Protocol Title : A Randomised, open labelled study in anti ... - EME

IV infusion:
The final 100ml infusion bag should be administered by IV infusion over a one hour period1 !
.
Using IV Volumat Pump:
The pump does not have a preset setting for Tocilizumab.
Using Injectomat Syringe driver:
The syringe driver does not have a preset setting for Tocilizumab.
Example Calculation: (Adult Patients)
For a 70kg, the dose is usually 560mg every 4 weeks (70kg x 8mg/kg). This dose requires 28ml of
Tocilizumab concentrate – ie 20ml from a 1 x 400mg vial and 2 x 4ml (2 x 80mg) doses. Twenty
eight ml is withdrawn form the 100ml infusion bag and the 28ml form the vials added to the infusion
bag. The resulting solution is then given as an IV infusion over a one hour period.
Flushes Compatible:
Sodium Chloride 0.9% 1
Adverse effects which may be caused by IV administration and suggested monitoring:
• Common side effects include abdominal pain, mouth ulceration, gastritis, raised hepatic
transaminases, dizziness, peripheral oedema, hypertension, hypercholesterolaemia,
headache and infection.
Special Handling Precautions:
The reconstituted solution should be used immediately due to sterile concentrate not containing
any preservatives.
The Tocilizumab will be administered at room temperature by controlled infusion into an arm vein
over a one hour period. In exceptional cases this time may be extended to up to 6 hours. The
infusion speed must be 10 mL/hour for 15 minutes and then increased to 130 mL/h to complete the
dosing over 1 hour. The entire 100 mL content of the infusion bag must be administered. 20 mL of
normal saline will be administered following the infusion of study medication to flush the remaining
study medication through the intravenous set.
4.2 Accountability/Receipt /Storage and Handling of IMP
The investigator is responsible for the control of drugs under investigation. Adequate
records for the receipt (e.g. Drug Receipt Record) and disposition (e.g. Drug Dispensing
Log) of the study drug must be maintained. Accountability will be assessed by maintaining
adequate drug dispensing and return records. This will be delegated to the local site pharmacy.
The IMP will be stored by the local pharmacy.
Accurate records must be kept for each study drug provided. These records must contain the
following:
• Documentation of drug shipments received from the sponsor (date received and
quantity)
• Disposition of unused study drug not dispensed to patient
When the study is completed, the investigator will return all completed Drug Dispensing
Logs to the trial co-ordinator. Also, any unused study drug and Drug Return Records should be
returned to the Monitor. The investigator's copy of the Drug Return Record(s) must accurately
document the return of all study drug supplied.
4.3 Dispensing of IMP
A Drug Dispensing Log will be kept current and will contain the following
information:
• the identification of the patient to whom the study medication was dispensed
• the date[s], quantity of the study medication dispensed to the patient
• the date[s] and quantity of the study medication returned by the patient.
All records and drug supplies must be available for inspection by the Monitor at every
monitoring visit.
When the study is completed, the investigator will return all completed Drug Dispensing
Logs to the monitors.
Study: R4RA EudraCT: 2012-002535-28 20 / 34