Clozapine Intramuscular Injection:

Application process
Contents
What is IM clozapine? ............................................................................................................................. 1
Which patients can be prescribed IM clozapine? ................................................................................... 1
What is the objective of using IM Clozapine? ......................................................................................... 2
Registration of patients for IM Clozapine ............................................................................................... 2
How long can the treatment continue for? ............................................................................................ 2
What are the equivalent oral and IM doses? ......................................................................................... 2
Starting clozapine IM injection ............................................................................................................... 3
Contacting CPMS..................................................................................................................................... 3
Monitoring of patients on IM clozapine treatment ................................................................................ 3
Monitoring Physical Observations .......................................................................................................... 3
Cost of medication .................................................................................................................................. 3
Appendix 1: Clozapine IM Injection Requirements Checklist ................................................................. 4
Appendix 2: Clozapine IM Injection Titration Chart................................................................................ 5

What is IM clozapine?
Intramuscular clozapine is an unlicensed product made in the Netherlands by
Brocacef and imported to the UK via Durbin PLC. It is a clear yellow solution for
injection. The strength of the injection is 25mg/ml and each ampoule contains 5mls
(125mg). It is administered by deep intramuscular injection into the gluteal muscle.
The injection is painful and the maximum volume that can be injected into each site
is 4ml (100mg). For doses greater than 100mg daily, the dose may be divided and
administered into two sites.

Which patients can be prescribed IM clozapine?

The injection is indicated only for inpatients within Forensics services:
• With a treatment-refractory psychotic disorder
• Who no longer have the capacity to consent.
• Who are refusing oral treatment after all approaches to administering oral
clozapine have been taken.

Title Clozapine Intramuscular Injection: Application process

th
Approved by Drug & Therapeutics Committee Date of Approval 28 September 2017
th
Protocol Number PHARM/0088/V1.0 Date of Review 28 September 2018

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 It can be used for patients who have never been exposed to clozapine previously or
patients previously treated with clozapine and known to have responded but
relapsed owing to noncompliance.
The need for clozapine injection must:
• Be agreed by the MDT and fully documented in PARIS
• Discussed at a Forensic Consultant peer review meeting
• Approved by the SOAD (clozapine IM specifically referenced)
• The Responsible Clinician must also apply for approval for use using the
Trust single application form ensuring the contents of appendix 1 are included
o The request will then be considered by an appropriate panel (which
will include the Clinical Director, Chief Pharmacist and Head of Service
or deputies, as a minimum).

What is the objective of using IM Clozapine?

The aim of using clozapine injection is a short-term intervention to initiate clozapine
for patients who refuse medication, with a view to convert to oral clozapine as soon
as possible.

Registration of patients for IM Clozapine

All patients for IM clozapine must only be registered with the Clozaril Patient
Monitoring Service (CPMS) as the objective is to use the injection for the shortest
possible time before switching to oral Clozaril treatment. After treatment with
clozapine injection has been agreed by the MDT and approved by the SOAD, CPMS
will be informed of the treatment plan and the patient registered accordingly. The
usual clozapine mandatory baseline and weekly blood monitoring and the necessary
precautions for amber and red warnings apply.

How long can the treatment continue for?

Clozapine injection should be used for the shortest duration possible. Before
administering each injection, the patient should be offered clozapine orally. The need
for ongoing IM treatment must be reviewed regularly by the MDT. In general, the
injection should be used for no longer than two weeks.
In exceptional cases, the injection may be used for longer than two weeks, with
further approval. The initial approval process should be repeated with the original
application form amended to include details of the patient’s progress and the case
for extending the duration.

What are the equivalent oral and IM doses?

The oral bioavailability of clozapine is about half that of the intramuscular injection.
For example, 50mg daily of the IM injection is roughly equivalent to 100mg daily of
the tablets.

Title Clozapine Intramuscular Injection: Application process

th
Approved by Drug & Therapeutics Committee Date of Approval 28 September 2017
th
Protocol Number PHARM/0088/V1.0 Date of Review 28 September 2018

Page 2 of 5
 Starting clozapine IM injection
The patient must be registered with CPMS the week before commencing treatment.
Treatment should start on a Monday whenever possible. Clozapine should be
prescribed on the Prescription and Administration Record chart and annotated ‘as
per titration chart’ – as an exception to Trust policy, the route may be stated as
“PO/IM” to provide nurses with the options covered by the titration chart. The
prescriber must complete the Clozapine IM Titration Chart (Appendix 2) and sign and
date each dose. The patient should always be offered the tablets first and if the
patient continues to refuse, then the injection is administered.

Contacting CPMS
The frequency of contact with CPMS is to be determined on an individual patient
basis. During the working week (Monday-Friday), pharmacy will contact CPMS to
inform them if the clozapine dose for that day has been given via the oral or
intramuscular route unless otherwise instructed. On Saturday and Sunday, ward
nursing staff will contact CPMS on-call pharmacist on 01276 692504, to inform them
if the clozapine dose for that day has been given via the oral or intramuscular route
unless otherwise instructed.

Monitoring of patients on IM clozapine treatment

Baseline assessment before starting clozapine must include ECG, FBC, lipids,
HbA1C, U&Es, LFT, CRP, troponin and prolactin. It is anticipated that daily
monitoring of blood pressure, pulse, respiratory rate and temperature will be difficult
for many patients; every effort must be made to obtain these and patient refusal of
observations must be documented. Importantly, patients should be observed for any
signs of being unwell, such as pallor, cough, shortness of breath, sweating etc.
After each injection has been given the patient must be observed every 15 minutes
for the first two hours to check for excess sedation. The usual weekly blood tests
should be performed whilst on treatment; the sample could be taken at the same
time as the administration of clozapine injection if needed.
N.B. If IM lorazepam is required leave at least ONE HOUR between
administration of IM clozapine and IM lorazepam.

Monitoring Physical Observations

Monitoring physical observations should carried out as per Clozapine Pathway and
enter onto PARIS and EWS.

Cost of medication
Clozapine injection costs around £100 per ampoule (or part thereof, as any unused
portion must be discarded). There would need to be a minimum order of 2 boxes of
10 ampoules which costs approx. £2,000.
Guideline written with acknowledgement and thanks to South London and Maudsley NHS
Foundation Trust, Sussex Partnership NHS Foundation Trust, Southern Health Foundation Trust and
Mersey Care NHS Foundation Trust.

Title Clozapine Intramuscular Injection: Application process

th
Approved by Drug & Therapeutics Committee Date of Approval 28 September 2017
th
Protocol Number PHARM/0088/V1.0 Date of Review 28 September 2018

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 Appendix 1: Clozapine IM Injection Requirements Checklist
The following need to be in place before initiating IM Clozapine.

The contents of this table should be completed and copy and pasted into the single
application form.

Confirm that there are no significant

physical health comorbidities that
contra-indicate the use of clozapine?

Has patient previously been

prescribed clozapine? If yes, state
reason clozapine was stopped
previously

MDT discussion documented in

PARIS (state date)
Peer Review Discussion (state date)

SOAD approval (with clozapine IM

specifically referenced)

Staff involved in administration are

familiar with Guidance

Nursing Care Plans in place

Title Clozapine Intramuscular Injection: Application process

th
Approved by Drug & Therapeutics Committee Date of Approval 28 September 2017
th
Protocol Number PHARM/0088/V1.0 Date of Review 28 September 2018

Page 4 of 5
 Appendix 2: Clozapine IM Injection Titration Chart
Patients name NHS number
D.O.B. CPMS Number
Consultant Ward/Clinical Team

Monitor Physical Observations as per Clozapine Pathway and record on PARIS and EWS
CAUTION: IM CLOZAPINE IS ONLY HALF THE ORAL DOSE

Day Date Oral IM Prescriber’s Specify route Given by

Dose Clozapine Signature Given (signature)
(25mg/ml) (PO or IM)
ALWAYS
OFFER ONLY USE IF If IM state side
FIRST ORAL DOSE given (L) or (R)
BEFORE REFUSED
IM ROUTE –
USING IM
GLUTEAL
ONLY
1 12.5mg 6.25mg
(0.25ml)
2 25mg 12.5mg
(0.5ml)
3 25mg 12.5mg
(0.5ml)
4 50mg 25mg
(1ml)
5 50mg 25mg
(1ml)
6 75mg 37.5mg
(1.5ml)
7 75mg 37.5mg
(1.5ml)
8 100mg 50mg
(2ml)
9 100mg 50mg
(2ml)
10 125mg 62.5mg
(2.5ml)
11 125mg 62.5mg
(2.5ml)
12 150mg 75mg
(3ml)
13 150mg 75mg
(3ml)
14 175mg 87.5mg
(3.5ml)

Title Clozapine Intramuscular Injection: Application process

th
Approved by Drug & Therapeutics Committee Date of Approval 28 September 2017
th
Protocol Number PHARM/0088/V1.0 Date of Review 28 September 2018

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