Mepact Guideline
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TVCN Principal Treatment Centre Children’s Hospital Oxford Administration of Mifamurtide (MEPACT) Mifamurtide (MEPACT) is an immunomodulator with antitumour effects, mediated via activation of monocytes and macrophages, used as an adjunctive therapy for patients with osteosarcoma. There is a national recommendation from NICE that patients who fulfill the criteria below should receive it. Due to its mechanism of action the risks of infusion related reactions such as chills/rigors (89%), fever (85%) and nausea (57%), tachycardia (50%) are very common (Takeda 2013). Therefore patients receiving the drug require careful management and observation to ensure safe administration. Indication Mifamurtide is indicated in children, adolescents, and young adults for the treatment of high- grade, resectable, non-metastatic osteosarcoma after macroscopically complete surgical resection (NICE 2011). Funding NICE has approved Mifamurtide for the treatment of osteosarcoma in children, adolescents and young adults if their tumour is high-grade and non-metastatic and they have had an operation to completely remove the tumour and they are also having chemotherapy with multiple drugs If any patient does not meet all of these criteria then funding will have to be requested from the patient’s Clinical Commissioning Group (CCG). Dose 2mg/m2 via intravenous (IV) infusion given post-surgical resection as adjuvant therapy to standard chemotherapy. It should be administered twice weekly at least 72 hours apart for 12 weeks, then once weekly for an additional 24 weeks. This is a total of 48 infusions over 36 weeks. Drug Contraindications Concurrent use of ciclosporin, NSAIDS or routine use of corticosteroids should be avoided during treatment with Mifamurtide. As a result dexamethasone should not be used with caution as an antiemetic during chemotherapy. MIFAMURTIDE should not be given within 1 hour of Doxorubicin or other lipophilic drugs. Filename: Page 1 of 5 Date agreed: Issue date: MEPACT administration 11/11/2015 11/11/2015 Version: Agreed by Chair Network Chemotherapy Review date: 2.0 Group: 11/11/2017 Children’s Cancer Author: Measure: Becky Hester TVCN Principal Treatment Centre Children’s Hospital Oxford Protocol for administration on Kamrans Ward (KW)/ Kamrans Day Care (KDC) Action Notes 1 Patients appointment for MIFAMURTIDE Baxters require at least 3 days’ notice for clearly documented in KW or KDC diary ordering any doses. MIFAMURTIDE has a 6 hour shelf life. Timing of off hold request and delivery is key NB MIFAMURTIDE cannot be manufactured on Bank Holidays or at weekends 2 All patients require pre Mifamurtide medical assessment Ensure criteria for administration are met -Clerking and pre MIFAMURTIDE assessment is -Prescription of pre medication complete- see Delaying rules Paracetamol PO Dosing as per BNF (max 1g) 3 ADMINISTRATION Nursing staff to administer MIFAMURTIDE with appropriate pre medication cover. See nursing care plan (IV competent and anaphylaxis trained) Patient must be nursed next to oxygen and suction with an allocated bed. Infusion- over 1 hour Observations- 0/ 15/30/60/90/120 mins including TPR and BP monitoring Patient must stay on ward for at least 1 hour post infusion Risk of delayed reaction- this can occur with any dose even if previously well During administration and for 1 hour post tolerated. infusion a doctor must be present of the ward. MIFAMURTIDE infusions must NOT be started later than 3pm. Only one patient See ‘red slots’ in KDC diary receiving MIFAMURTIDE can be booked Alteration of administration is not subject to in per morning or afternoon session parental wishes without prior negotiation with the Nurse in Charge and responsible doctor. MIFAMURTIDE should not be administered during LP/IT/BMA lists. NB. Patients should expect to be on the ward for approximately 3 hours to receive this treatment Filename: Page 2 of 5 Date agreed: Issue date: MEPACT administration 11/11/2015 11/11/2015 Version: Agreed by Chair Network Chemotherapy Review date: 2.0 Group: 11/11/2017 Children’s Cancer Author: Measure: Becky Hester TVCN Principal Treatment Centre Children’s Hospital Oxford Medical assessment prior to MIFAMURTIDE administration Patient must be well with no evidence of: . Fever . Active infection . Wheeze . Active bleeding . New complaint of moderate to severe pain . Previous significant reaction to MIFAMURTIDE (see stopping rules) Patients receiving MIFAMURTIDE should have weekly FBC monitoring although neutropenia and thrombocytopenia are not contraindications to administration. Delaying Rules . Evidence of any of the above mentioned exclusion criteria or any other concern about the patient’s condition . Delay in patient arrival or drug availability which would result in drug being administered outside stipulated administration hours. Stopping Rules- discontinuation of MIFAMURTIDE treatment . Significant reaction with associated: Respiratory collapse >Grade III hypotension . Thrombus or significant vascular event . Patient or clinician decision MIFAMURTIDE Reaction Acute Reaction: This must be quickly assessed and managed as with any acute drug reaction. See Management of acute MIFAMURTIDE reaction algorithm. Depending on the extent of the reaction consider the use of hydrocortisone, oxygen, fluid resuscitation and initiation of the anaphylaxis algorithm if necessary. Management should also include antibiotic cover for possible sepsis or line infection particularly in the case of the neutropenic patient. There is no evidence that the use of anti-histamines alleviates Mifamurtide side effects. Consider the use of Pethidine in the case or rigours (doses as per BNF depending on route of administration) Pethidine must be ordered in advance as it is a controlled drug. References Takeda (2013) A Practical Guide to using Mepact Takeda Working Group Publication Takeda 2013: MEPACT(Mifamurtide) Summary of Product Characteristics. Available online:http://www.medicines.org.uk/emc/medicine/22763/SPC (Accessed 23/04/13: Summary of Product Characteristics last updated on the eMC: 04/04/2013) National Institute for Health and Care Excellence (2011) Mifamurtide for the treatment of osteosarcoma. [TA235]. London: National Institute for Health and Care Excellence. Filename: Page 3 of 5 Date agreed: Issue date: MEPACT administration 11/11/2015 11/11/2015 Version: Agreed by Chair Network Chemotherapy Review date: 2.0 Group: 11/11/2017 Children’s Cancer Author: Measure: Becky Hester TVCN Principal Treatment Centre Children’s Hospital Oxford Review Name Revision Date Version Review date Becky Hester, New doc May 2013 1.0 May 2015 Paeds ANP Becky Hester, Changes to pre-medications- April 2014 1.1 April 2016 Paeds ANP removed chlorphenamine Update of time between Mifamurtide and doxorubicin Takeda (2013) A Practical Guide to using Mepact Takeda Working Group Publication Becky Hester, New documents approved: Nov 2015 2.0 Nov 2017 Paeds ANP ‘Management of acute MIFAMURTIDE reaction’ ‘MIFAMURTIDE: Rules & advice for staff, families and patients’ Filename: Page 4 of 5 Date agreed: Issue date: MEPACT administration 11/11/2015 11/11/2015 Version: Agreed by Chair Network Chemotherapy Review date: 2.0 Group: 11/11/2017 Children’s Cancer Author: Measure: Becky Hester TVCN Principle Treatment Centre Children’s Hospital, Oxford Administration of Mifamurtide (MEPACT) Patient addressograph Date Infusion Number Pre Infusion Checks Weight/Height in notes Fit for MEPACT Pre medication including Paracetamol Ondansetron (if required) PRN hydrocortisone prescribed Additional pre meds Observations: Time: 0/15/30/60/90/120 mins Date Time 24hr 40.0 39.5 39.0 38.5 38.0 37.5 Temp ْ C ْ 37.0 36.5 36.0 35.5 180 170 160 150 Pulse & 140 B.P. 130 120 110 100 90 80 70 60 50 40 Respiratory 30 Rate 20 10 Oxygen saturations % Route of oxygen administration Post Infusion Reaction noted? Next infusion date Patient aware Booked into diary Filename: Page 5 of 5 Date agreed: Issue date: MEPACT administration 11/11/2015 11/11/2015 Version: Agreed by Chair Network Chemotherapy Review date: 2.0 Group: 11/11/2017 Children’s Cancer Author: Measure: Becky Hester .