Altuvoct · 4.4 Special warnings and precautions for use · 1

HOS-100327 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock). Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ALTUVOCT (see section 5.1). If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. Tabulated list of adverse reactions Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies of adverse reactions are based on Phase 3 clinical studies in 277 previously treated patients (PTPs) with severe haemophilia A, of which 161 (58.2%) were adults (18 years of age and older), 37 (13.4%) were adolescents (12 to < 18 years of age), and 79 (28.5%) were children under the age of 12 years. Adverse drug reactions (ADRs) (summarized in Table 2) were reported in 111 (40.1%) of the 277 subjects treated in clinical studies with routine prophylaxis or on-demand therapy or reported in post- marketing setting. 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 the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 Table 2: Adverse reactions reported for ALTUVOCT MedDRA system organ class Adverse reactions Frequency category 1 Blood and lymphatic system disorders Factor VIII inhibition Very common (PUPs)2 Uncommon (PTPs)3 Immune system disorders Hypersensitivity, Not known anaphylactic reactions1 Nervous system disorders

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100323 · has-contraindication-information · PDF-Seite 5

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

HOS-100322 · has-indication-information · PDF-Seite 3

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). ALTUVOCT can be used for all age groups.

HOS-100325 · has-interaction-information · PDF-Seite 7

No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported. No interaction studies have been performed.

HOS-100326 · has-pregnancy-information · PDF-Seite 7

Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.

HOS-100324 · 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. 5 Hypersensitivity Allergic type hypersensitivity reactions, including anaphylactic reactions have been observed with ALTUVOCT. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, itching, nausea, vomiting, tightness of the chest, wheezing, hypotension, and anaphylaxis. In case of shock, standard medical treatment for shock should be implemented. Inhibitors The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII pro-coagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay. The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon. The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titres posing less of a risk of insufficient clinical response than high titre inhibitors. In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors. Monitoring laboratory tests If the chromogenic assay or the one-stage clotting assay with Actin-FS reagent are used, divide the result by 2.5 to approximate the patient’s factor VIII activity level (see section 4.2). Of note, this conversion factor only represents

Auszug; vollständigen Abschnitt im Original lesen.