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Pooled human immunoglobulin Pregnancy: SPC §4.6: 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 to be expected. Breast-feeding: immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry. Fertility: clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

Normal immunoglobulin (IVIG / SCIG)

Brand names: Privigen, Octagam, Hizentra, Cuvitru

Normal (human) immunoglobulin is a pooled preparation of IgG antibodies given intravenously (IVIG) or subcutaneously (SCIG) for antibody replacement in primary and secondary immunodeficiency and as immunomodulation in various immune-mediated disorders.

Adult dose

Dose: Adults, INTRAVENOUS Privigen 100 mg/ml only (doses are per kg body weight, bw; dose depends on the indication). PID replacement: starting dose 0.4 to 0.8 g/kg bw given once, then maintenance of at least 0.2 g/kg bw every 3 to 4 weeks (maintenance range 0.2 to 0.8 g/kg bw), adjusted to a trough IgG of at least 6 g/l. Secondary immunodeficiency: 0.2 to 0.4 g/kg bw every 3 to 4 weeks (trough IgG at least 6 g/l). Primary ITP (two alternative schedules): 0.8 to 1 g/kg bw on day 1, which may be repeated once within 3 days; or 0.4 g/kg bw/day for 2 to 5 days. Guillain-Barre syndrome: 0.4 g/kg bw/day over 5 days. Kawasaki disease: 2 g/kg bw as a single dose with acetylsalicylic acid. CIDP: starting dose 2 g/kg bw divided over 2 to 5 consecutive days, then maintenance 1 g/kg bw over 1 to 2 consecutive days every 3 weeks. MMN: starting dose 2 g/kg over 2 to 5 consecutive days, then maintenance 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Route: Intravenous infusion (Privigen 100 mg/ml solution for infusion). Initial rate 0.3 ml/kg bw/hr for approximately 30 min; if well tolerated, increase gradually to 4.8 ml/kg bw/hr; in PID patients who tolerate 4.8 ml/kg bw/hr well, may be increased gradually to a maximum of 7.2 ml/kg bw/hr. May be diluted with 5% glucose to 50 mg/ml (5%).
Frequency: Indication-dependent: every 3 to 4 weeks (PID and secondary immunodeficiency replacement); single course of 1 to 5 days (ITP, Guillain-Barre); single dose (Kawasaki); every 3 weeks (CIDP maintenance); every 2 to 4 weeks or every 4 to 8 weeks (MMN maintenance)
SCOPE: these figures come from the Privigen SPC only (an INTRAVENOUS product). This page also covers subcutaneous immunoglobulin (Hizentra, Cuvitru) and another IV brand (Octagam); their SPCs were not fetched, so NO subcutaneous regimen is given here and these figures must not be applied to another brand. No maximum dose is printed for any indication. The SPC calls the regimens 'a guideline': 'In replacement therapy the dose may need to be individualised for each patient depending on the clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients.' PID: 'Three to six months are required after the initiation of therapy for equilibration to occur'; to reduce the rate of bacterial infections it may be necessary to increase the dosage and aim for higher trough levels. SID: adjust dose to optimal protection; increase if infection persists, consider a decrease if infection-free. CIDP and MMN: evaluate the treatment effect after each cycle; if no (CIDP) or insufficient (MMN) effect after 6 months, discontinue; the CIDP dose is based on the Privigen clinical studies and treatment beyond 25 weeks is at the physician's discretion. Replacement therapy should be commenced and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Kawasaki disease: patients should receive concomitant acetylsalicylic acid. Elderly: no dose adjustment unless clinically warranted (see §4.4). Section 4.4 states that the recommended infusion rate given under section 4.2 must be closely followed, as certain severe adverse reactions may be related to the rate of infusion.

Paediatric dose

Dose: No separate paediatric figure. SPC §4.2: the posology in children and adolescents (0-18 years) is not different from that of adults, as the posology for each indication is given by body weight and adjusted to the clinical outcome. Use the per-kg regimen for the indication; confirm in a children's formulary.
Route: Intravenous infusion (Privigen)
Frequency: As for the indication in adults
SPC §4.1 covers children and adolescents (0-18 years) for replacement therapy (PID, secondary immunodeficiency) and for ITP, Guillain-Barre syndrome, Kawasaki disease, CIDP and MMN; for CIDP 'only limited experience is available of use of intravenous immunoglobulins in children'. Intravenous product only; no subcutaneous paediatric regimen is covered by the fetched source.

Dose adjustments

Renal

SPC §4.2: renal impairment — no dose adjustment unless clinically warranted (see §4.4). §4.4: in all patients IVIg requires adequate hydration before the infusion, monitoring of urine output and serum creatinine, and avoidance of concomitant loop diuretics. §4.8: increase in serum creatinine and/or acute renal failure have been observed.

Hepatic

SPC §4.2: hepatic impairment — no evidence is available to require a dose adjustment.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • 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
  • Patients with hyperprolinaemia type I or II — this is Privigen-specific (the L-proline excipient); check the excipients of the actual product being given
  • Section 4.4: IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern

Side effects

  • Infusion-associated, occasionally: chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain; certain severe adverse reactions may be related to the rate of infusion
  • Rarely: sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when there was no hypersensitivity to a previous administration
  • Reversible aseptic meningitis (uncommon per patient, rare per infusion); may occur more frequently with high-dose (2 g/kg bw) IVIg and/or rapid infusion
  • Reversible haemolytic reactions, especially in blood groups A, B and AB in immunomodulatory treatment; rarely haemolytic anaemia requiring transfusion after high-dose IVIg
  • Increase in serum creatinine and/or acute renal failure
  • Very rarely: transfusion-related acute lung injury (TRALI) and thromboembolic reactions (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis)
  • Haematological: anaemia, haemolysis, leukopenia (common); anisocytosis (uncommon); thrombocytosis (rare); decreased neutrophil count (frequency unknown)
  • Transient cutaneous reactions, including cutaneous lupus erythematosus (frequency unknown)
  • This side-effect list may be incomplete — check the full SPC.

Interactions

  • Loop diuretics — §4.4: IVIg administration requires avoidance of concomitant use of loop diuretics
  • Glucose diluent — §4.4: in diabetes mellitus, if Privigen is diluted to lower concentrations, take into account the glucose in the recommended diluent
  • This interaction list may be incomplete — check the full SPC.

Monitoring

  • Throughout the infusion: patients must be closely monitored and observed for any symptoms; if an adverse reaction occurs, reduce the rate of administration or stop the infusion
  • Patients naive to human normal immunoglobulin, switched from another IVIg product, or after a long interval since the last infusion: monitor during the first infusion and for the first hour after it; all other patients observe for at least 20 minutes after administration
  • Hydration before the infusion, urine output and serum creatinine in all patients
  • IgG trough levels (before the next infusion) in replacement therapy, assessed in conjunction with the incidence of infection; target at least 6 g/l or the normal reference range for age
  • Clinical signs and symptoms of haemolysis, with increased vigilance in non-0 blood group patients receiving high doses for non-PID indications
  • Signs of aseptic meningitis syndrome (severe headache, nuchal rigidity, drowsiness, fever, photophobia, nausea, vomiting), usually beginning within several hours to 2 days after treatment
  • Thromboembolism risk: caution in obese patients and in patients with pre-existing thrombotic risk factors
  • Record the product name and batch number for traceability
  • CIDP and MMN: evaluate the treatment effect after each cycle and stop if no or insufficient effect after 6 months

Clinical monograph

How it works

As replacement therapy it restores protective IgG antibody levels, while at higher immunomodulatory exposure it modifies immune and inflammatory responses through several mechanisms including Fc-receptor and complement effects.

Prescribing in practice

  • Thromboembolic events, acute kidney injury, aseptic meningitis and haemolysis can occur, so ensure adequate hydration and assess thrombotic and renal risk, infusing at the recommended rate.
  • It is a blood-derived product, so batch and product details must be recorded for traceability and use follows national demand-management guidance.
  • Anaphylactic reactions can occur, particularly in patients with IgA deficiency and anti-IgA antibodies.

Monitoring

Monitor renal function, haemoglobin and infusion-related reactions, and in replacement therapy review trough IgG levels and infection frequency.

Counselling the patient

  • This medicine is made from human plasma and replaces or modulates antibodies.
  • Report headache, dark urine, reduced urine output or any reaction during or after the infusion.

Evidence & guidelines

Its use is governed by national immunoglobulin demand-management guidance, which defines accepted clinical indications in the UK.

Reference: UK National Demand Management Programme; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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