TVCN Principle 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 patientswho 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/m2via 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 as an antiemetic during chemotherapy.

MEPACT should not be given within 24 hours of Doxorubicin or other lipophilic drugs.

Protocol for administration on Kamrans Ward (KW)/ Kamrans Day Care(KDC)

Action / Notes
1 / Patients appointment for MEPACT clearly documented in KW or KDC diary / Baxters require at least 3 days notice for ordering any doses.
MEPACT has a 6 hour shelf life. Timing of off hold request and delivery is key
NB MEPACT cannot be manufactured on Bank Holidays or at weekends
2 / All patients require pre MEPACT medical assessment
-Clerking
-Prescription of premedication
Ondansetron 5mg/m2 IV
Chlorphenamine as per BNF IV
Paracetamol 15mg/kg PO (max 1g)
PRN Hydrocortisone IV / Ensure criteria for administration are met and pre MEPACT assessment is complete- see Delaying rules
3 / ADMINISTRATION
Nursing staff to administer MEPACT with appropriate pre medication cover.
(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
During administration and for 1 hour post infusion a doctor must be present of the ward.
MEPACT infusions must NOT be started later than 3pm. Only one patient receiving MEPACT can be booked in per morning or afternoon session without prior negotiation with the Nurse in Charge and responsible doctor. MEPACT should not be administered during LP/IT/BMA lists. / See nursing care plan
Risk of delayed reaction- this can occur with any dose even if previously well tolerated.
See ‘red slots’ in KDC diary
Alteration of administration is not subject to parental wishes

NB. Patients should expect to be on the ward for approximately 3 hours to receive this treatment

Medical assessmentprior to MEPACT 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 MEPACT (see stopping rules)

Patients receiving MEPACT 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 MEPACT treatment

  • Significant reaction with associated:

Respiratory collapse

Grade III hypotension

  • Thrombus or significant vascular event
  • Patient or clinician decision

MEPACT Reaction

Acute Reaction:

This must be quicklyassessed and managed as with any acute drug reaction. 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.

Subsequent doses:

Consider the use of Pethidine as an additional premedication (doses as per BNF depending on route of administration) which must be ordered in advance as it is a controlled drug.

References

Takeda 2013: MEPACT(Mifamurtide) Summary of Product Characteristics. Available online: (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: Administration of Mifamurtide (MEPACT) / Page 1 of 4 / Date agreed:
15.05.13 / Issue date:
15.05.13
Version: 1.0 / Agreed by:
Dr Shaun Wilson / Review date: 15.05.15
Standard Operating Policy / Author: Becky Hester (ANP)
Dr. Shaun Wilson

TVCN Principle Treatment Centre

Children’s Hospital, Oxford

Administration of Mifamurtide (MEPACT)

Date

Infusion Number

Pre Infusion Checks

Weight/Height in notes

Fit for MEPACT

Pre medication including Ondansetron Chlorphenamine Paracetamol

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
TempْْC / 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: Administration of Mifamurtide (MEPACT) / Page 1 of 4 / Date agreed:
15.05.13 / Issue date:
15.05.13
Version: 1.0 / Agreed by:
Clare Jamieson / Review date: 15.05.15
Nursing Documentation / Author: Becky Hester (ANP)