- General Drug Summary
- Drug Name
- Intravenous Immunoglobulin
- Description
- Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders.
- Also Known As
- Ig alpha-2 chain C region; immune globulin; Immunoglobulin G
- Categories
- Anti-Infectives
- Structure
- Summary In Neonatal Jaundice
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1 record(s) for Intravenous Immunoglobulin Controvesial in Ulcerative Colitis in Neonatal Jaundice.
- PMID
- Drug Name
- Efficacy
- Evidence
- 19586760
- Intravenous Immunoglobulin
- Controvesial in Ulcerative Colitis
- Meta-Analysis
- Summary
- Efficient in treatment to Neonatal jaundice ,but may increase the risk of late transfusion.
- [High-dose intravenous immunoglobulin therapy and neonatal jaundice due to red blood cell alloimmunization]. Archives de pédiatrie : organe officiel de la Soc, 2009 Sep [Go to PubMed]
- Neonatal jaundice resulting from immunological hemolysis is not uncommon. While it is possible to prevent a large number of Rh-isoimmune hemolytic diseases by administration of specific anti-D immunoglobulins to the mother, the prevention of incompatibility in the ABO groups is not feasible. In spite of advances made in the use of phototherapy, and in order to avoid kernicterus, the treatment of these jaundices can require one or several exchange transfusions (ET), a therapy which is not devoid of risk. For some time now, the data concerning the efficiency of high-dose intravenous immunoglobulin therapy (HDIIT) in the treatment of these jaundices have been increasing. A review of the literature shows that, if used as soon as possible in newborn infants over 32 weeks of gestation age, afflicted with Rh or ABO hemolytic disease, the HDIIT brings about, with no undesirable side effects, a significant decrease in the ET number as well as a significant reduction in the length of phototherapy and hospitalization. he data suggesting that HDIIT could increase the risk of late transfusion is open to controversy.
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6 record(s) for Intravenous Immunoglobulin Effective in Inducing Remission in Neonatal Jaundice.
- PMID
- Drug Name
- Efficacy
- Evidence
- 21926893
- Intravenous Immunoglobulin
- Effective in Inducing Remission
- Clinical Trial
- Summary
- Increase use of transcutaneous bilirubin,and may decrease the need for exchange transfusions.
- Hyperbilirubinemia: current guidelines and emerging therapies. Pediatric emergency care, 2011 Sep [Go to PubMed]
- It is estimated that about two thirds of newborns will appear clinically jaundiced during their first weeks of life. As newborns and their mothers spend fewer days in the hospital after birth, the number of infants readmitted yearly in the United States for neonatal jaundice over the last 10 years has increased by 160%. A portion of these infants present to the emergency department, requiring a careful history and physical examination assessing them for the risk factors associated with pathologic bilirubin levels. Although the spectrum of illness may be great, the overwhelming etiology of neonatal jaundice presenting to an emergency department is physiologic and not due to infection or isoimmunization. Therefore, a little more than a good history, physical examination, and indirect/direct bilirubin levels are needed to evaluate an otherwise well-appearing jaundiced newborn. The American Academy of Pediatrics' 2004 clinical practice guidelines for"
Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestatio"
are a helpful and easily accessible resource when evaluating jaundiced newborns (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;114/1/297). There are several exciting developments on the horizon for the diagnosis and management of hyperbilirubinemia including increasing use of transcutaneous bilirubin measuring devices and medications such as tin mesoporphyrin and intravenous immunoglobulin that may decrease the need for exchange transfusions.
- 14596647
- Intravenous Immunoglobulin
- Effective in Inducing Remission
- Review
- Summary
- Exchange transfusion is now becoming rare due to treatment of sensitised infants with intravenous immunoglobulin.
- Recent advances in the pharmacotherapy for hyperbilirubinaemia in the neonate. Expert opinion on pharmacotherapy, 2003 Nov [Go to PubMed]
- Jaundice is a common cause for diagnostic works-up and therapeutic intervention in neonates. This is motivated by the risk for severe neurological sequelae (kernicterus). The mainstays of treatment for the past decades have been exchange transfusion and phototherapy. Exchange transfusion is now becoming rare due to immune prophylaxis in Rhesus-negative women, and treatment of sensitised infants with intravenous immunoglobulin. Several different pharmacological approaches have been studied as far as the treatment of neonatal jaundice. Of these, the focus of attention in recent years has been on the haem oxygenase inhibitors (metal meso- and protoporphyrins). These are effective inhibitors of bilirubin production and have been shown to significantly reduce peak serum bilirubin levels in several clinical trials, both when used prophylactically and therapeutically. However, questions remain regarding long-term safety, as well as the advisability of whole-scale inhibition of bilirubin production. Nevertheless, inselected infants with a high risk of severe jaundice, the use of haem oxygenase inhibitors may be acceptable. Pharmacotherapy in jaundiced infants is fraught with risks, as many drugs may increase the entry of bilirubin into the brain and presumably, the risk for neurotoxicity. Both the displacement of bilirubin from its albumin binding and interference with the function of phosphoglycoprotein in the blood-brain barrier are documented mechanisms in this respect.
- 8585207
- Intravenous Immunoglobulin
- Effective in Inducing Remission
- Clinical Trial
- Summary
- Effect on reduction in hemolysis and attenuation of jaundice.
- Carboxyhemoglobin levels in neonatal immune hemolytic jaundice treated with intravenous gammaglobulin. Vox sanguinis, 1995 [Go to PubMed]
- In order to examine the effect of intravenous immunoglobulin (IVIG) on the rate of hemolysis in immune hemolytic hyperbilirubinemia, we measured the carboxyhemoglobin levels of 5 newborn infants who were subjected to IVIG treatment. The pretreatment rate of hemolysis, in the 5 patients with isoimmune hemolytic jaundice (3 patients with Rh hemolytic disease of the newborn and 2 patients with ABO hemolytic disease of the newborn), as reflected by carboxyhemoglobin levels was higher than the rate of hemolysis in normal newborn infants. In 4 out of the 5 patients treated with IVIG, there was a rapid decline ( > 30%) of carboxyhemoglobin levels, a pattern which was different from that observed in normal newborn infants with no hemolytic jaundice and in 3 untreated patients with ABO hemolytic disease of the newborn. None of the treated patients required an exchange transfusion. Our preliminary results support the theory that the attenuation of jaundice observed following IVIG treatment in patients with immune hemolytic hyperbilirubinemia is caused, at least in part, by the reduction in hemolysis.
- 20013604
- Intravenous Immunoglobulin
- Effective in Inducing Remission
- Clinical Trial
- Summary
- intravenous immunoglobulin can treat hyperbilirubinemia.
- The influence of phototherapy on serum cytokine concentrations in newborn infants. American journal of perinatology, 2010 May [Go to PubMed]
- We sought to determine cytokine response in term and late preterm newborn infants on phototherapy. Twenty newborn infants with gestational age > or = 35 weeks and birth weight > or = 2000 g in the first week of life had serum interleukin (IL)-6, IL-8, IL-10, IL-1beta, and tumor necrosis factor (TNF)-alpha measured immediately prior to and after 24 hours on phototherapy. Exclusion criteria were newborns with severe congenital malformations, congenital infections, birth asphyxia, sepsis, hemolytic anemia that required blood transfusion, maternal-infant Rh incompatibility and those who required exchange transfusion or intravenous immunoglobulin treatment for hyperbilirubinemia. Median IL-6 concentrations significantly decreased after 24 hours on phototherapy (18.3 pg/mL and 7.85 pg/mL, respectively, p = 0.005). IL-6 concentrations decreased in 17 out of the 20 newborns. There were no statistical differences in IL-8, IL-10, IL-1beta, and TNF-alpha concentrations before and after 24 hours on phototherapy. There was a statistically significant correlation between IL-6 decline and irradiance (r = 0.57, p = 0.009). The finding that serum IL-6 decreases in newborn under phototherapy suggest that phototherapy possibly has an anti-inflammatory effect, although the clinical implications of this study deserve further studies.
- 21641491
- Intravenous Immunoglobulin
- Effective in Inducing Remission
- Practice Guideline
- Summary
- Until further experimental support can be gained, photoconversion of bilirubin does not constitute a viable argument against instituting further measures against bilirubin neurotoxicity, such as intravenous immune globulin (when indicated) and exchange transfusion.
- The role of phototherapy in the crash-cart approach to extreme neonatal jaundice. Seminars in perinatology, 2011 Jun [Go to PubMed]
- Extreme neonatal jaundice occurs infrequently but carries a high risk of permanent sequelae (kernicterus) when it does. Rapid therapeutic intervention has the potential to reduce this risk in some infants. Several case reports of infants with acute intermediate to advanced bilirubin encephalopathy shows that reversal may be possible. Phototherapy can be instituted at the flip of a switch, whereas other therapeutic measures necessarily involve delays. Therefore, high-intensity phototherapy must be regarded as an emergency measure in infants presenting with extreme jaundice and even more so in the presence of neurological symptoms. The principal and well-described effect of phototherapy involves conversion of bilirubin IXα (z, z) to more polar isomers, which are excreted in bile and urine. When care is taken to maximize the spectral power of phototherapy lights, and whenever possible with measures added to reduce the enterohepatic circulation of bilirubin, very rapid reductions in total serum bilirubin leves are possible. A hypothesis has been advanced that conversion of bilirubin to more polar photoisomers, which can reach relative concentrations of 20%-25% of total serum bilirubin within 1-2 hours, might have a direct neuroprotective effect. This theory posits that because polar molecules generally require a transporter to cross the blood-brain barrier, bilirubin photoisomers should be less prone to enter the brain. Although this theory has some support in in vitro toxicity studies, the evidence is controversial. Until further experimental support can be gained, photoconversion of bilirubin does not constitute a viable argument against instituting further measures against bilirubin neurotoxicity, such as intravenous immune globulin (when indicated) and exchange transfusion. Conversely, neither is the state of evidence an argument against immediate and effective phototherapy in the medical emergency of extreme neonatal jaundice.
- 11927726
- Intravenous Immunoglobulin
- Effective in Inducing Remission
- Clinical Trial
- Summary
- hyperbilirubinemia were started on phototherapy treatment. Additional treatment modalities, including intense phototherapy, intravenous immunoglobulin treatment, and exchange transfusion
- An early (sixth-hour) serum bilirubin measurement is useful in predicting the development of significant hyperbilirubinemia and severe ABO hemolytic disease in a selective high-risk population of newborns with ABO incompatibility. Pediatrics, 2002 Apr [Go to PubMed]
- In the era of early discharge of newborns from the hospital, newborns with ABO incompatibility are at especially greater risk for developing a subsequent significant hyperbilirubinemia because some of these infants also may present with some degree of ABO isoimmune disease. In this study, we aimed to determine prospectively the critical serum total bilirubin level to predict significant hyperbilirubinemia and severe hemolytic disease in healthy term newborns with ABO incompatibility based on a serum bilirubin measurement made at a postnatal age at which all newborns are at the hospital before discharge and at which any therapeutic intervention, if necessary, could be started as early as possible.
A total of 136 healthy term newborns with ABO (O-A or O-B) blood group incompatibility were followed prospectively with daily serum total bilirubin measurements for the first 5 days of life. Newborns with serum total bilirubin levels of > or =5 mg/dL and an increase in serum total bilirubin concentration of >0.5 mg/dL/h in the first 24 hours, > or =12 mg/dL on day 2, > or =15 mg/dL on day 3, and > or =17 mg/dL on days 4 and 5 were defined to have significant hyperbilirubinemia and were started on phototherapy treatment. Additional treatment modalities, including intense phototherapy, intravenous immunoglobulin treatment, and exchange transfusion, were used when serum bilirubin concentrations exceeded 20 mg/dL or increased by >1 mg/dL/h despite a phototherapy treatment of at least 4 hours. The additional assessment of the predictive ability of the sixth-hour serum total bilirubin value in determining the development of significant hyperbilirubinemia was made on the basis of the placement of any of the first 5 days' serum bilirubin measurements in the > or =90th percentile of the study population. On the basis of the percentile tracks constructed from the 10th, 35th, 50th, 60th, and 90th percentiles of serum total bilirubin values, a nomogram demonstrating the 3 percentile tracks as risk zone demarcators with divided risk zones was produced.
Twenty-nine newborns (21.3%) had significant hyperbilirubinemia. There were significant differences between the newborns who did and the newborns who did not develop significant hyperbilirubinemia with respect to the reticulocyte count (4.39 +/- 3.46% vs 2.95 +/- 1.63) and the presence of a direct antiglobulin test positivity (6 of 23 vs 0 of 107) and a sibling with neonatal jaundice (6 of 23 vs 5 of 102). A mean serum bilirubin level of > or =4 mg/dL at the sixth hour of life was determined to have the highest sensitivity (86.2%) and negative predictive value (94.5%) and a positive predictive value of 39.7% to predict the newborns who would develop significant hyperbilirubinemia. At the mean serum bilirubin level of 6 mg/dL, the sensitivity, specificity, and negative and positive predictive values were 100%, 91.5%, 100%, and 35.3%, respectively, in diagnosing 6 cases of severe ABO hemolytic disease. On the hour (age)-specific percentile-based nomogram, the zone above the 90th percentile was determined as high risk and that below the 35th percentile as low risk.
The reticulocyte count, a positive direct antiglobulin test, and the presence of a sibling with neonatal jaundice were determined to be the good predictors for the development of significant hyperbilirubinemia and severe hemolytic disease of the newborn. A serum bilirubin measurement and the use of the critical bilirubin levels of 4 mg/dL and 6 mg/dL at the sixth hour of life will predict nearly all newborns who will have significant hyperbilirubinemia and those who will develop severe hemolytic disease of the newborn, respectively. An hour (age)-specific percentile-based nomogram can be used to predict which newborn is at high risk (> or =90th percentile), intermediate risk (35th-90th percentiles), and low risk (<35th percentile) for developing significant hyperbilirubinemia. The 35th and 90th percentile tracks, approximating the serum bilirubin levels of 3.3 mg/dL and 6.5 mg/dL at the sixth hour of life, respectively, can be used as safe risk demarcators in deciding about the time of discharge of ABO-incompatible newborns from the hospital.
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1 record(s) for Intravenous Immunoglobulin Effective in Maintaining Remission in Neonatal Jaundice.
- PMID
- Drug Name
- Efficacy
- Evidence
- 16982453
- Intravenous Immunoglobulin
- Effective in Maintaining Remission
- Clinical Trial
- Summary
- High-dose IVIG can effectively arrest the progression of hemolytic disease, quickly reduce serum total billirubin concentration and shorten phototherapy time for early treatment of ABO-HDN.
- [Clinical study of early interventions for ABO hemolytic disease of the newborn]. Nan fang yi ke da xue xue bao = Journal of Souther, 2006 Sep [Go to PubMed]
- To investigate therapeutic effect of high-dose intravenous immunoglobulin (IVIG) for early management of ABO hemolytic disease of the newborn (ABO-HDN).
A total of 121 cases with ABO-HDN were randomly divided into treatment group (n=61) and control group (n=60). In addition to the routine treatment of the control group, IVIG were given at a daily dose of 400 mg/kg to the cases in the treatment group for 2-3 times, and therapeutic effects were evaluated and compared between the two groups.
The serum total billirubin concentration on the third day after treatment (153.42-/+45.21 micromol/L) and mean daily serum total billirubin concentration reduction (56.49-/+24.05 micromol/L) in treatment group were lower than those in the control group (P<0.01). The jaundice resolution time (23.51-/+11.19 h) and the phototherapy time (3.01-/+0.89 h) for billirubinemia treatment in treatment group were shorter than those in the control group (P<0.01). The patients in the the treatment group had higher hemoglobin level after treatment (15.59-/+2.01 g/L) than those of the control group (P<0.01).
High-dose IVIG can effectively arrest the progression of hemolytic disease, quickly reduce serum total billirubin concentration and shorten phototherapy time for early treatment of ABO-HDN.
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1 record(s) for Intravenous Immunoglobulin Adverse Event in Neonatal Jaundice.
- PMID
- Drug Name
- Efficacy
- Evidence
- 12137687
- Intravenous Immunoglobulin
- Adverse Event
- Clinical Trial
- Summary
- The use of intravenous immunoglobulin can not be recommended for the treatment of isoimmune haemolytic jaundice before further well designed studies.
- Immunoglobulin infusion for isoimmune haemolytic jaundice in neonates. The Cochrane database of systematic reviews, 2002 [Go to PubMed]
- Exchange transfusion and phototherapy have traditionally been used to treat jaundice and avoid the associated neurological complications. Exchange transfusion is not without risk and intravenous immunoglobulin has been suggested as an alternative therapy for isoimmune haemolytic jaundice to reduce the need for exchange transfusion.
To assess whether the use of intravenous immunoglobulin, in newborn infants with isoimmune haemolytic jaundice, is effective in reducing the need for exchange transfusion.
The search strategy of the Cochrane Neonatal Review group was used. Searches were made of MEDLINE 1966-2002, EMBASE Drugs and Pharmacology 1990-2002, Cochrane Controlled Trials Register, The Cochrane Library, Issue 1, 2002, expert informants, review articles, cross references, and hand searching of abstracts and conference proceedings of the annual meetings of The Society for Pediatric Research 1990-2001 and The European Society for Paediatric Research 1990-2001.
All randomised and quasi-randomised controlled trials of the use of intravenous immunoglobulin in the treatment of isoimmune haemolytic disease were considered.
The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Studies were assessed for inclusion and quality by two reviewers working independently, with the second reviewer blinded to trial author, institution and journal of publication. Data were extracted independently by the two reviewers. Any differences of opinion were discussed and a consensus reached. Investigators were contacted for additional or missing information. For categorical outcomes, the relative risk (RR), risk difference (RD) and the number needed to treat (NNT) were calculated. For continuous variables, the weighted mean difference (WMD) was calculated.
Seven studies were identified. Three of these fulfilled the inclusion criteria and included a total of 189 infants. Term and preterm infants and infants with rhesus and ABO incompatibility were included. The use of exchange transfusion decreased significantly in the immunoglobulin treated group (typical RR 0.28, 95% CI 0.17, 0.47; typical RD -0.37, 95% CI -0.49, -0.26; NNT 2.7). The mean number of exchange transfusions per infant was also significantly lower in the immunoglobulin treated group (WMD -0.52, 95% CI -0.70, -0.35). None of the studies assessed long term outcomes.
Although the results show a significant reduction in the need for exchange transfusion in those treated with intravenous immunoglobulin, the applicability of the results is limited. The number of studies and infants included is small and none of the three included studies was of high quality. The protocols of two of the studies mandated the use of early exchange transfusion, limiting the generalizability of the results. Further well designed studies are needed before routine use of intravenous immunoglobulin can be recommended for the treatment of isoimmune haemolytic jaundice.