Immune Globulin IV IGIV

Immune globulin IV (IGIV) is a prescription medication used to treat the symptoms of Primary Immunodeficiency Syndrome, Immune Thrombocytopenic Purpura, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Bone Marrow Transplant, B-cell Chronic Lymphocytic Leukemia, and Multifocal Motor Neuropathy.

• Immune globulin IV (IGIV) is available under the following different brand names: Gammagard S/D, Carimune NF, Carimune, Bivigam, Flebogamma, Gammagard, Gammaplex, Gamunex-C, IV Immune Globulin, IVIG, Octagam, Privigen, Flebogamma 10% DIF, Flebogamma 5% DIF, Gammaked, Panzyga, Asceniv

Adult and pediatric dosage

Injectable solution

• 5% (Flebogamma, Gammaplex)
• 10% (Flebogamma, Asceniv, Bivigam, Gammagard, Gammaplex, Gamunex-C, Gammaked, Octagam, Panzyga, Privigen)

Injectable solution, freeze-dried preparation (Gammagard S/D)

• 2.5g
• 5g
• 10g

Injection, lyophilized powder for reconstitution (Carimune NF)

• 3g
• 6g
• 12g

Primary Immunodeficiency Syndrome

Adult dosage

Carimune NF

• 400-800 mg/kg Intravenous every 3-4Week or may increase frequency based on patient response  
• Flebogamma, Gammagard S/D, Gamunex-C, Gammagard Liquid, Gammaked, Octagam, Panzyga
• 300-600 mg/kg Intravenous every 4Week; adjust based on dosage and interval as well as serum IgG concentrations  

Privigen

• 200-800 mg/kg Intravenous every 3-4 weeks; adjust based on dosage and interval as well as serum IgG concentrations  

Gammaplex, Bivigam, Asceniv

• 300-800 mg/kg Intravenous every 3-4week, dose-adjusted based on monitored trough serum IgG concentrations and clinical response  
• Gammagard Liquid, Gammaked, Gamunex-C (Subcutaneous administration) Gammagard Liquid (Subcutaneous administration)
• Initial Subcutaneous dose: 1.37 into the previous intravenous dose divided by # of weeks between intravenous doses
• Initial Subcutaneous infusion rate: Do not exceed 30 mL per infusion site and do not exceed the rate of 20 mL/hour/site
• Maintenance Subcutaneous dose: Based on clinical response and target IgG trough level
• Maintenance Subcutaneous infusion rate: Do not exceed 30 mL per infusion site and do not exceed the rate of 20-30 mL/hr/site

Pediatric dosage

• Gammagard S/D, Gammagard Liquid
• Children below 2 years: Safety and efficacy not established
• Children above 2 years: 300-600 mg/kg Intravenous every3-4week  
• Gammagard Liquid (Subcutaneous administration)
• Children below 2 years: Safety and efficacy not established
• 2-16 years (conversion from Intravenous): Previous Intravenous dose/week into1.53/Intravenous dosing interval (in weeks)
• Infusion rate below 40 kg: 15 mL/hr/site initially, may increase to 15-20 mL/hour/site (volume not to exceed 20 mL/site)
• Infusion rate 40 kg or greater: 20 mL/hr/site, may increase to 20-30 mL/hr/site (volume not to exceed 20 mL/site)

Gammaked

• 300-600 mg/kg Intravenous every 3-4 weeks
• Subcutaneous weekly maintenance
• May switch to a weekly Subcutaneous maintenance dose
• Initial Subcutaneous dose = 1.37 x previous IVIG dose (grams) ÷ number of weeks between IVIG doses
• Adjust dose according to trough levels

Gammaplex

• 300-800 mg/kg Intravenous every 3-4 weeks

Carimune NF

• 200 mg/kg Intravenous every4week; may increase to 300 mg/kg every 4week

Privigen

• Children below 3 years: 200-800 mg/kg Intravenous every 3-4 weeks

Asceniv

• Children below 12 years: Safety and efficacy not established
• Children 12-17 years: 300-800 mg/kg Intravenous every3-4week

Immune Thrombocytopenic Purpura

Adult dosage

Gamma Gard S/D

• 1 g/kg Intravenous; adjust doses based on platelet count and patient response; may administer up to 3 separate doses every other day or as needed

Gammaplex, Octagam, Privigen, Flebogamma 10%

• 1 g/kg/day Intravenous for 2 days

Gammaked, Gamunex-C

• 1 g/kg Intravenous for 2 days or 400 mg/kg Intravenous for 5 days

Carimune NF

• Acute: 400 mg/kg/day Intravenous for 2-5 days
• Chronic: 400 mg/kg Intravenous or as needed to control significant bleeding or maintain platelet count above 30,000/meter

Panzyga

• 1 g/kg Intravenous two times a day for 2 consecutive days

Pediatric dosage

Carimune NF

• Induction dose: 400 mg/kg/day Intravenous for 2-5 days
• Acute ITP of childhood: May discontinue dose after Day 2 if platelets are 30-50,000/microL
• Maintenance of chronic ITP: 400 mg/kg Intravenous or as needed to control significant bleeding or maintain platelet count above 30,000/microL

Gamunex-C

• 1 g/kg Intravenous for 2 days or 400 mg/kg Intravenous for 5 days

Privigen

• Children below15 years: Safety and efficacy not established
• Children above15 years: 1 g/kg/day Intravenous for 2 days

Flebogamma

• Children below2 years: Safety and efficacy not established
• Children above years: 300-600 mg/kg Intravenous every 3-4 weeks

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Adult dosage

Gamunex-C

• Load: 2 g/kg Intravenous in divided doses for 2-4 days
• Maintenance: 1000 mg/kg/day Intravenous for 1 day every 3 weeks or 500 mg/kg/day for 2 days every 3 Weeks

Privigen

• Loading dose: 2 g/kg (20 mL/kg) in divided doses over 2-5 consecutive days
• Maintenance dose: 1 g/kg (10 mL/kg) administered in 1-2 infusions on consecutive days, every 3 weeks

Panzyga

• Loading dose: 1 g/kg (10 mL/kg) Intravenous two times a day for 2 consecutive days
• Maintenance dose: 1-2 g/kg (10-20 mL/kg) divided into 2 daily doses given over 2 consecutive days every 3 weeks

Bone Marrow Transplant

Adult dosage

• 500 mg/kg Intravenous beginning on days 7 & 2 pretransplantation, then every Week through 90 days post-transplantation  

B-cell Chronic Lymphocytic Leukaemia

Adult dosage

Gammagard S/D

• 400 mg/kg/dose Intravenous every 3-4 weeks  

Multifocal Motor Neuropathy

Adult dosage

Gammagard Liquid

• 0.5-2.4 g/kg/month Intravenous based on clinical response  
• Initial infusion rate: 0.5 mL/kg/hr Intravenous (0.8 mg/kg/min)
• Maintenance infusion rate: Advance if tolerated to 5.4 mL/kg/hr Intravenous (9 mg/kg/min)

Dermatomyositis

Adult dosage

Octagam

• 2 g/kg Intravenous divided into equal doses over 2-5 consecutive days every 4 Weeks
• Guillain-Barre; Lambert-Eaton Myasthenic; Stiffman Syndrome (Off-label)

Adult dosage

• 400 mg/kg Intravenous once a day for 5 days or 1 g/kg once a day for 2 days  

Neonatal Hemochromatosis (Off-label)

Adult dosage

• 1g/kg Intravenous every week to a pregnant woman from the 18th week until the end of gestation

Kawasaki Disease

Pediatric dosage

• 2 g/kg Intravenous as a single dose over 10-12 hour
• Unless patients with Kawasaki disease present with comorbid influenza or viral illness, IVIGmust be used with high-dose aspirin (80-100 mg/kg/day orally divided every 6hour) or moderate-dose aspirin (30-50 mg/kg/day orally divided every 6 hours) for up to 14 days until fever resolved

Gammagard S/D

• 1 g/kg Intravenous as a single dose OR
• 400 mg/kg/day Intravenous for 4 consecutive days
• Begin treatment within 7 days of the onset of fever, administered concomitantly with appropriate aspirin therapy (80-100 mg/kg/day orally in 4 divided doses)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Immune globulin IV (IGIV) include:

• headache,
• back pain,
• joint pain,
• fever,
• chills,
• sweating,
• warmth or tingling,
• stomach pain,
• nausea,
• diarrhea,
• increased blood pressure,
• fast heartbeats,
• dizziness,
• tiredness,
• lack of energy,
• stuffy nose,
• sinus pain, and
• pain, swelling, burning, or irritation around the IV needle

Serious side effects of Immune globulin IV (IGIV) include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• dizziness,
• nausea,
• light-headedness,
• sweating,
• headache,
• pounding in the neck or ears,
• fever,
• chills,
• chest tightness,
• warmth or redness in the face,
• pale or yellowed skin,
• dark-colored urine,
• confusion,
• weakness,
• increased thirst,
• feeling hot,
• being unable to urinate,
• heavy sweating,
• hot and dry skin,
• little or no urination,
• swelling,
• rapid weight gain,
• shortness of breath,
• chest pain,
• trouble breathing,
• blue-colored lips, fingers, or toes,
• fever with a severe headache,
• neck stiffness,
• eye pain,
• increased sensitivity to light,
• chest pain with deep breathing,
• rapid heart rate,
• numbness or weakness on one side of the body, and
• swelling and warmth or discoloration in an arm or leg

Rare side effects of Immune globulin IV (IGIV) include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Immune globulin IV (IGIV) has severe interactions with no other drugs
• Immune globulin IV (IGIV) has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • bacitracin
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Immune globulin IV (IGIV) has moderate interactions with the following drugs:
  • BCG vaccine live
  • efgartigimod alfa
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, life
  • measles, mumps, rubella, and varicella vaccine, live
  • peramivir
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • varicella virus vaccine live
• Immune globulin IV (IGIV) has minor interactions with the following drugs:
  • ethotoin
  • fosphenytoin
  • phenytoin
  • protein a column

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to gamma globulin, thimerosal
• Isolated IgA deficiency
• Hyperprolinemia (Privigen)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Immune Globulin IV (IGIV)?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Immune Globulin IV (IGIV)?”

Cautions

• Risk of transmitting infectious agents (eg, viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent); all infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider
• Severe hypersensitivity reactions may occur; in case of hypersensitivity, discontinue the Privigen infusion immediately and institute appropriate treatment (see Contraindications)
• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients (see Black Box Warnings)
• Aseptic meningitis syndrome (AMS) may occur infrequently following treatment with immune globulin products; discontinuation of treatment has resulted in remission of AMS within several days without sequelae; AMS usually begins within several hours to 2 days following IGIV treatment
• Hyperproteinemia increased serum viscosity, and hyponatremia may occur following treatment with IGIV products
• Hemolytic anemia can develop after IGIV therapy due to enhanced RBC sequestration; IGIV recipients should be monitored for clinical signs and symptoms of hemolysis; if signs and/or symptoms of hemolysis are present after IGIV infusion, appropriate confirmatory laboratory testing should be done
• Postpone live virus vaccines for at least 3 months
• Maltose-containing brands may give false highs for glucose in certain glucose-testing systems
• Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing
• Transfusion-Related Acute Lung Injury (TRALI)
  • Noncardiogenic pulmonary edema may occur following treatment with IGIV products TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever
  • Symptoms typically appear within 1-6 hr following treatment; monitor patients for pulmonary adverse reactions
  • If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies and anti-human leukocyte antigen (HLA) antibodies in both the product and the patient's serum
  • TRALI may be managed using oxygen therapy with adequate ventilatory support

Pregnancy & Lactation

• No human data are available to indicate the presence or absence of drug-associated risk
• Animal reproduction studies have not been conducted
• Unknown if immune globulin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity
• Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation
• Lactation
  • No human data are available to indicate the presence or absence of drug-associated risk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition