Leitlinien & Arzneimittelsicherheit

HOS-288251 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile PNH The most commonly reported adverse reactions in patients with PNH treated with pegcetacoplan are injection site reactions: injection site erythema (29%), injection site pruritus (13%), injection site swelling (12%), injection site pain (8%), injection site bruising (10%), upper respiratory tract infection (26%), diarrhoea (18%), haemolysis (19%), abdominal pain (19%), headache (18%), fatigue (15%), pyrexia (14%), cough (11%), urinary tract infection (9%), vaccination complication (11%), pain in extremity (12%), dizziness (10%), arthralgia (10%) and back pain (8%). The most serious adverse reactions are haemolysis and sepsis. 7 C3G and primary IC-MPGN The most commonly reported adverse reactions in patients with C3G or primary IC-MPGN treated with pegcetacoplan are infusion site reactions (33%) and upper respiratory tract infections (33%). The most serious adverse reactions are acute kidney injury (13%) and pneumonia (9%). Tabulated list of adverse reactions Table 1 gives the adverse reactions observed from the clinical studies and postmarketing experience with pegcetacoplan in patients with PNH, C3G and primary IC-MPGN. Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100) or rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: Adverse reactions MedDRA System Organ Class Frequency in PNH Frequency in C3G or Adverse reaction primary IC-MPGN Infections and infestations Influenza Very common Upper respiratory tract infections1 Very common Very common Urinary tract infection Very common Common Sepsis Common2 Opportunistic infections Common3 COVID-19 Common Gastrointestinal infection Common Fungal infection Common Skin infection

Auszug; vollständigen Abschnitt im Original lesen.

HOS-288247 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pegcetacoplan therapy must not be initiated in patients: • with unresolved infection caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae (see section 4.4). • who are not currently vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section 4.4).

HOS-288246 · has-indication-information · PDF-Seite 2

ASPAVELI is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. ASPAVELI is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC- MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

HOS-288249 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed. Based on in vitro data, pegcetacoplan has low potential for clinical drug-drug interactions.

HOS-288250 · has-pregnancy-information · PDF-Seite 7

Women of childbearing potential It is recommended that women of childbearing potential use effective contraception methods to prevent pregnancy during treatment with pegcetacoplan and for at least 8 weeks after the last dose of pegcetacoplan. For women planning to become pregnant, the use of pegcetacoplan may be considered following an assessment of the risks and benefits (see Pregnancy). Pregnancy There is a limited amount of data from the use of pegcetacoplan in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Pegcetacoplan is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding It is unknown whether pegcetacoplan is excreted in human milk. The potential for absorption and harm to the breastfed infant is unknown. Animal data suggest a low excretion (less than 1%, not pharmacologically significant) of pegcetacoplan in monkey milk (see section 5.3). It is unlikely that a breastfed infant would have clinically relevant exposure. It is recommended to discontinue breast-feeding during pegcetacoplan treatment. Fertility No animal or human data on the effect of pegcetacoplan on fertility are available. In toxicity studies, there were no microscopic abnormalities in male or female reproductive organs in monkeys (see section 5.3).

HOS-288248 · has-warning-information · PDF-Seite 5

Serious infections caused by encapsulated bacteria The use of pegcetacoplan may predispose individuals to serious infections caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. To reduce the risk of infection, all patients must be vaccinated against these bacteria according to applicable local guidelines at least 2 weeks prior to receiving pegcetacoplan, unless the risk of delaying therapy outweighs the risk of developing an infection. Patients with known history of vaccination Before receiving treatment with pegcetacoplan, in patients with a known history of vaccination, it should be ensured that patients have received vaccines against encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae Type B within 2 years prior to starting pegcetacoplan. Patients without known history of vaccination For patients without known history of vaccination, the required vaccines should be administered at least 2 weeks prior to receiving the first dose of pegcetacoplan. If immediate therapy is indicated, the required vaccines should be administered as soon as possible and the patient treated with appropriate antibiotics until 2 weeks after vaccination. Monitoring patients for serious infections Vaccination may not be sufficient to prevent serious infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. All patients should be monitored for early signs of infections caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of these signs and symptoms, and steps taken to seek medical care immediately. Physicians must discuss the benefits and risks of pegcetacoplan therapy with patients. Hypersensitivity Hypersensitivity reactions have been reported (see section 4.8). If a severe hypersensitivity reaction (including anaphylaxis) occurs, infusion with pegcetacoplan must be discontinued immediately, and appropriate treatment instituted. Injection site reactions Injection site reactions have been reported with the use of subcutaneous pegcetacoplan (see section 4.8). Patients should be trained appropriately in proper injection technique.

Auszug; vollständigen Abschnitt im Original lesen.