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Pegcetacoplan infusion

Updated 2 Feb 2023 | Pegcetacoplan

Presentation

Infusion of pegcetacoplan.

Drugs List

  • ASPAVELI 1.08g/20ml solution for infusion vial
  • pegcetacoplan 1.08g/20ml solution for infusion vial
  • Therapeutic Indications

    Uses

    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.

    Dosage

    Adults

    Initial dose
    1080mg on day 1 and 4 of each week for 4 weeks.

    Dose adjustment
    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.

    Missed dose
    Administer the missed dose as soon as possible, regular scheduled dose can be resumed.

    Administration

    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.

    Contraindications

    Children under 12 years
    Unresolved infection caused by encapsulated bacteria
    Unvaccinated against N. meningitidis, S. pneumoniae and H. influenzae
    Breastfeeding
    Hereditary fructose intolerance
    Pregnancy

    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
    Contains sorbitol
    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

    Pregnancy

    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.

    Lactation

    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.

    Side Effects

    Abdominal pain
    Back pain
    Bacterial infection
    Bruising at injection site
    Diarrhoea
    Dizziness
    Ear infection
    Epistaxis
    Erythema
    Erythema at injection site
    Fatigue
    Fungal infection
    Furuncle
    Gastro-enteritis
    Gastro-intestinal infection
    Haemolysis
    Headache
    Hordeolum
    Induration (injection site)
    Influenza
    Injection site reactions
    Local pain (injection site)
    Myalgia
    Nasal abscess
    Nausea
    Ophthalmic herpes zoster
    Oral herpes
    Otitis externa
    Painful extremities
    Paronychia
    Periodontitis
    Pruritus
    Pulpitis dental
    Pyrexia
    Rash
    Sepsis
    Swelling (injection site)
    Thrombocytopenia
    Upper respiratory tract infection
    Urinary tract infections
    Viral infection
    Vulvovaginal 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).

    Overdosage

    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 ).

    Further Information

    Last Full Review Date: April 2022

    Reference Sources

    Summary of Product Characteristics: ASPAVELI 1080mg solution for infusion. Swedish Orphan Biovitrum Ltd. Revised March 2022.

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