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Brand Name :
ravulizumab-cwvz, Ultomiris
Synonyms :
ravulizumab
Class :
Monoclonal Antibodies; Complement Inhibitors
Brand Name :
ravulizumab-cwvz, Ultomiris
Synonyms :
ravulizumab
Class :
Monoclonal Antibodies; Complement Inhibitors
Dosage Forms & Strengths
Solution for Injection
10mg/ml (in a single dose vial of 30ml)
100mg/ml (in single-dose vials of 3ml & 11ml)
Solution for subcutaneous injection
70mg/ml (in a single dose prefilled cartridge 245mg/3.5ml)
Paroxysmal Nocturnal Hemoglobinuria
The dosing is based on weight, starting with a single loading dose intravenously and then after 2 weeks starting the maintenance dose every 8 weeks
Loading dose-
For 40-60 kg, 2400 mg intravenously
For 60-100 kg- 2700 mg intravenously
For more than 100 kg- 3000 mg intravenously
Maintenance dose-
For intravenous-
Start the maintenance dose 2 weeks later the loading dose
For 40-60 kg, 3000 mg intravenously every 8 weeks
For 60-100 kg- 3300 mg intravenously every 8 weeks
For more than 100 kg- 3600 mg intravenously every 8 weeks
For subcutaneous-
Start the maintenance dose 2 weeks later than the intravenous loading dose
or
8 weeks later, after the last intravenous maintenance dose
For more than 40 kg- 490 mg subcutaneously every week
490 mg through 2 on-body delivery systems
Each system consists of a prefilled cartridge (245 mg)
Indicated to treat Atypical Hemolytic Uremic Syndrome to stop complement-mediated TMA (thrombotic microangiopathy)
Loading dose-
For 40-60 kg, 2400 mg intravenously
For 60-100 kg- 2700 mg intravenously
For more than 100 kg- 3000 mg intravenously
Maintenance dose-
Start the maintenance dose 2 weeks later the loading dose
For 40-60 kg, 3000 mg intravenously every 8 weeks
For 60-100 kg- 3300 mg intravenously every 8 weeks
For more than 100 kg- 3600 mg intravenously every 8 weeks
Dosage Forms & Strengths
Solution for Injection
10mg/ml (in a single dose vial of 30ml)
100mg/ml (in single-dose vials of 3ml & 11ml)
Solution for subcutaneous injection
70mg/ml (in a single dose prefilled cartridge 245mg/3.5ml)
Paroxysmal Nocturnal Hemoglobinuria
Indicated for the treatment in children of more than 1 month
Loading dose-
For 5-10 kg, 600 mg intravenously
For 10-20 kg- 600 mg intravenously
For 20-30 kg, 900 mg intravenously
For 30-40 kg- 1200 mg intravenously
For 40-60 kg, 2400 mg intravenously
For 60-100 kg- 2700 mg intravenously
For more than 100 kg- 3000 mg intravenously
Maintenance dose-
Start the maintenance dose 2 weeks later the loading dose
For 5-10 kg, 300 mg intravenously every 4 weeks
For 10-20 kg- 600 mg intravenously every 4 weeks
For 20-30 kg, 2100 mg intravenously every 8 weeks
For 30-40 kg- 2700 mg intravenously every 8 weeks
For 40-60 kg, 3000 mg intravenously every 8 weeks
For 60-100 kg- 3300 mg intravenously every 8 weeks
For more than 100 kg- 3600 mg intravenously every 8 weeks
Refer to the adult dosing
Actions and Spectrum:
ravulizumab is a complement inhibitor that specifically targets and inhibits the C5 protein in the complement system. By inhibiting C5, ravulizumab prevents the formation of the C5a and C5b-9 components of the complement system, thereby blocking their damaging effects.
Spectrum
ravulizumab is primarily indicated for the treatment of two specific conditions:
Frequency defined
>10%
Upper respiratory tract infection (75%)
Constipation (25%)
Pain in extremity (25%)
Abdominal pain (38%)
Anemia (25%)
Headache (25%)
Pyrexia (20%)
Upper respiratory tract infection (20%)
Anemia (20%)
Pyrexia (13%)
1-10%
Hypokalemia, all grades (10%)
Pain in extremities, all grades (10%)
Muscle spasms, all grades (10%)
Urinary tract infection, Grade ≥3 (9%)
Gastrointestinal infection, Grade ≥3 (3%)
Nausea, Grade ≥3 (3%)
Diarrhea, Grade ≥3 (3%)
Vomiting, Grade ≥3 (3%)
Nausea (9%)
Diarrhea (9%)
Pyrexia (7%)
Pain in extremities (6%)
Abdominal pain (6%)
Dizziness (5%)
Arthralgia (5%)
<1%
Infusion-related reactions
Black Box Warning:
The usage of ravulizumab may lead to fatal meningococcal infections or sepsis. The patients who would be taking ravulizumab, should first get immunized against meningococci.
Contraindication/Caution:
Contraindications
Cautions
Pregnancy consideration:
No data is available regarding the administration of the drug during pregnancy.
Breastfeeding warnings:
No data is available regarding the excretion of drug in breast milk.
Pregnancy category:
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
ravulizumab specifically binds to the C5 protein in the complement system and inhibits its cleavage into C5a and C5b. By inhibiting C5, ravulizumab prevents the generation of the potent pro-inflammatory molecule C5a and the assembly of the membrane attack complex C5b-9. This blockade of C5 prevents the harmful effects of uncontrolled complement activation, such as red blood cell destruction, inflammation, and organ damage.
Pharmacodynamics:
ravulizumab’s pharmacodynamics are closely linked to its mechanism of action. By inhibiting the C5 protein, ravulizumab prevents the activation of the terminal complement pathway and subsequent formation of C5a and C5b-9. This leads to reduced inflammation, red blood cell destruction prevention, and protection against tissue and organ damage caused by uncontrolled complement activation.
Pharmacokinetics:
Absorption
The peak plasma concentration is 349ng/ml
The area under the curve is 3466ng⋅h/mL
Distribution
Protein-bound is more than 99%
The volume of distribution is 5.34 L (for PNH) and 5.22 L (for aHUS)
Metabolism
Monoclonal antibodies like ravulizumab are not extensively metabolized in the body. They are primarily broken down into smaller peptides and amino acids.
Elimination and Excretion
The half-life is 49.7 days (for PNH) and 51.8 days (for aHUS)
The rate of clearance is 0.08 L/day (for PNH); 0.08 L/day (for aHUS)
Administration:
ravulizumab is supplied as a concentrated solution for IV infusions. The healthcare professional will prepare the medication according to the instructions provided in the prescribing information.
The solution may need diluted with a compatible infusion solution before administration. ravulizumab is administered as a slow intravenous infusion. It is usually infused over several hours, and the exact duration differs depending on the specific protocol.
Patient information leaflet
Generic Name: ravulizumab
Pronounced: RAV-ue-LIZ-ue-mab
Why do we use ravulizumab?
ravulizumab (brand name Ultomiris) is used for the treatment of certain rare blood disorders, specifically paroxysmal nocturnal hemoglobinuria & atypical hemolytic uremic syndrome. Here’s why ravulizumab is used in these conditions:
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