Leitlinien & Arzneimittelsicherheit

HOS-096254 · has-adverse-reaction-information · PDF-Seite 11

Summary of the safety profile IG 10% Adverse reactions such as chills, headache, dizziness, 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, may frequently occur. Cases of transient aseptic meningitis, transient haemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin, see section 4.4. 11 Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have been rarely observed with IVIg and SCIg products. For safety with respect to transmissible agents, see section 4.4. rHuPH20 The most frequent adverse reactions reported during post-marketing use of rHuPH20 in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain. Oedema has been reported most frequently in association with large volume subcutaneous fluid administration. Antibodies against rHuPH20 A total of 13 out of 83 subjects who participated in pivotal PID study developed an antibody capable of binding to rHuPH20 at least once during the clinical study. These antibodies were not capable of neutralizing rHuPH20. No temporal association between adverse reactions and the presence of anti- rHuPH20 antibodies could be demonstrated. There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to rHuPH20. A total of 16 out of 132 patients who received rHuPH20 developed anti-rHuPH20 binding antibodies at least once in CIDP studies that included 289 patient-years of follow-up. Two subjects developed anti- rHuPH20 neutralizing antibodies. No efficacy or safety issues were identified with binding or neutralizing antibody positivity. Tabulated list of adverse reactions The safety of HyQvia was evaluated in 228 patients who received a total of 7 287 infusions across 6 clinical studies. It included 4 clinical studies (160602, 160603,

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HOS-096250 · has-contraindication-information · PDF-Seite 7

HyQvia must not be given intravenously or intramuscularly. Hypersensitivity to the active substance (IgG) or to any of the excipients listed in section 6.1 (see section 4.4). Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. Known systemic hypersensitivity to hyaluronidase or rHuPH20.

HOS-096249 · has-indication-information · PDF-Seite 3

Replacement therapy in adults, children, and adolescents (0 to 18 years) in: • Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4). • 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 to 18 years) in: • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg.

HOS-096252 · has-interaction-information · PDF-Seite 10

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 listed interactions apply both to adults and children.

HOS-096253 · has-pregnancy-information · PDF-Seite 10

Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical studies and therefore should only be given with caution to pregnant women and breast-feeding mothers. Nine women ever treated with HyQvia were enrolled in a prospective, uncontrolled, multicentre post- authorisation Pregnancy Registry (Study 161301). Of the 8 pregnancies with known outcomes, there were 8 live births with normal APGAR scores. There were no specified labour or delivery 10 complications. No adverse events were reported as related to this medicinal product. Four (4) mothers were tested for anti-rHuPH20 binding, or neutralizing antibodies and no antibodies were detected. Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Development and reproductive toxicology studies have been conducted with rHuPH20 in mice and rabbits. No adverse reactions on pregnancy and foetal development were associated with anti-rHuPH20 antibodies. In these studies, maternal antibodies to rHuPH20 were transferred to offspring in utero. The effects of antibodies to the rHuPH20 component of this medicinal product on the human embryo or on human foetal development are currently unknown (see section 5.3). Breast-feeding Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry. One infant in the Pregnancy Registry (Study 161301) was breastfed. All adverse events were reported as not related to previous or current HyQvia treatment. Fertility There are currently no clinical safety data for this medicinal product on fertility available. Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected. Animal studies do not indicate direct or indirect harmful effects of rHuPH20 with respect to reproductive potential at the doses used for facilitating administration of IG 10% (see section 5.3).

HOS-096251 · has-warning-information · PDF-Seite 7

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. Precautions for use If HyQvia is accidentally administered into a blood vessel, patients could develop shock. The recommended infusion rate given in section 4.2 should be adhered to. Patients must be closely monitored throughout the infusion period, particularly patients starting with therapy. 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 there has been a long interval since the previous infusion. Potential complications can often be avoided by: • initially infusing the product slowly (see section 4.2). • ensuring that patients are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative immunoglobulin product or when there has been a long interval since the previous 7  infusion should be monitored during the first infusion and for the first hour after the first infusion, to detect potential adverse signs. All other patients should be observed for at least 20 minutes after the administration. When treatment is given at home, support from another responsible person should be available for treating adverse reactions or to summon help should a serious adverse reaction occur. Patients on self- home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity reactions. In case of adverse reaction, either the rate of administration must be reduced, or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction. In case of shock, immediately discontinue the infusion and treat the patient for shock. No chronic changes in the skin were observed in the clinical studies. Patients should be reminded to report any chronic inflammation, nodules or inflammation that occurs at the infusion site and lasts more than a few days. Hypersensitivity to IG 10% True hypersensitivity 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 S

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