INTRATECT SOLUTION FOR INFUSION 50G/L [SIN14178P]

Product Info

INTRATECT SOLUTION FOR INFUSION 50G/L

[SIN14178P]

Indication

Indications

Replacement therapy in adults, children, and adolescents (0–18 years) in:

• Primary immunodeficiency syndromes (PID) 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, 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 Barre syndrome.

• Kawasaki disease (in conjunction with acetylsalicylic acid).

• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

• Multifocal motor neuropathy (MMN).

Dosing

Posology and Method of administration

IVIg therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immune system disorders.

Posology
The dose and dose regimen are dependent on the indication.

The dose may need to be individualized 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 guidance.

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. 3–6 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 3–4 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.

Replacement therapy in secondary immunodeficiencies (as defined in section “Indications”):

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.

Immunomodulation in:

Primary immune thrombocytopenia
There are two alternative treatment schedules:

• 0.8–1 g/kg given on day 1; this dose may be repeated once within 3 days

• 0.4 g/kg given daily for 2–5 days

The treatment can be repeated if relapse occurs.

Guillain Barre 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 divided 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 physician’s 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 divided 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 physician’s 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 the following table:

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 must be adjusted to the clinical outcome of the above mentioned conditions.

Hepatic impairment
No evidence is available to require a dose adjustment.

Renal impairment
No dose adjustment unless clinically warranted.

Elderly
No dose adjustment unless clinically warranted.

Method of administration

Intravenous use.
Intratect should be infused intravenously at an initial rate of not more than 0.3ml/kg/h for 30 minutes. 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.

The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used. The product should be brought to room or body temperature before use.

Contraindications

Contra-indications
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 IgA-containing product can result in anaphylaxis.