The dose and dosage regimen is dependant on the indication. In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dose regimens are given as a guideline: Replacement therapy in primary immunodeficiency syndromes:
The dose regimen should achieve a trough level of 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 8 - 16 ml (0.4 - 0.8 g)/kg body weight (b.w.) given once, followed by at least 4 ml (0.2 g)/kg b.w. every three to four weeks. The dose required to achieve a trough level of 5-6 g/l is of the order of 4 - 16 ml (0.2 - 0.8 g)/kg b.w./month. The dosage interval when steady state has been reached varies from 3 - 4 weeks.
Trough levels should be measured in order to adjust the dose and dosage interval.
Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS with recurrent bacterial infections:
The recommended dose is 4 - 8 ml (0.2 - 0.4 g)/kg b.w. every three to four weeks.
Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation:
The recommended dose is 4-8 ml (0.2-0.4 g)/kg every three to four weeks. The trough levels should be maintained above 5 g/l.
Primary immune thrombocytopenia:
There are two alternative treatment schedules: 16 - 20 ml (0.8 - 1 g)/kg b.w. on day one, this dose may be repeated once within 3 days.
8 ml (0.4 g)/kg b.w. given daily for two to five days. The treatment can be repeated if relapse occurs.
Guillain Barré syndrome:
8 ml (0.4 g)/kg b.w./day over 5 days.
32 - 40 ml (1.6 - 2.0 g)/kg b.w. should be administered in divided doses over two to five days or 40 ml (2.0 g)/kg b.w. as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
The dosage recommendations are summarised in the following table: (See table.)
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The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Intratect is intended for intravenous administration (infusion into a vein). It is given by a doctor or nurse. The dose will depend on the condition and the body weight. The doctor will know the right amount to give.
At the beginning of the infusion the patient will receive Intratect at a slow rate. The doctor may then gradually increase the infusion rate. The infusion rate and its frequency are dependent on the reason the patient is being given Intratect.
Use in children and adolescents:
The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the previously mentioned conditions.
For replacement therapy in patients with a weak immune system (immunodeficiency) and for patients with congenital AIDS, the infusion is given every 3 to 4 weeks.
To treat inflammatory disorders (immunomodulation) the infusion may be given as followed: Primary immune thrombocytopenia: for the treatment of an acute episode an infusion is given on day 1, this dose may be repeated once in 3 days. Alternatively a lower dosage may be given daily for 2 to 5 days.
Guillain Barré syndrome: the infusion is given for 5 days.
Kawasaki disease: the infusion should be administered over 2 to 5 days or as a single dose.
For hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation to treat infection and prevent rejection, the infusion is given every 3 to 4 weeks. Where there is lack of antibody production, the infusion is given every month until there are normal levels of antibodies.
If the patient misses an infusion:
Intratect will be given in the hospital by a doctor or nurse so it is unlikely to miss an infusion. However, tell the doctor if the patient missed an infusion.
Method of administration:
Intratect is intended for intravenous infusion. During the infusion, an initial rate of no more than 1.4 ml/kg/h for 30 minutes must not be exceeded. If well tolerated, the rate of administration may gradually be increased to a maximum of 1.9 ml/ kg/h for the remainder of the infusion.