Cinryze · 4.8 Undesirable effects · 1

HOS-095644 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The very common adverse reactions observed following Cinryze infusion in clinical studies were headache and nausea. Tabulated list of adverse reactions Adverse reaction frequencies were estimated from 2 pivotal placebo-controlled and 2 open-label studies in 251 unique subjects. Only frequencies based on reporting rates from clinical trials are used to assign frequency category. Adverse reactions to treatment with Cinryze are classified by MedDRA System Organ Class and absolute frequency in Table 1. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as 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), and not known (cannot be estimated from the available data). Table 1 Adverse reactions reported in clinical studies and in post marketing reports System Organ Class Frequency Adverse reaction Immune system disorders Common Hypersensitivity Metabolism and nutrition disorders Uncommon Hyperglycaemia Very common Headache Nervous system disorders Common Dizziness Venous thrombosis, phlebitis, venous Vascular disorders Uncommon burning, hot flush Respiratory, thoracic and mediastinal Uncommon Cough disorders Very common Nausea Gastrointestinal disorders Common Vomiting Uncommon Diarrhoea, abdominal pain Skin and subcutaneous tissue Common Rash, erythema, pruritus disorders Uncommon Contact dermatitis Musculoskeletal and connective tissue Uncommon Joint swelling, arthralgia, myalgia disorders Injection site rash/erythema, infusion General disorders and administration Common site pain, pyrexia site conditions

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HOS-095640 · has-contraindication-information · PDF-Seite 4

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

HOS-095639 · has-indication-information · PDF-Seite 2

Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE). Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

HOS-095642 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed.

HOS-095643 · has-pregnancy-information · PDF-Seite 5

Pregnancy Human C1-esterase inhibitor is a physiological component of human plasma. Therefore, no adverse effects on fertility, pre- and post-natal development are expected in humans. Animal-reproductive studies show no maternal or embryofoetal effects in rats at dose levels up to 28-times the recommended human dose (1 000 IU) based on an average adult body weight of 70 kg. Data on a limited number of exposed pregnancies are available from clinical studies and from post- marketing experience (including data from two observational studies) and indicate no adverse effects of human C1-esterase inhibitor on pregnancy or on the health of the foetus/newborn child (see section 5.1). Cinryze should be given to pregnant women only if clearly indicated. Breast-feeding It is unknown whether human C1-esterase inhibitor is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cinryze therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 5 Fertility No specific studies on fertility, early embryonic and postnatal development, or carcinogenicity studies were conducted (see section 5.3).

HOS-095641 · 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. Thrombotic events Thrombotic events have been reported in neonatal and infant subjects undergoing cardiac bypass procedures while receiving off-label high doses of another C1-esterase inhibitor product (up to 500 Units()/kg) to prevent capillary leak syndrome. Based upon an animal study there is a potential thrombogenic threshold at doses greater than 200 Units()/kg. Patients with known risk factors for thrombotic events (including indwelling catheters) should be monitored closely. () [Historically assigned potency values were relative to an in-house reference standard whereby 1 Unit (U) is equal to the mean quantity of C1-esterase inhibitor present in 1 ml of normal human plasma.] An international reference standard (IU) has now been implemented where IU is also defined as the amount of C1-esterase inhibitor present in 1 ml of normal human plasma. Transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19. Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1-esterase inhibitor product. 4 Hypersensitivity As with any biological product hypersensitivity reactions may occur. Hypersensitivity reactions may have symptoms similar to angioedema attacks. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur after administration, they should alert their physician. In case of anaphylactic reactions or shock, emergency medical treatment s

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