Rystiggo

HOS-100134 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most commonly reported adverse reactions were headache (48.4 %), diarrhoea (25.0 %) and pyrexia (12.5 %). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing experience in gMG are listed in Table 1 below, classified by MedDRA System Organ Class (SOC). Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories are defined as follows: 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), not known (cannot be estimated from the available data). 6 Table 1: List of adverse reactions MedDRA system organ class Adverse reactions Frequency category Infections and infestations Upper respiratory tract Common infections1 Herpes viral infection*6 Not known Nervous system disorders Headache2 Very common Aseptic meningitis* Not known Gastrointestinal disorders Diarrhoea Very common Nausea* Common Vomiting* Common Skin and subcutaneous tissue Rash3 Common disorders Angioedema4 Common Musculoskeletal and Arthralgia Common connective tissue disorders General disorders and Pyrexia Very common administration site conditions Injection site reactions5 Common 1 Includes cases of nasopharyngitis 2 Includes headache and migraine 3 Includes rash, rash papular and rash erythematous 4 Includes swollen tongue 5 Includes injection site rash, reaction, erythema, inflammation, discomfort, and infusion site erythema, pain 6 Includes cases of Herpes Zoster, simplex and oral *From spontaneous post-marketing reporting Description of selected adverse reactions Headac

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HOS-100130 · has-contraindication-information · PDF-Seite 4

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

HOS-100129 · has-indication-information · PDF-Seite 2

Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

HOS-100132 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. As rozanolixizumab interferes with the FcRn recycling mechanism of immunoglobulin G (IgG), the serum concentrations of IgG-based medicinal products (e.g. monoclonal antibodies and intravenous immunoglobulin [IVIg]) and Fc–peptide fusion proteins are expected to be decreased if administered concomitantly or within 2 weeks after administration of rozanolixizumab. It is recommended to initiate these treatments 2 weeks after administration of rozanolixizumab and to monitor for attenuated efficacy of these medicinal products when administered concomitantly. Treatment with IV or SC immunoglobulins, PLEX/plasmapheresis and immunoadsorption may reduce circulating levels of rozanolixizumab. Vaccination during treatment with rozanolixizumab has not been studied and the response to any vaccine is unknown. Because rozanolixizumab causes a reduction in IgG levels, vaccination with 5 live-attenuated or live vaccines is not recommended during treatment with rozanolixizumab (see sections 4.4 and 5.3).

HOS-100133 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are limited amount of data from the use of rozanolixizumab in pregnant women. In animal studies, offspring from treated dams had very low levels of IgG at birth, as expected by the pharmacological mode of action of rozanolixizumab (see section 5.3). However, animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Treatment of pregnant women with rozanolixizumab should only be considered if the clinical benefit outweighs the risks. As rozanolixizumab is expected to reduce maternal antibody levels, and is also expected to inhibit the transfer of maternal antibodies to the foetus, reduction in passive protection to the newborn is anticipated. Therefore, risks and benefits of administering live / live attenuated vaccines to infants exposed to rozanolixizumab in utero should be considered (see section 4.4, subsection “Vaccination”). Breast-feeding It is unknown whether rozanolixizumab is excreted in human milk. Maternal 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 rozanolixizumab could be considered during breast-feeding only if the clinical benefit outweighs the risks. Fertility The effect of rozanolixizumab on human fertility is not known. Animal studies do not indicate harmful effects with respect to fertility (see section 5.3).

HOS-100131 · 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. Myasthenic crisis Treatment with rozanolixizumab in patients with impending or manifest myasthenic crisis has not been studied. The sequence of therapy initiation between established therapies for MG crisis and rozanolixizumab, and their potential interactions, should be considered (see section 4.5). Aseptic meningitis Aseptic meningitis (drug induced aseptic meningitis) has been reported following rozanolixizumab treatment. If symptoms consistent with aseptic meningitis (headache, pyrexia, neck stiffness, nausea, vomiting) occur, diagnostic workup and treatment should be initiated as per standard of care. Infections As rozanolixizumab causes transient reduction in IgG levels the risk of infections may increase (see section 5.1). Overall, in phase 3 studies in gMG, infections were reported in 45.2 % of all rozanolixizumab treated patients. No increase in the incidence of infections was observed from cycle to cycle. Serious infections were reported in 4.3 % of patients. Treatment with rozanolixizumab should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. During treatment with rozanolixizumab, 4 clinical signs and symptoms of infections should be monitored. If a clinically important active infection occurs, withholding rozanolixizumab until the infection has resolved should be considered. Hypersensitivity Infusion reactions such as rash or angioedema may occur (see section 4.8). In the clinical trial, these were mild to moderate. Patients should be monitored during treatment with rozanolixizumab and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration (see section 4.8), rozanolixizumab infusion should be discontinued and appropriate measures should be initiated if needed. Once resolved, administration may be resumed. Vaccination Immunisation with vaccines during rozanolixizumab therapy has not been studied. The safety of immunisation with live or live-attenuated vaccines and the response to immunisation with vaccines are unknown. All vaccines should be administered according to immunisation guidelines and at least 4 weeks befor

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