sign in sign up
<<
Home , Retigabine, Topiramate

Shared Care Guidelines

DRUG: (Adults) ▼

Introduction: Indication:Adjunctive treatment of partial (focal) onset seizures with or without secondary generalisation.

NICE Guidance (TA232 July 2011)– Retigabine is recommended as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with , only when previous treatment with , , , , , , sodium , and have not provided an adequate response, or have not been tolerated.

Licensing Information:Licensed as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy.

Formulations: 50mg,100mg, 200mg, 300mg, 400mg tablets. Dosage & administration: Initially 50mg once daily, gradually increased by 50mg every 2 weeks. Daily dose is divided into three times a day dosing schedule

Licensed doses  Adult over 18 years, initially up to 100mg in 3 times a day, increased according to response by up to 150mg every week. Typical maintenance dose of 600mg – 1200mg per day.  Elderly over 65 years, initially 50mg three times a day, increased according to response by up to 150mg every week; maximum 900mg daily.  In moderate renal impairment (creatinine <50mL/min), initially 50mg three times a day increasing by up to 50mg per week; maximum 600mg daily. Contraindications Contraindications: & Warnings:  Hypersensitivity to the active substance or to any of the excipients.

Warnings:  :Urinary retention, dysuria, and urinary hesitation were reported in controlled clinical studies with retigabine, generally within the first 8 weeks of treatment. Use with caution in patients at risk of urinary retention.  QT Interval: Retigabine titrated to 1,200mg / day produces a QT – prolonging effect. Caution should be taken when retigabine is prescribed with medicinal products known to increase QT interval. A list of such drugs can be found on the following link:

Name: Retigabine Shared Care Guideline Page 1 of 6 Version: 1.1 Issue Date: June 2012 Review Date: June 2015

http://www.azcert.org/medical-pros/drug-lists/bycategory.cfm#

It should also be used with caution in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are >65 years of age. In these patients it is recommended that an electrocardiogram (ECG) is recorded before initiation of treatment with retigabine and in those with a corrected QT interval >440ms at baseline, an ECG should be recorded on reaching the maintenance dose.  Psychiatric disorders: Confusional state, psychotic disorders and were reported in controlled clinical studies with retigabine. These effects generally occurred within the first 8 weeks of treatment, and frequently led to treatment withdrawal in affected patients.  Risk: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. The risk cannot be excluded for retigabine. Interactions: - Alcohol taken in combination with retigabine may increase visual blurring. It is recommended that patients are advised about the possible effects on vision if they take retigabine with alcohol.

Other antiepilepics. The clearance of retigabine is increased by carbamazepine and , but not affected by , topiramate or valproate. Retigabine does not alter the of any of these antiepileptics.

Retigabine may increase clearance of lamotrigine (22%) and lamotrigine reduce clearance of retigabine (13%). These changes are unlikely to be of clinical importance but may be relevant at upper end of dose ranges.

Antidepressants- effect of antiepileptics antagonised by SSRIs and tricyclic antidepressants, and possibly antagonized by MAOIs and tricyclic- related antidepressants (seizure threshold lowered).

Antipsychotics - Anticonvulsant effect of antiepileptics antagonised by (seizure threshold lowered).

Others- Possible increased risk of seizures when antiepileptics given with . Anticonvulsant effect of antiepileptics antagonised by .

For full list see BNF or SPC at www.medicines.org.uk/EMC

Name: Retigabine Shared Care Guideline Page 2 of 6 Version: 1.1 Issue Date: June 2012 Review Date: June 2015

Adverse Effects: Gastrointestinal effects- , , dry mouth, dyspepsia.

Pigmentation of the skin, nails and eye- Pigmentation of the skin, nails, lips and eye tissue including the retina have been reported. An eye examination should be undertaken at the start of treatment and at least every 6 months during treatment. If retinal pigment or vision changes are detected, treatment with retigabine should only be continued after re-assessment of the balance of benefits and risks. Patients who develop a blue-grey pigmentation of the nails, lips or skin should also undergo a risk-benefit assessment.

CNS effects - , are very common. Other effects include balance and abnormal co-ordination occur commonly. Patients should be advised not to drive or operate machinery if affected.

Eye disorders - and are common - patients should be advised not to drive or operate machinery if affected.

Liver function tests – LFT results are commonly increased.

General – is very common

Metabolic – Increased appetite and weight gain are common.

Urinary retention, hallucinations and psychotic reactions as described in “contra-indications and warnings”, above.

For full list see BNF or SPC at www.medicines.org.uk/EMC Responsibilities General: of the specialist  To assess the suitability of the patient for treatment. initiating  To ensure that the patient/carer has received counselling and treatment: understands the therapy, its benefits, limitations, continued monitoring (where applicable), adverse effects, and is aware of actions to take if adverse effects are suspected.  Inform the GP of the information provided to the patient.  To review the patient as agreed intervals and copy all relevant results to the GP  Carry out disease and drug monitoring as listed below  Formally hand over to GP by letter and patient informed - send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care. Prescribing:  The Specialist will screen QT interval and obtain patient history of cardiac or urinary problems prior to commencement of the drug.  The Specialist will provide the initial prescriptions bringing the patient up to the initial maintenance dose of 100mg three times a day.  This will take the patient over the 8 week point when adverse

Name: Retigabine Shared Care Guideline Page 3 of 6 Version: 1.1 Issue Date: June 2012 Review Date: June 2015

reactions are most likely to occur. Disease & drug monitoring:  Drug monitoring according to schedule:

QT interval Electrocardiogram (ECG) before initiation of treatment. In those with a corrected QT interval >440ms at baseline, an ECG will be recorded on reaching the maintenance dose. function tests Before commencement At 6 months At 12 months Yearly thereafter Eye examination Before commencement and every 6 months thereafter.

 Discuss shared care arrangement with patient, and provide them with a copy of the titration schedule.  Support and advise GPs as required and provide the GP with a copy of the titration schedule.  Assess response to treatment and initiate any dose changes as clinically appropriate including discontinuation of treatment. Responsibilities General and Prescribing: of other  To reply to the request for shared care within 2 weeks of receipt prescribers (GP): of the Consultant letter.  Monitor* and prescribe as recommended by the Specialist. The GPs will be typically asked to take up the monitoring and prescribing 3 months after retigabine has been initiated  Notify Consultant if treatment with retigabine is discontinued.  Ensure there are no drug interactions with any other medications initiated in primary care.  * GP to monitor for side effects, drug interactions etc. Consultant will however do all routine blood/eye/heart monitoring.. Disease & drug monitoring:  Disease monitoring and drug monitoring of liver function tests and QT interval will normally be carried out by secondary care, unless otherwise requested.  Urgent drug discontinuation/ referral to Specialist as clinically appropriate  To stop treatment on the advice of the Specialist.  To refer back to the Specialist if the patient’s condition deteriorates.  To identify adverse effects if the patient presents with any signs and liaise with the hospital Specialist where necessary. To report adverse effects to the Specialist and where appropriate to the

Name: Retigabine Shared Care Guideline Page 4 of 6 Version: 1.1 Issue Date: June 2012 Review Date: June 2015

Commission on Human Medicines/MHRA (Yellow Card scheme).

Responsibilities General : of the Patient /  Report any possible side effects to their GP. In particular any Carer: changes in vision or colour of the skin, lips or nails..  Ensure they have adequate supply of medication.  Attend appointments. Disease & drug monitoring: As above –contact GP or initiating team if side effects develop (see adverse effects) and attend appointments including those for routine blood tests/investigations Communication: Specialist to GP:  The Specialist will inform the GP when they have initiated retigabine and when there are any subsequent changes in treatment via a standard clinic letter.  Send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care.  Inform the GP of the information provided to the patient GP to Specialist:  To reply to the request for shared care within 2 weeks of receipt of the Consultant letter.  Irrespective of whether you accept prescribing responsibility or not, you should inform the Consultant of relevant medical information regarding the patient and changes to the patient’s medication regime irrespective of indication.  Notify Consultant if treatment with retigabine is discontinued. Contact names & details: If you have any concerns regarding individual patients, see Consultant letter for medical contact details or contact one of the following:

Name Title/Location Telephone / Bleep Mary Clarke Epilepsy Specialist 01904 725742 / 43 Nurse (No Bleep) Professor Consultant Via secretary 01904 725754 Pamela Crawford Neurologist Scarborough Dr B Henderson 01723 342491 Costs: BNF No 64 Sept 2012- 50mg purple round tab, 84=£19.46. 100mg green round tab, 84=£38.93. 200mg yellow oblong tab, 84=£77.86. 300mg green oblong tab, 84=£116.78. 400mg purple oblong tab, 84=£127.68. References: Summary of Product Characteristics (SPC). Trobalt. Accessed 10.6.13 www.medicines.org.uk/emc

Stockley Drug Interactions. Accessed 1.2.13. www.medicinescomplete.com.

Name: Retigabine Shared Care Guideline Page 5 of 6 Version: 1.1 Issue Date: June 2012 Review Date: June 2015

European Medicines Agency- May 2013. Retigabine as last line therapy in partial epilepsy- http://www.ema.europa.eu/ema/index.jsp?curl=pages/ news_and_events/news/2013/05/news_detail_001802.jsp&mid=WC0b01ac058004d5c1

This information is not inclusive of all prescribing information and potential adverse effects. Please Document refer to the SPC (data sheet) or BNF for further prescribing information. Control: The original Microsoft Word file of this document is located on: York Teaching Hospital NHS Foundation Trust Pharmacy Department X:\MEDICINES INFORMATION\Shared Care Guidelines\Approved Shared Care Guidelines\Retigabine Shared Care Guideline V1.1

Shared Care Guidelines are also available electronically via http://www.yorkandscarboroughformulary.nhs.uk/

Prepared by: Mary Clarke Epilepsy Specialist Nurse 22-1-13

Checked by: Kirsten Evans, Pharmacist Diane Tomlinson (Pharmacist NY and Humber Commissioning Support Unit)

Version: 1.1 (Updated August 2013 to include new x drive location)

Date of Issue / Review: June 2013

Date for next Review: June 2015

Approved by: Drug & Therapeutics Committee June 2013

Name: Retigabine Shared Care Guideline Page 6 of 6 Version: 1.1 Issue Date: June 2012 Review Date: June 2015