Barts Health NHS Trust: Newham University Hospital, The London Chest Hospital, The Royal London Hospital, St Bartholomew’s Hospital and Whipps Cross Hospital. BartsMS Consent Sheet Cladribine, drafted by Drs Monica Marta & Niall MacDougall, reviewed & edited by Dr Klaus Schmierer 5 November 2015. Scheduled review October 2016

17th September 2015 Name: Hospital no:

NHS no:

Date of Birth:

Cladribine for treatment of people with multiple sclerosis

Consent Please initial as appropriate

Patient Witness Not applicable

1. I have read the BartsMS Patient Information Sheet “Cladribine for treatment of people with multiple sclerosis” and have been comprehensively informed about the risk benefit profile of Cladribine on the basis of clinical trial evidence and the management of potential adverse effects such as allergic reactions, injection site reactions and infections.

2. I am aware Cladribine is not licensed for MS, and that I receive this treatment at the discretion of the BartsMS team on a compassionate and voluntary basis.

3. Currently licensed treatment alternatives for my MS have been discussed with me. However, on the balance of their risk-benefit profile in my individual case I refuse these alternatives in favour of the treatment with Cladribine.

4. I agree to adhere to the monitoring protocol to ensure the safety of my treatment with Cladribine, including review of vital signs, blood tests, urinalysis, etc. I am aware I need to undergo regular blood tests and I have to notify my clinical team (neurologist, MS Specialist Nurse, GP, other health care professional involved in my care) of any infection to decide whether immediate treatment is required, and of any other unexpected event.

5. Women who may become pregnant and men who may father a child must use safe contraception whilst on treatment with Cladribine, and for 6 months after the last dose of Cladribine was administered. I hereby confirm I will use appropriate contraception measures during the treatment period and for 6 months after receiving my last dose of Cladribine.

________________________ ________________ ____________________ Name of Patient Date Signature _________________________ ________________ ____________________ Name of person taking consent Date Signature

Neurology Infusion and Planned Investigation Unit Department of Neurology

The Royal London Hospital Ward 11D, 11th Floor, Central Tower

Whitechapel, London, E1 1BB Switchboard: 020 3594 0000

Direct Dial Ward Number: 0203 5940637/0638 Ward Manager: Maria Espasandin

www.bartshealth.nhs.uk