IMMUNOREL (HUMAN NORMAL IMMUNOGLOBULIN) 10% 5G 100ML VIAL

Human normal immunoglobulin (IVIg) is a sterile preparation of concentrated human IgG antibodies pooled from thousands of healthy blood donors. The 10% formulation delivers a high-concentration, low-volume infusion. It acts through multiple immunomodulatory mechanisms: neutralising pathogens and toxins, blocking Fc receptors on macrophages, suppressing B-cell and T-cell activation, and modulating complement pathways.

It is used as:

•       Replacement therapy: Primary immunodeficiencies (PID) — agammaglobulinaemia, common variable immunodeficiency (CVID), IgG subclass deficiency with recurrent infections.

•       Secondary immunodeficiencies: Chronic lymphocytic leukaemia (CLL), multiple myeloma with recurrent infections, post-haematopoietic stem cell transplant.

•       Immunomodulation: Idiopathic thrombocytopenic purpura (ITP), Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), Kawasaki disease, multifocal motor neuropathy (MMN), dermatomyositis, and many other autoimmune/inflammatory conditions.

IVIg is administered exclusively by trained healthcare professionals as an intravenous infusion. The infusion rate must be started slowly and increased gradually per product-specific instructions to reduce infusion-related reactions. Typical rates: start at 0.5–1 mL/kg/hr for 30 minutes, increasing to a maximum of 4–8 mL/kg/hr if well tolerated.

Doses vary widely by indication: Replacement therapy: 400–600 mg/kg every 3–4 weeks. ITP/acute modulation: 1–2 g/kg as a single dose or divided over 2 days. GBS/CIDP: 2 g/kg over 2–5 days. Your specialist will calculate the exact dose and frequency.

Contraindicated in: absolute IgA deficiency with anti-IgA antibodies (anaphylaxis risk); known hypersensitivity to human immunoglobulin; and hyperprolinaemia (some formulations contain L-proline stabiliser).

Use with caution in: renal impairment; cardiovascular disease; hypercoagulable states; volume-sensitive patients (cardiac failure, hypertension).

•       Live attenuated vaccines (MMR, varicella, yellow fever): IVIg can impair vaccine response for 3 months (replacement therapy doses) up to 11 months (high-dose immunomodulation). Defer live vaccines accordingly.

•       Antihypertensives/diuretics: monitor blood pressure closely — IVIg-related hypertension may require adjustment.

•       Nephrotoxic agents: increased renal risk when combined — monitor renal function.

Store at 2–8°C (refrigerate). Do not freeze. Keep in original carton to protect from light. Once opened, begin infusion promptly and complete within the time specified in the product leaflet (typically 12 hours). Record batch number and lot number in patient records.

IVIg infusions are usually given every 3–4 weeks (for replacement therapy) or as needed for specific indications. The infusion takes 2–4 hours in a clinic setting. Many patients with primary immunodeficiency find that regular IVIg dramatically reduces the frequency of serious infections and improves quality of life.

Because IVIg contains antibodies from thousands of blood donors, it can temporarily interfere with some serological tests (blood type antibody screens, Coombs test, certain infection serology). Always tell any healthcare provider you are on IVIg before blood tests.

The 10% concentration (5g/100mL vial) delivers IgG in a smaller volume than 5% preparations — advantageous for patients requiring volume restriction. Dose by actual body weight; in obese patients, use adjusted body weight to avoid overdose.

IgA content varies by product — always check the IgA content in the summary of product characteristics if treating a patient with possible IgA deficiency. Pre-treatment IgG trough levels guide dose adjustment in replacement therapy (target trough ≥ 7 g/L for most PID patients).

Post-infusion monitoring: FBC, renal function, LFTs, and urine dipstick in at-risk patients.

Can I have vaccinations while on IVIg?

Live vaccines (MMR, chickenpox, yellow fever) should be deferred for 3–11 months after IVIg, depending on the dose received, as IVIg antibodies can neutralise live vaccine viruses. Killed/inactivated vaccines (flu, pneumococcal, COVID-19) can be given at any time.

How long does each IVIg infusion take?

Typically 2–4 hours, depending on the dose and your weight. The infusion always starts slowly and is increased over time — never rushed — to minimise side effects.

What should I do if I feel unwell during an infusion?

Tell your infusion nurse immediately. The first step is always to slow or stop the infusion. Most reactions resolve promptly when the rate is reduced or infusion is stopped.

Is IVIg made from blood — is it safe?

Yes, IVIg is made from pooled human plasma. All donors are screened and plasma undergoes multiple pathogen inactivation and removal steps (solvent/detergent treatment, nanofiltration). Modern IVIg products have an excellent safety record with no documented transmission of HIV, HBV, or HCV.

How long does the benefit of IVIg last?

For replacement therapy in immunodeficiency, IgG levels typically fall over 3–4 weeks — hence monthly infusions. For immune modulation (ITP, CIDP), the duration of benefit varies considerably between individuals and conditions.