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
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10% (100mg/mL)
  • 5% (50mg/mL)
more...

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

See Administration

Carimune NF

  • 400-800 mg/kg IV q3-4Week or may increase frequency based on patient response 
  • Initial infusion rate: 0.5 mg/kg/min for the first 30 minutes, may increase to 1 mg/kg/min if tolerated for the next 30 minutes; not to exceed 3 mg/kg/min

Flebogamma

  • 300-600 mg/kg q3-4Week
  • Initial infusion rate: 0.5 mg/kg/min for the first 30 min; may gradually increase and not to exceed 5 mg/kg/min if infusion is tolerated

Gammagard S/D, Gamunex-C, Gammagard Liquid

  • 300-600 mg/kg IV q4Week; adjust based on dosage and interval as well as serum IgG concentrations
  • Initial infusion rate is 0.8 mg/kg/min for the first 10 min; may increase q30min (if tolerated) up to 8 mg/kg/min

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

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

Bivigam (ready-to-use 10% liquid)

  • 300-800 mg/kg IV q3-4wk
  • Initial infusion rate is 0.5 mg/kg/min for the first 10 min; may increase q20min (if tolerated) by 0.8 mg/kg/min up to 6 mg/kg/min

Octagam

  • 300-600 mg/kg IV q3-4wk
  • Initial infusion rate: 0.5 mg/kg/min IV

Privigen

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

Immune Thrombocytopenic Purpura

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 

Privigen

  • 1 g/kg/day IV for 2 days

Gammaked

  • 2 g/kg IV divided into 2 doses of 1 g/kg given on 2 successive days, OR
  • 2 g/kg IV divided into 5 doses of 0.4 g/kg given on 5 consecutive days

Gammaplex

  • 1 g/kg IV for 2 consecutive days

Gamunex

  • 1 g/kg/day IV for 1-2 days or 400 mg/kg/day for 5 days

Gamunex-C

  • 1 g/kg IV x 2 days or 400 mg/kg IV x 5 days
  • Initial infusion rate is 1 mg/kg/min; may increase to 8 mg/kg/min if tolerated

Carimune

  • 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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (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

Kawasaki Disease

Initiate IVIG within 10 days of diagnosis; use in combination with aspirin 80-100 mg/kg/day divided q6hr for 14 days; administer aspirin at 3-5 mg/kg IV qDay for >6-8wk 

Gammagard S/D

  • 1000 mg/kg IV once administered over 10 hr OR
  • 400 mg/kg/day IV for 4 days; administer within 7 days of onset of fever

Bone Marrow Transplant

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

Chronic Inflammatory Demyelinating Polyneuropathy

Gamunex

  • Load: 2 g/kg IV divided q6012hr for 2-4 days 
  • Maintenance: 1000 mg/kg/day IV for 1 day q3wk or 500 mg/kg/day for 2 days q3wk

Gamunex-C

  • Load: 2 g/kg IV
  • Maintenance: 1 g/kg IV as a single dose or 500 mg/kg IV x 2 days q3weeks
  • Initial infusion rate is 2 mg/kg/min; may increase to 8 mg/kg/min if tolerated

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 (Off-label)

1 g/kg IV x2 consecutive days, THEN 400 mg/kg qMonth, generally for 6-mth course 

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 Therapuetics, 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

  • 10% (100mg/mL)
  • 5% (50mg/mL)
more...

Pediatric HIV, Prevention of Infection

400 mg/kg IV q2-4hr 

Primary Immunodeficiency Syndrome

Flebogamma, Gammagard S/D, Gammagard Liquid

  • 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

Octagam

  • 300-600 mg/kg IV q3-4wk
  • Initial infusion rate: 0.5 mg/kg/min IV

Privigen

  • 200-800 mg/kg IV q3-4wk

Immune Thrombocytopenic Purpura

As in adults

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Initial dose: 2 g/kg IV given in divided doses over 2-4 successive days

Maintenance dose: 1 g/kg IV given on 1 day or in 2 divided doses (0.5 g/kg/dose) on 2 consecutive days q3weeks

Kawasaki Disease

As in adults

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

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            Adverse Effects

            1-10%

            Chills (8.9%)

            Headache (5.4%)

            Generalized pain (3.6%)

            Hypotension

            Anaphylaxis related to infusion rate

            Aseptic meningitis syndrome (rare)

            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 the 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 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 Category: C

            Lactation: not known if excreted in breast milk

            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

            Pharmacokinetics

            Half-Life: 14-40 days (varies greatly by patients)

            Onset: Immediate

            Duration: 1-3 months (variable)

            Peak Plasma Time: 2.9 days (Gammagard, Hizentra); 2.5 days (Vivaglobin); 48 hr (IM serum)

            Vd: 0.09-0.13 L/kg

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            Administration

            IV Preparation

            Dilution is dependent upon mfr & brand; do not shake, avoid foaming; discard unused portion

            Iveegam EN: reconstitute with SWI; use immediately after reconstitution

            Gammagard S/D, Polygam S/D: reconstitute with SWI; 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 a filter, supplied by mfr.

            Sandoglobulin: reconstitute with NS, D5W or SWI; when diluted aseptically in a sterile laminar flow hood, may store diluted solution under refrigeration for up to 24 hr

            Gamunex incompatible w/ saline, dilute in D5W if necessary

            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

            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
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            Formulary

            FormularyPatient Discounts

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

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            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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