Registered South Africa · SAHPRA

ULTOMIRIS 300 mg

Ravulizumab

59/30.1/0014 INN generic

What it does

Ravulizumab is a medication used to help manage certain blood disorders by targeting the immune system.

Commonly used for: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
59/30.1/0014
Registration date
2025/07/02
Expiry date
-
Status
Registered
Active ingredient
Ravulizumab
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:29:46 · updated 2026-10-28 04:13:02

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ravulizumab is a medication used to help manage certain blood disorders by targeting the immune system.

What it treats

  • paroxysmal nocturnal hemoglobinuria (PNH)
  • atypical hemolytic uremic syndrome (aHUS)

How it works

It works by blocking a part of the immune system that can cause red blood cells to break down too quickly.

Who it's for

This medication is for adults and children with specific blood disorders.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Ravulizumab

BNF-referenced

Ravulizumab is a monoclonal antibody that acts as a complement inhibitor, specifically targeting the complement protein C5. It is used primarily for the treatment of certain conditions associated with excessive complement activation, such as atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis. By inhibiting complement activation, Ravulizumab helps to reduce inflammation and tissue damage caused by uncontrolled complement activation.

Indications

  • Atypical hemolytic uremic syndrome (aHUS)
  • Generalized myasthenia gravis

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Initially 900 mg once weekly for 4 weeks, then increase to 1.2 g once weekly for 1 week, followed by maintenance dosing of 1.2 g every 12–16 days. The infusion should be diluted to a concentration of 5 mg/mL and administered over 25–45 minutes, with a possibility of extending to 2 hours if infusion-related reactions occur.

Mechanism of action

Ravulizumab binds to and inhibits the complement protein C5, preventing its cleavage into C5a and C5b. This action interrupts the complement cascade, which is a part of the immune response, thereby reducing inflammation and the formation of the membrane attack complex (MAC) that can lead to cell lysis.

Pharmacodynamics

The pharmacodynamic effects of Ravulizumab are primarily observed through its ability to inhibit complement-mediated hemolysis and inflammation. This results in decreased levels of hemolysis markers and improved renal function in patients with aHUS. The therapeutic effects are typically seen within a few weeks of initiating treatment.

Pharmacokinetics

Ravulizumab has a half-life of approximately 15 to 20 days, allowing for less frequent dosing compared to its predecessor, eculizumab. It is administered via intravenous infusion and exhibits linear pharmacokinetics within the therapeutic dose range. The drug is primarily eliminated through the reticuloendothelial system and does not undergo significant metabolism. Renal or hepatic impairment may affect its clearance.

Contra-indications

  • Patients unvaccinated against Neisseria meningitidis
  • Active systemic infection

Adverse effects

  • Alopecia
  • Asthenia
  • Cough
  • Decreased leucocytes
  • Diarrhoea
  • Dizziness
  • Fever
  • Gastrointestinal discomfort
  • Headache
  • Hypertension
  • Increased risk of infection
  • Influenza-like illness
  • Joint pain
  • Anxiety
  • Decreased appetite
  • Chest discomfort
  • Chills
  • Constipation
  • Depression
  • Dysuria
  • Hemorrhage
  • Hepatosplenic abscess
  • Hot flush
  • Hyperhidrosis
  • Hypotension
  • Infusion-related reactions
  • Meningitis
  • Meningococcal infection
  • Mood swings
  • Nasal complaints
  • Oedema
  • Pain
  • Palpitations
  • Paraesthesia
  • Renal abscess
  • Sepsis
  • Spontaneous penile erection
  • Throat irritation
  • Tinnitus

Precautions

  • Vaccinate against Neisseria meningitidis at least 2 weeks before treatment
  • Patients receiving eculizumab less than 2 weeks after receiving meningococcal vaccine must be given prophylactic antibiotics until 2 weeks after vaccination
  • Other immunisations should be up to date

Pregnancy

Consult product literature for details regarding safety in pregnancy.

Breast-feeding

Consult product literature for details regarding safety during breastfeeding.

Storage

Store in a refrigerator (2-8°C) where available and protect from light.

Formulations

  • Soliris (Alexion Pharma UK Ltd) Eculizumab 10 mg per 1 ml concentrate for solution for infusion
  • Soliris 300mg/30ml concentrate for solution for infusion vials
BNF 85 (British National Formulary) p.1144 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.