Gammagard S/D, Carimune NF (immune globulin IV (IGIV)) dosing, indications, interactions, adverse effects, and more (original) (raw)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

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

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

Indicated as replacement therapy for primary humoral immunodeficiency (PI); this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID)

See Administration

Carimune NF

• 400-800 mg/kg IV q3-4Week or may increase frequency based on patient response

Flebogamma, Gammagard S/D, Gamunex-C, Gammagard Liquid, Gammaked, Octagam, Panzyga

• 300-600 mg/kg IV q4Week; adjust based on dosage and interval as well as serum IgG concentrations

Privigen

• 200-800 mg/kg IV q3-4 wk; adjust based on dosage and interval as well as serum IgG concentrations

Gammaplex, Bivigam, Alyglo, Asceniv, Yimmugo

• 300-800 mg/kg IV q3-4wk, dose adjusted based on monitored trough serum IgG concentrations and clinical response

Gammagard Liquid, Gammaked, Gamunex-C (SC administration) Gammagard Liquid (SC administration)

• Initial SC dose: 1.37 × previous intravenous dose divided by # of weeks between intravenous doses
• Initial SC infusion rate: Do not exceed 30 mL per infusion site and do not exceed rate of 20 mL/hr/site
• Maintenance SC dose: Based on clinical response and target IgG trough level
• Maintenance SC infusion rate: Do not exceed 30 mL per infusion site and do not exceed rate of 20-30 mL/hr/site

Immune Thrombocytopenic Purpura

Indicated for treatment of immune thrombocytopenic purpura (ITP) to raise platelet counts to control or prevent bleeding

Gammagard S/D

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

Gammaplex, Octagam, Privigen, Flebogamma 10%

• 1 g/kg/day IV for 2 days

Gammaked, Gamunex-C

• 1 g/kg IV x 2 days or 400 mg/kg IV x 5 days

Carimune NF

• Acute: 400 mg/kg/day IV for 2-5 days
• Chronic: 400 mg/kg IV PRN to control significant bleeding or maintain platelet count >30,000/cu.meter

Panzyga

• 1 g/kg IV BID for 2 consecutive days

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Indicated for CIDP to improve neuromuscular disability and impairment

Gamunex-C

• Induction: 2 g/kg IV in divided doses for 2-4 days
• Maintenance: 1 g/kg IV for 1 day q3Weeks or 500 mg/kg/day for 2 days q3Weeks

Privigen

• Induction: 2 g/kg IV in divided doses over 2-5 consecutive days
• Maintenance: 1 g/kg IV in 1-2 infusions on consecutive days, q3Week

Panzyga

• Induction: 2 g/kg IV in divded doses over 2 consecutive days
• Maintenance: 1-2 g/kg IV divided in 2 daily doses given over 2 consecutive days q3Weeks

Gammagard Liquid IV

• Induction: 2 g/kg IV in divided doses over 2-5 consecutive days
• Maintenance: 1 g/kg IV in divided doses over 1-4 consecutive days q3Weeks for up to 6 months
• Adjust maintenance dose level and dosing interval according to clinical response

• Limitation of use

  • Not studied in immunoglobulin-naïve patients with CIDP
  • Maintenance therapy in CIDP has NOT been studied >6 months
  • After responding during an initial treatment period, not all patients require indefinite maintenance therapy in order to remain free of CIDP symptoms
  • Individualize duration of any treatment >6 months based on patient response and demonstrated need for continued therapy

Bone Marrow Transplant

500 mg/kg IV beginning on days 7 & 2 pretransplantation, THEN qWk through 90 days post-transplantation

B-cell Chronic Lymphocytic Leukemia

Gammagard S/D

• 400 mg/kg/dose IV q3-4wk

Multifocal Motor Neuropathy

Gammagard Liquid

• Indicated as a maintenance therapy to improve muscle strength and disability in adults with multifocal motor neuropathy (MMN)
• 0.5-2.4 g/kg/month IV based on clinical response
• Initial infusion rate: 0.5 mL/kg/hr IV (0.8 mg/kg/min)
• Maintenance infusion rate: Advance if tolerated to 5.4 mL/kg/hr IV (9 mg/kg/min)

Dermatomyositis

Octagam

• Indicated for treatment of dermatomyositis
• 2 g/kg IV divided in equal doses over 2-5 consecutive days q4Weeks

Guillain-Barre; Lambert-Eaton Myasthenic; Stiffman Syndrome (Off-label)

400 mg/kg IV qDay x5 days or 1 g/kg qDay x 2 days

Neonatal Hemochromatosis (Off-label)

1 g/kg IV qWk to pregnant woman 18th week until end of gestation

Orphan Designations

Octagam: Stiff person syndrome

Octagam: Dermatomyositis

Gamunex-C: Myasthenia gravis

Sponsors

• Octapharma USA, Inc; 121 River Street; Hoboken, NJ 07030
• Grifols Therapeutics, Inc; 79 TW Alexander Drive; Research Triangle Park, NC

Other Indications & Uses

Primary immunodeficiencies

Bone marrow transplant indicated for Gamunex (Canada); was indicated for one US product (Gamimune N) which has been discontinued; other brands used off-label

Off-label: secondary immunodeficiencies, dermatomyositis, Guillain-Barre synd, myasthenia gravis, multifocal motor neuropathy, relapsing-remitting multiple sclerosis, Lambert-Eaton myasthenic syndrome, stiffman syndrome, pemphigus vulgaris, SLE, HDN, multiple myeloma, TSS, streptococcal necrotizing fasciitis, Churg-Strauss syndrome, refractory autoimmune hemolytic anemia, opsoclonus-myoclonus, Hyper IgE syndrome, FAIT, Parvovirus B19 infection w/ anemia, delayed pressure urticaria, epidermolysis bullosa, neonatal hemochromatosis, birdshot retinochoroidopathy, acute disseminated encephalomyelitis, Rasmussen's syndrome, enteroviral meningoencephalitis

Dosage Forms & Strengths

injectable solution

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

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

• 2.5g
• 5g
• 10g

injection, lyophilized powder for reconstitution (Carimune NF)

• 3g
• 6g
• 12g

Pediatric HIV, Prevention of Infection

400 mg/kg IV q2-4hr

Primary Immunodeficiency Syndrome

Indicated as replacement therapy for primary humoral immunodeficiency (PI); this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID)

See Administration

Gammagard S/D, Gammagard Liquid

• <2 years: Safety and efficacy not established
• ≥2 years: 300-600 mg/kg IV q3-4wk

Gammagard Liquid (SC administration)

• <2 years: Safety and efficacy not established
• 2-16 years (conversion from IV): Previous IV dose/wk X 1.53/IV dosing interval (in weeks)
• Infusion rate <40 kg: 15 mL/hr/site initially, may increase to 15-20 mL/hr/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 IV q3-4wk

• SC weekly maintenance

  • May switch to a weekly SC maintenance dose
  • Initial SC 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 IV q3-4wk

Carimune NF

• 200 mg/kg IV q4wk; may increase to 300 mg/kg q4wk

Privigen

• ≥3 years: 200-800 mg/kg IV q3-4wk

Asceniv

• <12 years: Safety and efficacy not established
• 12-17 years: 300-800 mg/kg IV q3-4wk

Yimmugo

• <2 years: Safety and efficacy not established
• 2-17 years: 300-800 mg/kg IV q3-4 weeks
• May adjust dose over time to achieve desired trough levels and clinical response

Bivigam

• <2 years: Safety and efficacy not established
• ≥2 years: 300-800 mg/kg IV q3-4 weeks

• Dose adjustments

  • May adjust dose over time to achieve desired trough levels and clinical response
  • Dose adjustments may be required in patients who fail to maintain trough total IgG concentrations of at least 500 mg/dL, with a target of 600 mg/dL
  • Starting with second infusion, adjust dose proportionally, targeting a trough of ≥600 mg/dL, based on previous trough and associated dose

Immune Thrombocytopenic Purpura

Indicated for treatment of immune thrombocytopenic purpura (ITP) to raise platelet counts to control or prevent bleeding

Carimune NF

• Induction dose: 400 mg/kg/day IV 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 IV PRN to control significant bleeding or maintain platelet count >30,000/microL

Gamunex-C

• 1 g/kg IV x 2 days or 400 mg/kg IV x 5 days

Privigen

• <15 years: Safety and efficacy not established
• ≥15 years: 1 g/kg/day IV for 2 days

Flebogamma

• <2 years: Safety and efficacy not established
• ≥2 years: 300-600 mg/kg IV q3-4wk

Kawasaki Disease

Indicated for acute disease in combination with aspirin to prevent or reduce occurrence of coronary artery abnormalities associated with Kawasaki disease

Ideally, initiate within 10 days of onset of fever with diagnosed or suspected Kawasaki disease (American Academy of Pediatrics, American Heart Association, American College of Chest Physicians guidelines)

2 g/kg IV as a single dose over 10-12 hr

Unless patients with Kawasaki disease present with comorbid influenza or viral illness, IVIG must be used with high-dose aspirin (80-100 mg/kg/day PO divided q6hr) or moderate-dose aspirin (30-50 mg/kg/day PO divided q6hr) for up to 14 days until fever resolved

Gammagard S/D

• 1 g/kg IV as a single dose OR
• 400 mg/kg/day IV 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 PO in 4 divided doses)

B-Cell Chronic Lymphocytic Leukemia

As in adults

Dermatomyositis (off-label)

As in adults

Guillain-Barre Syndrome (off-label)

As in adults

Interactions

Interaction Checker

Enter a drug name to check for any interactions. + immune globulin IV (IGIV)

No Interactions Found

Interactions Found

Contraindicated

Serious

Significant - Monitor Closely

Minor

All Interactions Sort By:

Contraindicated (0)

Serious (8)

• axicabtagene ciloleucel
  immune globulin IV (IGIV), axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
• bacitracin
  immune globulin IV (IGIV) and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs
• brexucabtagene autoleucel
  immune globulin IV (IGIV), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
• ciltacabtagene autoleucel
  immune globulin IV (IGIV), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
• idecabtagene vicleucel
  immune globulin IV (IGIV), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
• lisocabtagene maraleucel
  immune globulin IV (IGIV), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
• pozelimab
  immune globulin IV (IGIV) will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. IV immunoglobulin may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as pozelimab, and thereby decrease serum pozelimab concentrations. If use is avoidable, monitor for worsening of clinical signs and symptoms of CHAPLE disease.
• tisagenlecleucel
  immune globulin IV (IGIV), tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

Monitor Closely (9)

• BCG vaccine live
  immune globulin IV (IGIV) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
• efgartigimod alfa
  efgartigimod alfa will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
• efgartigimod/hyaluronidase
  efgartigimod/hyaluronidase will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
• measles mumps and rubella vaccine, live
  immune globulin IV (IGIV) decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
• measles, mumps, rubella and varicella vaccine, live
  immune globulin IV (IGIV) decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
• peramivir
  immune globulin IV (IGIV) increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.
• rozanolixizumab
  rozanolixizumab will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
• smallpox and mpox (vaccinia) vaccine, live
  immune globulin IV (IGIV) decreases effects of smallpox and mpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
• varicella virus vaccine live
  immune globulin IV (IGIV) decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

Minor (4)

• ethotoin
  ethotoin, immune globulin IV (IGIV). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.

• fosphenytoin
  fosphenytoin, immune globulin IV (IGIV). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.

• phenytoin
  phenytoin, immune globulin IV (IGIV). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.

• protein a column
  protein a column decreases levels of immune globulin IV (IGIV) by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.

• axicabtagene ciloleucel
  Serious - Use Alternative (1)immune globulin IV (IGIV), axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

• bacitracin
  Serious - Use Alternative (1)immune globulin IV (IGIV) and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs

• BCG vaccine live
  Monitor Closely (1)immune globulin IV (IGIV) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

• brexucabtagene autoleucel
  Serious - Use Alternative (1)immune globulin IV (IGIV), brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

• ciltacabtagene autoleucel
  Serious - Use Alternative (1)immune globulin IV (IGIV), ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

• efgartigimod alfa
  Monitor Closely (1)efgartigimod alfa will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

• efgartigimod/hyaluronidase
  Monitor Closely (1)efgartigimod/hyaluronidase will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

• ethotoin
  Minor (1)ethotoin, immune globulin IV (IGIV). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.

• fosphenytoin
  Minor (1)fosphenytoin, immune globulin IV (IGIV). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.

• idecabtagene vicleucel
  Serious - Use Alternative (1)immune globulin IV (IGIV), idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

• lisocabtagene maraleucel
  Serious - Use Alternative (1)immune globulin IV (IGIV), lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

• measles mumps and rubella vaccine, live
  Monitor Closely (1)immune globulin IV (IGIV) decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

• measles, mumps, rubella and varicella vaccine, live
  Monitor Closely (1)immune globulin IV (IGIV) decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

• peramivir
  Monitor Closely (1)immune globulin IV (IGIV) increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.

• phenytoin
  Minor (1)phenytoin, immune globulin IV (IGIV). Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis.

• pozelimab
  Serious - Use Alternative (1)immune globulin IV (IGIV) will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. IV immunoglobulin may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as pozelimab, and thereby decrease serum pozelimab concentrations. If use is avoidable, monitor for worsening of clinical signs and symptoms of CHAPLE disease.

• protein a column
  Minor (1)protein a column decreases levels of immune globulin IV (IGIV) by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.

• rozanolixizumab
  Monitor Closely (1)rozanolixizumab will decrease the level or effect of immune globulin IV (IGIV) by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.

• smallpox and mpox (vaccinia) vaccine, live
  Monitor Closely (1)immune globulin IV (IGIV) decreases effects of smallpox and mpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

• tisagenlecleucel
  Serious - Use Alternative (1)immune globulin IV (IGIV), tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

• varicella virus vaccine live
  Monitor Closely (1)immune globulin IV (IGIV) decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

Adverse Effects

>10%

Privigen

• Headache (45%)
• Fatigue (16.3%)
• Nausea (13.8%)
• Chills (11.3%)
• Vomiting (11.3%)

Flebogamma

• Headache (21.7%)
• Pyrexia (19.6%)
• Pain (15.2%)
• Injection site reaction (13%)

Asceniv

• Headache (24%)

1-10%

Privigen

• Back pain (10%)
• Pain (8.8%)
• Elevated body temperature (8.8%)
• Diarrhea (7.5%)
• Cough (6.3%)
• Stomach discomfort (6.3%)
• Blood total bilirubin increased (5.3%)
• Hematocrit decreased (5.3%)
• Blood lactate dehydrogenase increased (5.3%)

Flebogamma

• Diarrhea (8.7%)
• Rigors (8.7%)
• Infusion site inflammation (6.6%)
• Urticaria (6.5%)

Gammagard S/D or Gammagard

• Headache (5.1-5.2%)
• Chills (2.7%)
• Elevated temperature (1.8%)
• Fatigue (1-1.8%)
• Pyrexia (1.5%)
• Nausea (1.5%)
• Emesis (1.3%)
• Hypertension (1%)
• Flushing (1%)

Asceniv

• Sinusitis (10%)
• Nausea (9%)
• Acute sinusitis (7%)
• Fatigue (7%)
• Muscle spasms (7%)
• Bronchitis (5%)
• Diarrhea (5%)
• Nose bleed (5%)
• Muscle pain (5%)
• Oropharyngeal pain (5%)
• Pain in extremity (5%)
• Itching (5%)

<1%

Gammagard S/D or Gammagard

• Chills
• Rigor
• Pain in extremity
• Diarrhea
• Migraine
• Dizziness
• Vomiting
• Leg cramps
• Flu-like symptoms
• Exanthema
• Loss of appetite
• Anxiety
• Backache
• Urticaria

Frequency Not Defined

Carimune NF

• Arthralgia
• Myalgia
• Transient skin reactions (eg, rash, erythema, pruritus, urticaria, eczema, dermatitis)

Postmarketing Reports

Respiratory: Apnea, acute respiratory distress syndrome (ARDS), transfusion-related acute lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm

Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension

Neurological: Coma, loss of consciousness, seizures, tremor

Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis

Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test

General/Body: Whole pyrexia, rigors

Musculoskeletal: Back pain

Gastrointestinal: Hepatic dysfunction, abdominal pain

Warnings

Black Box Warnings

Acute renal dysfunction and renal failure

• Associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death
• Administer IV at minimum concentration available and minimum rate of infusion in patients predisposed to acute renal failure; IVIG products containing sucrose as a stabilizer or at daily doses >400 mg/kg account for a disproportionate share of case reports involving renal failure

• Patients predisposed to acute renal failure

  • Any degree of preexisting renal insufficiency
  • Diabetes mellitus
  • Age >65 years
  • Volume depletion
  • Sepsis
  • Paraproteinemia
  • Currently taking nephrotoxic drugs

Thrombosis

• Thrombosis may occur regardless of route of administration
• Risk factors include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors
• Thrombosis may also occur in the absence of known risk factors
• For patients at risk of thrombosis, administer at the minimum concentration available and at the minimum rate of infusion practicable
• Ensure adequate hydration in patients before administration
• Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity

Contraindications

Hypersensitivity to gamma globulin, thimerosal

Isolated IgA deficiency

Hyperprolinemia (Privigen)

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 subsequent to 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 high 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

Pregnancy

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

Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation

Lactation

No human data are available to indicate the presence or absence 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 from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

Pooled human immune globulins from donors used as replacement therapy for primary and secondary immunodeficiencies; may interfere with Fc receptors on the cells of the reticuloendothelial system for autoimmune disorders including cytopenias and ITP; may offer passive immunity by increasing antibody titer and antigen-antibody reaction potential

Absorption

Peak plasma concentration

• 2,227-2,427 mg/dL (Asceniv)
• 1,929-2,069 mg/dL (Flebogamma)
• 2,340 mg/dL (Privigen)
• 2,050 mg/dL (Gammagard)
• 2,122-2,184 mg/dL (Bivigam)

Peak plasma time

• 2.78-2.93 hr (Asceniv)
• 27.8-37.3 days (Privigen)
• 3.47-4.05 hr (Bivigam)

AUC

• 32,128-35,905 mg·day/dL (Asceniv)
• 31,159-32,894 mg·day/dL (Flebogamma)
• 78,748-98,521 mg·day/dL (Privigen)
• 29,139 mg·day/dL (Gammagard)
• 27,841-35,509 mg·day/dL (Bivigam)

Distribution

Vd (steady-state): 76.79-89.57 mL/kg (Asceniv); 44-87 mL/kg (Flebogamma); 0.584-0.640 dL/kg (Bivigam)

Elimination

Half-life

• 23.47-39.7 days (Asceniv)
• 34.1 days (Gammagard S/D)
• 21 days (Carimune NF)
• 30-32 days (Flebogamma)
• 27.8-37.3 days (Privigen)
• 35 days (Gammagard)
• 19.6-33.5 days (Bivigam)

Clearance

• 1.47-1.68 mL/day/kg (Asceniv)
• 109-139 mL/day (Flebogamma)
• 1.3 mL/kg/day (Privigen)
• 0.0197-0.0141 dL/kg/day (Bivigam)

Administration

IV Preparation

Dilution is dependent upon manufactuere and brand; do not shake, avoid foaming; discard unused portion

Gammagard S/D, Polygam S/D: reconstitute with sterile water for injection; when diluted aseptically in a sterile laminar air flow hood, may store diluted solution under refrigeration for up to 24 hr; if reconstituted outside of laminar flow hood, use within 2 hr

Gammagard requires filtration, supplied by manufacturer

Gamunex incompatible with 0.9% NaCl, dilute in D5W if necessary

Asceniv, Flebogamma: Do not mix with other IGIV products or other IV medications; do not dilute, do not microwave

Alyglo, Bivigam, Octagam: Do not dilute

IV Administration

For initial treatment, a lower concentration and/or a slower rate of infusion should be used

Administer in separate infusion line from other medications; if using primary line, flush with saline prior administration

Decrease dose, rate &/or concentration of infusion in pts who may be at risk of renal failure

Decreasing rate or stopping the infusion may help relieve some adverse effects (flushing, changes in pulse rate, changes in blood pressure)

Epinephrine should be available during administration

IV Infusion Rates

Alyglo

• Initial rate: 1 mg/kg/min (0.01 mL/kg/min); double infusion rate q30min (if tolerated) up to 8 mg/kg/min
• 2nd infusion onward: 2 mg/kg/min (0.02 mL/kg/min); double infusion rate q15min (if tolerated) up to 8 mg/kg/min

Asceniv

• Initial rate: 0.5 mg/kg/min for first 15 min
• May increase (if tolerated) q5min to up to 8 mg/kg/min (0.08 mL/kg/min)

Bivigam

• Initial rate: 0.5 mg/kg/min (0.005 mL/kg/min) for first 20 min
• May increase (if tolerated) q20min by 0.8 mg/kg/min; not to exceed 6 mg/kg/min

Yimmugo

• Dose 1

  • Initial rate: 0.5 mg/kg/min (0.005 mL/kg/min) for first 30 min
  • May increase q30min as tolerated up to 3 mg/kg/min (0.03 mL/kg/min)

• Dose 2 and thereafter

  • Initial rate: 0.5 mg/kg/min (0.005 mL/kg/min) for first 30 min
  • May increase as tolerated up to 13 mg/kg/min (0.13 mL/kg/min)

Carimune NF

• Infuse at <2 mg/kg/min
• Start at 10–20 drops (0.5–1 mL) per min
• After 15–30 min, rate of infusion may be further increase to 30-50 drops (1.5-2.5 mL) per min
• If patient tolerates first 3% soln infusion, subsequent infusions may be administered at higher rate or concentration

Flebogamma 5%

• Initiate at 0.5 mg/kg/min
• If well-tolerated during first 30 min, increase rate gradually to not to exceed 5 mg/kg/min
• Patients at risk for developing renal dysfunction: infuse at not to exceed 3 mg/kg/min

Gammagard S/D

• Infuse 5% soln at 0.5 mL/kg/hr
• If well tolerated (at each step) & no hx of ADRs to IGIV and no significant risk factors for renal dysfunction or thrombotic complications may gradually increase to not to exceed 4 mL/kg/hr, THEN 10% soln starting at 0.5 mL/kg/hr, and finally may increase gradually to not to exceed 8 mL/kg/hr
• Patients at risk of renal damage or thrombotic complications: NMT <3.3 mg/kg/min (<2 mL/kg/hr of a 10% solution or <4mL/kg/hr of a 5% solution)
• Recommend antecubital veins esp for 10% soln
• Rapid rate of admin may cause flushing and changes in pulse rate and BP

Gammagard Liquid IV

• Initial: 0.8 mg/kg/min (0.5 mL/kg/hr)

• Maintenance

  • PI: May increase if tolerated up to 8 mg/kg/min (5 mL/kg/hr)
  • MMN, CIDP: May increase if tolerated up to 9 mg/kg/min (5.4 mL/kg/hr)

Gammaplex

• 0.5 mg/kg/min (0.01 mL/kg/min) IV for 15 minutes, THEN
• May increase (if tolerated) to 4 mg/kg/min (0.08 mL/kg/min)
• Use inline 15-20 micron filter during infusion

Gammaked

• Primary immunodeficiency: 1 mg/kg/min IV initially; maintenance up to 8 mg/kg/min IV if tolerated
• Primary immunodeficiency (SC maintenance): 20 mL/hr/site
• ITP: 1 mg/kg/min IV initially; maintenance up to 8 mg/kg/min IV if tolerated
• CIDP: 2 mg/kg/min IV initially; maintenance up to 8 mg/kg/min IV if tolerated

Gamunex-C

• Primary immunodeficiency, ITP: initial 1 mg/kg/min; maint: 8 mg/kg/min if tolerated
• CIDP: initial 2 mg/kg/min; maint: 8 mg/kg/min if tolerated

Privigen

• Start at 0.5 mg/kg/min
• If well tolerated, gradually increase up 8 mg/kg/min
• Patients at risk of renal damage or thrombotic complications: administer at minimum infusion rate that is practicable

Panzyga

• First 30 min: 1 mg/kg/min (0.01 mL/kg/min)
• New patients; maximum rate (as tolerated): 8 mg/kg/min (0.08 mL/kg min)
• Experienced patients treated for primary immunodeficiency; maximum rate: 12-14 mg/kg/min (0.12-0.14 mL/kg/min)
• Patients with pre-existing or at risk for developing renal insufficiency: Not to exceed 3.3 mg/kg/min (0.033 mL/kg/min)

Octagam 10%

• Initial: 1 mg/kg/min (0.01 mL/kg/min) IV

• Maintenance

  • Chronic ITP: Up to 12 mg/kg/min (0.12 mL/kg/min) IV
  • Dermatomyositis: Up to 4 mg/kg/min (0.04 mL/kg/min) IV
  • Gradually increase every 30 minutes if tolerated by doubling infusion rate up to maximum recommended rate

Storage

Alyglo, Bivigam, Asceniv: Refrigerate at 2-8°C (36-46°F) for up to 36 months from date of manufacture (do not freeze); within the first 24 months of shelf-life, may store up to 4 weeks at ≤25°C (≤77°F); after 24 months, may store at ≤25°C (≤77°F) until expires; use or discard product after storing at room temperature

Carimune NF: Prior to reconstitution, store ≤30°C (86°F), do not freeze; following reconstitution, refrigerate at 2-8°C (36-46°F)

Flebogamma DIF: Store at 2-25°C (36-77°F); keep in original carton to protect from light; do not freeze or use if solution has been frozen

Gammagard Liquid: Prior to use, may store at 2-8°C (36-46°F) for up to 36 months or at ≤25°C (≤77°F) for up to 24 months; do not freeze

Gammagard S/D: Store at ≤25°C (≤77°F) for up to 24 months; refrigerate diluted solution at 2-8°C (36-46°F) for up to 24 hr if originally prepared in a sterile laminar air flow environment

Gammaked or Gamunex-C: Store at 2-8°C (36-46°F); may be stored at ≤25°C (≤77°F) for up to 6 months

Gammaplex: Store at 2-25°C (36-77°F); keep in original carton to protect from light; do not freeze or use if solution has been frozen

Octagam 10% or Panzyga: Store at 2-8°C (36-46°F) for 24 months from the date of manufacture; within these first 12 months, may store up to 9 months at ≤25°C (≤77°F); after storage at ≤25°C (≤77°F) use or discard product

Privigen: Store at ≤25°C (≤77°F); do not freeze or use if solution has been frozen; protect from light

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