Intravenous Immunoglobulin (IVIG): Uses, Dosage, Side Effects | DrugsAtlas
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DRUG NAME: Intravenous Immunoglobulin (IVIG)
Therapeutic Class: Immunomodulatory agent
Subclass: Human Normal Immunoglobulin
Speciality: Immunology
Schedule (India): Schedule H
Route(s): Intravenous
Formulations Available in India:
• Solution for infusion: 5% concentration (2.5 g/50 mL, 5 g/100 mL)
• Solution for infusion: 10% concentration (5 g/50 mL, 10 g/100 mL, 10 g/200 mL)
• Supplied in single-use vials or bottles
• Biologically derived from pooled human plasma (virally inactivated)
• Solution for infusion: 5% concentration (2.5 g/50 mL, 5 g/100 mL)
• Solution for infusion: 10% concentration (5 g/50 mL, 10 g/100 mL, 10 g/200 mL)
• Supplied in single-use vials or bottles
• Biologically derived from pooled human plasma (virally inactivated)
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Primary Immunodeficiency Disorders (e.g., CVID, X-linked Agammaglobulinemia)
| Parameter | Details |
|
Starting dose
|
400 mg/kg IV |
|
Titration
|
Adjust based on clinical response and IgG trough levels |
|
Usual maintenance dose
|
400–600 mg/kg every 3–4 weeks |
|
Maximum dose
|
600 mg/kg every 3–4 weeks |
|
Target
|
Maintain trough IgG level >5–6 g/L |
|
Clinical notes
|
Lifelong therapy required; individualise interval based on infection frequency |
2. Immune Thrombocytopenic Purpura (ITP)
| Parameter | Details |
|
Starting dose
|
1 g/kg IV as single infusion |
|
Titration
|
May repeat 1 g/kg on day 2 if platelet response inadequate |
|
Usual maintenance dose
|
Not applicable (acute treatment) |
|
Maximum dose
|
2 g/kg total over 2 days |
|
Alternative regimen
|
400 mg/kg/day IV for 5 consecutive days |
|
Clinical notes
|
Use when platelet count <30,000/μL with bleeding or pre-procedure; response expected within 1–5 days |
3. Guillain-Barré Syndrome (GBS)
| Parameter | Details |
|
Starting dose
|
0.4 g/kg/day IV |
|
Titration
|
Not applicable |
|
Usual maintenance dose
|
0.4 g/kg/day for 5 consecutive days (total 2 g/kg) |
|
Maximum dose
|
2 g/kg total course |
|
Clinical notes
|
Initiate within 2 weeks of symptom onset for best outcomes; efficacy comparable to plasma exchange |
4. Kawasaki Disease
| Parameter | Details |
|
Starting dose
|
2 g/kg IV as single infusion |
|
Titration
|
Not applicable |
|
Usual maintenance dose
|
Single dose only |
|
Maximum dose
|
2 g/kg |
|
Infusion duration
|
Over 10–12 hours |
|
Clinical notes
|
Administer within first 10 days of illness; combine with high-dose aspirin (80–100 mg/kg/day in divided doses); reduces coronary aneurysm risk |
5. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
| Parameter | Details |
|
Starting dose
|
2 g/kg total, divided over 2–5 days (induction) |
|
Titration
|
Adjust maintenance based on functional response |
|
Usual maintenance dose
|
1 g/kg every 3–4 weeks |
|
Maximum dose
|
2 g/kg per cycle |
|
Clinical notes
|
Individualise maintenance interval; monitor functional status and relapse pattern |
6. Multifocal Motor Neuropathy (MMN)
| Parameter | Details |
|
Starting dose
|
2 g/kg total, divided over 2–5 days |
|
Titration
|
Adjust based on motor function response |
|
Usual maintenance dose
|
1 g/kg every 2–4 weeks |
|
Maximum dose
|
2 g/kg per treatment cycle |
|
Clinical notes
|
Corticosteroids ineffective in MMN; IVIG is first-line therapy |
Secondary Indications – Adults Only (Off-label, if any)
| Indication | Dose | Duration | Notes |
|
Myasthenia Gravis Crisis (OFF-LABEL, Specialist-only)
|
2 g/kg divided over 2–5 days | Single course; repeat if relapse | Evidence: RCTs show comparable efficacy to plasma exchange; Indian neurology practice supports use |
|
Systemic Lupus Erythematosus — Severe Flare (OFF-LABEL, Specialist-only)
|
2 g/kg divided over 2–5 days | As needed for acute flares | Evidence: Limited RCT data; used for refractory cytopenias, neuropsychiatric lupus |
|
Autoimmune Encephalitis (OFF-LABEL, Specialist-only)
|
2 g/kg divided over 5 days | May repeat based on response | Evidence: International consensus guidelines; use with corticosteroids |
|
Dermatomyositis/Polymyositis — Refractory (OFF-LABEL, Specialist-only)
|
2 g/kg divided over 2–5 days monthly | 3–6 months trial | Evidence: RCTs support efficacy in dermatomyositis |
|
Neonatal Sepsis (OFF-LABEL)
|
Not recommended | — | Evidence: Cochrane meta-analysis and Indian Neonatology Forum do not support routine use |
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
1. Kawasaki Disease
| Parameter | Details |
|
Minimum age
|
≥1 month (typical presentation ≥6 months) |
|
Starting dose
|
2 g/kg IV as single infusion |
|
Titration
|
Not applicable |
|
Usual maintenance dose
|
Single dose only |
|
Maximum dose
|
2 g/kg |
|
Duration of infusion
|
Over 10–12 hours |
|
Clinical notes
|
Combine with aspirin 80–100 mg/kg/day in 4 divided doses during febrile phase, then 3–5 mg/kg/day for 6–8 weeks; echocardiography mandatory |
2. Primary Immunodeficiency Disorders
| Parameter | Details |
|
Minimum age
|
From infancy (when diagnosed) |
|
Starting dose
|
400 mg/kg IV |
|
Titration
|
Adjust based on IgG trough and infection frequency |
|
Usual maintenance dose
|
400–600 mg/kg every 3–4 weeks |
|
Maximum dose
|
600 mg/kg every 3–4 weeks |
|
Clinical notes
|
Monitor growth, infection frequency; lifelong therapy |
3. Guillain-Barré Syndrome
| Parameter | Details |
|
Minimum age
|
≥2 years (limited data below this age) |
|
Starting dose
|
0.4 g/kg/day IV |
|
Titration
|
Not applicable |
|
Usual maintenance dose
|
0.4 g/kg/day for 5 days (total 2 g/kg) |
|
Maximum dose
|
2 g/kg total course |
|
Clinical notes
|
Initiate within 7–14 days of symptom onset |
4. Immune Thrombocytopenic Purpura
| Parameter | Details |
|
Minimum age
|
No strict lower limit; use under specialist guidance |
|
Starting dose
|
0.8–1 g/kg IV as single infusion |
|
Titration
|
May repeat once if inadequate response |
|
Usual maintenance dose
|
Not applicable (acute treatment) |
|
Maximum dose
|
2 g/kg total |
|
Alternative regimen
|
400 mg/kg/day for 5 days |
|
Clinical notes
|
Monitor for haemolysis, especially with doses >1 g/kg; higher risk in non-O blood groups |
Secondary Indications – Paediatric Doses (Off-label, if any)
| Indication | Dose | Duration | Notes |
|
Neonatal Alloimmune Thrombocytopenia (OFF-LABEL, Specialist-only)
|
1 g/kg/day for 2 days | As guided by haematologist | Evidence: Case series and specialist practice |
|
PANDAS/PANS (OFF-LABEL, Specialist-only)
|
2 g/kg divided over 2–5 days | Single course; reassess | Evidence: Highly limited; controversial; requires multidisciplinary input |
General Paediatric Statement
• Not recommended below 3 months of age except under specialist supervision
• Close monitoring required for fluid overload, renal function, and haemolysis
• Weight-based dosing mandatory; use ideal body weight in obese children
• Slower infusion rates recommended in younger children
• Close monitoring required for fluid overload, renal function, and haemolysis
• Weight-based dosing mandatory; use ideal body weight in obese children
• Slower infusion rates recommended in younger children
RENAL ADJUSTMENT
| Risk Category | Recommendation |
|
Normal renal function
|
No adjustment required |
|
eGFR 30–60 mL/min
|
Use with caution; prefer sucrose-free formulations; slow infusion rate |
|
eGFR <30 mL/min
|
High risk of AKI; use only if essential; sucrose-free products mandatory; maximum slow infusion |
|
Haemodialysis
|
No specific supplementation; avoid sucrose-containing products |
|
High-risk patients
|
Elderly, diabetics, hypovolaemic, pre-existing CKD — use lowest effective dose, ensure adequate hydration |
HEPATIC ADJUSTMENT
| Severity | Recommendation |
|
Mild impairment
|
No dose adjustment required |
|
Moderate impairment
|
No dose adjustment; monitor liver function during therapy |
|
Severe impairment
|
Use with caution; adjust fluid load; monitor LFTs closely |
CONTRAINDICATIONS
• Known anaphylactic or severe systemic hypersensitivity reaction to human immunoglobulins or any excipient
• Selective IgA deficiency with documented anti-IgA antibodies and history of anaphylaxis
• Hereditary fructose intolerance (for sucrose-containing formulations)
• Severe hyperprolinaemia (for proline-containing formulations)
• Selective IgA deficiency with documented anti-IgA antibodies and history of anaphylaxis
• Hereditary fructose intolerance (for sucrose-containing formulations)
• Severe hyperprolinaemia (for proline-containing formulations)
CAUTIONS
• Pre-existing renal impairment or risk factors for AKI (diabetes, age >65 years, hypovolaemia, concurrent nephrotoxins)
• History of thromboembolic events (stroke, MI, DVT, PE)
• Cardiovascular disease or heart failure (risk of volume overload)
• Patients with non-O blood groups (higher haemolysis risk with high-dose regimens)
• Migraine history (risk of aseptic meningitis syndrome)
• Hyperviscosity syndromes (monoclonal gammopathies)
• History of thromboembolic events (stroke, MI, DVT, PE)
• Cardiovascular disease or heart failure (risk of volume overload)
• Patients with non-O blood groups (higher haemolysis risk with high-dose regimens)
• Migraine history (risk of aseptic meningitis syndrome)
• Hyperviscosity syndromes (monoclonal gammopathies)
PREGNANCY
| Parameter | Recommendation |
|
Safety category
|
Considered relatively safe when benefit outweighs risk |
|
Indications in pregnancy
|
ITP, GBS, recurrent pregnancy loss (antiphospholipid syndrome), myasthenia gravis exacerbation |
|
Preferred alternatives
|
IVIG preferred over cytotoxic immunosuppressants when immunomodulation needed |
|
When used
|
Only under specialist supervision (haematology, neurology, or rheumatology) |
|
Monitoring
|
Volume status, renal parameters, fetal well-being |
LACTATION
| Parameter | Recommendation |
|
Compatibility
|
Compatible with breastfeeding |
|
Excretion in milk
|
IgG present in breast milk at low levels; no systemic absorption expected in infant |
|
Preferred alternatives
|
IVIG preferred over cytotoxic agents when immunomodulation needed postpartum |
|
Infant monitoring
|
No specific monitoring required; observe for feeding difficulties if concerned |
ELDERLY
| Parameter | Recommendation |
|
Starting dose
|
Use lowest effective dose for indication |
|
Infusion rate
|
Mandatory slow infusion; start at lowest recommended rate |
|
Titration
|
Slower rate escalation than younger adults |
|
Special risks
|
Higher risk of acute kidney injury, thromboembolism, volume overload |
|
Product selection
|
Use sucrose-free, low-osmolality formulations |
|
Monitoring
|
Renal function before and after infusion; hydration status; signs of thrombosis |
MAJOR DRUG INTERACTIONS
| Interacting Drug/Class | Effect | Recommendation |
|
Live vaccines (MMR, varicella, rotavirus, yellow fever)
|
IVIG antibodies neutralise vaccine virus; impaired immunogenicity | Avoid live vaccines for 3–11 months after IVIG (duration depends on dose) |
|
Nephrotoxic drugs (aminoglycosides, amphotericin B, vancomycin, NSAIDs)
|
Additive nephrotoxicity risk | Avoid concurrent use if possible; if essential, ensure hydration and monitor renal function closely |
|
Loop diuretics (furosemide)
|
Dehydration increases AKI risk | Ensure euvolaemia before and during IVIG; avoid aggressive diuresis |
MODERATE DRUG INTERACTIONS
| Interacting Drug/Class | Effect | Recommendation |
|
ACE inhibitors
|
Possible increased risk of hypersensitivity reactions | Consider withholding during infusion if feasible; monitor closely |
|
Anticoagulants/Antiplatelets (warfarin, aspirin, clopidogrel)
|
High-dose IVIG increases blood viscosity and thrombosis risk | Monitor for thrombotic events; ensure adequate hydration |
|
Inactivated vaccines
|
Marginal reduction in immunogenicity possible | No need to delay; administer as scheduled |
|
Corticosteroids
|
Often used together in autoimmune conditions | No dose adjustment required; additive immunomodulatory effect |
COMMON ADVERSE EFFECTS
• Headache
• Fever, chills, rigors
• Nausea, vomiting
• Myalgia, arthralgia
• Back pain
• Fatigue, malaise
• Mild hypertension during infusion
• Flushing
• Transient elevation of liver enzymes
• Fever, chills, rigors
• Nausea, vomiting
• Myalgia, arthralgia
• Back pain
• Fatigue, malaise
• Mild hypertension during infusion
• Flushing
• Transient elevation of liver enzymes
SERIOUS ADVERSE EFFECTS
| Adverse Effect | Clinical Action |
|
Anaphylaxis (especially in IgA-deficient patients)
|
Stop infusion immediately; administer adrenaline; emergency resuscitation |
|
Acute renal failure
|
Discontinue; supportive care; may require dialysis |
|
Thromboembolic events (stroke, MI, DVT, PE)
|
Stop infusion; anticoagulation and supportive management |
|
Haemolytic anaemia
|
Monitor haemoglobin; may require transfusion; more common with high doses and non-O blood groups |
|
Aseptic meningitis syndrome
|
Supportive care; lumbar puncture to exclude infectious aetiology; usually self-limiting |
|
Transfusion-related acute lung injury (TRALI)
|
Rare; discontinue infusion; respiratory support |
|
Severe hypotension
|
Slow or stop infusion; fluid resuscitation |
MONITORING REQUIREMENTS
| Timing | Parameters |
|
Baseline
|
CBC with differential, renal function (serum creatinine, urea, eGFR), LFTs, IgA level (if IgA deficiency suspected), blood group, hydration status |
|
During infusion
|
Vital signs every 15–30 minutes initially; watch for infusion reactions (fever, chills, urticaria, hypotension) |
|
After infusion (24–72 hours)
|
Renal function; haemolysis panel (LDH, bilirubin, haptoglobin, DAT) if symptomatic or high-dose used |
|
Long-term (chronic IVIG)
|
IgG trough levels (for replacement therapy), CBC, eGFR every 3–6 months; assess for infection frequency |
BRANDS AVAILABLE IN INDIA
• ImmunoRel (Reliance Life Sciences)
• Globucel (Intas)
• IVIgG-SN (Bharat Serums and Vaccines)
• Immunorel-P (Reliance Life Sciences)
• Intraglobin (Biocon)
• Gamunex-C (imported — Grifols)
• Octagam (imported — Octapharma)
• Privigen (imported — CSL Behring)
• Flebogamma (imported — Grifols)
• Globucel (Intas)
• IVIgG-SN (Bharat Serums and Vaccines)
• Immunorel-P (Reliance Life Sciences)
• Intraglobin (Biocon)
• Gamunex-C (imported — Grifols)
• Octagam (imported — Octapharma)
• Privigen (imported — CSL Behring)
• Flebogamma (imported — Grifols)
Note: Formulation excipients (sucrose, maltose, proline, glycine) vary between products — verify before use in renal or diabetic patients
PRICE RANGE (INR)
| Pack Size | Approximate Price |
| 5 g vial | ₹4,000–₹8,000 |
| 10 g vial | ₹8,000–₹15,000 |
| Full adult course (2 g/kg for 70 kg) | ₹50,000–₹1,00,000+ |
• Not listed under NLEM
• Some government hospitals procure under special schemes for eligible conditions (PID, Kawasaki disease)
• Significant cost variation between domestic and imported brands
• Some government hospitals procure under special schemes for eligible conditions (PID, Kawasaki disease)
• Significant cost variation between domestic and imported brands
CLINICAL PEARLS
• Check formulation excipients before prescribing — sucrose-containing products carry higher AKI risk; avoid in renal impairment, diabetes, elderly
• Dose based on ideal body weight in obese patients to avoid overdosing and reduce cost
• Pre-medication (paracetamol, antihistamine) may reduce infusion reactions; not routinely required
• Slow infusion rate reduces adverse effects — start at 0.5–1 mL/kg/hr and escalate gradually if tolerated
• Delay live vaccines for 3–11 months post-IVIG depending on dose (consult IAP guidelines for specific intervals)
• Monitor for haemolysis in high-dose regimens, especially in non-O blood group patients — check haemoglobin, LDH, DAT
• IVIG is not interchangeable between brands without re-evaluation — different excipients and tolerability profiles
• Dose based on ideal body weight in obese patients to avoid overdosing and reduce cost
• Pre-medication (paracetamol, antihistamine) may reduce infusion reactions; not routinely required
• Slow infusion rate reduces adverse effects — start at 0.5–1 mL/kg/hr and escalate gradually if tolerated
• Delay live vaccines for 3–11 months post-IVIG depending on dose (consult IAP guidelines for specific intervals)
• Monitor for haemolysis in high-dose regimens, especially in non-O blood group patients — check haemoglobin, LDH, DAT
• IVIG is not interchangeable between brands without re-evaluation — different excipients and tolerability profiles
TAGS
IVIG; intravenous immunoglobulin; immunomodulatory; Kawasaki disease; GBS; ITP; CIDP; primary immunodeficiency; autoimmune; schedule H; renal-caution; paediatric
VERSION
RxIndia v0.1 — 03 Feb 2026
REFERENCES
• CDSCO — Product approvals and registered formulations
• Indian Pharmacopoeia
• API Textbook of Medicine — Immunodeficiency and autoimmune disorders sections
• ICMR National Guidelines on Kawasaki Disease
• IAP Guidelines — IVIG use in paediatric conditions; vaccine intervals post-IVIG
• AIIMS Treatment Protocols — Neurology (GBS, CIDP, MG) and Haematology (ITP)
• Indian Pediatrics — Consensus statements on Kawasaki disease
• Cochrane Review — IVIG for neonatal sepsis (for off-label evidence)
• Harrison’s Principles of Internal Medicine, 21st edition (supportive)
• Indian Pharmacopoeia
• API Textbook of Medicine — Immunodeficiency and autoimmune disorders sections
• ICMR National Guidelines on Kawasaki Disease
• IAP Guidelines — IVIG use in paediatric conditions; vaccine intervals post-IVIG
• AIIMS Treatment Protocols — Neurology (GBS, CIDP, MG) and Haematology (ITP)
• Indian Pediatrics — Consensus statements on Kawasaki disease
• Cochrane Review — IVIG for neonatal sepsis (for off-label evidence)
• Harrison’s Principles of Internal Medicine, 21st edition (supportive)
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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