Intratect 50 g/l

/ Kamada

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.
Replacement therapy in primary immunodeficiency syndromes:
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.
Secondary immunodeficiencies
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.
Primary immune thrombocytopenia:
There are two alternative treatment schedules:
– 0.8-1 g/kg given on day one, this dose may be repeated once within 3 days.
– 0.4 g/kg given daily for two to five days.
The treatment can be repeated if relapse occurs.
Guillain Barré syndrome:  0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
Kawasaki disease: 2.0 g/kg should be administered as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
Chronic inflammatory demyelinating polyneuropathy (CIDP)
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.
Multifocal Motor Neuropathy (MMN)
Starting dose: 2 g/kg given 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 dosage recommendations are summarised in table 1 at the attached doctor’s leaflet.
Paediatric population:
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.
Method of administration:
Intravenous use. Intratect 50 g/l should be infused intravenously at an initial rate of not more than 0.3 ml/kg/h for 30 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 1.9 ml/kg/h.
See prescribing information for full details.

Replacement therapy in adults, and children and adolescents (0-18 years) in:
– Primary immunodeficiency syndromes with impaired antibody production.
-Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
* 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:
– Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
– Guillain Barré syndrome.
– Kawasaki disease (in conjunction with acetylsalicylic acid).
– Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
– Multifocal motor neuropathy (MMN).
See prescribing information for full details.

Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients.
Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgAcontaining product can result in anaphylaxis.

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Precautions for use: Potential complications can often be avoided by ensuring that patients:
• are not sensitive to human normal immunoglobulin by initially injecting the product slowly (0.3 ml/kg/h corresponding to 0.005ml/kg/min),
• are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored at the hospital during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.
In all patients, IVIg administration requires:
• adequate hydration prior to the initiation of the infusion of IVIg
• monitoring of urine output
• monitoring of serum creatinine levels
• avoidance of concomitant use of loop diuretics
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction.
Infusion reaction: Certain adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion. The recommended infusion rate given under section 4.2 at the attached doctor’s leaflet must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Adverse reactions may occur more frequently
• in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion
• in patients with an untreated infection or underlying chronic inflammation
Hypersensitivity: Hypersensitivity reactions are rare.
Anaphylaxis can develop in patients
• with undetectable IgA who have anti-IgA antibodies
• who had tolerated previous treatment with human normal immunoglobulin
In case of shock, standard medical treatment for shock should be implemented.
See prescribing information for full details.

Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass:
– chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain.
– reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion.
– (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
– (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus – frequency unknown).
– (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.
– cases of reversible aseptic meningitis.
– cases of increased serum creatinine level and/or occurrence of acute renal failure.
– cases of Transfusion Related Acute Lung Injury (TRALI).
See prescribing information for full details.

Live attenuated virus 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.
Loop diuretics: Avoidance of concomitant use of loop diuretics.
Paediatric population: It is expected that the same interaction mentioned for the adults may also occur in the paediatric population.

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 during 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 expected.
Lactation: Immunoglobulins are excreted into human milk. No negative effects on the breastfed newborns/infants are anticipated.

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

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, or with any other IVIg products.
Shelf life: After first opening, an immediate use is recommended.
Storage: Do not store above 25°C. Do not freeze.