Privigen 100 mg/mL solution for infusion – human normal immunoglobulin (IVIg) for immunodeficiency and immunomodulation

Privigen is a solution for infusion containing human normal immunoglobulin for intravenous use (IVIg) – antibodies isolated from the plasma of healthy donors, which work in the same way as the immunoglobulins naturally present in the blood and help the body fight infections. At least 98% of the protein is immunoglobulin G (IgG).

One mL contains 100 mg immunoglobulin; the 25, 50 and 100 mL vials contain 2.5 g, 5 g and 10 g. The medicine is used in adults and children (0–18 years) as antibody replacement in immunodeficiencies and to treat certain inflammatory and autoimmune disorders. It is given only as an intravenous infusion in hospital, under medical supervision.

What is Privigen used for and how is it given?

Key information about the medicine

What is Privigen used for?

According to the leaflet, Privigen is used in adults and children (0–18 years) for:

• Replacement therapy: primary immunodeficiency with impaired antibody production; acquired (secondary) immunodeficiency with severe or recurrent infections where antimicrobial treatment has failed, with proven specific antibody failure or serum IgG < 4 g/L.
• Immunomodulation: primary immune thrombocytopenia (ITP) with high risk of bleeding or before surgery; Guillain-Barré syndrome; Kawasaki disease (with acetylsalicylic acid); chronic inflammatory demyelinating polyneuropathy (CIDP); multifocal motor neuropathy (MMN).

How is Privigen given?

The medicine is given by a doctor or nurse as an infusion into a vein. The dose depends on the indication, body weight and response to treatment; for children it is determined in the same way as for adults. According to the leaflet (guidance for healthcare professionals):

• Primary immunodeficiency: initially 0.4–0.8 g/kg, then 0.2–0.8 g/kg every 3–4 weeks, aiming for a trough IgG level of at least 6 g/L.
• Secondary immunodeficiency: 0.2–0.4 g/kg every 3–4 weeks.
• ITP: 0.8–1 g/kg on day one (may be repeated once within 3 days) or 0.4 g/kg daily for 2–5 days.
• Guillain-Barré syndrome: 0.4 g/kg daily for 5 days. Kawasaki disease: 2 g/kg as a single dose, with acetylsalicylic acid.
• CIDP: initially 2 g/kg over 2–5 days, then 1 g/kg over 1–2 days every 3 weeks. MMN: initially 2 g/kg over 2–5 days, then 1 g/kg every 2–4 weeks or 2 g/kg every 4–8 weeks.
• Infusion rate: slow at first; if well tolerated, the doctor gradually increases it.

Special patient groups

• Children and adolescents: the medicine is indicated for ages 0–18; the dose is determined as for adults (experience in children with CIDP is limited).
• Patients at risk: elderly people, overweight people, those immobile for long periods, people with diabetes, high blood pressure, hypovolaemia, vascular disease, a tendency to thrombosis or kidney disease – the doctor monitors the infusion more closely and chooses a suitable rate.
• Diabetes: the medicine contains no sugar, but it may be diluted with 5% glucose solution, which can affect blood sugar.

Contraindications – when the medicine must not be used

• allergy to human immunoglobulins (antibodies), proline or any of the excipients;
• antibodies against immunoglobulin A (IgA);
• hyperprolinaemia type I or II (a very rare genetic disorder).

Precautions and warnings

Tell your doctor before treatment if:

• you receive high doses, have blood group A, B or AB and/or an inflammatory condition – increased risk of breakdown of red blood cells (haemolysis);
• you are overweight, elderly, immobile for long periods, have diabetes, high blood pressure, low blood volume, vascular disease or a tendency to clotting – very rarely a risk of heart attack, stroke, pulmonary embolism or venous thrombosis;
• you have or have had kidney disease or take medicines that may damage the kidneys – very rarely acute kidney failure.
• True allergic reactions are rare but can occur even with a previously well-tolerated medicine (especially with antibodies against IgA). Very rarely, transfusion-related acute lung injury (TRALI) may occur, usually during or within 6 hours of the infusion.
• The medicine is made from human plasma; despite safety measures (donor selection, testing, virus inactivation), transmission of infection cannot be totally excluded. Recording the name and batch number at each administration is recommended.
• After administration, some serological blood test results may be temporarily altered – tell your doctor before tests.

Interactions with other medicines, food and drink

• During treatment loop diuretics should be avoided; the doctor decides on their use.
• Vaccines: the effectiveness of live attenuated vaccines (measles, mumps, rubella, chickenpox) may be reduced – vaccination should be postponed for at least 3 months after the last administration, and for measles vaccine the reduced effect may last up to one year. Before vaccination tell your doctor that you receive Privigen.
• Tell your doctor about all medicines you take.

Pregnancy and breast-feeding

• The doctor decides whether you can receive Privigen during pregnancy or breast-feeding. Long experience with antibody-containing medicines shows that no harmful effects on the course of pregnancy or on the newborn are expected.
• If you receive the medicine while breast-feeding, the antibodies will also be present in the milk, so your baby will receive protective antibodies too.

Driving and using machines

• Dizziness or nausea may occur during treatment; if they do, do not drive or use machines until the reactions have passed.

Possible side effects

• Rare and isolated (tell the doctor immediately): serious hypersensitivity reactions – sudden fall in blood pressure or anaphylactic shock (light-headedness, fainting, cold hands and feet, irregular heartbeat, chest pain, blurred vision); blood clots (sudden chest pain, shortness of breath, weakness or loss of sensation, difficulty speaking, swelling and pain in a leg); transfusion-related acute lung injury; aseptic meningitis (stiff neck, fever, headache, sensitivity to light); raised creatinine and protein in urine, acute kidney failure; transient haemolytic anaemia, anaemia, leukopenia.
• Very common: headache, pain (back, limbs, joints, neck, face), fever with chills, flu-like illness (runny nose, sore throat), blisters in the mouth and throat, throat tightness.
• Common: anaemia, haemolysis, leukopenia, hypersensitivity, dizziness, high or low blood pressure, flushing, difficulty breathing and chest discomfort, nausea, vomiting, diarrhoea, stomach pain, rash, itching, hives, skin redness and peeling, muscle pain and cramps, fatigue, weakness; in tests raised bilirubin, positive Coombs test, raised liver enzymes and LDH.
• Uncommon: aseptic meningitis, thrombocytosis, drowsiness, trembling, palpitations and fast heartbeat, thromboembolic events, poor circulation in the legs, proteinuria, pain at the infusion site.

Overdose, missed dose and stopping treatment

• Overdose: unlikely because the medicine is given under medical supervision; too high a dose may make the blood too thick and increase the risk of clots, especially in elderly people or those with heart or kidney disease.
• The infusion schedule is set by the doctor; if an infusion is missed, the doctor decides how to continue.

Related information

The medicine is given as an intravenous infusion, only in hospital. For questions about treatment, please contact your treating doctor.

Composition, pack and manufacturer

• Active substance: human normal immunoglobulin for intravenous use, 100 mg/mL (purity at least 98% IgG); subclass distribution approx. IgG1 69%, IgG2 26%, IgG3 3%, IgG4 2%; maximum IgA 25 micrograms/mL.
• Excipients: L-proline, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment). The medicine contains less than 2.3 mg sodium per 100 mL.
• Appearance: clear or slightly opalescent, colourless or pale yellow solution.
• Pack: glass vial with elastomeric stopper, aluminium cap, flip-off cap and a label with integrated hanger – 25 mL (2.5 g), 50 mL (5 g) or 100 mL (10 g); 1 vial per box.
• Marketing authorisation holder: PharmaSwiss d.o.o., Batajnički drum 5A, Belgrade; manufacturer: CSL Behring AG, Wankdorfstrasse 10, Bern, Switzerland.
• Marketing authorisation numbers (23.12.2021): 25 mL – 515-01-04809-20-001; 50 mL – 515-01-04810-20-001; 100 mL – 515-01-04811-20-001.

Storage

• Store below 25 °C. Do not freeze. Keep the vial in the outer carton to protect from light.
• Shelf life: 3 years. After opening, the contents are used immediately (no preservatives); a diluted solution is administered immediately.
• Do not use if the solution is cloudy or contains particles. Keep out of the reach and sight of children.

Frequently asked questions

What is Privigen and how does it work?

Privigen contains antibodies (immunoglobulins) isolated from the plasma of healthy donors. In immunodeficiencies it replaces missing antibodies, and in some autoimmune and inflammatory diseases (e.g. ITP, Guillain-Barré syndrome) it modulates the disturbed immune response.

How long is the monitoring during the infusion?

The patient is monitored throughout the infusion and for at least 20 minutes afterwards. With the first infusion, a high infusion rate or after a long treatment break, monitoring lasts at least 1 hour after the infusion.

Can I be vaccinated after Privigen?

Live attenuated vaccines (measles, mumps, rubella, chickenpox) should be postponed for at least 3 months after the last infusion, as their effectiveness may be reduced. Tell your doctor before vaccination.

Is Privigen safe given that it comes from plasma?

Donor selection, testing of each donation and virus inactivation and removal steps are used in manufacture and are considered effective against HIV, hepatitis B and C, hepatitis A and parvovirus B19. Nevertheless, transmission of infection cannot be totally excluded.

Sources

• ALIMS – Privigen 100 mg/mL package leaflet (PIL, in Serbian)
• ALIMS – Privigen 100 mg/mL summary of product characteristics (SmPC, in Serbian)

Sources checked on: 25.10.2026.