- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusion of pegcetacoplan.
Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
Patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.
1080mg on day 1 and 4 of each week for 4 weeks.
1080mg every third day (e.g. day 1, day 4, day 7, etc).
Adjustment are suited for patients with lactate dehydrogenase (LDH) levels greater than 2x upper limit of normal.
Additional Dosage Information
Patients switching from a C5 inhibitor to pegcetacoplan
The initial dose is administered alongside the patient's current dose of C5 inhibitor treatment. The C5 inhibitor should be discontinued after 4 weeks before continuing with pegcetacoplan as a monotherapy.
Administer the missed dose as soon as possible, regular scheduled dose can be resumed.
Administered via subcutaneous infusion.
Infusions should rotate between the abdomen, thigh or upper arms.
The infusion time is approximately 30 minutes when using two sites or 60 minutes when using one site.
Children under 12 years
Unresolved infection caused by encapsulated bacteria
Unvaccinated against N. meningitidis, S. pneumoniae and H. influenzae
Hereditary fructose intolerance
Precautions and Warnings
Children aged 12 to 18 years
Before starting therapy ensure immunisations are up to date
Treatment to be initiated and supervised by a specialist
Potential for polyethylene glycol accumulation: Monitor renal function
If dose is increased, monitor LDH at least every 4 weeks
Monitor lactate dehydrogenase (LDH) regularly
Monitor patient closely for haemolysis
Monitor patient for signs of serious infection
Advise patient to report symptoms of infection immediately
May interfere with certain laboratory measurements
Interrupt treatment if severe infusion reaction occurs
Female: Contraception required during and for 2 months after treatment
Give patient package leaflet and patient reminder card
All patients must be vaccinated against encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae following vaccination guidelines at least 2 weeks prior to treatment. Patients with a history of vaccinations against Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae type B should ensure that it occurred within the last 2 years.
Patients without a history of vaccinations will need the required vaccinations to be administered at least 2 weeks prior to receiving the first dose of treatment. If immediate therapy is required, administer the required vaccinations and treat the patient with suitable antibiotics until 2 weeks after vaccination.
If treatment is discontinued, monitor patients for at least 8 weeks for signs and symptoms of serious intravascular haemolysis and other reactions. Serious intravascular haemolysis is identified by elevated LDH levels with sudden decrease in PNH close size or haemoglobin, or reappearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, dyspnoea, major adverse vascular even (including thrombosis), dysphagia or erectile dysfunction. Consider the following treatments for serious haemolysis: blood transfusions (packed RBCs), exchange transfusions, anticoagulation, and corticosteroids.
Avoid administration into areas with tattoos, scars, stretch marks. Skin that is tender, bruised, red or hard should also be avoided.
Pregnancy and Lactation
Pegcetacoplan is contraindicated during pregnancy.
The manufacturer advises that pegcetacoplan is not recommended during pregnancy. There are limited data for use of pegcetacoplan during pregnancy and animal studies have indicated reproductive toxicity.
Pegcetacoplan is contraindicated during breastfeeding.
The manufacturer advises that pegcetacoplan should be discontinued during breastfeeding. It is unknown whether pegcetacoplan is excreted in human milk, however it has been noted that it is unlikely a breastfed infant will have clinically relevant exposure. Animal studies have indicated a low excretion level.
Bruising at injection site
Erythema at injection site
Induration (injection site)
Injection site reactions
Local pain (injection site)
Ophthalmic herpes zoster
Swelling (injection site)
Upper respiratory tract infection
Urinary tract infections
Effects on Laboratory Tests
Use of silica reagents in coagulation panels should be avoided due to possible interference with pegcetacoplan, which can result in artificially prolonged activated partial thromboplastin time (aPTT).
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2022
Summary of Product Characteristics: ASPAVELI 1080mg solution for infusion. Swedish Orphan Biovitrum Ltd. Revised March 2022.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.