoring and muscle weakness Initiation and baseline monitoring to be done by the specialist. GP to continue prescribing therapy and be aware of the following: Interactions Monitoring of prolactin levels will be done according to clinical requirements and dose adjusted as required A baseline ECHO will be performed at initiation of therapy with any clinical issues highlighted being used to determine further monitoring and use Monitoring for signs of pituitary enlargement is only necessary when a prolactinoma has been diagnosed. Pregnancy: Cabergoline to be stopped once a positive pregnancy test has been achieved Mechanical contraception should only be used if fertility is not the therapy endpoint. A smear test will be done as recommended by the public health cervical cancer screening programme. No further gynaecological input Is required for cabergoline use in Hyperprolactinaemia Not recommended for use with other ergot alkaloids Avoid concomitant use with droperidol, prochloperazine, benperidol, haloperidol, flupentixol, zuclopentixol and metoclopramide Avoid with macrolide antibiotics due to increased systemic bioavailability of cabergoline Contact names and details Contact Details Telephone number Email Professor Hugh Jones, Consultant Physician & Endocrinologist Chris Lawson, Head of Medicines management, NHS Barnsley CCG Gillian Turrell, Lead Pharmacist Medicines Information / Cardiology, BHNFT 01226 431896 [email protected] 01266 733798 [email protected] 01226 432857 [email protected] References British National Formulary. March 2015. Available at www.bnf.org Accessed: 20.08.2015 Cabergoline (Dostinex). Summary of Product Characteristics. December 2013. Available at http://www.medicines.org.uk/emc/medicine/10003#PHARMACODYNAMIC_PROPS. Accessed on 20/08/2015 Development Process This guideline was developed following an AMBER-G (Amber with guidance) classification status of cabergoline for the treatment of hyperprolactinaemic disorders, by the Barnsley Area Prescribing Committee. This information has been subject to consultation and endorsement by the Endocrinologists in Barnsley and was ratified at the Area Prescribing Committee on 14th October 2015and the LMC on 10th November 2015. Cabergoline Guidance Date Prepared: October 2015 Page 2 of 2 Review Date: October 2017