Daclizumab

Daclizumab Uses, Dosage, Side Effects, Food Interaction and all others data.

Humanized IgG1 Mab that binds to the human interleukin-2 receptor (anti-Tac or anti-CD25). Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody.

On 22 April 2008, Roche Registration Limited chose to voluntarily withdraw the marketing authorization for their product Zenapax (daclizumab), as indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen like cyclosporine and corticosteroids in patients who are not hight immunized, for commercial reasons and confirmed that this decision was not related to any safety concerns associated with the use of Zenapax (daclizumab) . Regardless of the withdrawal of Zenapax, Biogen and Abbvie's Zinbryta (daclizumab), as indicated for the treatment of adult patients with relapsing forms of multiple sclerosis, was approved for use by the FDA in 2016 .

Despite being approved for use, Zinbryta (daclizumab)'s complex pre-existing safety profile consisting of its restricted availability through a Risk Evaluation and Mitigation Strategy program and its black box warning for possible hepatic injury, autoimmune hepatitis, and other immune mediated disorders meant its therapeutic usage, adverse effects, and prescribing information was subject to continuous monitoring and updating.

Daclizumab
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Daclizumab
Availability	Discontinued
Generic	Daclizumab
Daclizumab Other Names	Dacliximab, Daclizumab, Daclizumab beta
Related Drugs	Gilenya, Tysabri, Vumerity, tacrolimus, azathioprine, cyclosporine, mycophenolate mofetil, CellCept, Imuran, Copaxone
Type	Subcutaneous
Formula	C₆₃₃₂H₉₈₀₈N₁₆₇₈O₁₉₈₉S₄₂
Weight	142612.1 Da
Groups	Investigational, Withdrawn
Therapeutic Class
Manufacturer
Available Country	United States
Last Updated:	September 19, 2023 at 7:00 am

Uses

Daclizumab is a monoclonal anti-CD25 antibody that blocks the interleukin-2 receptor which is used to treat relapsing forms of multiple sclerosis.

Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection

Daclizumab is also used to associated treatment for these conditions: Relapsing Multiple Sclerosis (RMS)

How Daclizumab works

Zenepax binds with high-affinity to the Tac subunit of the high-affinity IL-2 receptor complex and inhibits IL-2 binding. The IL-2 receptor (Tac) subunit is expressed on activated but not resting lymphocytes.

Daclizumab Alcohol interaction

[Moderate]

Coadministration of daclizumab with other agents known to induce hepatotoxicity may increase the risk of liver injury.

Serious drug-related hepatic injury, including liver failure and autoimmune hepatitis, has been reported across controlled and open-label studies in 1.7% of daclizumab-treated patients and may occur at any time during treatment and up to 5 months after treatment cessation.

Fatal cases have occurred.

In addition, cases of hepatic injury have occurred in patients taking daclizumab concomitantly with other hepatotoxic drugs; however, the contributory role of these other medicines has not been established.

Caution is advised if daclizumab is used with other potentially hepatotoxic agents, including non-prescription products and herbal supplements.

Patients treated with daclizumab should have serum transaminase levels and total bilirubin measured prior to initiation of treatment and monthly during treatment in accordance with the manufacturer's recommendations, and the dosing adjusted or interrupted as necessary.

Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.