Enspryng · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-098751 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile The most frequently reported adverse reactions observed were: headache (19.2%), arthralgia (13.5%), white blood cell count decreased (13.5%), hyperlipidaemia (13.5%), and injection-related reactions (12.5%). Tabulated list of adverse reactions Table 3 summarises the adverse reactions that have been reported in association with the use of satralizumab as a monotherapy or in combination with IST in clinical trials. Adverse reactions from clinical trials (Table 3) are listed by MedDRA system organ class. Adverse reactions are presented using number of adverse events per 100 patient years and by frequency figures. The corresponding frequency category for each adverse reaction is based on frequency figures and the following convention: 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). Table 3: Adverse reactions System Organ Class Frequency Very common Common Blood and lymphatic system disorders Hypofibrinogenaemia Metabolism and nutrition disorders Hyperlipidaemia Psychiatric disorders Insomnia Nervous system disorders Headache Migraine Cardiac disorders Bradycardia Vascular disorders Hypertension Respiratory, thoracic and mediastinal Allergic rhinitis disorders Gastrointestinal disorders Gastritis Skin and subcutaneous tissue disorders Rash, pruritus Musculoskeletal and connective tissue Arthralgia Musculoskeletal stiffness disorders General disorders and administration Injection-related reactions Peripheral oedema site conditions Investigations White blood cell count Neutrophil count decreased decreased platelet count decreased,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098747 · has-contraindication-information · PDF-Seite 5

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

HOS-098746 · has-indication-information · PDF-Seite 2

Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive (see section 5.1).

HOS-098749 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed. Population pharmacokinetic (PK) analyses did not detect any effect of azathioprine (AZA), oral corticosteroids (OCs) or mycophenolate mofetil (MMF) on the clearance of satralizumab. Both in vitro and in vivo studies have shown that the expression of specific hepatic CYP450 enzymes (CYP1A2, CYP2C9, CYP2C19, and CYP3A4) is suppressed by cytokines such as IL-6. Therefore caution should be exercised when starting or discontinuing satralizumab 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. Given the prolonged terminal half-life of satralizumab, the effect of satralizumab may persist for several weeks after stopping treatment.

HOS-098750 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no data from the use of satralizumab in pregnant women. Studies in monkeys do not indicate harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Enspryng during pregnancy. Breast-feeding It is unknown whether satralizumab is excreted in human breast milk. Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of Enspryng could be considered during breast-feeding only if clinically needed. Fertility No clinical data are available on the effect of satralizumab on human fertility. Animal studies showed no impairment of male or female fertility (see section 5.3). 6

HOS-098748 · has-warning-information · PDF-Seite 5

Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Administration of satralizumab should be delayed in patients with an active infection until the infection is controlled (see section 4.2). Vigilance for the timely detection and diagnosis of infection is recommended for patients receiving treatment with satralizumab. Treatment should be delayed in case the patient develops any serious or opportunistic infection and appropriate therapy should be initiated under further monitoring. Patients should be instructed on seeking early medical attention in case of signs and symptoms of infections to facilitate timely diagnosis of infections. Patients should be provided with a patient alert card. Vaccinations Live and live-attenuated vaccines should not be given concurrently with satralizumab as clinical safety has not been established. The interval between live vaccinations and initiation of satralizumab treatment should be in accordance with current vaccination guidelines regarding immunomodulatory or immunosuppressive agents. No data are available on the effects of vaccination in patients receiving satralizumab. It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating satralizumab treatment. 5 Liver enzymes Mild and moderate elevations of liver transaminases have been observed with satralizumab treatment, most elevations were below 5 x ULN (see section 4.8). ALT and AST levels should be monitored every four weeks for the first three months of treatment, followed by every three months for one year, thereafter as clinically indicated. Treatment with satralizumab should be discontinued in patients with ALT or AST >5 x ULN (see section 4.2). Neutrophil count Decreases in neutrophil counts have occurred following treatment with satralizumab (see section 4.8). Neutrophil counts should be monitored 4 to 8 weeks after start of treatment and thereafter as clinically indicated. For recommended dose interruption see section 4.2.