What is Ultomiris (ravulizumab) for?
Buy Ultomiris (ravulizumab). Ultomiris (ravulizumab) is a treatment for:
- Adults with paroxysmal nocturnal haemoglobinuria (PNH) who show signs of active disease. It’s also for those who have used eculizumab for at least 6 months and see it working.
- Patients weighing at least 10 kg with atypical haemolytic uraemic syndrome (aHUS). This includes those who have never used complement inhibitors before or have used eculizumab for 3 months and see it working.
It comes in vial form for intravenous infusion. It has 300 mg/10 mL (30 mg/mL) or 1,100 mg/11 mL (100 mg/mL) for faster infusion.
How does Ultomiris (ravulizumab) work?
Ravulizumab, the active ingredient in Ultomiris, works as a ‘complement inhibitor’. It blocks the C5 protein in the immune system’s terminal complement cascade. This is important because in PNH and aHUS, the complement system is too active.
In PNH, this leads to red blood cell breakdown. In aHUS, it causes blood clots in small blood vessels.
Where has Ultomiris (ravulizumab) been approved?
Ultomiris (ravulizumab) has been approved by:
- The Food and Drug Administration (FDA), USA
- On December 21, 2018 for adults with PNH.
- On October 18, 2019 for adults and children with aHUS.
- On October 12, 2020 for a new 100 mg/mL formulation which will reduce infusion time by approximately 60 percent.
- On June 7, 2021 for children (one month of age and older) and adolescents with PNH.
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan:
- On June 18, 2019 for adults with PNH.
- On September 25, 2020 for adults and children with aHUS.
- The European Medicines Agency (EMA), Europe:
- On July 3, 2019 for adults with PNH.
- On June 29, 2020 for adults and children with aHUS.
It was approved by the FDA under priority review. It also has Orphan Drug designation.
This medicine may be approved in other regions too. If you have questions about its approval in a specific country, contact our support team.
How is Ultomiris (ravulizumab) taken?
The dosage depends on the patient’s body weight. You can find the standard dosage in the official prescribing information.
After the starting dose, the medicine is given every 8 weeks for adults. For kids, it’s every 4 or 8 weeks, based on weight. PNH patients need this treatment for life. For aHUS, treatment lasts at least 6 months, but the doctor decides based on each patient.
For more details on dosage and administration, see the official prescribing information in our references section.
Note: Please consult with your treating doctor for personalized dosing.
Are there any known adverse reactions or side effects of Ultomiris (ravulizumab)?
Common adverse reactions
The most common side effects ( ≥10% of patients) listed in the prescribing information include:
- Diarrhoea
- Nausea (feeling sick)
- Vomiting
- Nasopharyngitis (inflammation of the nose and throat)
- Headache
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Infections, including meningococcal infection
Use in a specific population
It is now known if Ultomiris (ravulizumab) can cause harm to an unborn baby. It is advised to avoid breastfeeding and pregnancies. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Ultomiris and for 8 months after the last dose.
Warning: Ultomiris is contraindicated in patients with unresolved Neisseria Meningitidis infection.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.