ravulizumab: clinical use

Prescribing considerations

• Treatment requires supervision by a clinician experienced in the relevant haematological, renal, neuromuscular or neuroinflammatory disorder.
• Confirm meningococcal immunisation is current before initiation; arrange appropriate antibacterial prophylaxis if adequate vaccine protection has not yet developed.
• Vaccination does not eliminate meningococcal risk. Provide education and a patient alert card.
• Patients under 18 also require age-appropriate pneumococcal and Haemophilus influenzae immunisation.
• Use caution with active systemic infection and advise about other Neisseria infections, including gonorrhoea.
• Plan carefully before interruption or withdrawal because PNH haemolysis, aHUS thrombotic microangiopathy, gMG symptoms or NMOSD relapse may recur.

Contraindications and cautions

• Hypersensitivity to ravulizumab or an excipient.
• Unresolved Neisseria meningitidis infection when treatment is initiated.
• Absence of current meningococcal vaccination unless appropriate antibiotic prophylaxis is provided.

Monitoring

• Check immunisation status and assess for active infection before treatment.
• Monitor continuously for infusion-related hypersensitivity during administration.
• Maintain vigilance for meningococcal sepsis, other Neisseria infection and infections with encapsulated bacteria.
• Use disease-specific clinical and laboratory markers to assess response and detect breakthrough activity.
• After discontinuation, monitor for recurrence of haemolysis, thrombotic microangiopathy, myasthenic symptoms or NMOSD relapse as appropriate.
• Record the product name and batch number for biological-medicine traceability.

Clinical pharmacology

Ravulizumab is a humanised IgG2/4κ monoclonal antibody that binds C5, preventing generation of C5a and C5b-9. Like endogenous IgG, it is expected to be catabolised into peptides and amino acids and has no known active metabolites.

Formulation and product differences

• The selected product is a sterile concentrate supplied in two single-use vial sizes at the same concentration.
• Both presentations require dilution with sodium chloride solution before intravenous infusion.
• The formulation contains sodium and polysorbate 80; polysorbates can cause allergic reactions.