Kiovig · 4.3 Contraindications · 1

HOS-094168 · has-adverse-reaction-information · PDF-Seite 10

Summary of the safety profile 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. Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin. Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see also Section 4.4). Increase in serum creatinine level and/or acute renal failure have been observed. Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses. Cases of Transfusion Related Acute Lung Injury (TRALI). Tabulated list of adverse reactions The tables presented below are according to the MedDRA system organ classification (SOC and Preferred Term Level). Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post-marketing ARs. Frequencies have been evaluated according to 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); not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 Frequency of Adverse Reactions (ADRs) in clinical studies with KIOVIG MedDRA System Organ Class Adverse reaction Frequency (SOC) Infections and infestations Bronchitis, nasopharyngitis Common Chronic sinusitis, fungal infection, infection, kidney Uncommon infection, sinusitis, upper respiratory tract infection, urinary tract infection, bacterial urinary tract infection, meningitis aseptic Blood and lymphatic Anaemia, lymphadenopathy Common s

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HOS-094164 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA. 5 Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA containing product can result in anaphylaxis.

HOS-094163 · has-indication-information · PDF-Seite 2

Replacement therapy in adults, and children and adolescents (0-18 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 2 Immunomodulation in adults, and children and adolescents (0-18 years) in:  Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.  Guillain Barré syndrome.  Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2).  Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).  Multifocal Motor Neuropathy (MMN).

HOS-094166 · has-interaction-information · PDF-Seite 9

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 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. Dilution of KIOVIG with a 5% glucose solution may result in increased blood glucose levels. Loop diuretics Avoidance of concomitant use of loop diuretics. Paediatric population The listed interactions apply both to adults and children.

HOS-094167 · has-pregnancy-information · PDF-Seite 9

Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women and breast-feeding mothers. IVIg 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. Breast-feeding Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry. No negative effects on the breastfed newborn/infants are anticipated. Fertility Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

HOS-094165 · has-warning-information · PDF-Seite 6

Infusion reaction Certain severe adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion. The recommended infusion rate given under section 4.2 must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Certain adverse reactions may occur more frequently  in case of high rate of infusion  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.  in patients with an untreated infection or underlying chronic inflammation. Precautions for use Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (0.5 ml/kg BW/hr); - are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration. In all patients, IVIg administration requires:  adequate hydration prior to the initiation of the infusion of IVIg  monitoring of urine output  monitoring of serum creatinine levels  monitoring for signs and symptoms of thrombosis  assessment of blood viscosity in patients at risk for hyperviscosity  avoidance of concomitant use of loop diuretics (see 4.5). 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. If dilution of KIOVIG to lower concentrations is required for patients suffering from diabetes mellitus, the use of 5% glucose solution for dilution may have to be reconsidered. Hypersensitivity Hypersensitivity reactions are rare. Anaphylaxis can develop in patients  with undetectable IgA who have anti-IgA antibodies  who had tolerated previous treatment wit

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