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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)

FDA approves blood test developed by UPMC researchers to predict rejection in organ transplant recipients
Source: Transplants / Organ Donations News From Medical News Today [2014.11.07]
A first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants has received U.S.

Screening Organ Donors Can Prevent Transmission of Ebola Virus
Source: Medscape Transplantation Headlines [2014.12.17]
To prevent transmission of Ebola virus disease (EVD) through solid-organ transplantation, individuals who have had contact with an Ebola virus-infected individual within the previous 21 days should be excluded as donors, experts say.
Reuters Health Information

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)

Human Anti-Tac (Daclizumab) to Treat JIA-Associated Uveitis [Completed]
This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The HAT antibody is designed to prevent a specific chemical interaction needed for immune cells to produce inflammation. Current treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not always work or they may cause significant side effects. This study will determine whether daclizumab can improve uveitis in children and reduce the need for other medicines.

Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis requiring treatment with anti-inflammatory medications as often as three times a day or more may be eligible for this study.

Each candidate is screened with a medical history, physical examination, blood tests, eye examination, and the following specialized tests:

- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected

into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating the presence of inflammation.

- Optical coherence tomography to measure retinal thickness. The eyes are examined through

a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening.

- Stereoscopic color fundus photography to examine the back of the eye. The pupils are

dilated with eye drops to examine and photograph the back of the eye.

Upon entering the study, participants receive a 90-minute infusion of daclizumab through a catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four weeks after the third infusion, patients are examined for response to treatment. Those who have benefited from daclizumab may continue receiving monthly infusions of the drug for up to one year. A blood test and eye examination are done at the time of each infusion. Patients whose disease has remained active 12 weeks after the first infusion are taken off the study and treated with other medications.

Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis [Active, not recruiting]
This study will examine the safety of Zenapax (daclizumab) in patients with multiple sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes (cells of the immune system), are thought to damage myelin, a substance that covers the nerve and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin that occurs in multiple sclerosis.

Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this study. Patients with secondary-progressive or primary progressive MS may not participate. Candidates will be screened with a complete neurological and medical evaluation and review of medical records.

Participants will undergo the following tests and procedures:

- Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over

a 3-month period to assess disease activity. For the MRI scans, the patient lies on a

table that slides into the scanner - a narrow metal cylinder with a strong magnetic

field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Only patients with activity at or above a certain level are eligible to continue with the treatment phase of the study.

- Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax.

The first two infusions are 2 weeks apart, followed by 13 monthly infusions.

- MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease

activity and identify new brain lesions.

- Blood and urine tests: Blood and urine samples are collected at each clinic visit for

routine laboratory evaluations, immunologic study, and genetic testing to determine a predisposition for responding to Zenapax treatment.

- Lumbar puncture (spinal tap): This procedure will be done during the last month before

starting treatment and during the seventh month of treatment to examine immune changes that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the brain and spinal cord. A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.

- Skin test: A needle is placed just under the skin is done to assess the patient's immune

status to common antigens such as tetanus, mumps and candida.

- Lymphocytopheresis: Lymphocytes are collected three times - once during the last month

of baseline before starting treatment, once during the fifth month of treatment, and

once during the last month of treatment - for immunologic study. Blood is collected

through a needle in an arm vein in a similar way to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The lymphocytes are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body, either through the same needle or through another needle in the other arm.

ANTI-TAC THERAPY FOR UVEITIS [Completed]
Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects. Consequently, an effective treatment with a safer side effect profile is highly desirable.

This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate or posterior uveitis who require treatments to maintain visual function. This extended protocol began with an evaluation of the safety and potential efficacy of intravenous (IV) daclizumab treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care. As subcutaneous (SC) daclizumab treatments become available, eligible participants will be offered continuing daclizumab treatments using the new SC formulation, though they may elect to remain on the IV treatments. If the therapeutic benefit is sustained using the SC formulation, maintenance therapy will continue as clinically indicated. Participants who repeatedly fail the SC therapy will be permitted to revert to the IV daclizumab regimen they previously used, or may exit the study as treatment failures. SC treatments begin with a short SC induction at 2 mg/kg followed by 1 mg/kg treatments on a 4-week schedule as the protocol originally specified. Participants will be monitored routinely when each dose is received and additionally will participate in pharmacokinetic studies to monitor SC formulation bioavailability.

Daclizumab is a humanized anti-Tac monoclonal antibody (HAT, Zenapax) that interferes with inflammatory processes by its involvement with the interleukin 2 receptor (IL-2R). During the first 5 years of this study, only an IV product was available. The SC formulation is now available containing the same daclizumab drug product. Preliminary studies indicate that the SC formulation is well tolerated by normal control subjects and other autoimmune disease patients at repeated doses up to 2 mg/kg.

The primary objectives are to examine the safety and potential efficacy of IV and later, SC daclizumab, while continuing to reduce other immunosuppressive medications commensurate with the standard of care. Primary safety outcomes are the discontinuation of study therapy due to reduced vision or the occurrence of adverse events. Secondary outcome measures include visual acuity and the grading of immunosuppressive medications, anterior chamber and vitreous cells, and vitreous haze.

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.

Zenapax to Treat Multiple Sclerosis [Active, not recruiting]
This study will examine the safety and effectiveness of Zenapax (a laboratory-manufactured antibody) in treating multiple sclerosis. Multiple sclerosis may be caused by an abnormal immune response in which white blood cells called T lymphocytes attack the myelin sheath that covers nerves and parts of the spinal cord. Zenapax binds to protein receptors on lymphocytes, keeping them from interacting with interleukin-2, a substance necessary for their growth.

Patients with multiple sclerosis who have had at least one relapse within 18 months of the start of the study and in whom interferon-beta treatment has not been successful may be considered for this study. There are two study phases: baseline and treatment. During the baseline phase, patients will have three magnetic resonance imaging (MRI) scans over 2 months to evaluate their disease activity. During treatment, patients will receive seven intravenous (I. V.) infusions of Zenapax in the clinic. The first two infusions will be given 2 weeks apart; the next five will be given once a month.

Patients will have MRI scans before each infusion. The MRIs will be done using the standard procedure and again using a contrast agent, gadolinium, injected into a vein. Gadolinium helps identify new multiple sclerosis lesions in the brain. Blood and urine samples will be taken during each clinic visit. In addition, patients will have skin tests, similar to a tuberculin test, to evaluate immune status, and will be asked to undergo two lumbar punctures (spinal tap; these will be optional)-one before the treatment phase begins, and another when treatment is completed. Lymphocytes will also be collected from patients before, during and after treatment. The lymphocytes are obtained by a procedure called apheresis: about a pint of whole blood is drawn through a needle in the arm, the lymphocytes are separated out and removed by a machine, and the rest of the blood is returned through a needle in the other arm. These studies will hopefully allow conclusions about the safety of Zenapax in MS, but also address its effectiveness with respect to modifying the inflammatory activity in the brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease process.

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: 2014-12-17

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