OCTAGAM SOLUTION FOR INFUSION 50 MG/ML [SIN10859P]

Product Info

OCTAGAM SOLUTION FOR INFUSION 50 MG/ML

[SIN10859P]

4.1 Therapeutic Indications

4.1.1 Replacement therapy in:

• Primary immunodeficiency syndromes such as:

  • congenital agammaglobulinaemia and hypogammaglobulinaemia

  • common variable immunodeficiency

  • severe combined immunodeficiency

  • Wiskott Aldrich syndrome

• Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections

• Children with congenital AIDS and recurrent infections.

4.1.2 Immunomodulation:

• Idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

• Guillain Barré syndrome

• Kawasaki disease

4.1.3 Allogeneic bone marrow transplantation

4.2 Posology and method of administration

4.2.1 Posology

The dose and dosage regimen is dependant on the indication.

In replacement therapy the dosage may need to be individualised for each patient dependant 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 level of IgG (measured before the next infusion) of at least 4.0 – 6.0 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, followed by at least 0.2 g/kg every three weeks.

• The dose required to achieve a trough level of 6.0 g/l is of the order of 0.2 – 0.8 g/kg/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 myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia 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.

Idiopathic Thrombocytopenic Purpura:

• For the treatment of an acute episode, 0.8–1.0 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days.

• The treatment can be repeated if relapse occurs.

Guillain Barré syndrome:

• 0.4g/kg/day for 3 to 7 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 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 the case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.

The dosage recommendations are summarised in the following table:

4.2.2 Method of administration

Human normal immunoglobulin should be infused intravenously at an initial rate of 1 ml/kg/hour for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 5 ml/kg/hour.

4.3 Contraindications

Hypersensitivity to any of the components of Octagam.

Hypersensitivity to homologous immunoglobulins, especially in the very rare cases of IgA deficiency when the patient has antibodies against IgA.