ESCA: Cinacalcet (Mimpara )

Transcription

1 ESCA: Cinacalcet (Mimpara ) Effective Shared Care Agreement for the Treatment of Primary hyperparathyroidism when parathyroidectomy is contraindicated or not clinically appropriate. Specialist details Patient identifier Name: Tel: The aim of an Effective Shared Care Agreement (ESCA) is to provide information to General Practitioners (GPs) about complex or high cost therapies that their patients may receive following specialist referral. An ESCA will only be written when it has been agreed that shared care is an appropriate option and will include a statement of Specialist and GP responsibilities. This effective shared care agreement (ESCA) sets out details for the sharing of care for patients taking oral cinacalcet. It should be read in conjunction with the Summary of Products Characteristics (SPC; datasheet). Shared Care Guidelines will ensure that all GPs have sufficient information to enable them to undertake prescribing responsibility for the Specialist and other therapies. This guidance is not intended to be prescriptive and may be amended according to the individual clinician s view and patient circumstances. It is not the intention to insist that GPs prescribe this therapy and any doctor who does not wish to undertake the clinical and legal responsibility is not so obliged. If the GP decides not to agree on the shared care the GP is advised to inform the specialist in writing. 1

2 Section 1: Shared Care Responsibilities and Roles AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the treatment of Primary hyperparathyroidism when parathyroidectomy is contraindicated or not clinically appropriate with cinacalcet can be shared between the specialist and General Practitioner (GP). GPs are invited and requested to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If the Specialist asks the GP to prescribe this drug, if the GP does not wish to take part in the ESCA, then they should reply to this request as soon as practicable. Sharing of care assumes communication between the Specialist, GP and patient. The intention to share care is usually explained to the patient by the clinician initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients on cinacalcet should undergo regular follow-up, which provides opportunities to discuss drug therapy. The clinician who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. Specialist Responsibilities Diagnose the condition and assess if the patient is suitable for treatment with cinacalcet. Ensure that the indication is confirmed at the parathyroid MDT. Discuss with the patient options for treatment and the suitability of cinacalcet. Discuss with the patient relevant information on use, side effects and need for monitoring of medication. Advise the patient to inform the Specialist of any change in their smoking status. Confirm shared care by letter with the patient s GP - include the shared care agreement. Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will discuss the shared care arrangement with the patient. Commence treatment with cinacalcet and once patient is on a stable dose between visits (at least two treatments), consider transfer of prescribing and monitoring to GP. Provide the GP with relevant information for each patient, including: i) Treatment to be undertaken by GP (dose, any dosage titrations etc) ii) System of monitoring, secondary care will be responsible for monitoring: Parameter Frequency of monitoring Serum Calcium and Phosphate Within 1 week of initiation or dosage adjustment Every month during maintenance Ensure agreed signed shared care form has been received back from GP to indicate that the GP is in agreement with prescribing and monitoring. Ensure this has been discussed with patient, and that patient has signed SCA form Review the patient's condition and monitor response to treatment regularly where indicated. Communicate promptly with the GP when treatment is changed. Advise GP on dosage adjustment and when and how to stop treatment. 2

3 Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition and ensure that clear backup arrangements exist for GPs to obtain advice and support. Review the treatment regularly; sending a written summary to the GP if any change in cinacalcet therapy occurs. Report adverse events to the MHRA (via Yellow Card). General Practitioner Responsibilities To confirm, without delay, their agreement or otherwise to participate in shared care. Prescribe cinacalcet at the dose recommended and adjust dosing as advised by the Specialist. To monitor side effects of treatment and seek advice from the Specialist if necessary. To liaise with Specialist regarding any complications of treatment or the discontinuation of treatment. To check for possible drug interactions when newly prescribing concurrent treatment. To monitor calcium levels every three months. Refer promptly to Specialist when any loss of clinical efficacy is suspected (e.g. worsening of disease-related symptoms, new symptoms suggestive of disease recurrence or progression) or intolerance to therapy occurs. Stop treatment on the advice of the Specialist. Report adverse events to the MHRA (via Yellow Card). Patient s Role (or carer where applicable) To take the prescribed medication regularly unless advised by the Specialist or GP. To attend scheduled appointments with the Specialist or GP and for monitoring as above. Report any adverse effects to the Specialist or GP. Share any concerns in relation to treatment. Report to the Specialist or GP if they do not have a clear understanding of the treatment. Section 2: General Information on Cinacalcet Licensed Indication Cinacalcet is indicated for the treatment of significant hypercalcaemia (calcium > 3.0mmol/l) due to Primary Hyperparathyroidism, when parathyroidectomy is contraindicated or not clinically appropriate. Dosage and administration The usual dose of cinacalcet is between 30-60mg twice daily. The calcium lowering effect is substantially present within two to three weeks (85-90%) after initiating therapy with 30mg twice daily. In patients whose serum calcium is not adequately controlled, the dose may be increased to 90mg twice daily. If adequate control of hypercalcaemia has not been achieved on 60mg of cinacalcet, the Specialist should review the benefit of on-going treatment with cinacalcet and reconsider alternative treatment options. 3

4 Cinacalcet should be taken with or after food once a day, preferably at the same time each day. Contraindications Cinacalcet is contraindicated: Known hypersensitivity to the drug or any of the excipients Pregnancy Breast-feeding Cinacalcet should be used with caution in: Epilepsy (reduction of seizure threshold in some studies in patients with CKD, with seizure activity in 1.4% of patients with epilepsy on cinacalcet versus 0.4% of controls). Moderate to severe hepatic insufficiency (potential for 2-4 fold higher plasma levels of cinacalcet in these patients). Heart failure/ prolonged QT interval Monitoring Serum calcium should be checked one week post initiation of cinacalcet. Further review of serum calcium should occur at six weeks to review dosing (with a view to reducing the starting dose from 60mg to 30mg once a day). Three monthly assessment of calcium should occur thereafter. Side effects Relatively common adverse effects include: Nausea, vomiting, dizziness, paraesthesia, reduced testosterone concentrations, rash, myalgia, asthenia, hypotension. Hypocalcaemia. A reduction in serum calcium is part of the pharmacological effect of cinacalcet, however, symptomatic hypocalcaemia may occur. Less common side effects are: seizure, dyspepsia. Use in hepatic impairment: use cautiously in patients with moderate to severe hepatic impairment; there is potential for 2-4 fold higher plasma levels of cinacalcet in these patients. Drug Interactions Caution is advised with substrates of CYP2D6 as levels and side-effects may be increased (e.g. flecainide, metoprolol, tricyclic antidepressants). Cinacalcet is metabolised in part by the enzyme CYP3A4. Caution is advised with potent inhibitors (e.g. ketoconazole increase in cinacalcet levels) and inducers (e.g. rifampicin) of this enzyme. Metabolism of cinacalcet is inhibited by ketoconazole leading to increased plasma concentration. Cinacalcet is also metabolised by CYP1A2 - cautious use of ciprofloxacin (CYP1A2 inhibitor) is advised. Smoking induces CYP1A2 and therefore dose adjustments may be required if the patient starts or stops smoking during cinacalcet treatment. Cinacalcet possibly inhibits metabolism for Tamoxifen to active metabolite- avoid concomitant 4

5 use. Warfarin is not affected by cinacalcet. Dose adjustment may also be necessary if a patient starts or stops smoking. References 1) Amgen Limited. Mimpara. Summary of Product Characeteristics for Mimpara tablets (last updated on the emc: 04 Sep 2017) accessed via on ) UK Medicines Information. Cinacalcet. New Medicines Profile; May ) Midlands Therapeutics Review and Advisory Committee Verdict and Summary: Cinacalcet (Mimpara) for secondary hyperparathyroidism; June 2005 Dudley Group of Hospitals NHS Foundation Trust NHS Dudley CCG Original December 2015 Updated September 2018 Review date September I agree to participate in this shared care agreement for the treatment of the below named patient with Cincalcet for the treatment of Primary Hyperparathyroidism General Practitioner Name (please print) Signature Date Hospital Specialist/Consultant Name (please print) Signature Date Patient Name (please print) Signature Date Patient s name Date of birth Sex Home Address NHS Number 5