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Aripiprazole Long Acting Injection (Abilify Maintena®) Guidance for Prescribing and Administration Main points: 1. Aripiprazole Long Acting Injection (‘Aripiprazole LAI’), is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. 2. Aripiprazole LAI may not be used for treatment-resistant schizophrenia, unlicensed indications or service users intolerant to or unresponsive oral aripiprazole. 3. Aripiprazole LAI may ONLY be newly prescribed by consultant psychiatrists. Other grades may initiate, but ONLY with direct instruction from their consultant. 4. ALL service users MUST have been on oral aripiprazole for at least 2 to 4 weeks before the injection is started to establish tolerability and response . 5. The recommended starting and maintenance dose of Aripiprazole LAI is 400 mg once-monthly i.e. once per calendar month, (not 4-weekly) by deep intramuscular (IM) injection into the gluteal muscle (no sooner than 26 days after the previous injection). 6. Oral aripiprazole at 10mg-20mg per day must continue for two weeks after the first injection to maintain therapeutic aripiprazole concentrations during initiation of therapy. 7. As aripiprazole LAI requires oral supplementation for the first 2 weeks (as point 6 above), consideration must be made for those patients where compliance with oral medication is an issue, for both clinical and financial reasons. 8. The dose maybe reduced to 300mg a month if 400mg is poorly tolerated (NB: this will incur waste as only 400mg vial for ALAI exists). No other doses may be used except in those service users receiving potent enzyme inhibiting drugs (See ‘Special populations’ (page 2) and SPC for further information). 9. At the recommended dose, aripiprazole LAI costs £220.41 per service user per month. This is considerably more than older depots such as flupentixol and zuclopenthixol but less than risperidone and paliperidone LAI (See Appendix 1 for cost comparisons). 10. Practical comparisons with risperidone and paliperidone LAI are given in Appendix 2. 11. For actions for ‘Missed doses’, please see Appendix 3. 12. Administration of aripiprazole LAI requires some special precautions so nursing staff should familiarise themselves with the instructions as per SPC. 13. Please note, that as a direct delivery service (e.g. Polar Speed) has not been arranged for Aripiprazole LAI then the VAT exemption for community patients does not apply. Please consider the cost impact this may have on your locality drug budget before prescribing, 14. Regular reports will also be run on Ascribe to gauge usage across the Trust and impact on drug budgets. 15. For ‘Place in Therapy’ please see next section. Prescribing Guidelines May 2014 Final V1.1 BLS Place in therapy The following criteria must be fulfilled BEFORE Aripiprazole LAI is prescribed: 1. ALL service users MUST have been on oral aripiprazole for at least 2 to 4 weeks before the injection is started to establish tolerability and response . 2. The service users MUST have a documented proven response and tolerability to oral aripiprazole Providing both criteria above are fulfilled (with no ADRs) aripiprazole Long Acting injection (ALAI) may be a treatment option for those service users where: 1. previous treatment with typical depot antipsychotics or other LAI have not been tolerated or are contra-indicated OR 2. there has been documented metabolic disturbances with previous treatment. As aripiprazole is associated with fewer metabolic disturbances the LAI improves patient outcomes e.g. in first episode psychosis, due to the more favoured side effect profile. The Trust will be monitoring outcomes for patients prescribed Aripiprazole LAI. Prescribers (see ‘3’ above) are therefore asked to complete the initiation form (Appendix 4) for each service user, and send it to the Formulary Pharmacist ([email protected]) then their usual supplying pharmacy with the first prescription. Special populations 1. Elderly patients The safety and efficacy of Aripiprazole LAI in the treatment of schizophrenia in patients 65 years of age or older has not been established. 2. Renal impairment No dosage adjustment is required for patients with renal impairment.. 3. Hepatic impairment No dosage adjustment is required for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, the data available are insufficient to establish recommendations. In these patients requiring cautious dosing, oral formulation should be preferred. 4. Smoking No dose adjustment is necessary in smokers. 5. Known CYP2D6 poor metabolisers / strong enzyme inhibitors In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should be 300 mg. When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 200 mg. Please see SPC for more information. Prescribing Guidelines May 2014 Final V1.1 BLS For those patients prescribed Aripiprazole LAI 400mg Strong CYP2D6 or strong CYP3A4 inhibitors Adjusted dose 300mg Strong CYP2D6 and strong CYP3A4 inhibitors CYP3A4 inducers Lithium or Valproate For those patients prescribed Aripiprazole LAI 300mg Strong CYP2D6 or strong CYP3A4 inhibitors 200mg Avoid use No adjustment necessary Adjusted dose 200mg Strong CYP2D6 and strong CYP3A4 inhibitors 160mg CYP3A4 inducers Lithium or Valproate Avoid use Examples of interacting drug CYP2D6 e.g. Fluoxetine, paroxetine and quinidine. CYP3A4 e.g. HIV protease inhibitors, ketoconazole CYP2D6 e.g. Fluoxetine, paroxetine and quinidine. CYP3A4 e.g. HIV protease inhibitors, ketoconazole Examples of interacting drug CYP2D6 e.g. Fluoxetine, paroxetine and quinidine. CYP3A4 e.g. HIV protease inhibitors, ketoconazole CYP2D6 e.g. Fluoxetine, paroxetine and quinidine. CYP3A4 e.g. HIV protease inhibitors, ketoconazole e.g. Carbamazepine, rifampicin, phenytoin, St Johns Wort, No adjustment necessary Dosage adjustments should be done in patients taking concomitant strong CYP3A4 inhibitors or strong CYP2D6 inhibitors for more than 14 days. Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of Aripiprazole LAI should be increased to the dose prior to the initiation of the concomitant therapy. When weak inhibitors of CYP3A4 (e.g.diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with this medicinal product, modest increases in plasma aripiprazole concentrations may be expected. Prescribing Guidelines May 2014 Final V1.1 BLS Appendix 1: Cost comparison of Long-Acting and depot antipsychotic injections (Drug Tariff March 2014). Name Aripiprazole LAI Paliperidone LAI Risperidone LAI Olanzapine LAI Dose 400mg monthly 50mg monthly 75mg monthly 100mg monthly 150mg monthly 25mg 2- weekly 37.5mg 2-weekly 50mg 2-weekly 150mg 2- weekly 300mg 4-weekly 210mg 2-weekly 405mg 4-weekly 300mg 2 weekly Traditional depot antipsychotics: Flupentixol 200mg every 2 weeks Cost per unit £ 220.41 x 12 £ 183.92 x 12 £ 244.90 x 12 £ 314.07 x 12 £ 392.59 x 12 £ 79.69 x 26 £111.32 x 26 £142.76 x 26 £ 142.76 x 26 £ 222.64 x13 £ 142.76 x 26 £ 285.52 x 13 £ 222.64 x 26 Cost per year £ 2644.92 £ 2207.04 £ 2938.80 £ 3768.84 £ 4711.08 £ 2071.94 £ 2894.32 £ 3711.76 £3711.76 £2894.32 £3711.76 £3711.76 £5788.64 £19.52 x 26 £ 507.52 (200mg/mL) Fluphenazine 100mg every 2 weeks Haloperidol 200mg every 4 weeks £8.79 x 26 £ 228.54 (100mg/mL) £10.10 x 13 £ 131.30 (100mg/mL x 2) Pipotiazine 200mg every 4 weeks Zuclopenthixol 500mg every 2 weeks £53.30 x 13 £ 692.90 (50mg/mL.2x2mL amp) £7.44 x 26 (500mg/mL) Prescribing Guidelines May 2014 Final V1.1 BLS £ 193.44 Appendix 2: Practical comparisons of Aripiprazole LAI with Risperidone and Paliperidone LAI. Paliperidone Long Acting Injection (PLAI) Presentation Storage Preparation Dose interval Aripiprazole Long Acting Injection (ALAI) Pre-filled syringe: no reconstitution needed; may also help reduce anxiety by service user. Vial & solvent for reconstitution requiring more nurse time. Vial & solvent for reconstitution requiring more nurse time. None fridge line Requires refrigeration & appropriate shelving None fridge line BUT once reconstituted must be stored <25C and used within 4 hours. Less logistical issues especially in the community e.g. when patient is not home when the CPN arrives to administer injection. Waste Risperidone Long Acting Injection (RLAI) Some service users have c/o cold injections. Less of an issue as non fridge line; no re-constitution needed Waste is an issue especially once cold chain is broken or problems with re-constituting. Also, if compliance with oral is an issue. Could potentially be a waste issue if not used once reconstituted or compliance with oral is an issue. No special instructions: prefilled syringe. Needs reconstituting. Must also be removed from fridge ~30minutes before administration. Needs to be reconstituted with solvent prior to administration. Monthly (12 injections per year) so may be more convenient for the service user Two weekly (26 injections per year) Monthly injection. If more than 5 weeks has lapsed before next injection, then supplementation with 2 weeks oral aripiprazole is needed.(see ‘missed doses’ below). Dosing allows 7 day leeway with missed dosages or rescheduling: greater flexibility No flexibility in dosing recommended Service users seem to prefer monthly injections (from feedback). Strengths available 4 strengths 3 strengths 1 strength (although a *300mg dose maybe given if ADRs from 400mg) Site of administration Gluteal or Deltoid Gluteal or deltoid Gluteal (looking at deltoid but not licensed yet). Initiation of treatment Easier initiation Initiation can be ‘complex’ No oral supplementation necessary; reducing Requires oral supplementation for at least 3 weeks. Prescribing Guidelines May 2014 Final V1.1 BLS Requires 2 weeks treatment with oral aripiprazole to allow time for LAI to reach polypharmacy. steady state. Requires first 2 doses one week apart then monthly thereafter; reduces poly-pharmacy *1.5mL from same 400mg vial 200mg/mL Appendix 3 Missed doses If 2nd or 3rd dose is missed and time of last injection is: Action 4 weeks and 5 weeks The injection should be administered as soon as possible, then monthly administration resumed. 5 weeks Re-start concomitant oral aripiprazole for 14 days with next depot and resume monthly schedule. If 4th or subsequent doses are missed (i.e. after steady state has been reached) and time since last injection is: Action 4 weeks and 6 weeks The injection should be administered as soon as possible, then monthly administration resumed. 6 weeks Re-start concomitant oral aripiprazole for 14 days with next depot and resume monthly schedule. Prescribing Guidelines May 2014 Final V1.1 BLS Appendix 4: Aripiprazole Long Acting Injection: Initiation form To be completed by the consultant psychiatrist or under direct instruction from consultant psychiatrist. Patients details: Name Rio Number Gender DOB Consultant Current ICD-10 diagnosis Patient setting (please delete) In-patient Out-patient under CTO Number of hospital admissions in last 2 years If inpatient, date admitted: …../…../ ….. Reason for request of Aripiprazole LAI. Have other depot/ LAI preparations been considered? Y N I wish to prescribe Aripiprazole LAI because (please tick all that apply): The service user has developed unacceptable side effects from (delete as appropriate) Typical depot Paliperidone LAI Risperidone LAI A formal rating scale has been used and outcomes documented in the notes. There are problems with oral compliance that are likely to be improved by a long-acting injection. To avoid the need for oral medication (i.e. convenience) Low risk of weight gain Low risk of hyperprolactinaemia Low risk of cardiac effects Low risk of metabolic adverse effects Poor response from other antipsychotics Please list others already tried: Other : Please give details Who will be administering aripiprazole LAI and where? Current regular antipsychotic(s) and dose: Declaration 1. I confirm that arrangements are in place for administration of aripiprazole LAI on a monthly basis. 2. I confirm that the patient will be closely monitored for efficacy and tolerability using the Glasgow Antipsychotic Side-effect Scale (GASS) and that a full assessment will be undertaken at 3 months,6 months and regularly thereafter. 3. I confirm that the patients care-coordinator is aware that they may be contacted to organise the completion of a feedback form so that data on the use of the drugs can be collected and evaluated. 4. I understand that the Trust will remain responsible for prescribing until agreement is reached between the Trust and local CCGs. Referral cannot be made to primary care for continuation of prescribing, even if local arrangements are in place for GP prescribing of other LAI / depot antipsychotic injections, unless a shared care agreement has been approved for that CCG. Name of initiating Senior psychiatrist Signature Grade Date Thank you for completing this form. Please send completed form to the Formulary Pharmacist [email protected]. For supplying pharmacies: Please ensure that a copy of this form is received with the first prescription for aripiprazole LAI before it is supplied & keep a copy filed in the dispensary. Prescribing Guidelines May 2014 Final V1.1 BLS References 1. 2. 3. 4. The Summary of Product Characteristics (SPC) BNF (66) Sussex Partnership, NHS Foundation Trust (CMHP UK) Taylor D, South London and Maudsley Hospital, Guidance on Aripiprazole Long Acting Injection. 5. AWP Product Evaluation for Aripiprazole LAI (Presented at ‘Medicines Optimisation Group’ 24.1.14) Prescribing Guidelines May 2014 Final V1.1 BLS