Octagam (Human Normal Immunoglobulin)
Intravenous immunoglobulin solution for immune deficiency and autoimmune conditions
Quick Facts About Octagam
Key Takeaways About Octagam
- Broad therapeutic use: Octagam treats both immune deficiency (replacement therapy) and autoimmune/inflammatory conditions (immunomodulatory therapy) including ITP, Kawasaki disease, GBS, CIDP, and multifocal motor neuropathy
- Hospital-administered only: Octagam is given as an intravenous infusion under medical supervision, typically in a hospital or infusion clinic, with careful monitoring of vital signs throughout
- Critical blood glucose warning: The maltose excipient in Octagam can cause falsely elevated blood glucose readings with certain monitors – only glucose-specific test methods must be used
- Thromboembolic risk: IVIg products including Octagam carry a risk of blood clots, particularly in elderly patients, those with cardiovascular risk factors, and patients who are immobilised or dehydrated
- Derived from human plasma: Octagam is manufactured from pooled human blood donations and undergoes rigorous viral safety procedures including solvent/detergent treatment to minimise the risk of transmitting infectious agents
What Is Octagam and What Is It Used For?
Octagam is a human normal immunoglobulin (IVIg) solution administered by intravenous infusion. It provides the body with protective IgG antibodies, either as replacement therapy for patients with immune deficiency or as immunomodulatory treatment for autoimmune and inflammatory conditions including immune thrombocytopenic purpura, Kawasaki disease, and Guillain-Barré syndrome.
Octagam belongs to a group of medicines known as immunoglobulins, specifically human normal immunoglobulin for intravenous administration (IVIg). The active ingredient is a concentrate of immunoglobulin G (IgG) antibodies purified from pooled plasma collected from thousands of healthy blood donors. This pooled source ensures that Octagam contains a broad spectrum of antibodies reflecting the collective immune experience of the general population, providing protection against a wide range of bacteria, viruses, and other pathogens.
The mechanism of action of Octagam depends on the condition being treated. In patients with primary immunodeficiency (PID), the immune system is unable to produce sufficient amounts of its own antibodies. Octagam works as a direct replacement therapy, restoring IgG levels to the normal range and providing the patient with the antibodies needed to fight infections. Common primary immunodeficiency conditions treated with Octagam include X-linked agammaglobulinaemia, common variable immunodeficiency (CVID), severe combined immunodeficiency (SCID), and IgG subclass deficiency with recurrent infections. Regular infusions, typically every 3 to 4 weeks, are needed to maintain protective antibody levels.
In patients with secondary immunodeficiency, the low antibody levels result from another underlying condition or treatment, such as chronic lymphocytic leukaemia, multiple myeloma, or immunosuppressive therapy following bone marrow transplantation. Octagam is indicated when these patients experience severe or recurrent bacterial infections despite appropriate antibiotic treatment and when they have proven specific antibody failure or a serum IgG level below 4 g/l. The European Medicines Agency (EMA) and the World Health Organization (WHO) both recognise IVIg as a standard treatment for secondary immunodeficiency associated with haematological malignancies.
Octagam is also indicated for immunomodulatory therapy in several autoimmune and inflammatory conditions. In these situations, higher doses are used and the mechanism of action is different from replacement therapy. The immunomodulatory effects of IVIg are thought to involve multiple pathways, including blockade of Fc receptors on macrophages (particularly important in ITP), modulation of complement activation, provision of anti-idiotypic antibodies that neutralise pathogenic autoantibodies, and regulation of cytokine production and T-cell function. The specific conditions for which Octagam is approved include:
- Immune thrombocytopenic purpura (ITP): An autoimmune condition in which antibodies destroy platelets, leading to abnormal bleeding. IVIg is used when there is a high risk of bleeding, when platelet counts need to be rapidly increased before surgery, or when other treatments have been insufficient.
- Kawasaki disease: An acute inflammatory condition primarily affecting young children, causing inflammation of blood vessel walls (vasculitis) with a significant risk of coronary artery aneurysm. IVIg given within 10 days of fever onset, combined with aspirin, is the standard treatment and has been shown to reduce the incidence of coronary artery abnormalities from approximately 25% to under 5%.
- Guillain-Barré syndrome (GBS): An acute autoimmune polyneuropathy causing rapidly progressive muscle weakness. IVIg is a first-line treatment that has been shown to speed recovery and improve outcomes. Treatment is most effective when started within 2 weeks of symptom onset.
- Chronic inflammatory demyelinating polyneuropathy (CIDP): A chronic autoimmune disorder affecting peripheral nerves, causing progressive weakness and impaired sensory function. IVIg is recommended as first-line treatment by the European Federation of Neurological Societies (EFNS) and the Peripheral Nerve Society.
- Multifocal motor neuropathy (MMN): A rare immune-mediated neuropathy characterised by progressive asymmetric limb weakness. IVIg is the only treatment with proven efficacy for MMN and is recommended as first-line therapy.
Octagam is manufactured from pooled human plasma donations. Each batch is derived from plasma collected from thousands of donors and undergoes extensive safety testing and viral inactivation procedures, including solvent/detergent treatment, to minimise the theoretical risk of transmission of infectious agents. Despite these measures, the risk of transmitting known or unknown infectious agents cannot be completely excluded, which is why each batch is carefully documented and traceable.
What Should You Know Before Taking Octagam?
Before receiving Octagam, your doctor must assess your risk factors for thromboembolic events, renal impairment, and haemolysis. Octagam is contraindicated in patients with hypersensitivity to human immunoglobulins and in IgA-deficient patients with anti-IgA antibodies. Several important precautions apply, particularly regarding blood glucose monitoring due to maltose interference.
Contraindications
You should not receive Octagam if any of the following apply to you:
- Hypersensitivity to human immunoglobulins – if you have previously had an allergic or anaphylactic reaction to any immunoglobulin preparation, including IVIg or subcutaneous immunoglobulin products
- IgA deficiency with anti-IgA antibodies – patients who lack immunoglobulin A (IgA) may develop antibodies against IgA. In these individuals, administration of products containing trace amounts of IgA (as Octagam does) can trigger severe anaphylactic reactions. This is a rare but potentially life-threatening contraindication. IgA levels should be measured before the first infusion in patients suspected of having selective IgA deficiency.
- Known hypersensitivity to any excipient – particularly maltose, which is used as a stabiliser in Octagam
Warnings and Precautions
Talk to your doctor before receiving Octagam if you have or have had any of the following conditions. Several serious adverse events have been associated with IVIg therapy, and your doctor needs to weigh the benefits against these risks:
Thromboembolic events: IVIg products, including Octagam, have been associated with thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke. The risk is particularly elevated in patients who are elderly, have cardiovascular risk factors (hypertension, diabetes, history of atherosclerosis), have thrombotic tendencies, are immobilised for prolonged periods, are severely hypovolaemic (dehydrated), or have conditions that increase blood viscosity. Before starting treatment, your doctor should ensure you are adequately hydrated and will monitor you during and after the infusion. The infusion rate should be kept at the minimum practicable rate, especially in patients at risk.
Renal impairment and acute renal failure: Cases of acute renal failure have been reported in patients receiving IVIg products. Most cases have occurred in patients with pre-existing renal insufficiency, diabetes mellitus, dehydration, overweight, concurrent nephrotoxic medications, or in patients over 65 years of age. Although Octagam contains maltose rather than sucrose (sucrose-containing IVIg products have been associated with the highest rate of renal events), caution is still warranted. Renal function should be assessed before starting treatment and monitored at appropriate intervals, particularly in patients at increased risk.
Haemolysis: IVIg products contain blood group antibodies (anti-A, anti-B) that can act as haemolysins and trigger coating of red blood cells with immunoglobulin. This can lead to a positive direct antiglobulin test (Coombs test) and, rarely, clinically significant haemolytic anaemia. Risk factors for haemolysis include high-dose IVIg treatment, non-O blood group, and underlying inflammatory conditions. Patients should be monitored for signs of haemolysis including pallor, fatigue, dark urine, and shortness of breath.
Transfusion-related acute lung injury (TRALI): In rare cases, IVIg administration has been associated with TRALI, characterised by severe respiratory distress, pulmonary oedema, low oxygen levels, and fever occurring within 1 to 6 hours of infusion. Patients should be monitored for respiratory symptoms during and after infusion.
Aseptic meningitis syndrome (AMS): Cases of aseptic meningitis have been reported with IVIg treatment, particularly at high doses. Symptoms include severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting, typically starting within hours to 2 days after infusion. The condition is usually self-limiting and resolves within several days after discontinuation of IVIg.
Blood Glucose Testing – Critical Safety Information
Octagam contains maltose as an excipient. Maltose can be falsely interpreted as glucose by certain blood glucose monitoring systems that use non-glucose-specific methods, such as those based on glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) or glucose-dye-oxidoreductase methods. This can produce falsely elevated blood glucose readings, which may lead to inappropriate administration of insulin and potentially life-threatening hypoglycaemia (dangerously low blood sugar).
During and for at least 15 hours after Octagam infusion, blood glucose must only be measured using glucose-specific methods (glucose oxidase or glucose hexokinase methods). Always inform the healthcare staff monitoring you that you are receiving or have recently received Octagam, so they can use the correct blood glucose testing method.
Pregnancy and Breastfeeding
The safety of Octagam during pregnancy has not been established in controlled clinical trials. However, clinical experience with immunoglobulins over many decades suggests that no harmful effects on the course of pregnancy, the foetus, or the newborn are expected. Immunoglobulins are naturally present in the blood and cross the placenta, particularly during the third trimester, providing the developing baby with passive immune protection.
Women who have been receiving regular IVIg therapy for an immunodeficiency or autoimmune condition before becoming pregnant can generally continue treatment during pregnancy, under close medical supervision. Your doctor will assess the individual risk–benefit ratio for your situation. IVIg has in fact been used therapeutically during pregnancy for conditions such as recurrent miscarriage associated with antiphospholipid syndrome, neonatal alloimmune thrombocytopenia (NAIT), and severe ITP.
Immunoglobulins are secreted into breast milk and may contribute to the passive transfer of protective antibodies to the breastfed infant. No adverse effects on breastfed infants are expected.
Driving and Operating Machinery
Certain adverse effects associated with Octagam, such as dizziness, headache, or nausea, may impair the ability to drive or operate machinery. If you experience any of these symptoms during or after your infusion, you should not drive or operate machinery until the symptoms have completely resolved. As infusions are administered in clinical settings, patients should plan for someone else to drive them home if needed.
How Does Octagam Interact with Other Drugs?
The most important drug interaction with Octagam involves live attenuated vaccines, which should not be given for at least 3 months after IVIg treatment. Octagam can also interfere with certain blood glucose monitoring systems and serological tests. Loop diuretics should be avoided during infusion as they may increase renal immunoglobulin loss.
Although Octagam does not interact with most conventional medications in the way that small-molecule drugs do, several clinically important interactions and interferences must be considered. The passively transferred antibodies in IVIg can interfere with the immune response to certain vaccines and can affect the results of serological testing. Healthcare providers should be informed of recent or planned IVIg therapy when ordering laboratory tests or scheduling vaccinations.
| Substance / Test | Category | Effect | Recommendation |
|---|---|---|---|
| Live attenuated vaccines (MMR, varicella, yellow fever, rotavirus) | Vaccines | Passively transferred antibodies can reduce or neutralise the vaccine virus, leading to vaccine failure | Wait at least 3 months after Octagam infusion before giving live vaccines. If a live vaccine was given recently, consider re-vaccination after antibody levels decline. |
| Inactivated vaccines (influenza, pneumococcal, hepatitis B) | Vaccines | Generally not affected, but serological confirmation of vaccine response may be unreliable | Can be given at any time; however, antibody response measurement may require timing adjustments. |
| Loop diuretics (furosemide, bumetanide) | Diuretic | May increase renal excretion of immunoglobulin, potentially reducing therapeutic effect | Avoid concurrent use during and immediately after IVIg infusion if possible. Discuss with your doctor. |
| Non-glucose-specific blood glucose monitors | Diagnostic device | Maltose in Octagam causes falsely elevated glucose readings, risking inappropriate insulin use and hypoglycaemia | Use only glucose-specific methods (glucose oxidase or hexokinase) during and for 15+ hours after infusion. |
| Serological tests (antibody assays, Coombs test) | Laboratory tests | Passively transferred antibodies can cause false-positive results in serological tests (e.g., hepatitis A, hepatitis B, measles, CMV antibody tests) and a positive direct Coombs test | Inform the laboratory that the patient has recently received IVIg. Interpret serological results with caution. |
It is important to note that Octagam can temporarily raise the blood levels of various passively transferred antibodies. This means that blood tests performed shortly after an infusion may show antibody levels that do not reflect the patient's own immune status. For example, a patient may test positive for measles or hepatitis B antibodies simply because these antibodies were present in the donor plasma pool, not because the patient has been infected or vaccinated. This phenomenon should be taken into account when interpreting serological results.
Inform your doctor about all medications, supplements, and herbal products you are currently taking or have recently taken. While direct pharmacokinetic drug–drug interactions with Octagam are uncommon, the clinical context of immunoglobulin therapy often involves patients who are receiving multiple other medications for their underlying condition, and comprehensive medication review is important for patient safety.
What Is the Correct Dosage of Octagam?
Octagam dosing varies widely depending on the indication. For replacement therapy in immunodeficiency, typical doses are 0.2–0.4 g/kg every 3–4 weeks. For immunomodulatory therapy in autoimmune conditions, higher doses of 0.4–2 g/kg are used. The dose and schedule are always determined by a specialist physician based on clinical response.
Octagam is always administered by intravenous infusion under medical supervision. The dose and dosing schedule are individualised by your doctor based on your specific condition, body weight, clinical response, and IgG trough levels (for replacement therapy). The following table provides the standard dosing guidelines for each approved indication.
| Indication | Dose | Frequency | Goal / Notes |
|---|---|---|---|
| Primary immunodeficiency (PID) | 0.2–0.4 g/kg body weight | Every 3–4 weeks | Target IgG trough level of at least 6 g/l (measured before next infusion). Dose adjusted based on infection rate and trough levels. |
| Secondary immunodeficiency | 0.2–0.4 g/kg body weight | Every 3–4 weeks | Target IgG trough level of at least 6 g/l. Indicated when IgG <4 g/l or proven specific antibody failure with recurrent infections. |
| Immune thrombocytopenic purpura (ITP) | 0.8–1 g/kg body weight | Day 1; may repeat on day 3 | Alternative: 0.4 g/kg/day for 2–5 days. Rapid platelet increase expected within 24–48 hours. |
| Kawasaki disease | 1.6–2 g/kg body weight | Single dose or divided over 2–5 days | Given with aspirin therapy. Single 2 g/kg dose preferred. Most effective within 10 days of fever onset. |
| Guillain-Barré syndrome (GBS) | 0.4 g/kg/day | For 5 consecutive days | Total dose: 2 g/kg over 5 days. Most effective when started within 2 weeks of symptom onset. |
| CIDP | Loading: 2 g/kg; Maintenance: 1 g/kg | Loading over 2–5 days; maintenance every 3 weeks | Maintenance dose and interval adjusted based on clinical response. Some patients may require 0.4–1.2 g/kg every 2–6 weeks. |
| Multifocal motor neuropathy (MMN) | Loading: 2 g/kg; Maintenance: 0.4–2 g/kg | Loading over 2–5 days; maintenance every 2–6 weeks | Highly individualised dosing. Long-term treatment usually required. Dose titrated to maintain functional improvement. |
Administration
Octagam must be administered by intravenous infusion only. It must never be injected intramuscularly or subcutaneously. The infusion must begin at a slow rate to minimise the risk of adverse reactions, and the rate can be gradually increased if the patient tolerates it well. The recommended infusion rates differ between the two available concentrations:
For Octagam 50 mg/ml (5%), the initial infusion rate is 0.01–0.02 ml/kg/min for the first 30 minutes. If well tolerated, the rate may be gradually increased to a maximum of 0.04 ml/kg/min. For Octagam 100 mg/ml (10%), the initial rate is 0.01 ml/kg/min for the first 30 minutes, with gradual increases to a maximum of 0.08 ml/kg/min if tolerated.
Patients who are receiving Octagam for the first time, who have been switched from a different IVIg product, or who have had a long interval since their last infusion should be monitored more closely. Vital signs (temperature, pulse, blood pressure, respiratory rate) are typically checked before the infusion, at regular intervals during the infusion, and for at least 20 minutes after the infusion has been completed.
Octagam should be at room temperature or body temperature before administration. Do not mix Octagam with other medicinal products or intravenous fluids. If dilution is necessary, only 5% glucose solution should be used. Do not use sodium chloride (saline) for dilution. Any unused solution should be discarded immediately.
Overdose
Overdose of immunoglobulin may lead to fluid overload, increased blood viscosity, and hyperviscosity syndrome, particularly in patients at risk including elderly patients and those with renal impairment. Symptoms of fluid overload may include headache, shortness of breath, and peripheral oedema. Symptoms of hyperviscosity may include confusion, visual disturbances, chest pain, and stroke-like symptoms. In the event of an overdose, the infusion should be stopped immediately, and supportive care should be provided. In severe cases with hyperviscosity, plasmapheresis may be considered.
What Are the Side Effects of Octagam?
The most common side effects of Octagam include headache and hypersensitivity reactions. Uncommon side effects include nausea, vomiting, blood pressure changes, heart rhythm changes, and injection site reactions. Rare but serious adverse effects include thromboembolic events, aseptic meningitis, haemolytic anaemia, transfusion-related acute lung injury (TRALI), and acute renal failure.
Like all medicines, Octagam can cause side effects, although not everybody gets them. Most side effects associated with IVIg therapy are related to the infusion itself and can often be managed by slowing the infusion rate or by pre-medication with paracetamol and/or antihistamines. Patients receiving IVIg for the first time, those switching from a different product, or those who have had a long interval since their last infusion may be at higher risk of adverse reactions.
The frequency of side effects is classified as follows: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), rare (affects 1 in 1,000 to 1 in 10,000 people), and very rare (affects fewer than 1 in 10,000 people).
Common (may affect up to 1 in 10 people)
- Headache – one of the most frequently reported side effects
- Hypersensitivity reactions – including flushing, itching, skin rash, or urticaria
Uncommon (may affect up to 1 in 100 people)
- White blood cell count decrease (leukopenia)
- Heart rhythm changes (tachycardia)
- Blood pressure increase (hypertension) or decrease (hypotension)
- Nausea
- Vomiting
- Back pain
- Chest pain or tightness
- Chills and rigors
- Fever (pyrexia)
- Fatigue and malaise
- Injection site reactions (pain, swelling, redness at infusion site)
- Changes in liver function tests (elevated transaminases)
Rare and Very Rare (reported in post-marketing surveillance)
- Thromboembolic events – including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke
- Aseptic meningitis syndrome – severe headache, neck stiffness, drowsiness, fever, photophobia
- Haemolytic anaemia – destruction of red blood cells, potentially severe
- Transfusion-related acute lung injury (TRALI) – acute respiratory distress within hours of infusion
- Acute renal failure – particularly in patients with pre-existing renal impairment or risk factors
- Severe anaphylactic or anaphylactoid reactions – including circulatory collapse
- Serum sickness-like reaction
- Reversible aseptic meningitis
- Sudden difficulty breathing, wheezing, or chest tightness
- Severe drop in blood pressure, dizziness, or feeling faint
- Swelling of the face, lips, tongue, or throat
- Severe headache with neck stiffness, sensitivity to light, nausea, or vomiting (possible aseptic meningitis)
- Severe back pain, dark or red-coloured urine (possible haemolysis or renal problems)
- Sudden weakness on one side of the body, slurred speech, visual disturbances (possible stroke or thromboembolic event)
- Sudden leg swelling, pain, or warmth (possible deep vein thrombosis)
- Severe shortness of breath developing hours after the infusion (possible TRALI)
These symptoms may indicate a serious adverse reaction that requires immediate medical treatment. If you are still in the clinical setting, alert your healthcare team immediately. If symptoms develop after you have left the clinic, seek emergency medical care without delay.
Many of the milder side effects of Octagam are related to the infusion rate. If you experience headache, chills, or nausea during the infusion, your healthcare provider may slow the infusion rate or temporarily pause it. Pre-medication with paracetamol (acetaminophen) and an antihistamine (such as diphenhydramine or cetirizine) may help prevent or reduce these infusion-related reactions, particularly in patients who have experienced them previously. Adequate hydration before the infusion can also help reduce the risk of side effects.
Long-term monitoring is important for patients receiving regular IVIg therapy. Your doctor will periodically check blood counts (including haemoglobin to monitor for haemolysis), renal function (creatinine, urea), liver function tests, and IgG trough levels. Any new or worsening symptoms should be reported to your healthcare team promptly.
How Should You Store Octagam?
Octagam should be stored at or below 25°C, protected from light, and must not be frozen. Once the vial has been opened, the solution should be used immediately. Do not use the product after the expiry date printed on the label.
Store Octagam in a refrigerator (2–8°C) or at room temperature up to a maximum of 25°C. Keep the vials in the outer carton to protect them from light. Do not freeze Octagam – frozen product must be discarded as freezing can denature the immunoglobulin proteins and compromise the safety and efficacy of the product.
If Octagam has been stored in a refrigerator, allow it to reach room temperature or body temperature before administration. This helps reduce the incidence of infusion-related side effects. Do not use a microwave or heat source to warm the product – allow it to equilibrate naturally.
Once the vial has been opened or the seal has been punctured, the contents should be used immediately. Any unused solution should be discarded, as Octagam does not contain preservatives and opened vials are susceptible to microbial contamination. Do not save partially used vials for later use.
Before use, visually inspect the solution. Octagam should appear as a clear to slightly opalescent, colourless to pale yellow liquid. Do not use if the solution is cloudy, contains visible particles, or has a different colour than expected. Do not use after the expiry date (EXP) printed on the label and carton.
Keep this medicine out of the sight and reach of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
What Does Octagam Contain?
Octagam contains human normal immunoglobulin as the active substance (50 mg/ml or 100 mg/ml), with at least 95% IgG. The excipients are maltose and water for injections. The product is available in multiple vial sizes from 1 g to 25 g of immunoglobulin.
The active substance in Octagam is human normal immunoglobulin, containing a minimum of 95% immunoglobulin G (IgG). The IgG subclass distribution closely corresponds to that of natural human plasma, typically comprising approximately 60–70% IgG1, 20–30% IgG2, 5–8% IgG3, and 1–3% IgG4. The product also contains trace amounts of IgA (typically less than 0.2 mg/ml in the 50 mg/ml formulation), which is an important consideration for patients with IgA deficiency and anti-IgA antibodies.
The excipients (inactive ingredients) are:
- Maltose – used as a stabiliser to maintain the structure and activity of the immunoglobulin molecules during storage
- Water for injections – the solvent for the solution
Octagam contains approximately 35 mg of sodium per 100 ml, which is equivalent to 1.75% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This should be taken into consideration for patients on a controlled sodium diet, particularly when large volumes are infused.
The packaging does not contain latex. Octagam is available in the following vial sizes:
| IgG Content | Volume | Vial Type |
|---|---|---|
| 1 g | 20 ml | Glass vial |
| 2.5 g | 50 ml | Glass vial |
| 5 g | 100 ml | Glass vial |
| 10 g | 200 ml | Glass vial |
| 25 g | 500 ml | Glass bottle |
Not all pack sizes may be marketed in every country. The appearance of Octagam is a clear to slightly opalescent, colourless to pale yellow solution. Any solution that appears cloudy or contains particles should not be used.
Frequently Asked Questions
Octagam 50 mg/ml (5%) and Octagam 100 mg/ml (10%) contain the same active substance – human normal immunoglobulin – but at different concentrations. The 10% formulation delivers twice the amount of IgG per millilitre, which means that for the same dose, a smaller total volume of fluid is required. This results in shorter infusion times and is particularly advantageous for patients who need higher doses (e.g., for immunomodulatory indications like ITP or GBS) or those with fluid restrictions (e.g., patients with heart failure or renal impairment). Both formulations use maltose as a stabiliser and have similar safety profiles. The maximum infusion rate may differ between the two concentrations, and your doctor will select the most appropriate formulation for your clinical situation.
The duration of an Octagam infusion depends on the dose, the concentration of the product, and how well you tolerate the infusion. A typical infusion takes between 2 and 5 hours. All infusions start at a slow rate (0.01–0.02 ml/kg/min) for the first 30 minutes as a safety precaution. If you tolerate this initial phase well without any side effects, the rate is gradually increased to the maximum tolerated rate. For patients who have received multiple infusions without problems, subsequent infusions may be administered somewhat faster, potentially reducing the overall duration. Your healthcare team will monitor you throughout and adjust the rate based on your response. You should plan to spend several hours at the infusion clinic for each treatment session, including the monitoring period after the infusion is complete.
Yes, Octagam may be used during pregnancy when clinically indicated. Decades of clinical experience with immunoglobulin therapy suggest that no harmful effects on the course of pregnancy, the developing foetus, or the newborn baby are expected. Immunoglobulin G (IgG) naturally crosses the placenta, particularly during the third trimester, providing the baby with passive immune protection. Women who depend on regular IVIg therapy for an immunodeficiency disorder should generally continue treatment during pregnancy to maintain adequate antibody levels and prevent infections. IVIg has also been used therapeutically during pregnancy for conditions such as severe ITP and neonatal alloimmune thrombocytopenia. Your specialist will assess your individual situation and determine the most appropriate treatment plan.
This is a critical safety concern. Octagam contains maltose as a stabiliser, and certain blood glucose test strips and monitors use methods that cannot distinguish between maltose and glucose. Specifically, test systems based on glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) or glucose-dye-oxidoreductase methods will read maltose as if it were glucose, producing falsely high blood glucose results. If a patient or healthcare provider acts on these false readings by administering insulin, the patient’s blood sugar could drop to dangerously low levels (hypoglycaemia), which can be life-threatening. Only glucose-specific methods – such as glucose oxidase or glucose hexokinase methods – give accurate readings when maltose is present. This precaution applies during the infusion and for at least 15 hours afterwards, as maltose takes time to be cleared from the bloodstream.
If you notice any symptoms during an Octagam infusion, tell your healthcare provider immediately. Mild reactions such as headache, chills, slight nausea, or a feeling of warmth are relatively common and can usually be managed by reducing the infusion rate or temporarily pausing it. Your healthcare team may also give you paracetamol (acetaminophen) or an antihistamine to help manage these symptoms. If you develop more concerning signs such as difficulty breathing, chest tightness, severe back or abdominal pain, a drop in blood pressure, or any sign of an allergic reaction (such as hives or swelling), the infusion will be stopped immediately and appropriate medical treatment will be given. Never attempt to adjust the infusion rate yourself. After the infusion, report any delayed side effects (which can occur up to several days later) to your doctor or the infusion clinic.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- World Health Organization (WHO). WHO Guidelines on the Use of Immunoglobulins. Geneva: WHO; 2023.
- European Medicines Agency (EMA). Octagam – Summary of Product Characteristics. EMA product information database. Accessed December 2025.
- Bonilla FA, Khan DA, Ballas ZK, et al. Practice Parameter for the Diagnosis and Management of Primary Immunodeficiency. Journal of Allergy and Clinical Immunology. 2015;136(5):1186–1205. doi:10.1016/j.jaci.2015.04.049
- Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases. European Journal of Neurology. 2008;15(9):893–908. doi:10.1111/j.1468-1331.2008.02246.x
- Hughes RA, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Database of Systematic Reviews. 2014;(9):CD002063. doi:10.1002/14651858.CD002063.pub6
- Eftimov F, Winer JB, Vermeulen M, de Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database of Systematic Reviews. 2013;(12):CD001797. doi:10.1002/14651858.CD001797.pub3
- British National Formulary (BNF). Normal immunoglobulin. NICE BNF monograph. Accessed December 2025.
- Newburger JW, Takahashi M, Gerber MA, et al. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease. Circulation. 2004;110(17):2747–2771. doi:10.1161/01.CIR.0000145143.19711.78
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in immunology, haematology, and clinical pharmacology.
Medical Writers
Board-certified physicians specialising in immunology and clinical pharmacology with documented academic and clinical experience in immunoglobulin therapy.
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