A Framework for Fitness-for-Purpose and Reuse in Computational Phenotyping
November 17, 2025
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Brand Name :
Zinbryta
Synonyms :
daclizumab
Class :
Monoclonal antibodies, Interleukin inhibitors
Brand Name :
Zinbryta
Synonyms :
daclizumab
Class :
Monoclonal antibodies, Interleukin inhibitors
Dosage Forms & StrengthsÂ
Injectable solutionÂ
5mg/mlÂ
150mg/mlÂ
150
mg
Solution
Subcutaneous (SC)
once a month
Safety study not established for use in the pediatric population under the age of 17yearsÂ
Safety study not established for use in geriatric population above the age of 65 yearsÂ
It may diminish the effects when combined with rozanolixizumab by receptor binding competition
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of infection can be increased
allogeneic processed thymus tissueÂ
a decrease in the therapeutic activity of allogenic processed thymus tissue may be seen
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of adverse effects can be increased
the risk of adverse effects can be increased
synthetic conjugated estrogens, aÂ
an increase in thrombogenic activity of daclizumab may be seen
synthetic conjugated estrogens, bÂ
an increase in thrombogenic activity of daclizumab may be seen
the risk of adverse effects can be increased
an increase in the thrombogenic activity of daclizumab may be seen
tick-borne encephalitis vaccineÂ
the therapeutic activity of the tick-borne encephalitis vaccine (whole virus, inactivated) may be reduced
may enhance the immunosuppressive effects of trimetrexate
when both drugs are combined, there may be an increased risk or severity of adverse effects   
may enhance the immunosuppressive effects of pemetrexed
Actions and spectrum:Â Â
Daclizumab is thought to modulate IL-2-mediated lymphocyte activation by binding to CD25, a subunit of the high-affinity IL-2 receptor. The exact mechanism by which daclizumab causes therapeutic properties in multiple sclerosis is undetermined.Â
Frequency not definedÂ
CoughingÂ
Chest painÂ
VomitingÂ
Shaking or trembling of hands or feetÂ
Shortness of breathÂ
WeaknessÂ
NauseaÂ
VomitingÂ
Frequent urination (rare)Â
Trouble sleepingÂ
HeadacheÂ
Pain in the muscleÂ
Oropharyngeal painÂ
Frequency definedÂ
Lymphadenopathy (1-10%)Â
Toxic skin eruption (0.1-1%)Â
Dermatitis (1-10%)Â
Erythematous rash (1-10%)Â
Vesicular rash (11%)Â
Tonsillitis (1-10%)Â
Decrease in lymphocyte count (1-10%)Â
Anemia (1-10%)Â
Depression (1-10%)Â
Infection of the upper respiratory tract (17%)Â
Nasopharyngitis (25%)Â
Black Box Warning Â
Daclizumab is available only through the REMS program (Risk Evaluation and Mitigation Strategy) because of the risk of hepatic injury and immune-mediated disorders.Â
Contraindication/Caution:Â
Contraindication:Â
HypersensitivityÂ
Hepatic impairmentÂ
Pregnancy consideration:Â Â
No adequate data is established for the use of daclizumab in pregnancy Â
Lactation:Â Â
There is no data about the excretion of drugs in breast milkÂ
Pregnancy category:Â Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus `in either the first or second trimester.Â
Category B: There was a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category
Pharmacology:Â
Pharmacodynamics:Â Â
The mean cell counts of the three main immune subsets—T, B, and NK cells—stayed within normal limits while under ZINBRYTA (daclizumab) treatment. During the first year of treatment, the total lymphocyte, B, and T cell counts are reduced by less than 10% from baseline. About 8–12 weeks after the last ZINBRYTA (daclizumab) (150 mg) dose, total lymphocyte counts got back to baseline.Â
Pharmacokinetics:Â
AbsorptionÂ
The maximum serum concentration of daclizumab at steady state was observed to be 30µg/ml, and 90% bioavailability was seen with subcutaneous administration of 150mg dose.Â
DistributionÂ
Volume of distribution: 6.34lÂ
MetabolismÂ
Being a protein, daclizumab should be catalyzed to amino acids and peptides similar to endogenous IgG proteins. Â
Elimination and excretionÂ
Rate of clearance- 0.212 liters/day Â
Half-life:Â
21 daysÂ
Administration:Â
Daclizumab should be administered subcutaneously to the patient only by the medical practitioner
Patient information leafletÂ
Generic Name: daclizumab Â
Why do we use daclizumab?Â
Daclizumab is indicated in the treatment of multiple sclerosis, especially relapsing forms. It is an antibody that blocks interleukin-2 receptors.
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