Enjaymo

HOS-288545 · has-adverse-reaction-information · PDF-Seite 6

Summary of safety profile The most frequently reported adverse reactions with Enjaymo in CADENZA and CARDINAL clinical studies were headache, hypertension, urinary tract infection, upper respiratory tract infection, nasopharyngitis, nausea, abdominal pain, infusion-related reactions and cyanosis (reported as acrocyanosis). Tabulated list of adverse reactions The safety evaluation of Enjaymo in patients with CAD was primarily based on data from 66 patients who participated in the phase 3, randomized, placebo-controlled study (CADENZA) and in an open- label single-arm study (CARDINAL). Listed in Table 2 are adverse reactions observed in the CADENZA and CARDINAL studies presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 Table 2 List of adverse reactions in CADENZA and CARDINAL studies MedDRA System Organ Class Very common Common Infections and infestations Urinary tract infection Lower respiratory tract Cystitis infectionsc Upper respiratory tract Urosepsis infectionsa Escherichia urinary tract Nasopharyngitisb infection Gastroenteritis Urinary tract infection bacterial Rhinitis Cystitis bacterial Oral herpes Herpes simplex viraemia Herpes zoster Herpes simplex General disorders and Pyrexiaf administration site conditio

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HOS-288541 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-288540 · has-indication-information · PDF-Seite 2

Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD).

HOS-288543 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. Enjaymo is an unlikely candidate for cytochrome P450 mediated drug-drug interactions as it is a recombinant human protein. The interaction of sutimlimab with substrates of CYPs has not been studied. However, sutimlimab decreases the levels of proinflammatory cytokines in patients, such as IL-6 which is known to supress the expression of specific hepatic CYP450 enzymes (CYP1A2, CYP2C9, CYP2C19, and CYP3A4). Therefore, caution should be exercised when starting or discontinuing sutimlimab treatment in patients also receiving substrates of CYP450 3A4, 1A2, 2C9 or 2C19, particularly those with a narrow therapeutic index (such as warfarin, carbamazepine, phenytoin and theophylline), and doses adjusted if needed. 5

HOS-288544 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no available data on sutimlimab from the use in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human IgG antibodies are known to cross the placental barrier; therefore, sutimlimab may be transmitted from the mother to the developing foetus. As a precautionary measure, it is preferable to avoid the use of sutimlimab during pregnancy. Sutimlimab should be given during pregnancy only if clearly indicated. Breast-feeding Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. It is unknown whether sutimlimab/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sutimlimab therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Fertility Effects of sutimlimab on male and female fertility have not been studied in animals. In repeat-dose studies with sutimlimab with exposures at up to approximately 4 times the recommended human dose, no effects on reproductive organs were observed in cynomolgus monkeys.

HOS-288542 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Enjaymo targets the classical complement pathway (CP) specifically binding to complement protein component 1, s subcomponent (C1s) preventing the cleavage of complement protein C4. Although the lectin and alternate pathways remain unaffected, patients may have an increased susceptibility to serious infections, especially infections caused by encapsulated bacteria such as Neisseria meningitides, Streptococcus pneumoniae, and Haemophilus influenza. Patients should be vaccinated against encapsulated bacteria before treatment with Enjaymo is started, please see “Vaccinations” below. In clinical studies with CAD, serious infections, including sepsis, have been reported in patients receiving treatment with Enjaymo (see section 4.8). Enjaymo should not be initiated in patients with active, serious infections. Patients should be monitored for early signs and symptoms of infections and should be informed to seek immediate medical care if such symptoms should occur. 4 Patients with viral hepatitis and HIV were excluded from the clinical studies. Before and during treatment, patients must notify their physician if they have been diagnosed with hepatitis B, hepatitis C, or HIV infection. Be cautious when treating patients with a history of hepatitis B, hepatitis C, or HIV infection. Vaccinations Vaccinate patients according to the most current local recommendations for patients with persistent complement deficiencies, including meningococcal and streptococcal vaccines. Revaccinate patients in accordance with local recommendations. Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of Enjaymo. If urgent Enjaymo therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible. The benefits and risks of antibiotic prophylaxis for prevention of infections in patients receiving Enjaymo have not been established. Hypersensitivity reactions As with other protein products, administration of Enjaymo may result in hypersensitivity reactions, including anaphylaxis. In clinical studies, no serious hypersensitivity reactions were observed with Enjaymo. If hypersensitivity reactions occur, discontinue Enjaymo and initiate appropriate

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