Omr-IgG-am 5% IV

/ Omrix Biopharmaceuticals

The dose and dosage regimen is dependent on the indication.
In replacement therapy, the dosage may need to be individualized for each patient, dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.
Replacement therapy
Replacement therapy in Primary Immunodeficiency: The dosage regimen should achieve a trough level of immunoglobulin G (IgG) (measured before the next infusion) of at least 5-6 g/L. Three to six months are required after the initiation of therapy for equilibration to occur.
The recommended starting dose is 0.4-0.8 g/kg depending of the circumstances (e.g. active infection) followed by at least 0.2 g/kg every three to four weeks.
The dose required to achieve a trough level of 5-6 g/L are of the order of 0.2-0.8 g/kg/month.
The dosage interval when steady state has been reached varies from 3-4 weekly.
Trough levels should be measured every 6-12 months in order to adjust the dose and the dosage interval.
Replacement therapy in Myeloma or Chronic Lymphocytic Leukemia with severe secondary hypogammaglobulinemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections: The recommended dose is 0.2-0.4 g/kg every three to four weeks.
Immunomodulation
Idiopathic Thrombocytopenic Purpura: For the treatment of an acute episode, 0.8-1 g/kg on day one, repeated on day three if necessary, or 0.4 g/kg daily for two to five days. The treatment can be repeated if relapse occurs. In the first treatment regimen, if an adequate increase in the platelet count is observed at 24 hours, the second dose of 1000 mg/kg body weight may be withheld.
The high dose regimen (1,000 mg/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.
Guillain Barré Syndrome: 0.4 g/kg/day for 3 to 5 days. Experience in children is limited.
Kawasaki Disease: 1.6-2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Allogeneic Bone Marrow Transplantation: Human normal immunoglobulin treatment can be used as part of the conditioning regimen before and after the transplant.
For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation. In case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.
Administration:
– Omr-IgG-am ™ 5% IV should be infused intravenously at an initial rate of 0.01-0.02 mL/kg/min for 15 minutes.
– Infusion rate may increase gradually to a maximum of 0.08 mL/kg/min.

Replacement Therapy:
• Primary immunodeficiency (patients with primary defective antibody synthesis such as agammaglobulinemia or hypogammaglobulinemia).
• Myeloma or Chronic Lymphocytic Leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections.
• Children with congenital AIDS and recurrent infections.
Immunomodulation:
• Idiopathic Thrombocytopenic Purpura (ITP)
• Guillain Barré Syndrome
• Kawasaki Disease
Allogenic Bone Marrow Transplantation

Omr-IgG-am ™ 5% IV is contra- indicated in individuals who are known to have anaphylactic or severe systemic response to intramuscular or intravenous immunoglobulin preparations or to any of the excipients.
As with other immunoglobulin preparations Omr-IgG-am ™ 5% IV should not be given to patients with antibodies to IgA or selective IgA deficiency.

See prescribing information for full details.

During or shortly after the application of intravenous immunoglobulins minor side effects such as headache, chills, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate back pain may occur occasionally. Dyspnea and tachycardia may occur more frequently and require medical attention. Reversible aseptic meningitis and nephrotoxicity have occurred rarely.
See prescribing information for full details.

Live attenuated 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.
Interference with serological testing: Passive transmission of antibodies to erythrocyte antigen- e.g. A,B or D may interfere with some serological testse.g.
Coomb’s test, haptoglobin, reticulocyte count.
Incompatibilities: Omr-IgG-am ™ 5 % IV should not be mixed with other medicinal products. A separate intravenous line should be used for the infusion.
See prescribing information for full details.

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 after 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.

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.