Ravulizumab: Uses, Dosage, Side Effects and More

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Singapore prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Paroxysmal nocturnal haemoglobinuria

Adult: In patients with haemolysis with clinical symptoms indicating high disease activity and those who are clinically stable after treatment with eculizumab for at least the past 6 months: Patients weighing ≥40-<60 kg: Loading dose: 2,400 mg. Maintenance dose: 3,000 mg once every 8 weeks. ≥60-<100 kg: Loading dose: 2,700 mg. Maintenance dose: 3,300 mg once every 8 weeks. ≥100 kg: Loading dose: 3,000 mg. Maintenance dose: 3,600 mg once every 8 weeks. All doses are given via IV infusion through 0.2 micron or 0.22 micron filter. Administer the 1st maintenance dose 2 weeks after the loading dose. Dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the initial maintenance dose), but subsequent dose should be administered according to the original schedule. For patients switching from eculizumab, administer ravulizumab loading dose at the time of the next scheduled eculizumab dose. Duration of infusion depends on the patient's weight and dose (refer to specific product guidelines).
Child: In patients with haemolysis with clinical symptoms indicating high disease activity and in those who are clinically stable after treatment with eculizumab for at least the past 6 months: Patients weighing 5-<10 kg: Loading dose: 600 mg. Maintenance dose: 300 mg once every 4 weeks. ≥10-<20 kg: Loading dose: 600 mg. Maintenance dose: 600 mg once every 4 weeks. ≥20-<30 kg: Loading dose: 900 mg. Maintenance dose: 2,100 mg once every 8 weeks. ≥30-<40 kg: Loading dose: 1,200 mg. Maintenance dose: 2,700 mg once every 8 weeks. ≥40 kg: Same as adult dose. All doses are given via IV infusion through 0.2 micron or 0.22 micron filter. Administer the 1st maintenance dose 2 weeks after the loading dose. Dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the initial maintenance dose), but subsequent dose should be administered according to the original schedule. For patients switching from eculizumab, administer ravulizumab loading dose 2 weeks after the last eculizumab dose. Duration of infusion depends on the patient's weight and dose. Dosage and treatment recommendations may vary among countries (refer to specific product guidelines).

Intravenous
Neuromyelitis optica spectrum disorder

Adult: In patients who are anti-aquaporin 4 (AQP4) antibody-positive: Patients weighing ≥40-<60 kg: Loading dose: 2,400 mg. Maintenance dose: 3,000 mg once every 8 weeks. ≥60-<100 kg: Loading dose: 2,700 mg. Maintenance dose: 3,300 mg once every 8 weeks. ≥100 kg: Loading dose: 3,000 mg. Maintenance dose: 3,600 mg once every 8 weeks. All doses are given via IV infusion through 0.2 micron or 0.22 micron filter. Administer the 1st maintenance dose 2 weeks after the loading dose. Dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the initial maintenance dose), but subsequent dose should be administered according to the original schedule. For patients switching from eculizumab treatment, administer ravulizumab loading dose at the time of the next scheduled eculizumab dose. Duration of infusion depends on the patient's weight and dose (refer to specific product guidelines).

Intravenous
Atypical haemolytic uraemic syndrome

Adult: In patients who are complement inhibitor treatment-naive or have received eculizumab for at least 3 months with evidence of response to eculizumab: Patients weighing ≥40-<60 kg: Loading dose: 2,400 mg. Maintenance dose: 3,000 mg once every 8 weeks. ≥60-<100 kg: Loading dose: 2,700 mg. Maintenance dose: 3,300 mg once every 8 weeks. ≥100 kg: Loading dose: 3,000 mg. Maintenance dose: 3,600 mg once every 8 weeks. All doses are given via IV infusion through 0.2 micron or 0.22 micron filter. Administer the 1st maintenance dose 2 weeks after the loading dose. Dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the initial maintenance dose), but subsequent dose should be administered according to the original schedule. For patients switching from eculizumab treatment, administer ravulizumab loading dose at the time of the next scheduled eculizumab dose. Duration of infusion depends on the patient's weight and dose. Treatment recommendations may vary among countries (refer to specific product guidelines).
Child: In patients who are complement inhibitor treatment-naive or have received eculizumab for at least 3 months with evidence of response to eculizumab: Patients weighing 5-<10 kg: Loading dose: 600 mg. Maintenance dose: 300 mg once every 4 weeks. ≥10-<20 kg: Loading dose: 600 mg. Maintenance dose: 600 mg once every 4 weeks. ≥20-<30 kg: Loading dose: 900 mg. Maintenance dose: 2,100 mg once every 8 weeks. ≥30-<40 kg: Loading dose: 1,200 mg. Maintenance dose: 2,700 mg once every 8 weeks. ≥40 kg: Same as adult dose. All doses are given via IV infusion through 0.2 micron or 0.22 micron filter. Administer the 1st maintenance dose 2 weeks after the loading dose. Dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the initial maintenance dose), but subsequent dose should be administered according to the original schedule. For patients switching from eculizumab, administer ravulizumab loading dose 2 weeks after the last eculizumab dose. Duration of infusion depends on the patient's weight and dose. Treatment recommendations may vary among countries (refer to specific product guidelines).

Intravenous
Generalised myasthenia gravis

Adult: As add-on treatment to standard therapy in patients who are anti-acetylcholine receptor (AChR) antibody-positive: Patients weighing ≥40-<60 kg: Loading dose: 2,400 mg. Maintenance dose: 3,000 mg once every 8 weeks. ≥60-<100 kg: Loading dose: 2,700 mg. Maintenance dose: 3,300 mg once every 8 weeks. ≥100 kg: Loading dose: 3,000 mg. Maintenance dose: 3,600 mg once every 8 weeks. All doses are given via IV infusion through 0.2 micron or 0.22 micron filter. Administer the 1st maintenance dose 2 weeks after the loading dose. Dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the initial maintenance dose), but subsequent dose should be administered according to the original schedule. For patients switching from eculizumab treatment, administer ravulizumab loading dose at the time of the next scheduled eculizumab dose. Duration of infusion depends on the patient's weight and dose (refer to specific product guidelines).

What are the brands available for Ravulizumab in Singapore?

Ultomiris

Special Patient Group

In patients undergoing plasmapheresis (PP) or plasma exchange (PE): Patients weighing ≥40-<60 kg: If the most recent ravulizumab dose is 2,400 mg, administer a supplemental dose of 1,200 mg after each PP or PE. If the most recent ravulizumab dose is 3,000 mg, administer a supplemental dose of 1,500 mg after each PP or PE. ≥60-<100 kg: If the most recent ravulizumab dose is 2,700 mg, administer a supplemental dose of 1,500 mg after each PP or PE. If the most recent ravulizumab dose is 3,300 mg, administer a supplemental dose of 1,800 mg after each PP or PE. ≥100 kg: If the most recent ravulizumab dose is 3,000 mg, administer a supplemental dose of 1,500 mg after each PP or PE. If the most recent ravulizumab dose is 3,600 mg, administer a supplemental dose of 1,800 mg after each PP or PE. All supplemental doses must be given within 4 hours after each PP or PE.

In patients receiving IVIg: Patients weighing ≥40-<60 kg: If the most recent ravulizumab dose is 2,400 mg or 3,000 mg, administer a supplemental dose of 600 mg after completion of an IVIg cycle. ≥60-<100 kg: If the most recent ravulizumab dose is 2,700 mg or 3,300 mg, administer a supplemental dose of 600 mg after completion of an IVIg cycle. ≥100 kg: If the most recent ravulizumab dose is 3,000 mg or 3,600 mg, administer a supplemental dose of 600 mg after completion of an IVIg cycle. All supplemental doses must be given within 4 hours after completion of an IVIg cycle.

Reconstitution

Dilute the calculated volume of ravulizumab with NaCl 0.9% solution to a final concentration of 50 mg/mL (for 3 mL and 11 mL vials) or 5 mg/mL (for 30 mL vial). Mix gently. Do not shake.

Contraindications

Hypersensitivity. Unresolved Neisseria meningitidis (N. meningitidis) infection. Patient unvaccinated against N. meningitidis unless receiving prophylactic treatment with antibiotics until 2 weeks after vaccination.

Special Precautions

Patient with active systemic infection. Patient undergoing plasmapheresis or plasma exchange or receiving IVIg treatment. Update or complete vaccination for meningococcal bacteria (serogroups A, C, W, Y and B) at least 2 weeks before the initial dose, unless the risks of delaying ravulizumab treatment outweigh the risk of serious infection (refer to current local immunisation guidelines). After discontinuation, consider restarting ravulizumab treatment in patients with atypical haemolytic uraemic syndrome (aHUS) if thrombotic microangiopathy complications occur, and in patients with paroxysmal nocturnal haemoglobinuria (PNH) if signs and symptoms of haemolysis occur. Children. Pregnancy. Breastfeeding must be discontinued during treatment and up to 8 months after treatment.

Adverse Reactions

Significant: Infusion reactions (including anaphylaxis and hypersensitivity); infections with Neisseria species other than Neisseria meningitidis (including disseminated gonococcal infections).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain.
General disorders and administration site conditions: Fatigue, pyrexia, chills, asthenia, flu-like illness.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, myalgia, muscle spasms, pain in extremities.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: URTI, nasopharyngitis.
Skin and subcutaneous tissue disorders: Urticaria, rash, pruritus.
Potentially Fatal: Meningococcal infections (septicaemia and meningitis).

Patient Counseling Information

Women of childbearing age must use effective birth control methods during treatment and for up to 8 months after therapy. Breastfeeding must be discontinued during treatment and up to 8 months after the last dose.

Monitoring Parameters

Evaluate immunisation status before treatment. Assess for early signs of meningococcal infection and sepsis. Monitor for worsening infection (in patients with active systemic infections); signs and symptoms of infusion reaction; generalised myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) relapse. Observe patient during and for at least 1 hour after infusion. For patients with PNH: After discontinuing treatment, closely monitor for ≥16 weeks for haemolysis and other reactions. For patients with aHUS: After discontinuing treatment, closely monitor for ≥12 months for thrombotic microangiopathy complications.

Drug Interactions

Concomitant administration with chronic IVIg treatment may reduce serum ravulizumab concentration. May reduce the pharmacodynamic effects of rituximab.

Action

Description:
Mechanism of Action: Ravulizumab, a humanised monoclonal antibody IgG_2/4K, specifically binds to the complement protein C5 with high affinity, thus blocking its cleavage to C5a (proinflammatory anaphylatoxin) and C5b (initiating subunit of membrane attack complex [C5b-9]) and preventing the generation of terminal complement complex C5b-9. It antagonises the terminal complement-mediated inflammation and cell lysis while maintaining the early components of complement activation, which are necessary for the clearance of immune complexes and opsonisation of microorganisms.
Pharmacokinetics:
Absorption: Bioavailability: 100%.
Metabolism: Degraded into small peptides and amino acids via catabolic pathways.
Excretion: Terminal elimination half-life: 49.6 days (PNH patients); 51.8 days (aHUS patients); 56.6 days (gMG patients); 64.3 days (NMOSD patients).

Storage

Store between 2-8°C. Do not freeze. Protect from light. Do not shake. Diluted solution for infusion: Store between 2-8°C up to a Max of 24 hours (including the expected infusion time). Do not freeze. Once removed from refrigeration, administer the diluted solution within 6 hours (30 mL vial) or 4 hours (3 mL or 11 mL vial).

MIMS Class

Immunosuppressants

ATC Classification

L04AJ02 - ravulizumab ; Belongs to the class of complement inhibitors. Used as immunosuppressants.

References

Brayfield A, Cadart C (eds). Ravulizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/04/2025.

Joint Formulary Committee. Ravulizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/04/2025.

Ravulizumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 30/04/2025.

Ultomiris 100 mg/mL Concentrate for Solution for Infusion (AstraZeneca Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/04/2025.

Ultomiris 300 mg/3 mL and 1,100 mg/11 mL Concentrate for Solution for Infusion (Alexion Europe SAS). MHRA. https://products.mhra.gov.uk. Accessed 30/04/2025.

Ultomiris 300 mg/3 mL and 1,100 mg/11 mL Concentrate for Solution for Infusion (AstraZeneca Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 30/04/2025.

Ultomiris Solution, Concentrate (Alexion Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/04/2025.

Disclaimer: This information is independently developed by MIMS based on Ravulizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com