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Anti-C5 monoclonal antibody Pregnancy: Available data in pregnant women are insufficient to evaluate drug-associated risk; human IgG crosses the placenta (increasing in the third trimester) so crovalimab may be transmitted to the fetus. Untreated PNH in pregnancy carries maternal and fetal risks. No adverse developmental outcomes were seen in monkeys at 14 times the maximum recommended human exposure (US label 8.1).

Crovalimab

Brand names: PiaSky

Crovalimab is a humanised anti-complement C5 monoclonal antibody used in paroxysmal nocturnal haemoglobinuria (PNH).

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Weight-banded. Body weight 40 kg to less than 100 kg: loading dose 1,000 mg IV on Day 1, then 340 mg SC on Days 2, 8, 15 and 22, then maintenance 680 mg SC. Body weight 100 kg or more: loading dose 1,500 mg IV on Day 1, then 340 mg SC on Days 2, 8, 15 and 22, then maintenance 1,020 mg SC
Route: First loading dose by intravenous infusion (1,000 mg over 60 +/- 10 minutes; 1,500 mg over 90 +/- 10 minutes, diluted in 0.9% sodium chloride to 4-15 mg/mL, via a dedicated line with a 0.2 micron in-line filter); all subsequent doses by subcutaneous injection
Frequency: Loading: Day 1 (IV) then Days 2, 8, 15 and 22 (SC weekly). Maintenance: starting Day 29 and every 4 weeks thereafter (SC)
Indication: paroxysmal nocturnal haemoglobinuria. Doses are based on the patient's ACTUAL body weight; modify the maintenance dose if body weight becomes consistently above or below 100 kg during therapy. Vaccinate against meningococcal disease (serogroups A, C, W, Y and B) at least 2 weeks before the first dose; if urgent treatment is needed in an unvaccinated patient, give antibacterial prophylaxis and vaccinate as soon as possible. Prescribers must enrol in the REMS programme (US). Switching from another C5 inhibitor (eculizumab or ravulizumab): give the first IV loading dose no sooner than the time the next dose of the previous complement inhibitor would have been due, then follow the standard schedule; drug-target-drug complexes may cause Type III hypersensitivity reactions. Scheduling may vary occasionally by up to 2 days (except Days 1 and 2), after which the regular schedule resumes. Missed dose: give as soon as possible before the day of the next scheduled dose, then resume the regular schedule; never give two doses or more than the prescribed dose on the same day. Only healthcare providers should administer. Paediatric: safety and effectiveness established in patients 13 years and older weighing 40 kg or more, using the same weight-banded regimen; not established below 13 years or below 40 kg. No UK SPC was retrieved for this bundle; the entry derives from US labelling (Piasky, label date 2025-11-11) and must be verified against the UK SPC.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Initiation in patients with an unresolved serious Neisseria meningitidis infection
  • Known serious hypersensitivity reaction to crovalimab or to any of the excipients

Side effects

  • Infusion-related reactions
  • Respiratory tract infection
  • Viral infection
  • Type III hypersensitivity reactions (drug-target-drug complexes)
  • Serious meningococcal infection (meningococcaemia and/or meningitis), which may be life-threatening or fatal, and increased susceptibility to other encapsulated-bacterial infections

Interactions

  • Eculizumab or ravulizumab: crovalimab binds a different C5 epitope, so switching to or from these agents can form drug-target-drug complexes (cleared over approximately 8 weeks for eculizumab, longer for ravulizumab) and cause Type III hypersensitivity reactions - monitor patients switching in either direction

Clinical monograph

How it works

It binds complement component C5 and inhibits its cleavage, preventing formation of the terminal membrane attack complex and thereby reducing complement-mediated intravascular haemolysis in PNH.

Prescribing in practice

  • Terminal complement inhibition markedly increases susceptibility to meningococcal disease; meningococcal vaccination and a clear plan for febrile illness are essential before starting.
  • Confirm meningococcal vaccination status is current and consider antibiotic cover when treatment must begin before immunity is established.
  • Switching to or from other complement inhibitors requires care to avoid drug-drug interaction effects and breakthrough haemolysis.

Monitoring

Monitor for signs of haemolysis and, critically, for any features of meningococcal or other encapsulated-organism infection.

Counselling the patient

  • Carry a patient safety card and seek urgent medical care for fever, headache, neck stiffness or rash.
  • Ensure you are up to date with meningococcal vaccination as advised by your team.
  • Do not stop treatment abruptly without discussing the risk of breakthrough haemolysis.

Evidence & guidelines

Crovalimab demonstrated control of haemolysis in PNH in the COMMODORE programme; consult the SPC and current prescribing references for use.

Reference: Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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