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Zenapax (Daclizumab) - Summary

 
 



ZENAPAX SUMMARY

ZENAPAX® (Daclizumab) is an immunosuppressive, humanized IgG1 monoclonal antibody produced by recombinant DNA technology that binds specifically to the alpha subunit (p55 alpha, CD25, or Tac subunit) of the human high-affinity interleukin-2 (IL-2) receptor that is expressed on the surface of activated lymphocytes.

ZENAPAX is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplants. It is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

The efficacy of ZENAPAX for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.


See all Zenapax indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zenapax (Daclizumab)

Deadly Skin Cancer More Common in Organ Transplant Recipients: Study
Source: MedicineNet Melanoma Specialty [2015.08.18]
Title: Deadly Skin Cancer More Common in Organ Transplant Recipients: Study
Category: Health News
Created: 8/17/2015 12:00:00 AM
Last Editorial Review: 8/18/2015 12:00:00 AM

Organ transplantation linked to greater risk of aggressive melanoma
Source: Dermatology News From Medical News Today [2015.08.16]
New research from Johns Hopkins finds organ transplant recipients are at increased risk of melanoma skin cancer, with many likely to be diagnosed in the advanced stages.

Too Few Kidney Dialysis Patients Referred for Organ Transplant, Study Finds
Source: MedicineNet Dialysis Specialty [2015.08.12]
Title: Too Few Kidney Dialysis Patients Referred for Organ Transplant, Study Finds
Category: Health News
Created: 8/11/2015 12:00:00 AM
Last Editorial Review: 8/12/2015 12:00:00 AM

Organ rejection can be overcome, shows mouse study
Source: Transplants / Organ Donations News From Medical News Today [2015.07.08]
The immune system's 'memory' of rejecting a first organ transplant is not necessarily permanent, suggest the results of a new study.

more news >>

Published Studies Related to Zenapax (Daclizumab)

Disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with daclizumab high-yield process in the SELECT study. [2014]
versus placebo-treated patients who were free from disease activity... CONCLUSION: At one year, DAC HYP resulted in a meaningful increase in the

Daclizumab reduces CD25 levels on T cells through monocyte-mediated trogocytosis. [2014]
Daclizumab is a humanized monoclonal antibody that prevents interleukin-2 (IL-2) binding to CD25, blocking IL-2 signaling by cells that require high-affinity IL-2 receptors to mediate IL-2 signaling...

Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation. [2010.11]
BACKGROUND: We performed a randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation. METHODS: Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C)...

Assessing renal function with daclizumab induction and delayed tacrolimus introduction in liver transplant recipients. [2010.06.27]
BACKGROUND: Calcineurin inhibitor-induced renal dysfunction is a major problem in liver transplantation. Interleukin-2 receptor antagonist induction followed by delayed tacrolimus (Tac) administration may minimize the renal insult without compromising immunoprotection... CONCLUSIONS: Delay of Tac does not benefit renal function in liver transplant recipients with a good renal function at baseline.

Daclizumab for relapsing remitting multiple sclerosis. [2010.06.16]
CONCLUSIONS: Although studies examining daclizumab for relapsing remitting multiple sclerosis were located, methodologic limitations resulted in the exclusion of all studies. Some of the studies were labelled as crossover trials, however they only compared the effect of different interventions for the same individual. The true randomized crossover trial should compare the effect of different groups, which receive the same intervention, only with the difference in sequence. In other words, the crossover comparison should be between the different groups, rather than on the individual between pretreatment and post treatment. At the same time, all the individuals should be randomly allocated to different groups. There was also a rigorous randomized controlled trial, but the follow-up was shorter than one year (only 44 weeks). In general, daclizumab is safe and well tolerated in combination of interferon treated multiple sclerosis population. Improvements in methodology in future studies are required for meaningful synthesis of data.

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Clinical Trials Related to Zenapax (Daclizumab)

Anti-Tac for Treatment of Leukemia [Completed]
The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD) of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult T-cell leukemia/lymphoma (ATL); (2) to define the dose of Zenapax(Registered Trademark) required to saturate interleukin 2 receptor alpha (IL-2R) alpha in patients with ATL; (3) determine the clinical response to humanized (Hu) anti-Tac (Zenapax(Registered Trademark) of patients with Tac-expressing adult T-cell leukemia; and (4) determine the serum dieaway curve (pharmacokinetics) of infused humanized (Hu)-anti-Tac in patients who have ATL. This study represented an extension of Metabolism Branch National Cancer Institute (NCI) protocols utilizing modifications of the original murine anti-Tac monoclonal antibody (mAb) developed by our group for the treatment of ATL. The scientific basis for these therapeutic studies is that the leukemic cells of patients with ATL express abnormally high levels of the Tac antigen (IL-2R alpha) on their surface whereas resting normal cells including normal T-cells of the patients do not. One presumed mode of action of Hu-anti-Tac in the treatment of ATL involves the interruption of the interaction of interleukin 2 (IL-2) with its growth factor receptor. To be effective in this goal we must maintain saturation of the IL-2 receptors (IL-2R) with humanized anti-Tac thereby preventing IL-2 mediated proliferation and yielding cytokine deprivation and apoptotic cell death of the leukemic cells. Eligible patients with ATL were treated with escalating doses of Zenapax(Registered Trademark) between groups in the Clinical Center of the National Institutes of Health (NIH). Groups of patients received sufficient Zenapax(Registered Trademark) to yield saturation of the IL-2 receptor for a period of 17 weeks. Clinical response was evaluated using routine immunological and clinical evaluation and by monitoring the saturation of the IL-2R and the absolute number of residual circulating malignant cells by fluorescence activated cell sorting (FACS) analysis using two fluorochrome-labeled non-crossreacting antibodies to the IL-2 receptor, anti-Tac and 7G7/B6, as well as antibodies to cluster of differentiation 3 (CD3), cluster of differentiation 4 (CD4), cluster of differentiation 7 (CD7), and cluster of differentiation 8 (CD8). Furthermore, responses were evaluated in patients with leukemia by Southern blot analysis of the arrangement of the T-cell receptor genes and human T-lymphotropic virus type 1 (HTLV-I) integration. Finally, in select patients, to define the pharmacokinetics of the therapeutic antibody, had planned to monitor the serum levels of the infused Hu-anti-Tac (Zenapax(Registered Trademark)) as a function of time. This study is an essential element of our program involving IL-2R-directed therapeutic studies. If as anticipated the therapy with humanized anti-Tac yields some partial and complete remissions in patients with ATL, we will propose that it be used as a single agent for patients with smoldering and chronic ATL and in association with chemotherapeutic agents to provide a novel approach for the treatment of acute and lymphoma forms of ATL. We also plan a future clinical trial where tentative plans also had been made to evaluate the efficacy and toxicity in ATL patients of saturating doses of Zenapax(Registered Trademark) as compared to identical doses of Zenapax(Registered Trademark) given in association with (90)Y-armed 7G7/B6, a non-competing antibody to IL-2R alpha or in combination with chemotherapy.

A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure [Terminated]
Participants in this study are suffering from rare and serious blood disorders. In aplastic anemia, the bone marrow stops producing red blood cells, platelets, and white blood cells. In pure red cell aplasia, the bone marrow stops producing red cells, and in amegakaryocytic thrombocytopenic purpura, the bone marrow stops producing platelets. Current treatment approaches for these disorders include bone marrow transplant and/or immunosuppression. However, bone marrow transplant is not always possible, and immunosuppression has serious side effects. This study will investigate whether daclizumab can be used to treat these disorders. Daclizumab is a genetically engineered human antibody that blocks the interleukin-2 receptor on immune cells. It has been used successfully in many transplant patients to reduce the rate of organ rejection. Participants will undergo a complete history and physical examination. A bone marrow aspiration and biopsy will be performed to confirm the type of bone marrow failure. About 5 tablespoons of blood will be drawn for baseline tests and research purposes. Daclizumab will be administered every 2 weeks by vein in a 30-minute infusion. The first dose will be given at NIH and the next four may be given at NIH or by the participant's primary hematologist. The treatment will last 8 weeks. Participants must also see their referring physician or NIH physicians every 2 weeks for blood counts. In the fourth and eighth weeks of the study and at the 3-month follow-up visit, 2 tablespoons of blood will be drawn at NIH. At the 1-month follow-up visit to NIH, 5 tablespoons of blood will be drawn and another bone marrow aspiration and biopsy performed. Risks from bone marrow aspiration and biopsy and blood draws include discomfort. Daclizumab is usually well-tolerated; however, it may weaken immunity against certain bacteria and viruses.

Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk [Completed]
To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.

Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab) [Completed]
The purpose of this study is to determine the safety of the combination of CHOP plus daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.

Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration [Completed]
This study examined whether the anti-inflammatory medicines infliximab, sirolimus or daclizumab, when given with a participant's current therapies, would prevent the growth of new blood vessels in the eye in participants with age-related macular degeneration (AMD). Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible for this study. Vision in the study eye was between 20/20 and 20/400.

Participants were randomly assigned to one of three treatments - infliximab, sirolimus, or

daclizumab - or to observation only. In addition, participants may have been treated by

their ophthalmologist as needed for their AMD. Infliximab and daclizumab were given intravenously (through a vein); infusions were given at enrollment in the study, then at 2 weeks, and then monthly. Sirolimus was a pill that was taken every other day for the duration of the study. At 6 months, participants were evaluated to see whether continuing treatment would be beneficial. In addition to treatment or observation, participants underwent the following procedures: Physical examination at enrollment and 6 months. Photographs of the back of the eye, fluorescein angiography, indocyanine green angiography and measurement of retinal thickness at enrollment and months 1, 3 and 6.

- Fluorescein angiography evaluated the eye's blood vessels. A yellow dye was injected

into an arm vein and traveled to the blood vessels in the eyes. Pictures of the retina were taken using a camera that flashed a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.

- Indocyanine green angiography identified feeder vessels that may have supplied abnormal

blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.

- Optical coherence tomography measures retinal thickness. This test shines a light into

the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine whether retinal thickening is getting better or worse, or staying the same. Tuberculin skin test and chest x-ray at enrollment and 6 months. Blood tests at enrollment and months 1, 3 and 6.

more trials >>

Reports of Suspected Zenapax (Daclizumab) Side Effects

Viith Nerve Paralysis (3)Cytomegalovirus Infection (3)Abdominal Pain (2)Arachnoiditis (2)Infection (2)Skin Toxicity (2)Tachycardia (2)Pyrexia (2)Fatigue (2)Neuropathy Peripheral (2)more >>


Page last updated: 2015-08-18

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