- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusion of ravulizumab.
Ravulizumab is a humanised monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary cells.
Atypical haemolytic uremic syndrome (aHUS): treatment
Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
Treatment of adults and paediatrics with body weight 10kg or above with paroxysmal nocturnal haemoglobinuria (PNH) in patients:
With haemolysis with clinical symptom(s) indicative of high disease activity.
Who are clinically stable after been treated with eculizumab for at least the past 6 months.
Treatment of patients with body weight 10kg or above with atypical haemolytic uraemic syndrome (aHUS) untreated with complement inhibitor or who have received eculizumab for at least 3 months and have evidence of response to eculizumab.
PNH and aHUS
Body weight 40kg to less than 60kg
Loading dose: 2.4g given as an intravenous infusion.
Maintenance dose, starting 2 weeks after loading dose: 3g given as an intravenous infusion, once every 8 weeks.
Body weight 60kg to less than 100kg
Loading dose: 2.7g given as an intravenous infusion.
Maintenance dose, starting 2 weeks after loading dose: 3.3g given as an intravenous infusion, once every 8 weeks.
Body weight 100kg and over
Loading dose: 3g given as an intravenous infusion.
Maintenance dose, starting 2 weeks after loading dose: 3.6g given as an intravenous infusion, once every 8 weeks.
PNH and aHUS
Body weight 10kg to less than 20kg
Loading dose: 600mg given as an intravenous infusion.
Maintenance dose, starting 2 weeks after loading dose: 600mg given as an intravenous infusion, once every 4 weeks.
Body weight 20kg to less than 30kg
Loading dose: 900mg given as an intravenous infusion.
Maintenance dose, starting 2 weeks after loading dose: 2.1g given as an intravenous infusion, once every 8 weeks.
Body weight 30kg to less than 40kg
Loading dose: 1.2g given as an intravenous infusion.
Maintenance dose, starting 2 weeks after loading dose: 2.7g given as an intravenous infusion, once every 8 weeks.
Body weight 40kg and over
See Dosage; Adults
There is limited data to support safety and efficacy in patients with body weight less than 10kg and no recommendation can be made on dosage.
Ravulizumab has not been studied in paediatric patients with PNH who weigh less than 30kg.
Additional Dosage Information
Maintenance dosing schedule
Apart from the first maintenance dose, the dosing schedule can occasionally vary by 7 days before or after the scheduled infusion day, with the subsequent dose being administered according to the original schedule.
Switching from eculizumab to ravulizumab
The loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion.
Patients not currently vaccinated against Neisseria meningitidis
Uncontrolled Neisseria meningitidis infection
Precautions and Warnings
Restricted sodium intake
Sodium content of formulation may be significant
Before starting therapy ensure immunisations are up to date
Children require vaccination against H.influenzae and pneumococcal infec.
Patients must be vaccinated against Neisseria meningitidis
Record name and batch number of administered product
Treatment to be administered under the supervision of a specialist
Monitor patient for signs of meningococcal infection
Monitor patient for some months after discontinuing treatment
Advise patient on signs/symptoms of meningococcal infection/sepsis
Advise patient to report symptoms of infection immediately
Interrupt treatment if severe infusion reaction occurs
Female: contraception required during and for 8 months after treatment
Breastfeeding: Do not breastfeed during & for 8 months after treatment
Advise patient about gonorrhoea prevention
Give patient package leaflet and patient reminder card
Serious meningococcal infection
Patients who start ravulizumab treatment less than 2 weeks after receiving a meningococcal vaccine, must receive appropriate prophylactic antibiotics until 2 weeks after vaccination. Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use. Patients switching from eculizumab, the prescriber should verify that the patients meningococcal vaccination is current according to national guidelines for vaccination use.
Vaccination may activate complement. Patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease (e.g. haemolysis). Patients should be closely monitored for disease symptoms after vaccinations.
Thrombotic microangiopathy (TMA)
Treatment to resolve TMA in aHUS should be for a minimum of 6 months. After this time, the treatment length should be considered for each patient individually. Patients at higher risk of TMA recurrence may require long term therapy.
Treatment discontinuation for PNH
Patients should be monitored for at least 16 weeks after discontinuing ravulizumab for PNH, to detect haemolysis and other reactions. If signs and symptoms of haemolysis occur after discontinuation, including raised lactate dehydrogenase (LDH), consider restarting treatment with ravulizumab.
Treatment discontinuation for aHUS
Monitor patients closely for signs and symptoms of thrombotic microangiopathy on an on-going basis after discontinuing treatment with ravulizumab for aHUS. If complications occur after discontinuation for aHUS, consider restarting treatment with ravulizumab, beginning with the loading dose and maintenance dose.
Concomitant plasmapheresis, plasma exchange or fresh frozen plasma infusion
Although there is no experience of concomitant plasmapheresis, plasma exchange or fresh frozen plasma infusion use with ravulizumab, administration may reduce the serum levels of ravulizumab.
Pregnancy and Lactation
Use ravulizumab with caution during pregnancy.
The manufacturer states the use of ravulizumab in pregnancy may be considered following an assessment of the risks and benefits. There is no data from the use of ravulizumab in pregnancy. Animal studies on reproductive toxicity were insufficient. Human IgG is known to cross the human placental barrier, therefore, ravulizumab may potentially cause terminal complement inhibition in foetal circulation.
Ravulizumab is contraindicated during breastfeeding.
The manufacturer does not indicate for the use of ravulizumab during breastfeeding. There is no data available on the excretion of ravulizumab in human milk. It is known that human IgGs are excreted in breast, therefore, a risk to the breast-fed infant cannot be excluded. Breastfeeding should be discontinued during treatment and up to 8 months after treatment.
Antibody formation (transient)
Infusion related reaction
Upper respiratory tract infection
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: July 2021
Summary of Product Characteristics: Ultomiris 300mg/3ml concentrate for solution for infusion. Alexion Pharma UK Ltd. Revised November 2021.
Summary of Product Characteristics: Ultomiris 300mg/30ml concentrate for solution for infusion. Alexion Pharma UK Ltd. Revised November 2021.
Summary of Product Characteristics: Ultomiris 1100mg/11ml concentrate for solution for infusion. Alexion Pharma UK Ltd. Revised November 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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