Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Instituto Grifols, S.A., Can Guasc, 2 Parets del Vallès, 08150, Barcelona Spain
Replacement therapy in adults, children and adolescents (2-18 years) in:
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Immunomodulation in adults, children and adolescents (2-18 years) in:
Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
The dose and dose regimen is dependent on the indication.
The dose may need to be individualised for each patient dependent on the clinical response. Dose based on body weight may require adjustment in underweight or overweight patients. The following dose regimens are given as a guideline.
The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 6 g/l or within the normal reference range for the population age. Three to six months are required after the initiation of therapy for equilibration (steady-state IgG levels) to occur. The recommended starting dose is 0.4-0.8 g/kg given once followed by at least 0.2 g/kg given every three to four weeks.
The dose required to achieve a trough level of IgG of 6 g/l is of the order of 0.2-0.8 g/kg/month. The dose interval when steady state has been reached varies from 3-4 weeks.
IgG trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of bacterial infections, it may be necessary to increase the dosage and aim for higher trough levels.
The recommended dose is 0.2-0.4 g/kg every three to four weeks.
IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
There are two alternative treatment schedules:
The treatment can be repeated if relapse occurs.
0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
2.0 g/kg should be administered as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Starting dose: 2 g/kg divided over 2-5 consecutive days.
Maintenance doses: 1 g/kg over 1-2 consecutive days every 3 weeks.
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease.
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 every 4 to 8 weeks.
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease.
The dose recommendations are summarised in the following table:
| Indication | Dose | Frequency of injections |
|---|---|---|
| Replacement therapy | ||
| Primary immunodeficiency syndromes | Starting dose: 0.4-0.8 g/kg | every 3-4 weeks |
| Maintenance dose: 0.2-0.8 g/kg | ||
| Secondary immunodeficiencies (as defined in 4.1) | 0.2-0.4 g/kg | every 3-4 weeks |
| Immunomodulation | ||
| Primary immune thrombocytopenia 0.8-1 g/kg or | on day 1, possibly repeated once within 3 days | |
| 0.4 g/kg/d | for 2-5 days | |
| Guillain Barré syndrome | 0.4 g/kg/d | for 5 days |
| Kawasaki disease | 2 g/kg | in one dose in association with acetylsalicylic acid |
| Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Starting dose: 2 g/kg | in divided doses over 2-5 days |
| Maintenance dose: 1 g/kg | every 3 weeks over 1-2 days | |
| Multifocal motor neuropathy (MMN) | Starting dose: 2 g/kg | in divided doses over 2-5 consecutive days |
| Maintenance dose: 1 g/kg or | every 2-4 weeks | |
| 2 g/kg | every 4-8 weeks in divided doses over 2-5 days | |
Flebogamma DIF 50 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
The posology in children and adolescents (2-18 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.
No evidence is available to require a dose adjustment.
No dose adjustment unless clinically warranted, see section 4.4.
No dose adjustment unless clinically warranted, see section 4.4.
For intravenous use.
Flebogamma DIF 50 mg/ml should be infused intravenously at an initial rate of 0.01-0.02 ml/kg/min for the first thirty minutes. See section 4.4. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min.
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).
Information on overdose in children has not been established with Flebogamma DIF. However, as in adult population, overdose may lead to fluid overload and hyperviscosity as with any other intravenous immunoglobulins.
2 years.
Do not store above 30°C.
Do not freeze.
10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Pack size: 1 vial
Not all pack sizes may be marketed.
The product should be brought to room or body temperature before use.
The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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