Switching to Ravulizumab

Once it has been agreed that a patient will switch to ravulizumab there are some administrative issues that need to be undertaken prior to the switch.

Certificate of vaccination against meningococcal infection / Ordering ravulizumab

Alexion require a new certificate of vaccination for ravulizumab. This is needed at the point of order, i.e. when Customer Operations at Alexion receives a Purchase Order.

They are not able to fulfil the Purchase Order and deliver the drug unless a certificate of vaccination has been submitted.

In practical terms, it would seem sensible to submit a revised certificate of vaccination at the point of issuing the prescription for ravulizumab. This should be emailed to Alexion. Their email address is customeroperationsUK@alexion.com

There is a blank certificate of vaccination available on our website.

We have been informed by Alexion, that you can only submit the certificate of vaccination and order ravulizumab after the last dose of eculizumab has been given. Practically, this leaves a very short window to order the drug, as the first dose of ravulizumab is due 2 weeks after the last dose of eculizumab is given, and the first dose of ravulizumab is given in hospital.

Meningitis titres / vaccinations

The National aHUS Service hold records on aHUS patient’s meningococcal titres and vaccination history. However, you may wish the check GP and hospital records for the most up to date vaccination information.

We recommend that patients on eculizumab or ravulizumab receive a single-dose Bexsero booster 5 yearly whilst on treatment. If it has been greater than 5 years since your patient received a Bexsero vaccination, we would recommend that they are offered a single-dose booster.

Prophylaxis in relation to meningococcal disease

Your patient should remain on antibiotic prophylaxis, using the same regime as they are currently on for eculizumab.

Linking in with pharmacist

It will be worth making your pharmacists aware of this potential switch now, as they will need to ensure that all the necessary local processes are in place to have ravulizumab available. Your Trust Strategy panel (or equivalent of) would need to approve the use of ravulizumab for treating atypical haemolytic uraemic syndrome if they have not done so already.

Blueteq

This is the system that NHS England introduced to approve payment of high cost drugs. Your pharmacists will likely be very familiar with this system and will probably fill this out for you if they are made aware

  • A new Blueteq registration will need to be completed for ravulizumab.
  • There is a form to complete at your end (referring team)
  • We (National aHUS Service) will complete the specialist centre form once we are made aware the patient is going to be switched from eculizumab to ravulizumab

Administration location (hospital and homecare)

The first dose of ravulizumab must be given in hospital (with a recommended one hour post-infusion observation period). After this, the drug can be given via the same homecare company your Trust uses for eculizumab.

If your patient received eculizumab via homecare, please see the section below for further guidance.

We have liaised with the homecare companies involved with eculizumab and ravulizumab administration, and they are well prepared to accept aHUS patients switching to ravulizumab.

Homecare

You will largely be following your normal process for setting a patient up on homecare, and liaising with the homecare company. For your information, we have listed out the steps below.

Alexion pay the homecare company directly, and The Trust does not pay anything to homecare unless they require an additional service that Alexion do not fund. Alexion provide funding for patients to receive ravulizumab at home (and they reimburse the cost of homecare to your hospital Trust). If your patient receives eculizumab via homecare you will need to:

    • Email the relevant homecare company to let them know the planned date of first ravulizumab in hospital, and highlight the date the first homecare dose will be due (2 weeks after 1st dose of hospital ravulizumab). We would recommend doing this
    • Complete a new homecare registration form
    • Complete a homecare prescription
    • Liaise with your pharmacist to obtain these forms
      • Submit both / all of these in exactly the same way you did when patients were started on eculizumab (this is usually via pharmacy and homecare procurement team in the Trust)
      • Homecare companies have requested receipt of the registration form and prescription for the patient 2 weeks before a home visit is required, to allow enough time for ordering stock, as well as nurse capacity planning.

The homecare provider will then schedule further visits once they have this information.

Weight based dosing – ravulizumab

All patients:

  • should receive the first dose (which is a loading dose) of ravulizumab 2 weeks after their last dose of eculizumab
Loading dose

Weight range

(Kg)

Loading dose (mg)

Ravulizumab volume (100mg/ml)

Volume of NaCl dilutent (ml)

Total volume (ml)

Minimum infusion time (mins)

10kg to < 20

600

6

6

12

45

>20 to <30

900

9

9

18

35

>30 to 40

1200

12

12

24

31

>40 to <60

2400

24

24

48

45

>60 to 100

2700

27

27

54

35

>100

3000

30

30

60

25

  • 2 weeks after the first dose of ravulizumab, patients should be moved onto a maintenance regime:
Maintenance dose

 

Weight range (Kg)

 

Maintenance dose (mg)

Ravulizumab volume (100mg/ml)

Volume of NaCl dilutent (ml)

Total volume (ml)

Minimum infusion time (mins)

10kg to < 20

600

6

6

12

45

>20 to <30

2100

21

21

42

75

>30 to 40

2700

27

27

54

65

>40 to <60

3000

30

30

60

55

>60 to 100

3300

33

33

66

40

>100

3600

36

36

72

30

 

Maintenance infusions should be given:

  • every 8 weeks for patients >20kg
  • every 4 weeks for patients under 20kg

Recommended blood monitoring on ravulizumab for patients greater than 20kg

Patients greater than 20kg will require additional blood monitoring following the switch:

  • 4 weeks after the first dose of ravulizumab: U&E’s, LDH, full blood count
  • a blood test at 18 weeks pre-ravulizumab (for U&E’s, LDH, full blood count and complement blockade monitoring). These bloods should be sent to Newcastle, using the form available on this website. These bloods require our courier to collect he samples and bring them up to Newcastle. Our service pays for the cost of this.

Recommended blood monitoring on ravulizumab for patients under 20kg

Patients under 20kg will require additional blood monitoring following the switch:

  • 4 weeks after the first dose of ravulizumab: U&E’s, LDH, full blood count
  • a blood test at 10 weeks pre-ravulizumab (for U&E’s, LDH, full blood count and complement blockade monitoring). These bloods should be sent to Newcastle, using the form available on the website. These bloods require our courier to collect he samples and bring them up to Newcastle. Our service pays for the cost of this.

What we need from you:

  • If you could let us know the planned start date for ravulizumab, we will:
    • enter the patient onto the Bluteq system from a specialist centre perspective
    • get in touch to organise to collect the 18 weeks pre-ravulizumab complement monitoring bloods. If you email our nurses at ahus.nurses@nhs.net they can liaise with our courier to ensure that the appropriate samples are done at that time.
  • If this is a paediatric patient, we would be grateful if you could inform us of the child’s weight so we can calculate when complement monitoring bloods will be due, and can send out email reminders at the appropriate time
  • It would be very useful if you could also give us the contact details of:
    • any specialist nurses that may be looking after your patient (or named nurse from day unit)
    • your local renal pharmacist (or general pharmacist in cases where there is not a renal pharmacist)
  • We would be grateful if you could please provide this information to the aHUS Specialist Nurses at the NRCTC in Newcastle. Email address: ahus.nurses@nhs.net

Please do not hesitate to get in touch if you have any questions.

Ravulizumab complement blockade bloods form

Eculizumab to Ravulizumab transition – a graphical guide

Certificate of vaccination UK form for Alexion for Eculizumab and Ravulizumab