A rational dosing algorithm for basiliximab (Simulect) in pediatric renal transplantation based on pharmacokinetic-dynamic evaluations1

Kovarik, John M.; Offner, G.; Broyer, M.; Niaudet, Patrick; Loirat, Chantal; Mentser, Mark; Lemire, Jacques; Crocker, John F. S.; Cochat, Pierre; Clark, Godfrey; Gerbeau, C; Chodoff, Lawrence; Korn, Alexander; Hall, Michael

doi:10.1097/00007890-200210150-00011

Cited by 45 publications

(44 citation statements)

References 11 publications

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“…40 kg should receive 20 mg IV, which is similar to adult dosing. 276 A case report has been published on basiliximab therapy in two infants who received lung transplants for interstitial pneumonia. 277 Adverse events are not described.…”

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

“…261 An open-label pharmacokinetic/pharmacodynamic safety study evaluating basiliximab in 41 pediatric renal transplant patients aged 1 to 17 years has been published. 276 The most common adverse events were hypertension, hypertrichosis, and rhinitis (49% each); urinary tract infection (46%); fever (39%); upper respiratory infection (29%); and sepsis and constipation (24% each). 276 Three serious adverse events were possibly medication related and included fever, enteritis, and CMV infection.…”

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

“…276 The most common adverse events were hypertension, hypertrichosis, and rhinitis (49% each); urinary tract infection (46%); fever (39%); upper respiratory infection (29%); and sepsis and constipation (24% each). 276 Three serious adverse events were possibly medication related and included fever, enteritis, and CMV infection. Six patients (15%) experienced adverse events suspected to be basiliximab related.…”

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

“…Biochemical and hematologic abnormalities were low except for reduced magnesium levels (56%), elevated serum uric acid and potassium levels (20% each), and leukocytosis (51%). 276 3.4.1.3 Pregnancy Classifi cation-There are no adequate studies on the use of basiliximab in pregnant women. It is classifi ed as pregnancy category B.…”

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

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Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

Baughman

Meyer

Nathanson

et al. 2012

Chest

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Objectives: Immunosuppressive pharmacologic agents prescribed to patients with diffuse interstitial and infl ammatory lung disease and lung transplant recipients are associated with potential risks for adverse reactions. Strategies for minimizing such risks include administering these drugs according to established, safe protocols; monitoring to detect manifestations of toxicity; and patient education. Hence, an evidence-based guideline for physicians can improve safety and optimize the likelihood of a successful outcome. To maximize the likelihood that these agents will be used safely, the American College of Chest Physicians established a committee to examine the clinical evidence for the administration and monitoring of immunosuppressive drugs (with the exception of corticosteroids) to identify associated toxicities associated with each drug and appropriate protocols for monitoring these agents. Methods: Committee members developed and refi ned a series of questions about toxicities of immunosuppressives and current approaches to administration and monitoring. A systematic review was carried out by the American College of Chest Physicians. Committee members were supplied with this information and created this evidence-based guideline. Conclusions: It is hoped that these guidelines will improve patient safety when immunosuppressive drugs are given to lung transplant recipients and to patients with diffuse interstitial lung disease. CHEST 2012; 142(5):e1S-e111SAbbreviations: ACCP 5 American College of Chest Physicians; ALT 5 alanine aminotransferase; ATG 5 antithymocyte globulin; CHF 5 congestive heart failure; CMV 5 cytomegalovirus; CNI 5 calcineurin inhibitor; COI 5 confl ict of interest; CsA 5 cyclosporin A; FDA 5 US Food and Drug Administration; HBV 5 hepatitis B virus; HMG-CoA 5 b -hydroxy-bmethylglutaryl-coenzyme A; HSP 5 Health and Science Policy Committee; IL2RA 5 IL-2 receptor a ; ILD 5 interstitial lung disease; IPF 5 idiopathic pulmonary fi brosis; ITP 5 idiopathic thrombocytopenia purpura; LAM 5 lymphangioleiomyomatosis; MESNA 5 sodium 2-sulfonylethanesufonate; MPA 5 mycophenolic acid; mTOR 5 mammalian target of rapamycin; PTLD 5 posttransplant lymphoproliferative disease; RCT 5 randomized controlled trial; SIRS 5 systemic infl ammatory response syndrome; TNF 5 tumor necrosis factor; TPMT 5 thiopurine methyltransferase

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Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

Section: Il-2 Receptor Antagonistsmentioning

confidence: 99%

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Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

Baughman

Meyer

Nathanson

et al. 2012

Chest

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“…This level is consistent with literature data from clinical studies evaluating the efficacy of therapeutic antibodies. Kovarik et al [57] assessed the immunodynamics of basiliximab (anti-CD25) in pediatric kidney allograft patients and concluded that patients should receive two doses of 1 mg/kg to obtain plasma concentrations above 1 Ag/ml to ensure the prolonged CD25 saturation needed for prevention of rejection. Similarly, in the treatment of rejections, muronomab-CD3 (Orthoclone) is given in daily doses of 5 mg for 10-14 days [58].…”

Section: Effective Therapeutic Antibody Levelsmentioning

confidence: 99%

Therapeutic Antibody Gene Transfer: An Active Approach to Passive Immunity

Bakker¹,

Bleeker²,

Parren³

2004

Molecular Therapy

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Advances in gene transfer approaches are enabling the possibility of applying therapeutic antibodies using DNA. In particular gene transfer in combination with electroporation is promising and can result in generating in vivo antibody concentrations in the low therapeutic range. However, several important problems need to be dealt with before antibody gene transfer can become a valuable supplement to the current therapies. As antibody production following gene transfer is difficult to control, the danger of inducing autoimmune conditions or uncontrollable side effects occurs in cases in which autologous antigens are targeted. It is suggested that the most promising area of application therefore appears to be infectious disease in which heterologous antigens are targeted and concerns for long-term antibody exposure are minimal. Finally, genes encoding fully human antibodies will enhance long-term expression and decrease problems linked to immunogenicity.

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Quantitative Pharmacology Approach to Select Optimal Dose and Study the Important Factors in Determining Disposition of Therapeutic Monoclonal Antibody in Pediatric Subjects – Some Considerations

Hardiansyah

2019

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune‐Mediated Infl

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A rational dosing algorithm for basiliximab (Simulect) in pediatric renal transplantation based on pharmacokinetic-dynamic evaluations1

Cited by 45 publications

References 11 publications

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

Therapeutic Antibody Gene Transfer: An Active Approach to Passive Immunity

Quantitative Pharmacology Approach to Select Optimal Dose and Study the Important Factors in Determining Disposition of Therapeutic Monoclonal Antibody in Pediatric Subjects – Some Considerations

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