Hizentra · 4.6 Fertility, pregnancy and lactation · 1

HOS-095854 · has-adverse-reaction-information · PDF-Seite 7

Summary of safety profile Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration. Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash. 7 For safety with respect to transmissible agents, see section 4.4. Tabulated list of adverse reactions Adverse Reactions (ARs) have been collected in Hizentra clinical trials from 7 phase III studies in patients with primary immunodeficiency (n = 231), 2 phase IV studies in patients with PID (n = 74), 1 phase III study (n = 115), and 1 extension study (n = 82) in patients with CIDP (total N = 502 patients; 26,646 infusions). The ADRs reported in these clinical studies are summarised and categorised according to the MedDRA System Organ Class (SOC and Preferred Term level) and frequency below. Frequency per patient or per infusion has been evaluated using the following criteria: 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). For spontaneous post-marketing ADRs, the reporting frequency is categorised as unknown. Within each frequency grouping, the adverse reactions are presented in the order of decreasing frequency. Frequency of Adverse Drug Reactions (ADR) associated with Hizentra obtained from clinical studies and post-marketing surveillance, reporting rate per patient or per infusion System Organ ADRs (MedDRA Preferred Term, PT) ADR frequency ADR frequency Class category per patient category per (SOC, MedDRA) infusion Immune system Hypersensitivity Uncommon Rare disorders Anaphylactic reaction Unknown Unknown Nervous system Headache Very common Uncommon disorders Dizziness, Migraine Common Rare

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HOS-095850 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Patients with hyperprolinaemia type I or II. Hizentra must not be given intravascularly.

HOS-095849 · has-indication-information · PDF-Seite 2

Replacement therapy in adults, children and adolescents (0-18 years) in: − Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). 2 − Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0-18 years): − Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

HOS-095852 · has-interaction-information · PDF-Seite 7

Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked. Paediatric population The same interactions may occur in the paediatric population. Elderly The same interactions may occur in the elderly.

HOS-095853 · has-pregnancy-information · PDF-Seite 7

Pregnancy Data from prospective clinical trials on the use of human normal immunoglobulin in pregnant women is limited. Therefore, Hizentra should only be given with caution to pregnant women. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus or the neonate are to be expected. Continued treatment of the pregnant woman ensures a passive immunity for the neonate. Breast-feeding Data from prospective clinical trials on the use of human normal immunoglobulin in breast feeding women is limited. Therefore, Hizentra should only be given with caution to breast-feeding mothers. Clinical experience with immunoglobulins suggests however that no harmful effects on the neonate are to be expected. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate. Fertility Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

HOS-095851 · has-warning-information · PDF-Seite 5

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. Hizentra is for subcutaneous use only. If Hizentra is accidentally administered into a blood vessel, patients could develop shock. The recommended infusion rate given under section 4.2 should be adhered to. Patients should be closely monitored and carefully observed for any adverse events throughout the infusion period. Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when treatment has been stopped for more than eight weeks. Potential complications can often be avoided by ensuring that patients: − are not sensitive to human normal immunoglobulin, by initially injecting the product slowly (see section 4.2); − are carefully monitored for any symptoms throughout the infusion period. In particular, patients naïve to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse reactions. All other patients should be observed for at least 20 minutes after administration. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment should be administered. Hypersensitivity True allergic reactions are rare. They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution. Patients with anti-IgA antibodies, in whom treatment with 5 subcutaneous IgG products remains the only option, should be treated with Hizentra only under close medical supervision. Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin. Thromboembolism Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Caution should be exercised in patients with pre-existing risk factors f

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