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pegcetacoplan

Aspaveli · ATC code L04AJ03

Also known as: Pegsetakoplan

Key facts
Active substance
pegcetacoplan
Drug class
Immunosuppressive drug
ATC code
L04AJ03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ASPAVELI 1 080 mg solution for infusion
Marketing authorisation holder
Swedish Orphan Biovitrum AB (publ)
Information as of
2026-10-28

Key facts

Pegcetacoplan (Aspaveli) is a complement C3 inhibitor used to treat paroxysmal nocturnal haemoglobinuria (PNH), C3 glomerulopathy and primary immune-complex MPGN.

What it is used for

  • Monotherapy in adults with PNH who have haemolytic anaemia.
  • Adults and adolescents aged 12 to 17 years with C3 glomerulopathy (C3G) or primary IC-MPGN in combination with a RAS inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

Dosing

  • PNH, adults: 1,080 mg twice weekly by subcutaneous infusion (Day 1 and Day 4 of each week), lifelong unless discontinuation is clinically indicated.
  • Switching from a C5 inhibitor: for the first 4 weeks give pegcetacoplan in addition to the current C5 inhibitor, then stop the C5 inhibitor.
  • PNH with LDH greater than 2 x ULN: 1,080 mg every third day may be used; monitor LDH twice weekly for at least 4 weeks.
  • C3G/IC-MPGN, adults: 1,080 mg twice weekly. Adolescents by weight: ≥ 50 kg 1,080 mg; 35 to < 50 kg maintenance 810 mg; 30 to < 35 kg maintenance 648 mg twice weekly (initial doses see the full text).
  • Missed dose: give as soon as possible, then resume the regular schedule.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Do not initiate with unresolved infection by encapsulated bacteria (Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae).
  • Do not initiate without current vaccination against these bacteria unless antibiotic prophylaxis is given until 2 weeks after vaccination.

Important warnings

  • Serious infections with encapsulated bacteria may occur; vaccinate at least 2 weeks before starting, or confirm vaccination within 2 years before starting.
  • Monitor patients for signs of serious infection.
  • In PNH, monitor for haemolysis after discontinuation; see the full text.

Side effects

  • PNH: most common injection site reactions (e.g. erythema 29%, pruritus 13%, swelling 12%), upper respiratory tract infection (26%), haemolysis (19%), abdominal pain (19%), diarrhoea (18%), headache (18%), fatigue (15%) and pyrexia (14%). Most serious: haemolysis and sepsis.
  • C3G/IC-MPGN: most common infusion site reactions (33%) and upper respiratory tract infections (33%); most serious acute kidney injury (13%) and pneumonia (9%).

Interactions

  • No interaction studies; low potential for drug-drug interactions in vitro.

Pregnancy and breastfeeding

  • Not recommended in pregnancy; effective contraception during treatment and for at least 8 weeks after the last dose.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • AspaveliSwedish Orphan Biovitrum AB (publ) · EMEA/H/C/005553

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Aspaveli
Liechtenstein
Aspaveli
Norway
Aspaveli

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Aspaveli – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/aspaveli-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L04AJ.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.