Iqymune (Human Normal Immunoglobulin)
Intravenous immunoglobulin (IVIg) – 100 mg/ml solution for infusion
Iqymune is a human normal immunoglobulin (IVIg) solution used to replace missing antibodies in patients with immune deficiencies and to modulate the immune system in certain autoimmune and inflammatory conditions. It is administered by intravenous infusion under medical supervision and contains immunoglobulin G (IgG) derived from pooled human plasma donations.
Quick Facts
Key Takeaways
- Iqymune is a human normal immunoglobulin (IVIg) given by intravenous infusion to replace missing IgG antibodies or to modulate immune function.
- It is used for primary immunodeficiency (PID), secondary immunodeficiency, and immunomodulatory conditions including ITP, Guillain-Barré syndrome, and Kawasaki disease.
- Infusions must be administered in a healthcare setting by trained professionals, with careful monitoring for infusion-related reactions.
- Common side effects include headache, fatigue, nausea, and infusion-site reactions; serious but rare risks include thromboembolic events and renal impairment.
- Live attenuated vaccines should be delayed for at least 3 months after Iqymune treatment due to potential interference with vaccine efficacy.
What Is Iqymune and What Is It Used For?
Iqymune belongs to a class of biological medicines known as intravenous immunoglobulins (IVIg). It contains human normal immunoglobulin, primarily immunoglobulin G (IgG), which is the most abundant type of antibody in the blood. These antibodies play a critical role in the body's defence against infections by recognising and neutralising pathogens such as bacteria and viruses.
The active substance in Iqymune is obtained from pooled plasma donated by thousands of screened healthy donors. The manufacturing process includes multiple viral inactivation and removal steps, ensuring a high safety profile in line with European Medicines Agency (EMA) requirements. The final product contains a broad spectrum of IgG antibodies that reflect the collective immune experience of the donor population, providing broad-spectrum passive immunity.
Iqymune is manufactured by LFB Biomedicaments, a French biopharmaceutical company specialising in plasma-derived medicinal products. It is available as a ready-to-use 100 mg/ml solution for intravenous infusion, supplied in vials of various sizes to accommodate different dosing requirements.
Replacement Therapy
In replacement therapy, Iqymune is used to restore IgG levels in patients who cannot produce adequate amounts of antibodies on their own. This includes patients with:
- Primary immunodeficiency syndromes (PID): Genetic conditions such as X-linked agammaglobulinaemia (Bruton's disease), common variable immunodeficiency (CVID), severe combined immunodeficiency (SCID), and IgG subclass deficiencies with recurrent infections.
- Secondary immunodeficiency: Acquired immune deficiency due to conditions such as chronic lymphocytic leukaemia (CLL), multiple myeloma, or following haematopoietic stem cell transplantation, particularly when patients experience severe or recurrent bacterial infections despite prophylactic antibiotics.
Immunomodulatory Therapy
At higher doses, Iqymune can modulate the immune system and is used in the treatment of several autoimmune and inflammatory conditions:
- Immune thrombocytopenia (ITP): An autoimmune condition causing dangerously low platelet counts, where rapid platelet increase is needed before surgery or to control significant bleeding.
- Guillain-Barré syndrome (GBS): An acute autoimmune peripheral neuropathy causing progressive muscle weakness and potentially respiratory failure.
- Kawasaki disease: A childhood vasculitis that can cause coronary artery aneurysms if untreated, where IVIg is first-line therapy alongside aspirin.
- Chronic inflammatory demyelinating polyneuropathy (CIDP): A chronic autoimmune neuropathy requiring long-term immunomodulatory treatment.
- Multifocal motor neuropathy (MMN): A rare immune-mediated neuropathy causing progressive, asymmetric weakness.
What Should You Know Before Taking Iqymune?
Iqymune, like all intravenous immunoglobulins, must be administered under medical supervision by healthcare professionals experienced in the use of immunoglobulin therapy. Before starting treatment, your doctor will conduct a thorough evaluation of your health status to ensure that the benefits outweigh any potential risks.
Contraindications
You should not receive Iqymune if you have:
- Hypersensitivity to human immunoglobulins or any of the excipients in the product. Patients with known allergic reactions to blood products should inform their healthcare provider.
- Selective IgA deficiency with anti-IgA antibodies, as this can lead to severe anaphylactic reactions. Although Iqymune contains minimal IgA, trace amounts may still be present.
- Hyperprolinaemia (a rare metabolic disorder), since Iqymune contains proline as a stabiliser.
True anaphylactic reactions to immunoglobulins are rare but can be life-threatening. Emergency resuscitation equipment and trained personnel must be available during every infusion. If a severe hypersensitivity reaction occurs, the infusion must be stopped immediately.
Warnings and Precautions
Tell your doctor if you have any of the following conditions, as they may require additional monitoring or dose adjustments:
- Renal impairment or risk factors for renal dysfunction: IVIg products have been associated with acute renal failure. Risk factors include pre-existing renal insufficiency, diabetes mellitus, dehydration, age over 65, obesity, concomitant nephrotoxic medicines, and volume depletion. Adequate hydration should be ensured before and during infusion.
- Thromboembolic risk factors: IVIg can increase blood viscosity, potentially leading to thromboembolic events including myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis. Patients with obesity, advanced age, hypertension, diabetes mellitus, a history of vascular disease, thrombotic episodes, or prolonged immobilisation are at increased risk.
- Cardiovascular conditions: The fluid volume associated with high-dose IVIg infusions may increase the risk of fluid overload in patients with compromised cardiac function.
- Haemolytic anaemia: IVIg products can contain blood group antibodies that may cause a positive direct antiglobulin test (Coombs test) and, rarely, haemolysis. Risk is increased with higher doses and non-O blood types.
Pregnancy and Breastfeeding
Clinical experience with immunoglobulins during pregnancy suggests no harmful effects on the course of pregnancy, the foetus, or the newborn. IgG antibodies naturally cross the placenta, especially during the third trimester, and may provide passive immunological protection to the infant. Iqymune should be used during pregnancy only when clearly indicated and under medical supervision.
Immunoglobulins are secreted into breast milk and may contribute to the transfer of protective antibodies to the breastfed infant. Therefore, breastfeeding is generally considered compatible with IVIg therapy.
Iqymune is manufactured from pooled human plasma using validated processes for viral inactivation and removal, including solvent/detergent treatment and nanofiltration. These steps effectively reduce the risk of transmission of known enveloped and non-enveloped viruses. All plasma donations are tested for HIV, hepatitis B, and hepatitis C.
How Does Iqymune Interact with Other Drugs?
Intravenous immunoglobulins can interact with other medicines and laboratory tests in several important ways. It is essential to tell your healthcare provider about all medicines, supplements, and vaccines you are currently taking or planning to take.
Major Interactions
The most clinically significant interaction involves live attenuated vaccines. The passively transferred antibodies in Iqymune can neutralise the vaccine viruses, reducing the immune response and potentially rendering the vaccination ineffective. This applies to vaccines including:
- Measles, mumps, and rubella (MMR)
- Varicella (chickenpox)
- Rotavirus
- Yellow fever
- Live attenuated influenza vaccine (nasal spray)
A waiting period of at least 3 months is recommended after the last Iqymune infusion before administering any live attenuated vaccine. If a live vaccine was given shortly before IVIg, revaccination may be needed after the waiting period.
Minor Interactions
Iqymune may also affect certain laboratory results and has minor interactions with some medicines:
| Interacting Drug/Test | Type | Effect | Clinical Advice |
|---|---|---|---|
| Live attenuated vaccines (MMR, varicella) | Major | Reduced vaccine efficacy due to passive antibody interference | Wait at least 3 months after IVIg before vaccination |
| Loop diuretics (furosemide) | Moderate | May reduce IVIg efficacy by increasing renal elimination | Avoid concurrent use if possible; monitor clinical response |
| Blood glucose monitoring (certain strips) | Laboratory | Some IVIg products contain maltose which can cause falsely elevated glucose readings | Iqymune does not contain maltose; glucose-specific methods are preferred |
| Serological tests (e.g., Coombs test) | Laboratory | Passive transfer of antibodies can cause false-positive results | Inform the laboratory that the patient is receiving IVIg therapy |
| Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs) | Moderate | Increased risk of renal dysfunction when combined with IVIg | Ensure adequate hydration; monitor renal function closely |
What Is the Correct Dosage of Iqymune?
The dosage and infusion schedule of Iqymune are determined by the treating physician based on the clinical indication, the patient's body weight, clinical response, and serum IgG trough levels. The dose may need to be individualised for each patient based on the pharmacokinetic and clinical response. The following are general dosing guidelines based on EMA-approved recommendations.
Adults
| Indication | Dose | Frequency | Goal |
|---|---|---|---|
| Primary immunodeficiency (PID) | 0.2–0.4 g/kg | Every 3–4 weeks | IgG trough level ≥6 g/L (above age-related reference) |
| Secondary immunodeficiency | 0.2–0.4 g/kg | Every 3–4 weeks | IgG trough level ≥6 g/L; reduction in infection rate |
| Immune thrombocytopenia (ITP) | 0.8–1 g/kg | Day 1; may repeat on day 3 | Platelet count ≥30 × 10⁹/L |
| Guillain-Barré syndrome | 0.4 g/kg/day | For 5 consecutive days (total 2 g/kg) | Neurological improvement; prevention of respiratory failure |
| Kawasaki disease | 2 g/kg | Single dose (with aspirin) | Resolution of fever; prevention of coronary aneurysms |
| CIDP | Loading: 2 g/kg over 2–5 days; Maintenance: 1 g/kg | Maintenance every 3 weeks | Improvement in disability score; sustained neurological function |
Children
The dosage of Iqymune in children is generally the same as in adults and is calculated on a per-kilogram body weight basis. Children with primary immunodeficiency typically receive 0.2–0.4 g/kg every 3–4 weeks, titrated to maintain protective IgG trough levels. For Kawasaki disease, which primarily affects children under 5 years of age, the standard dose of 2 g/kg as a single infusion alongside aspirin is well-established as first-line therapy based on landmark randomised controlled trials.
Paediatric patients may be more sensitive to fluid volume, so careful attention to infusion rate and hydration status is necessary. The infusion rate should be adjusted according to the child's tolerance and body weight.
Elderly
Elderly patients (over 65 years) may require more cautious dosing and slower infusion rates. Renal function should be assessed before starting therapy, as age-related decline in kidney function increases the risk of IVIg-associated renal adverse events. Adequate hydration is particularly important in this population. The dose per kilogram remains the same, but the initial infusion rate should be at the lower end of the recommended range.
Infusion Rate
The infusion rate is critical for tolerability. For patients who have not previously received Iqymune or are switching from another IVIg product:
- Initial rate: 0.5 ml/kg/hour for the first 30 minutes
- Gradual increase: If well tolerated, increase to 1 ml/kg/hour for the next 30 minutes, then gradually increase up to a maximum of 8 ml/kg/hour
- Subsequent infusions: If previous infusions were well tolerated, the starting rate may be higher
Missed Dose
If you miss a scheduled Iqymune infusion, contact your healthcare provider as soon as possible to reschedule. For patients on replacement therapy, maintaining regular infusion intervals is important to prevent IgG trough levels from falling below the protective range, which could increase susceptibility to infections. Your doctor will advise on the best timing for your next infusion without adjusting the dose.
Overdose
Overdose of intravenous immunoglobulin can lead to fluid overload and hyperviscosity, particularly in elderly patients and those with renal or cardiac impairment. Symptoms may include headache, flushing, nausea, dizziness, and in severe cases, thromboembolic events. If overdose is suspected, treatment is supportive with monitoring of vital signs, fluid balance, and renal function. In patients at risk, diuretics may be considered to manage fluid overload.
What Are the Side Effects of Iqymune?
Like all medicines, Iqymune can cause side effects, although not everybody gets them. Side effects are more common during the first infusion or when switching from another IVIg product. Many infusion-related reactions can be managed by reducing the infusion rate or temporarily stopping the infusion. Pre-medication with paracetamol and an antihistamine may be considered for patients who have experienced previous infusion reactions.
Side effects are classified below according to their frequency as reported in clinical trials and post-marketing surveillance data.
Very Common
Affects more than 1 in 10 patients
- Headache
- Infusion-site reactions (pain, swelling, redness)
Common
Affects 1 in 10 to 1 in 100 patients
- Nausea and vomiting
- Fatigue and malaise
- Fever (pyrexia)
- Chills and rigors
- Myalgia (muscle pain)
- Arthralgia (joint pain)
- Back pain
- Dizziness
- Hypertension or hypotension
- Skin rash or urticaria
Uncommon
Affects 1 in 100 to 1 in 1,000 patients
- Aseptic meningitis syndrome (severe headache, neck stiffness, photophobia)
- Haemolytic anaemia (breakdown of red blood cells)
- Elevated liver enzymes (transaminases)
- Tachycardia (rapid heart rate)
- Dyspnoea (shortness of breath)
- Chest tightness or pain
- Abdominal pain
Rare
Affects fewer than 1 in 1,000 patients
- Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
- Acute renal failure or renal impairment
- Transfusion-related acute lung injury (TRALI)
- Severe anaphylactic or anaphylactoid reactions
- Seizures
Stop the infusion and seek emergency care if you experience: difficulty breathing, swelling of the face or throat, severe chest pain, sudden weakness on one side of the body, sudden severe headache, signs of a blood clot (leg swelling, pain, warmth), or significantly reduced urine output. These may indicate serious adverse reactions requiring urgent treatment.
Your healthcare provider will monitor you during each infusion and for a period afterwards, especially during initial treatments. If you experience any new or worsening symptoms between infusions, contact your treatment centre promptly. Regular blood tests including kidney function, blood counts, and IgG levels are typically performed to monitor for potential adverse effects.
How Should You Store Iqymune?
Proper storage of Iqymune is essential to maintain the stability and efficacy of the immunoglobulin proteins. As a biological product derived from human plasma, Iqymune is sensitive to temperature extremes and must be handled according to specific guidelines.
- Refrigerated storage: Store at 2–8°C (36–46°F) in a refrigerator. Keep the vials in the original outer carton to protect from light.
- Do not freeze: Freezing can damage the immunoglobulin proteins, causing aggregation and loss of efficacy. If the product has been frozen, it must not be used.
- Room temperature storage: Iqymune may be stored at room temperature (up to 25°C / 77°F) for a single period of up to 3 months, provided it is not returned to the refrigerator. The expiry date during room temperature storage must be noted on the carton.
- Once opened: Use immediately after opening. Any unused product remaining in the vial should be discarded, as the product does not contain preservatives.
- Visual inspection: Before use, visually inspect the solution. It should be clear or slightly opalescent and colourless to pale yellow. Do not use if the solution is cloudy, contains particles, or has changed colour.
- Expiry date: Do not use Iqymune after the expiry date printed on the label and carton. The expiry date refers to the last day of that month.
As with all medicines, keep Iqymune out of the sight and reach of children. Do not dispose of medicines via household waste or wastewater. Healthcare facilities should follow local guidelines for the disposal of unused biological products.
What Does Iqymune Contain?
Understanding the composition of Iqymune is important, particularly for patients with known allergies to specific excipients or metabolic conditions that may be affected by certain stabilisers.
Active Ingredient
Each millilitre of Iqymune contains 100 mg of human normal immunoglobulin, of which at least 98% is IgG. The IgG subclass distribution closely mirrors that found in normal human plasma:
- IgG1: approximately 60–70%
- IgG2: approximately 20–30%
- IgG3: approximately 5–8%
- IgG4: approximately 1–3%
The maximum IgA content is specified to be very low, which is relevant for patients with IgA deficiency and anti-IgA antibodies.
Excipients (Inactive Ingredients)
- Glycine (amino acid): Used as a stabiliser to protect the immunoglobulin proteins during manufacturing and storage.
- Water for injections: The solvent for the final formulation.
Iqymune does not contain sucrose, maltose, sorbitol, or glucose – sugars that have been associated with renal toxicity in some older IVIg formulations. It also does not contain sodium, making it suitable for patients on sodium-restricted diets. The absence of these potentially nephrotoxic sugars contributes to Iqymune's improved renal safety profile.
Frequently Asked Questions About Iqymune
Medical References
All medical information is based on peer-reviewed research and international guidelines.
- European Medicines Agency (EMA). "Iqymune – Summary of Product Characteristics (SmPC)." Official EMA-approved prescribing information for Iqymune. Evidence level: Regulatory.
- Perez EE, et al. (2017). "Update on the use of immunoglobulin in human disease: A review of evidence." Journal of Allergy and Clinical Immunology. 139(3):S1–S46. Comprehensive evidence-based review of IVIg indications and dosing. Evidence level: 1A.
- Bonilla FA, et al. (2015). "Practice parameter for the diagnosis and management of primary immunodeficiency." Journal of Allergy and Clinical Immunology. 136(5):1186–1205. American Academy of Allergy, Asthma & Immunology guidelines for PID management.
- Elovaara I, et al. (2008). "EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases." European Journal of Neurology. 15(9):893–908. European guidelines for IVIg in GBS, CIDP, and other neurological conditions.
- Newburger JW, et al. (1986). "The treatment of Kawasaki syndrome with intravenous gamma globulin." New England Journal of Medicine. 315(6):341–347. Landmark RCT establishing IVIg as first-line treatment for Kawasaki disease.
- World Health Organization (WHO). "WHO Guidelines on blood products – Immunoglobulins." WHO guidelines on safe and rational use of immunoglobulin products.
- British National Formulary (BNF). "Normal immunoglobulin – Intravenous use." UK prescribing guidance for intravenous immunoglobulin therapy.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.
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