Summary of Product Characteristics octagam 10%

Abbreviated prescribing information for octagam 10% (Human Normal Immunoglobulin)

This information is designed for international use and may deviate from the product information valid in your country. Please refer to your national Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Solution for infusion containing 100 mg/ml protein of which ≥95% is human normal immunoglobulin G (IgG). IgA content ≤ 0.4 mg/ml.

Indications: Replacement therapy in adults, and children and adolescents (0-18 years) with: - Primary immunodeficiency syndromes (PID) with impaired antibody production. - 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 <4g/l.

Immunomodulation in adults, and children and adolescents (0-18 years) with: 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); Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); Multifocal motor neuropathy (MMN); Immunomodulation in adults with: Active dermatomyositis (DM) treated with immunosuppressive drugs including corticosteroids, or with intolerance or contra-indications to those drugs

Dosage and Method of Administration: The dose is dependent on the indication: Replacement therapy in PID: Starting dose is 0.4 - 0.8 g/kg, maintenance dose 0.2 – 0.8 g/kg every 3 - 4 weeks. Replacement therapy in secondary immunodeficiencies (SID): 0.2 - 0.4 g/kg every 3 - 4 weeks.  Immunmodulation in: ITP: for acute episodes 0.8 – 1 g/kg on day 1, may be repeated once within 3 days, or 0.4 g/kg daily for 2 - 5 days. Guillain Barré syndrome: 0.4 g/kg/day on 5 consecutive days. Kawasaki Disease: 2.0 g/kg as a single dose in association with acetylsalicylic acid. CIDP: Starting dose: 2 g/kg divided over 2-5 consecutive days. Maintenance dose: 1 g/kg divided over 1-2 consecutive days every 3 weeks. MMN: Starting dose: 2 g/kg divided over 2-5 consecutive days. Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg divided over 2-5 consecutive days every 4 to 8 weeks. Infuse intravenously at an initial rate of 0.01 mL/kg/min for 30 min. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.12 mL/kg/min. DM: 2g/kg given divided in equal doses over 2-5 consecutive days every 4 weeks. The treatment effect should be evaluated after each cycle. Patients with dermatomyositis are considered patients at increased risk for thromboembolic events, should therefore be carefully monitored and infusion rate should not exceed 0.04 ml/kg/min.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Patients with selective IgA deficiency who developed antibodies to IgA.

Special warnings and precautions for use: Octagam 10% contains 90 mg of maltose per ml. Interference of maltose with certain blood glucose assays may result in falsely elevated glucose readings and in inappropriate administration of insulin resulting in life threatening hypoglycaemia and death. Also true cases of hypoglycaemia may go untreated. Always read product information of your blood glucose testing system. Record the name and the batch number for each infusion. Do not exceed the recommended infusion rate. Adverse reactions may occur more frequently if administered at a high rate of infusion, in patients new to human normal immunoglobulin, in patients switching product or when there has been a long interval since the previous infusion or if patients have untreated infection or underlying chronic inflammation. In case of adverse reaction, either decrease rate of administration or stop the infusion. Additional necessary treatment depends on the nature and severity of the adverse reaction. In all patients, IVIg administration requires adequate hydration prior to the infusion, monitoring of urine output, monitoring of serum creatinine levels, avoidance of concomitant use of loop diuretics. Hypersensitivity reactions are rare. Anaphylaxis can develop in patients with undetectable IgA who have anti-IgA antibodies or in patients who had tolerated previous treatment with human normal immunoglobulin. In case of shock, standard medical treatment for shock should be implemented. There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including stroke), pulmonary embolism and deep vein thromboses. Risk patients are obese patients and patients with pre-existing risk factors for thrombotic events (e.g. advanced age, hypertension, diabetes mellitus, dermatomyositis, a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, or with prolonged periods of immobilisation, severely hypovolaemic patients, patients with diseases which increase blood viscosity). There is clinical evidence of association between IVIg and acute renal failure. Patients with risk factors (e.g. pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65) should be closely monitored. In patients at risk for thromboembolic or renal adverse reactions, IVIG products should be administered at the minimum rate and dose practicable. Aseptic meningitis syndrome (AMS) has been reported in connection with IVIg treatment. IVIg products can contain blood group antibodies, which may act as haemolysins and may induce a positive direct antiglobulin reaction (Coombs’ test) and, rarely, haemolysis. Monitor for clinical signs and symptoms of haemolysis.  Transient decreases in neutrophil count have been reported. There have been rare reports of transfusion related acute lung injury (TRALI) in connection with IVIG administration. Infusions must be immediately stopped in case of pulmonary adverse reactions. The transitory rise of passively transferred antibodies during/after IVIG infusion may result in misleading positive results in serological testing. IVIG administration has been associated with falsely raised erythrocyte sedimentation rate, circulatory volume overload and local injections site reactions. 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. This medicinal product contains 69 mg sodium per 100 ml.

Interaction with other medicinal products and other forms of interactions: IVIG administration may impair for a period of at least 6 weeks and up to 3 months (up to 1 year in case of measles) the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.

Undesirable effects: Adverse reactions in decreasing frequency: hypersensitivity, headache, chills, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain. Rare to very rare are reversible haemolytic reactions and haemolytic anaemia requiring transfusion; a sudden fall in blood pressure, anaphylactic shock, transient cutaneous reactions (including cutaneous lupus erythematosus), thromboembolic reactions, reversible aseptic meningitis, increased serum creatinine level and/or occurrence of acute renal failure. For a full list of undesirable effects see section 4.8 of your local SmPC.

Special precautions for disposal and storage: The shelf life is 2 years at +2 to +8°C. Do not freeze. Protect from light. The product may be stored at temperatures above +8°C and below +25°C for up to 9 months, and must be discarded if not used after this. The product should be brought to room or body temperature before use.

Legal Category: POM.

Marketing Authorisation Number: refer to your local Country for relevant information

Marketing Authorisation Holder: Octapharma AG, Seidenstrasse 2, 8853 Lachen, Switzerland

Date of Preparation: May 2021. This information was prepared in the EU based on 20210422_spc_853_DCP_29.24_en.doc.

Adverse events should be reported to www.octapharma.com

European Summary of Product Characteristics

This is an international website for octagam® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).

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