Nanogam: Uses, Dosage & Side Effects
Human normal immunoglobulin (IVIg) solution for intravenous infusion used in immunodeficiency replacement therapy and immunomodulatory treatment of autoimmune and inflammatory conditions
Nanogam is a human normal immunoglobulin (IVIg) solution for intravenous infusion, manufactured from pooled plasma of thousands of healthy blood donors. It contains a broad spectrum of immunoglobulin G (IgG) antibodies that provide passive immunity and immunomodulatory effects. Nanogam is used as replacement therapy in patients with primary and secondary immunodeficiency syndromes who are unable to produce sufficient antibodies on their own, as well as immunomodulatory therapy in autoimmune and inflammatory conditions such as immune thrombocytopenia (ITP), Guillain-Barré syndrome, Kawasaki disease, and chronic inflammatory demyelinating polyneuropathy (CIDP). It is administered by intravenous infusion under medical supervision in a hospital or clinical setting.
Quick Facts: Nanogam
Key Takeaways
- Nanogam is a 10% (100 mg/mL) intravenous immunoglobulin (IVIg) preparation derived from pooled human plasma containing a broad spectrum of IgG antibodies against a wide range of infectious agents and self-antigens.
- It is indicated for replacement therapy in primary immunodeficiency syndromes (such as congenital agammaglobulinemia, CVID, and severe combined immunodeficiency) and secondary immunodeficiencies resulting from chronic lymphocytic leukemia, multiple myeloma, or after bone marrow transplantation.
- Nanogam is also used as immunomodulatory therapy in autoimmune conditions including immune thrombocytopenia (ITP), Guillain-Barré syndrome, Kawasaki disease, and chronic inflammatory demyelinating polyneuropathy (CIDP).
- Infusion must be administered by a healthcare professional in a supervised clinical setting, starting at a slow rate and increasing gradually as tolerated, with vital sign monitoring throughout.
- Important safety considerations include risk of thromboembolic events, potential anaphylactic reactions (particularly in IgA-deficient patients with anti-IgA antibodies), and temporary interference with the efficacy of live attenuated vaccines for up to 3 months after infusion.
What Is Nanogam and What Is It Used For?
Nanogam contains human normal immunoglobulin, also known as intravenous immunoglobulin (IVIg). It is a sterile, liquid preparation of highly purified immunoglobulin G (IgG) derived from pooled human plasma collected from a large number of healthy blood donors (typically more than 1,000 donors per batch). This pooling process ensures that the final product contains a broad and diverse repertoire of IgG antibodies that reflect the collective immune experience of the donor population, providing protection against a wide range of bacteria, viruses, and other pathogens that circulate in the community.
The manufacturing process for Nanogam involves several critical steps designed to ensure both the safety and efficacy of the final product. Plasma is collected from carefully screened donors who meet strict health criteria. The IgG fraction is then isolated and purified using a modified Cohn-Oncley cold ethanol fractionation process, followed by additional chromatographic and filtration steps. These manufacturing steps serve a dual purpose: they concentrate and purify the IgG while simultaneously inactivating and removing potential viral contaminants. Specific viral inactivation steps, including solvent/detergent treatment and nanofiltration (using filters with a pore size of approximately 20 nanometers), provide additional layers of safety against enveloped and non-enveloped viruses respectively.
The final Nanogam product is a 10% protein solution (100 mg/mL), of which at least 96% is IgG. The IgG subclass distribution closely mirrors that found in normal human plasma, with IgG1 comprising approximately 60–70%, IgG2 approximately 20–30%, IgG3 approximately 5–8%, and IgG4 approximately 1–4%. This natural distribution is clinically important because each IgG subclass has distinct biological functions. The product contains minimal amounts of IgA and IgM, though trace amounts of IgA are present—a consideration that is clinically relevant for IgA-deficient patients.
Nanogam works through two fundamentally different mechanisms depending on the clinical indication:
Replacement Therapy in Immunodeficiency
In patients with primary immunodeficiency diseases (PID)—a group of more than 400 inherited disorders of the immune system—the body is unable to produce adequate levels of functional antibodies. These patients are susceptible to recurrent and often severe infections, particularly of the respiratory and gastrointestinal tracts. Common primary immunodeficiencies treated with Nanogam include:
- Congenital agammaglobulinemia and hypogammaglobulinemia: Conditions such as X-linked agammaglobulinemia (Bruton disease) where patients produce little or no IgG.
- Common variable immunodeficiency (CVID): The most prevalent symptomatic primary immunodeficiency, characterized by low levels of IgG and often IgA, with impaired antibody responses to vaccines and infections.
- Severe combined immunodeficiency (SCID): Life-threatening conditions affecting both T-cell and B-cell immunity, where IgG replacement is a critical supportive therapy.
- Wiskott-Aldrich syndrome: An X-linked disorder with immune deficiency, eczema, and thrombocytopenia.
In these patients, Nanogam provides passive immunity by supplying the IgG antibodies that the patient’s own immune system cannot produce. Regular infusions maintain protective serum IgG levels (the therapeutic target is typically a trough level above 5–6 g/L, though higher targets of 8–10 g/L may be pursued based on clinical response). This replacement therapy significantly reduces the frequency and severity of infections, decreases hospitalization rates, and improves quality of life and survival. For most patients, IgG replacement therapy is a lifelong treatment.
Secondary immunodeficiencies that may require IgG replacement therapy include those resulting from:
- Chronic lymphocytic leukemia (CLL): Where hypogammaglobulinemia is a common complication.
- Multiple myeloma: With secondary antibody deficiency and recurrent infections.
- Hematopoietic stem cell transplantation (HSCT): To prevent infections during the period of immune reconstitution.
- HIV/AIDS in children: With recurrent bacterial infections despite antiretroviral therapy.
Immunomodulatory Therapy
At higher doses, Nanogam exerts complex immunomodulatory effects that are beneficial in a range of autoimmune and inflammatory conditions. The exact mechanisms are not fully understood but involve multiple complementary pathways:
- Fc receptor blockade: High-dose IVIg saturates Fc receptors on macrophages and other phagocytic cells, reducing the clearance of antibody-coated (opsonized) cells—this is the primary mechanism in immune thrombocytopenia (ITP).
- Anti-idiotypic antibody interactions: IVIg contains anti-idiotypic antibodies that can neutralize pathogenic autoantibodies.
- Complement modulation: IVIg can scavenge activated complement components, reducing complement-mediated tissue damage.
- Cytokine modulation: IVIg influences the production and activity of pro-inflammatory and anti-inflammatory cytokines.
- T-cell regulation: IVIg can modulate T-cell activation, proliferation, and effector functions.
Key immunomodulatory indications for Nanogam include:
- Immune thrombocytopenia (ITP): When rapid platelet count elevation is needed, such as before surgery, to control excessive bleeding, or when corticosteroids are contraindicated or ineffective.
- Guillain-Barré syndrome (GBS): An acute inflammatory demyelinating polyneuropathy where IVIg is a first-line treatment equivalent to plasma exchange, shown in randomized controlled trials to improve recovery and reduce disability.
- Kawasaki disease: Where high-dose IVIg combined with aspirin is the standard of care, significantly reducing the risk of coronary artery aneurysms from approximately 25% to less than 5%.
- Chronic inflammatory demyelinating polyneuropathy (CIDP): A chronic autoimmune neuropathy where IVIg is one of the first-line treatments, improving muscle strength and functional disability.
- Multifocal motor neuropathy (MMN): Where IVIg is the only treatment with proven efficacy in randomized controlled trials.
The dose of Nanogam varies significantly depending on whether it is used for replacement therapy or immunomodulation. Replacement therapy typically requires 0.2–0.4 g/kg every 3–4 weeks, while immunomodulatory therapy (e.g., for ITP or GBS) requires much higher doses of 1–2 g/kg administered over 2–5 days. Your healthcare team will determine the appropriate dose based on your specific condition and clinical response.
What Should You Know Before Receiving Nanogam?
Contraindications
The primary contraindication to Nanogam is hypersensitivity to human normal immunoglobulin or to any of the excipients in the formulation. In particular, patients with selective IgA deficiency who have developed anti-IgA antibodies are at significantly elevated risk of severe anaphylactic reactions. Although Nanogam contains only trace amounts of IgA, even these small quantities can trigger a life-threatening anaphylactic reaction in sensitized patients. Prior to initiating IVIg therapy, patients should be tested for IgA deficiency and anti-IgA antibodies if there is clinical suspicion.
Patients who have previously experienced a severe systemic reaction to any human immunoglobulin product, regardless of the brand, should not receive Nanogam unless the potential benefit clearly outweighs the risk and the infusion is performed under close medical supervision with immediate access to resuscitation equipment and medications including epinephrine.
Warnings and Precautions
Patients with selective IgA deficiency who have developed antibodies against IgA are at particular risk of anaphylaxis during IVIg infusion. If you have been told you are IgA-deficient, inform your doctor before receiving Nanogam. The infusion must be administered in a setting with full resuscitation capability.
Before starting Nanogam, your healthcare provider should be informed about the following conditions and risk factors:
- Thromboembolic events: IVIg products, including Nanogam, carry a risk of thromboembolic complications including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke. Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors, and high-dose rapid infusions. Adequate hydration should be ensured before and during infusion, and the infusion rate should be kept as low as practicable, especially in patients with risk factors.
- Renal dysfunction: Acute renal failure, osmotic nephrosis, and renal tubular damage have been reported with IVIg use. Risk factors include pre-existing renal insufficiency, diabetes mellitus, hypovolemia, obesity, concomitant nephrotoxic medications, and age over 65 years. Renal function, including serum creatinine and urine output, should be monitored before and during treatment. For patients at risk, IVIg should be infused at the minimum practicable rate and concentration.
- Aseptic meningitis syndrome (AMS): Reported primarily with high-dose IVIg treatment (2 g/kg), AMS typically presents within hours to 2 days after infusion with severe headache, neck stiffness, photophobia, fever, and nausea. Cerebrospinal fluid analysis shows pleocytosis (elevated white cell count) with negative bacterial cultures. AMS is self-limiting and resolves within several days after IVIg discontinuation.
- Hemolytic anemia: IVIg products contain blood group antibodies (anti-A, anti-B, anti-D, and others) that can act as hemolysins and lead to hemolytic anemia, particularly in patients with blood groups A, B, or AB. Delayed hemolysis may occur up to 10 days after infusion. Monitor patients for signs of hemolysis including unexplained decrease in hemoglobin, jaundice, and dark urine.
- Transfusion-related acute lung injury (TRALI): A rare but serious complication characterized by non-cardiogenic pulmonary edema, hypoxia, and respiratory distress, typically occurring within 1–6 hours of infusion. TRALI is a medical emergency requiring immediate respiratory support.
Most adverse reactions to Nanogam are rate-related and can be avoided or minimized by adhering to the recommended infusion rate. Always start the infusion slowly and increase the rate gradually. If you experience any symptoms during the infusion—such as chills, headache, flushing, back pain, nausea, or changes in blood pressure—alert your healthcare provider immediately so the infusion can be slowed or temporarily stopped.
Pregnancy and Breastfeeding
Nanogam can be used during pregnancy when clinically indicated. Human normal immunoglobulin has been used in pregnant women for decades, and extensive clinical experience has not demonstrated harmful effects on the course of pregnancy or on the fetus and newborn. IgG antibodies naturally cross the placenta, particularly during the third trimester, and may confer passive protection to the newborn during the first weeks of life. In clinical practice, IVIg is an important treatment during pregnancy for conditions such as immune thrombocytopenia and recurrent pregnancy loss associated with antiphospholipid syndrome.
Immunoglobulin G is a natural component of human breast milk, and the use of Nanogam during breastfeeding is considered compatible. The IgG present in breast milk may contribute to passive protection of the infant against infections during the neonatal period.
Use in Children
Nanogam is used in pediatric patients across all age groups, from neonates to adolescents. The indications in children are similar to those in adults, with some conditions being particularly relevant in the pediatric population, such as Kawasaki disease (predominantly affects children under 5 years of age), primary immunodeficiency diseases (many of which present in infancy or early childhood), and pediatric immune thrombocytopenia. Dosing in children is calculated based on body weight (g/kg) using the same dose ranges as in adults, adjusted for the specific indication. Careful monitoring during infusion is essential, particularly in young children who may have difficulty communicating symptoms of adverse reactions.
Driving and Operating Machinery
Nanogam may cause adverse reactions such as dizziness, headache, and nausea that could potentially impair the ability to drive or operate machinery. Patients who experience such effects during or after infusion should wait until symptoms have fully resolved before driving or operating heavy equipment. Since Nanogam is administered in a clinical setting, patients should consider having someone accompany them for transport after the infusion, particularly during the initial treatments when individual tolerability has not yet been established.
How Does Nanogam Interact with Other Drugs?
The drug interaction profile of Nanogam is distinct from conventional pharmaceutical agents because it is a biological product composed of natural human antibodies rather than a chemically synthesized molecule. Consequently, it does not interact with other drugs through traditional pharmacokinetic mechanisms such as cytochrome P450 enzyme inhibition or induction. However, there are several clinically significant interactions that healthcare providers and patients must be aware of:
Interaction with Live Attenuated Vaccines
The most clinically important drug interaction involves live attenuated vaccines. The antibodies contained in Nanogam can neutralize the vaccine virus strains before they have time to replicate and stimulate the recipient’s own immune response. This can significantly reduce or completely negate the effectiveness of the vaccination. The duration of this interference depends on the dose of IVIg administered and the specific vaccine in question.
| Vaccine Type | Examples | Recommended Wait Period | Interaction |
|---|---|---|---|
| Live attenuated (injected) | MMR, varicella, yellow fever | At least 3 months after IVIg | Reduced efficacy; antibodies neutralize vaccine virus |
| Live attenuated (oral) | Oral polio (OPV), rotavirus, oral typhoid | Generally not affected | Minimal; acts locally in gut mucosa |
| Inactivated / mRNA | Influenza, COVID-19, tetanus, HPV | No waiting period required | No clinically significant interference |
| Polysaccharide / conjugate | Pneumococcal, meningococcal | No waiting period required | No clinically significant interference |
Patients receiving regular IVIg replacement therapy should be aware that some live vaccines may need to be administered in the window between infusions, or their immune response to these vaccines may need to be verified by serological testing after vaccination. In some cases, particularly for measles and varicella, it may be necessary to wait up to 6 months after high-dose IVIg (2 g/kg) before vaccination is likely to be effective.
Interference with Laboratory Tests
Nanogam can interfere with a variety of serological (blood-based) laboratory tests, which is an important consideration for both clinicians and patients:
- Serological testing: After Nanogam infusion, the passive transfer of antibodies may cause false-positive results in serological tests for infections such as hepatitis A, hepatitis B surface antibody, measles, and other conditions. This can lead to incorrect diagnoses and unnecessary treatments. Inform the laboratory and requesting physician that you have recently received IVIg.
- Blood group serology: The anti-A and anti-B antibodies present in Nanogam can transiently interfere with blood typing and cross-matching tests, potentially leading to false-positive results in the direct antiglobulin test (Coombs test). This is clinically important if blood transfusion is required.
- Blood glucose monitoring: Some blood glucose testing systems (particularly those using glucose dehydrogenase pyrroloquinolinequinone—GDH-PQQ—based methods) can give falsely elevated glucose readings in patients receiving products containing maltose. While Nanogam uses glycine as a stabilizer rather than maltose, patients should confirm with their healthcare provider which glucose monitoring system is appropriate.
Interactions with Other Medications
| Drug Category | Examples | Interaction |
|---|---|---|
| Nephrotoxic drugs | Aminoglycosides, NSAIDs, ciclosporin | Increased risk of renal impairment; monitor renal function |
| Anticoagulants | Warfarin, heparin, DOACs | IVIg may increase blood viscosity; monitor for thromboembolic events |
| Loop diuretics | Furosemide | May reduce IVIg efficacy; avoid concurrent use if possible |
| Corticosteroids | Prednisolone, methylprednisolone | Often used together (e.g., ITP, Kawasaki); no adverse interaction |
| Other immunoglobulins | Anti-D immunoglobulin, specific immunoglobulins | No interaction; can be administered concurrently |
Always inform all your healthcare providers (including dentists and laboratory staff) that you are receiving Nanogam treatment. The antibodies in the product can affect numerous laboratory tests and may influence clinical decision-making. Carry a patient alert card if one has been provided by your treatment center.
What Is the Correct Dosage of Nanogam?
Nanogam dosing is individualized based on the specific clinical indication, the severity of the condition, the patient’s body weight, and the clinical response. The dose and dosing regimen are determined by the treating physician and depend on the pharmacokinetic and clinical response in the individual patient. Below are the recommended dosing guidelines for the major indications.
Replacement Therapy in Immunodeficiency
| Indication | Starting Dose | Maintenance Dose | Frequency |
|---|---|---|---|
| Primary immunodeficiency | 0.4–0.8 g/kg | 0.2–0.4 g/kg | Every 3–4 weeks |
| Secondary immunodeficiency | 0.2–0.4 g/kg | 0.2–0.4 g/kg | Every 3–4 weeks |
| Post-HSCT | 0.2–0.4 g/kg | 0.2–0.4 g/kg | Every 3–4 weeks (until immune reconstitution) |
The goal of replacement therapy is to maintain serum IgG trough levels (measured just before the next infusion) at a protective level. Current guidelines from the European Society for Immunodeficiencies (ESID) recommend targeting a trough IgG level of at least 5–6 g/L, though many experts now advocate for individualized targets based on clinical response, with some patients requiring trough levels of 8 g/L or higher to achieve adequate infection control. The dose should be adjusted to achieve the clinical goal of reducing infection frequency rather than targeting a specific laboratory number alone.
Immunomodulatory Therapy
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Immune thrombocytopenia (ITP) | 0.8–1 g/kg | Day 1; may repeat on day 3 | Or 0.4 g/kg daily for 2–5 days |
| Guillain-Barré syndrome | 0.4 g/kg/day | 5 consecutive days (total 2 g/kg) | Start within 2 weeks of symptom onset |
| Kawasaki disease | 2 g/kg | Single infusion over 10–12 hours | Combined with aspirin; give within 10 days of fever onset |
| CIDP | 2 g/kg loading; 1 g/kg maintenance | Loading over 2–5 days; maintenance every 3 weeks | Adjust based on clinical response |
| Multifocal motor neuropathy | 2 g/kg loading; 1 g/kg maintenance | Loading over 2–5 days; maintenance every 2–4 weeks | Dose titrated to lowest effective maintenance |
Infusion Rate
The infusion rate of Nanogam is a critical safety parameter. Infusion-related adverse reactions are often rate-dependent, and careful adherence to the recommended infusion rates significantly reduces the risk of complications. The infusion should be started at a slow rate and gradually increased as tolerated:
Recommended Infusion Rate Schedule
- Initial rate (first 30 minutes): 0.5 mL/kg/hour (0.8 mg/kg/min)
- If tolerated, increase to: 1.0 mL/kg/hour for the next 30 minutes
- Subsequent increases: Up to a maximum of 4.0 mL/kg/hour (6.7 mg/kg/min)
- For patients with risk factors: Maximum rate of 2.0 mL/kg/hour recommended
For patients receiving Nanogam for the first time, switching from another IVIg product, or who have not received IVIg for a prolonged period (more than 8 weeks), particular caution should be exercised with the infusion rate. These patients should be monitored closely throughout the entire infusion and for at least 1 hour after completion. Patients who have previously tolerated IVIg well and are on a regular infusion schedule may tolerate a faster increase in infusion rate at the discretion of the treating physician.
Children
Dosing in pediatric patients follows the same weight-based (g/kg) dosing guidelines as in adults, adjusted for the specific indication. In Kawasaki disease, which primarily affects young children, the standard dose of 2 g/kg as a single infusion with concurrent aspirin therapy is well-established. For primary immunodeficiency in children, the dose is individualized based on serum IgG trough levels and clinical response, typically starting at 0.4 g/kg every 3–4 weeks. Close monitoring during infusion is essential in pediatric patients, particularly in infants and toddlers.
Elderly Patients
Elderly patients (over 65 years) are at increased risk of thromboembolic complications and renal adverse events with IVIg therapy. In these patients, the infusion rate should be kept at the minimum practicable level. Adequate hydration should be ensured before, during, and after the infusion. Renal function should be monitored before and after treatment. The dose is the same as for younger adults, calculated on a per-kilogram basis, but closer monitoring is required.
Missed Dose
If you miss a scheduled Nanogam infusion, contact your healthcare provider to reschedule as soon as possible. For patients receiving regular replacement therapy, maintaining the scheduled infusion interval is important to keep serum IgG levels within the protective range. A missed or delayed infusion can result in a drop in IgG levels below the therapeutic threshold, increasing susceptibility to infections. Do not attempt to “double up” on the next infusion; instead, resume the regular schedule after the rescheduled dose.
Overdose
Overdose with Nanogam is rare due to its administration by healthcare professionals in a controlled setting. However, if excessive doses are administered, it may lead to fluid overload, increased blood viscosity (particularly in patients with renal impairment or the elderly), and potentially thromboembolic complications. There is no specific antidote for IVIg overdose. Management is supportive, with focus on maintaining adequate hydration and monitoring for signs of thrombosis, renal dysfunction, and hemolysis. In patients with renal risk factors, urine output and serum creatinine should be closely monitored.
What Are the Side Effects of Nanogam?
Like all medicines, Nanogam can cause side effects, although not everybody gets them. The most frequently observed adverse reactions are infusion-related and are often linked to the speed at which the medication is infused. Many adverse reactions can be managed by slowing the infusion rate, temporarily pausing the infusion, or by administering premedication with acetaminophen (paracetamol), antihistamines, or in some cases, corticosteroids before the infusion. Adverse reactions are more likely to occur in patients receiving IVIg for the first time, in those switching from a different IVIg product, or after a long interval since the previous infusion.
The following side effects have been reported with Nanogam and other IVIg products, classified by frequency according to the MedDRA convention:
Very Common
May affect more than 1 in 10 people
- Headache
- Fever (pyrexia)
- Chills and rigors
- Fatigue and malaise
Common
May affect up to 1 in 10 people
- Nausea, vomiting, diarrhea
- Flushing, skin rash, urticaria (hives)
- Back pain, myalgia (muscle pain), arthralgia (joint pain)
- Dizziness, drowsiness
- Hypertension or hypotension (changes in blood pressure)
- Tachycardia (rapid heart rate)
- Chest tightness, dyspnea (shortness of breath)
- Injection site pain or swelling
Uncommon
May affect up to 1 in 100 people
- Aseptic meningitis (severe headache, neck stiffness, photophobia)
- Hemolytic anemia (positive direct Coombs test, decreased hemoglobin)
- Leukopenia (low white blood cell count)
- Acute renal impairment or worsening of pre-existing renal disease
- Eczema, pruritus (itching), alopecia (hair loss)
- Abdominal pain
Rare
May affect up to 1 in 1,000 people
- Anaphylaxis and severe allergic reactions
- Thromboembolic events (deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke)
- Transfusion-related acute lung injury (TRALI)
- Acute renal failure, osmotic nephrosis
- Hepatitis (liver inflammation)
- Severe hemolysis requiring transfusion
Not Known
Frequency cannot be estimated from available data
- Reversible aseptic meningitis syndrome
- Pseudohyponatremia (falsely low sodium levels on blood tests)
- Posterior reversible encephalopathy syndrome (PRES)
Most infusion-related reactions are mild to moderate and self-limiting. They occur most frequently during the first hour of infusion and can often be managed by slowing or temporarily pausing the infusion. Premedication with paracetamol (acetaminophen) and/or an antihistamine 30 minutes before the infusion can help reduce the frequency and severity of these reactions. For patients who experience recurrent infusion reactions, the treating physician may prescribe corticosteroid premedication (such as hydrocortisone) for subsequent infusions.
Patients should be monitored for at least 20 minutes after completion of the infusion. Any delayed reactions—such as rash, fever, headache, or malaise occurring hours to days after the infusion—should be reported to the treating physician. In particular, signs of hemolytic anemia (unexplained anemia, jaundice, dark urine) may appear up to 10 days after infusion and require prompt investigation.
Contact your doctor or seek emergency care immediately if you experience any of the following after receiving Nanogam: severe headache with neck stiffness and sensitivity to light (possible aseptic meningitis); sudden onset of chest pain, shortness of breath, or leg swelling (possible thromboembolic event); decreased urine output or dark brown urine (possible kidney problems or hemolysis); widespread rash with difficulty breathing (possible anaphylaxis); or sudden severe respiratory distress (possible TRALI).
How Should You Store Nanogam?
Proper storage of Nanogam is essential to maintain the efficacy and safety of the product. As a biological preparation containing human immunoglobulin proteins, Nanogam is sensitive to temperature extremes, light exposure, and agitation. Improper storage can lead to protein denaturation, aggregation, or loss of biological activity, potentially rendering the product ineffective or increasing the risk of adverse reactions.
The recommended storage conditions for Nanogam are as follows:
- Temperature: Store at 2–8°C (36–46°F) in a refrigerator. The product may be stored at room temperature (up to 25°C / 77°F) for a single period of up to 3 months within the shelf life, provided it is not returned to the refrigerator after storage at room temperature. Record the date when the product is first removed from refrigeration.
- Freezing: Do not freeze Nanogam. Freezing can cause protein aggregation and denaturation, which may affect both efficacy and safety. If the product has been accidentally frozen, it must not be used.
- Light protection: Keep the vial in the outer carton to protect from light. Prolonged exposure to light can degrade the immunoglobulin proteins.
- After opening: Once the vial has been penetrated, the product should be used immediately. Any unused solution should be discarded in accordance with local requirements for disposal of biological waste.
- Visual inspection: Before use, the solution should be visually inspected for particulate matter, discoloration, and turbidity. Nanogam is a clear to slightly opalescent and colorless to pale yellow solution. Do not use the product if it appears cloudy, contains particles, or has changed color.
- Expiry date: Do not use Nanogam after the expiry date (EXP) printed on the vial label and outer carton. The expiry date refers to the last day of that month.
In the clinical setting, the nursing and pharmacy staff are responsible for ensuring proper storage conditions. For patients who receive home infusions (if applicable), your treatment center will provide specific instructions on storage and handling of the product during transport and at home.
Refrigerate (2–8°C), do not freeze, protect from light, use immediately after opening, inspect visually before use. If stored at room temperature (up to 25°C), use within 3 months and do not return to refrigerator.
What Does Nanogam Contain?
Understanding the composition of Nanogam is important for both healthcare providers and patients, particularly to identify potential allergens and to appreciate the safety measures incorporated into the manufacturing process.
Active Substance
The active substance in Nanogam is human normal immunoglobulin, present at a concentration of 100 mg/mL (10% solution). Each milliliter of solution contains 100 mg of human plasma proteins, of which at least 96% is immunoglobulin G (IgG). The IgG subclass distribution reflects the natural composition found in normal human plasma:
- IgG1: Approximately 60–70% (mediates complement activation and Fc receptor binding)
- IgG2: Approximately 20–30% (important for responses to polysaccharide antigens)
- IgG3: Approximately 5–8% (most potent complement activator among IgG subclasses)
- IgG4: Approximately 1–4% (does not activate complement; involved in tolerance mechanisms)
The product contains trace amounts of IgA (typically less than 0.025 mg/mL, which is among the lowest IgA content of commercially available IVIg products). This low IgA content is a relevant consideration for IgA-deficient patients, though it does not completely eliminate the risk of anaphylaxis in patients with anti-IgA antibodies.
Excipients
- Glycine (aminoacetic acid): Used as a stabilizer to maintain the structural integrity and biological activity of the immunoglobulin molecules during storage. Glycine is a naturally occurring amino acid and is generally well tolerated.
- Water for injections: The solvent used to prepare the final solution.
Nanogam does not contain sucrose, maltose, or other sugars as stabilizers. This is clinically significant because IVIg products containing sucrose have been associated with an increased risk of osmotic nephrosis and acute renal failure. The use of glycine as a stabilizer is considered to be associated with a lower risk of renal adverse effects.
Plasma Source and Viral Safety
Nanogam is manufactured from pooled human plasma collected by Sanquin Blood Supply in the Netherlands. All plasma donations are obtained from carefully screened, voluntary, unpaid donors who meet strict eligibility criteria. Each donation is individually tested for hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (anti-HCV), antibodies to HIV-1 and HIV-2, and HCV RNA and HIV RNA by nucleic acid testing (NAT).
The manufacturing process includes multiple dedicated viral inactivation and removal steps:
- Solvent/detergent (S/D) treatment: Inactivates enveloped viruses (such as HIV, HBV, HCV) by disrupting their lipid membranes.
- Nanofiltration: Removes viruses based on size using filters with a pore size of approximately 20 nm, effective against both enveloped and non-enveloped viruses.
- Cold ethanol fractionation: The Cohn-Oncley fractionation process used to purify IgG also serves as a viral reduction step.
Despite these comprehensive safety measures, the theoretical risk of transmission of infectious agents, including unknown or emerging pathogens, cannot be completely eliminated when administering products derived from human blood or plasma. This risk is considered extremely small with current manufacturing practices.
Frequently Asked Questions About Nanogam
Nanogam is a human normal immunoglobulin (IVIg) used for two main purposes: (1) replacement therapy in patients with primary or secondary immunodeficiency syndromes who cannot produce adequate antibodies on their own, reducing the frequency and severity of infections; and (2) immunomodulatory therapy in autoimmune and inflammatory conditions such as immune thrombocytopenia (ITP), Guillain-Barré syndrome, Kawasaki disease, and chronic inflammatory demyelinating polyneuropathy (CIDP). The specific indication determines the dose, frequency, and duration of treatment.
Nanogam is given as an intravenous infusion (a drip directly into a vein), typically in a hospital or infusion center under the supervision of a healthcare professional. The infusion starts at a slow rate and is gradually increased as tolerated. A typical infusion session takes 2 to 6 hours depending on the dose and the patient’s tolerance. You will be monitored throughout the infusion and for at least 20 minutes afterward. Nanogam must never be injected subcutaneously or intramuscularly.
The most common side effects are infusion-related reactions including headache, chills, fever, fatigue, nausea, and flushing. These reactions are usually mild to moderate and often resolve when the infusion rate is reduced or paused. Back pain, muscle aches, and changes in blood pressure may also occur. Most side effects are more common during the first few infusions and tend to decrease with subsequent treatments. Premedication with paracetamol (acetaminophen) and/or antihistamines can help reduce these reactions.
Yes, Nanogam can be used during pregnancy when clinically indicated. Human normal immunoglobulin has been used in pregnant women for decades with extensive clinical experience showing no harmful effects on pregnancy, the fetus, or the newborn. IgG antibodies naturally cross the placenta and may provide passive immune protection to the baby. IVIg is an important treatment during pregnancy for conditions such as immune thrombocytopenia and antiphospholipid syndrome. Always discuss the use with your healthcare provider.
Nanogam can reduce the effectiveness of live attenuated vaccines (such as MMR, varicella, and yellow fever vaccines) for up to 3 months after infusion because the antibodies in Nanogam can neutralize the vaccine virus. Vaccination with these live vaccines should be postponed for at least 3 months after the last Nanogam infusion. After high-dose IVIg (2 g/kg), a waiting period of up to 6 months may be recommended for measles and varicella vaccines. Inactivated vaccines (such as influenza, COVID-19, and tetanus) are generally not affected and can be given at any time.
Nanogam is an intravenous immunoglobulin (IVIg) product, meaning it is infused directly into a vein. This route achieves high peak serum IgG levels rapidly and is necessary for immunomodulatory indications (such as ITP and Guillain-Barré syndrome) that require high-dose therapy. Subcutaneous immunoglobulin (SCIg) products are injected under the skin, often self-administered at home, and provide more stable serum IgG levels with smaller, more frequent doses. SCIg is commonly used for ongoing replacement therapy in primary immunodeficiency. Your immunologist will help determine which route is best suited to your condition and lifestyle.
References
- European Medicines Agency (EMA). Nanogam – Summary of Product Characteristics. Last updated 2024. Available from: www.ema.europa.eu
- Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. Journal of Allergy and Clinical Immunology. 2017;139(3S):S1–S46. doi:10.1016/j.jaci.2016.09.023
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Editorial Team
Medical Author
iMedic Medical Editorial Team – Specialists in Clinical Immunology and Pharmacology
Medical Reviewer
iMedic Medical Review Board – Independent panel of medical experts
Evidence Standard
Level 1A – Systematic reviews and meta-analyses of RCTs (GRADE framework)
Guidelines Followed
WHO, EMA, ESID, British Society for Immunology, Cochrane Library
This article was written and reviewed by licensed medical professionals with expertise in clinical immunology, hematology, and clinical pharmacology. All information is based on current international guidelines and peer-reviewed evidence. This content is independent and has no commercial funding. Last reviewed: .