Off-Licence Agreement Zaponex Treatment

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Please be aware this form can only be completed by the treating consultant.

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Patient Details
Name First Name
ZTAS PIN Date Of Birth  -  - 
Reason Off-licence treatment
Unlicensed treatment indication Rechallenge Other
Contraindicated medication Contraindicated medical condition  
Please specify
Reference Ranges
Normal ZTAS reference ranges will be observed for Off-Licence treatment:

Classification WBC
(x 109/L)
(x 109/L)
Green ≥ 3.5 ≥ 2.0
  • The result is valid to initiate or continue Zaponex treatment.
Amber ≥ 3.0 and < 3.5 ≥ 1.5 and < 2.0
  • Result not valid to initiate Zaponex treatment.
  • Zaponex may be continued at the discretion of the consultant.
  • ZTAS starts the Amber Warning procedure.
  • Increase of monitoring frequency to twice a week.
Red < 3.0 < 1.5
  • Result not valid to initiate OR continue Zaponex treatment.
  • STOP ongoing Zaponex treatment immediately.
  • ZTAS starts the Red Alert procedure (daily blood monitoring).
Adjusted references ranges are necessary (i.e. for concomitant use of myelosuppressive therapies such as chemotherapy, etc.), the adjusted cut-off values for a RED result are stated below:

WBC (x 109/L)  .    Neutrophils (x 109/L)  . 
Clozapine use outside the terms for use as described in the Zaponex Product Information (e.g use in a patient on contra-indicated co-medication or diagnosed with a non-registered indication) applies to the patient above. In order to treat this patient with Zaponex® (clozapine), I, the undersigned, agree to the following conditions for use and acknowledge that the monitoring criteria listed above apply:
  1. The patient is/will be treated off-licence with Zaponex. The use of Zaponex is/will be outside of the marketing authorisation and is at the request and the responsibility of myself, the patient's consultant. I will absolve Leyden Delta from any liability should, as a result of the Zaponex treatment, the patient's medical condition deteriorates.
  2. It is my opinion, as the consultant, that the benefit of Zaponex treatment outweighs any possible risks to the patient. It would, indeed, be considered detrimental to withhold Zaponex treatment.
  3. The patient has been informed of the risks involved in being treated with Zaponex and is in agreement with me that Zaponex treatment outweighs any possible risks. Where the patient was not competent to provide their informed consent, I confirm that I have taken all necessary steps to reach the decision that Zaponex treatment is in the best interests of this patient. In reaching this decision, I have taken into account the views of the patient's relatives/caregivers and, where appropriate, have sought a second opinion from another consultant psychiatrist.
Signature consultant psychiatrist
Name GMC
Personal email
  Example: Please do not use group email addresses or gmail/yahoo, etc.
Submission Date 08-Dec-2023 Signature