immune globulin IV (IGIV) (Rx)

Brand and Other Names:Gammagard S/D, Carimune NF, more...Carimune, Bivigam, Flebogamma, Gammagard, Gammaplex, Gamunex-C, IV Immune Globulin, IVIG, Octagam, Privigen, Flebogamma 10% DIF, Flebogamma 5% DIF, Gammaked, Panzyga, Asceniv

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

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

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, Asceniv

  • 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

  • Load: 2 g/kg IV in divided doses for 2-4 days
  • Maintenance: 1000 mg/kg/day IV for 1 day q3Week or 500 mg/kg/day for 2 days q3Week

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, q3Week

Panzyga

  • Loading dose: 1 g/kg (10 mL/kg) IV BID x 2 consecutive days
  • Maintenance dose: 1-2 g/kg (10-20 mL/kg) divided in 2 daily doses given over 2 consecutive days every 3 weeks

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
  • 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% (Flebogamma, Asceniv, 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

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

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

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Interactions

Interaction Checker

and immune globulin IV (IGIV)

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (7)

              • 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.

              • 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.

              • measles (rubeola) vaccine

                immune globulin IV (IGIV) decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

              • 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.

              • rubella vaccine

                immune globulin IV (IGIV) decreases effects of rubella vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

              • smallpox (vaccinia) vaccine, live

                immune globulin IV (IGIV) decreases effects of smallpox (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.

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              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

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              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
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              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.

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              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)
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              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

              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

              Asceniv

              • Initial rate: 0.5 mg/kg/min for the first 15 min
              • May increase (if tolerated) q5min to up to 8 mg/kg/min (0.08 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 incr 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 & no significant risk factors for renal dysfunction or thrombotic complications may gradually incr 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 & changes in pulse rate & BP

              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: Do not exceed infusion rate of 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

              Bivigam, Asceniv: Refrigerate at 2-8°C (36-46°F) or at room temperature (25ºC) for up to 4 weeks during the first 24 months of the 36-month approved shelf life; do not freeze

              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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              GamaSTAN S/D intramuscular
              -
              15-18 % range vial
              GamaSTAN S/D intramuscular
              -
              15-18 % range vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.