Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Grifols Deutschland GmbH, Colmarer Straße 22, 60528 Frankfurt, Germany, Tel.: +49 69-660 593 100
Replacement therapy in adults, and children and adolescents (0-18 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, and children and adolescents (0-18 years) in:
Immunomodulation in adults aged ≥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 bodyweight 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 dosage 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.
2 g/kg divided over 2 consecutive days (dose of 1 g/kg per day).
Clinical studies of Gamunex 10% did not include sufficient numbers of subjects aged 65 and over to determine a precise treatment effect.
The dosage 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 Maintenance dose: 0.2-0.8 g/kg | every 3-4 weeks |
| 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 0.4 g/kg/d | on day 1, possibly repeated once within 3 days 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 polyneuropathy (CIDP) | Starting dose: 2 g/kg Maintenance dose: 1 g/kg | br />in divided doses over 2-5 days every 3 weeks over 1-2 days |
| Multifocal motor neuropathy (MMN) | Loading dose: 2 g/kg Maintenance dose: 1 g/kg or 2 g/kg | in divided doses over 2-5 consecutive days every 2-4 weeks or every 4-8 weeks in divided doses over 2-5 days |
| Severe acute exacerbations of myasthenia gravis | 2 g/kg | administered over 2 consecutive days (dose of 1 g/kg per day) |
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.
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.
Human normal immunoglobulin should be infused intravenously at an initial rate of 0.6–1.2 ml/kg/hr for 0.5 hr. 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 4.8–8.4 ml/kg/hr.
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).
3 years.
Store at +2°C to +8°C (in a refrigerator). Do not freeze. Keep in outer carton.
The product may be stored in its outer carton for a one-off period of up to 6 months at room temperature (not above 25°C). In that case, the shelf life of the product expires at the end of this 6-month period. The new expiry date must be noted on the outer carton. The new expiry date must be no later than the printed expiry date. Thereafter, it must be used or destroyed. Subsequent refrigeration or freezing is not possible.
Solution for intravenous infusion in Type I or II glass vials with chlorobutyl stoppers.
Pack sizes:
One vial of 10 ml contains: 1 g of human normal immunoglobulin.
One vial of 50 ml contains: 5 g of human normal immunoglobulin.
One vial of 100 ml contains: 10 g of human normal immunoglobulin.
One vial of 200 ml contains: 20 g of human normal immunoglobulin.
One vial of 400 ml contains: 40 g of human normal immunoglobulin.
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 product or waste material should be disposed of in accordance with local requirement. Once the container has been opened, the contents should be infused immediately. Subsequent storage, even in a refrigerator, is not permitted on account of possible microbial colonisation.
If dilution is necessary prior to infusion, 50 mg/ml glucose solution may be used for this purpose. Do not dilute with saline solutions.
Simultaneous administration of Gamunex 10% and heparin through a single lumen delivery device must be avoided.
Infusion lines can be flushed with 50 mg/ml glucose or with sodium chloride solution (9 mg/ml) and should not be flushed with heparin.
Heparin Lock through which Gamunex 10% was administered should be flushed with 50 mg/ml glucose or sodium chloride solution (9 mg/ml) and should not be flushed with heparin.
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