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Solution for Infusion
100 ml X 100 g/L
Solution for Infusion
50 ml X 100 g/L
The dosage and dosage regimen is dependent on the indication. In replacement therapy the dosage may need to be individualised for each patient depending on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.
Replacement therapy in primary immunodeficiency syndromes: The dosage regimen should achieve a trough IgG level (measured before the next infusion) of at least 4 to 6 g/l. 3 to 6 months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) followed by at least 0.2 g/kg bw every three weeks. The dose required to achieve a trough level of 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month. The dosage interval when steady state has been reached varies from 2 to 4 weeks. Trough levels should be measured in order to adjust the dose and dosage interval.
Replacement therapy in myelomas or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections: replacement therapy in children with congenital AIDS and recurrent infections. The recommended dosage is 0.2 to 0.4 g/kg bw every 3 to 4 weeks.
Immune thrombocytopenic purpura: For the treatment of an acute episode, 0.8 to 1 g/kg bw on day one, which may be repeated once within 3 days, or 0.4 g/kg bw daily for 2 to 5 days. The treatment can be repeated if relapse occurs (see also section “Properties/effects”).
Guillain-Barré syndrome: 0.4 g/kg bw/day over 5 days. Experience in children is limited.
Kawasaki disease: 1.6 to 2.0 g/kg bw should be administered in divided doses over 2 to 5 days or 2.0 g/kg bw as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Chronic inflammatory demyelinating polyneuropathy (CIDP): The recommended starting dose is 2 g/kg bw divided over 2 to 5 consecutive days followed by maintenance doses of 1 g/kg bw given on one day or divided over 2 consecutive days every 3 weeks. The long-term therapy over 24 weeks depends on the patient’s response to the maintenance therapy. The lowest effective maintenance dose and the dosage regimen are to adjust according to the individual course of the disease.
Allogeneic bone marrow transplantation: Human immunoglobulin therapy can be used as part of the conditioning regimen and after transplantation. To treat infections and prevent graft-versus-host disease, the dosage should be individually adjusted. The starting dosage is usually 0.5 g/kg bw/week, commencing seven days before the transplant. The treatment is continued for up to 3 months after the transplant. If the lack of antibody production persists, a dosage of 0.5 g/kg bw/month is recommended until IgG antibody levels return to normal.
Use of the product in children: In the phase III pivotal study on patients with primary immunodeficiency diseases (n=80),19 patients between 3 and 11 years of age and 15 patients from 12 up to and including 18 years of age were treated. In an extension study on patients with primary immunodeficiency diseases (n=50), 13 patients between 3 and 11 years of age and 11 between 12 and including 18 years of age were treated. In a clinical study on 57 patients with chronic immune thrombocytopenic purpura, 2 paediatric patients (15 and 16 years of age) were treated.
No dose adjustment for children was required in these three studies.
Primary immunodeficiency syndromes:
Starting dose: 0.4-0.8 g/kg bw
Thereafter: 0.2-0.8 g/kg bw – every 2-4 weeks to obtain IgG trough levels of at least 4-6 g/l.
Secondary immunodeficiency syndromes: 0.2-0.4 g/kg bw – every 3-4 weeks to obtain IgG trough levels of at least 4-6 g/l.
children with congenital HIV infection and recurrent infections: 0.2-0.4 g/kg bw every 3-4 weeks.
Immune thrombocytopenic purpura: 0.8-1 g/kg bw – on the first day; the therapy may be repeated once within 3 days.
Or 0.4 g/kg bw/day for 2-5 days.
Guillain-Barré syndrome: 0.4 g/kg bw/day for 5 days.
Kawasaki disease: 1.6-2 g/kg bw divided into several doses given over 2-5 days in conjunction with acetylsalicylic acid.
Or 2 g/kg bw as a single dose in conjunction with acetylsalicylic acid.
Chronic inflammatory demyelinatingpolyneuropathy (CIDP): starting dose:
2 g/kg bw in divided doses over 2-5 days. maintenance dose: 1 g/kg bw every 3 weeks over 1-2 days.
Allogeneic bone marrow transplantation:
Treatment of infections and prevention of graftversus-host disease – 0.5 g/kg bw, weekly, from day 7 before up to 3 months after the transplant
Persistent lack of antibody production: 0.5 g/kg bw, monthly, until antibody levels return to normal.
*bw = body weight
Method of administration: Privigen should be infused intravenously.
Rate of infusion: The product should initially be infused at a rate of 0.3 ml/kg bw/hr (for approximately 30 min).
If well tolerated, the infusion rate can be gradually increased to 4.8 ml/kg bw/hr. In patients with immunodeficiency syndrome who have tolerated substitution treatment with Privigen well, the infusion rate may be gradually increased to a maximal value of 7.2 ml/kg bw/hr.
Replacement therapy in:
– Primary immunodeficiency syndromes such as: Congenital agammaglobulinemia and hypogammaglobulinemia; Common variable immunodeficiency; Severe combined immunodeficiency; Wiskott-Aldrich syndrome.
– Myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.
– Children with congenital AIDS and recurrent infections.
– Immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count.
– Guillain-Barre syndrome.
– Kawasaki disease.
– Chronic inflammatory demyelinating polyneuropathy (CIDP).
Allogeneic bone marrow transplantation.
Hypersensitivity to the active substance or the excipient. Hypersensitivity to homologous immunoglobulins, particularly in very rare cases of IgA deficiency where the patient has anti-IgA antibodies. Patients with hyperprolinemia. This is a very rare disease, which affects only a few families worldwide.
Certain severe side effects can be related to the infusion rate. The recommended infusion rate given in the prescribing information must be followed closely. Patients must be observed during and after the infusion and carefully monitored for symptoms of any kind.
See prescribing information for full details.
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally in connection with intravenous administration of human immunoglobulin.
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 have been observed with human normal immunoglobulin.
Reversible haemolytic reactions have been observed in patients, especially those with non-0 blood groups in immunomodulatory treatment. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment.
Increase in serum creatinine level and/or acute renal failure have been observed.
Very rarely: Transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
See prescribing information for full details.
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: Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
Pregnancy and Lactation
Pregnancy: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore 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.
Experimental studies of the excipient L-proline carried out in animals found no direct or indirect toxicity affecting pregnancy, embryonal or foetal development.
Lactation: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.