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Daclizumab Brand Names- Zenapax | ZINBRYTA
What is Daclizumab
Daclizumab was an immunosuppressant previously indicated for the treatment of relapsing forms of multiple sclerosis.
Daclizumab was also historically used for rejection prophylaxis in renal allograft recipients and marketed under the trade name Zenapax, but this product was discontinued from marketing in 2009.
Daclizumab is a humanized monoclonal antibody (IgG1) produced by recombinant DNA technology that binds specifically to the alpha subunit (p55 alpha, CD25, or Tac subunit) of the human high-affinity interleukin (IL)-2 receptor.
During clinical trials, daclizumab produced a 45% relative reduction in annualized relapse rate and a 54% relative reduction in the mean number of new or newly enlarging T2 hyperintense lesions when compared to interferon beta-1a. Daclizumab is associated with hepatotoxicity.
Daclizumab was initially FDA-approved in December 1997. Daclizumab was withdrawn from the worldwide market in March 2018 due to safety concerns.
Eight cases of inflammation of the brain, including inflammatory encephalitis and meningoencephalitis, severe hepatic damage, and other immune-mediated disorders were associated with Zinbryta.
In the U.S., the use of Zinbryta in multiple sclerosis patients was previously limited to patients who did not respond to prior therapies because of safety concerns associated with use
Indications
- multiple sclerosis
For the treatment of relapsing forms of multiple sclerosis
Side Effects
- abdominal pain
- acne vulgaris
- agranulocytosis
- anaphylactic shock
- anaphylactoid reactions
- anemia
- antibody formation
- colitis
- constipation
- dehydration
- depression
- diabetes mellitus
- diarrhea
- elevated hepatic enzymes
- erythema
- erythema multiforme
- erythema nodosum
- exfoliative dermatitis
- fever
- flatulence
- folliculitis
- gastritis
- glomerulonephritis
- hemolytic anemia
- hemorrhoids
- hepatic failure
- hepatitis
- hepatotoxicity
- hyperglycemia
- immune-mediated reactions
- infection
- influenza
- interstitial lung disease
- laryngitis
- lupus-like symptoms
- lymphadenopathy
- maculopapular rash
- nausea
- new primary malignancy
- oral ulceration
- pancreatitis
- pancytopenia
- pharyngitis
- pruritus
- psoriasis
- pyrosis (heartburn)
- rash
- rhinitis
- seizures
- sialadenitis
- suicidal ideation
- thrombocytopenia
- vasculitis
- vesicular rash
- vomiting
- xerosis
Monitoring Parameters
- CBC
- LFTs
- serum bilirubin
Contraindications
- breast-feeding
- children
- contraception requirements
- depression
- eczema
- fungal infection
- hepatic disease
- hepatitis
- hepatotoxicity
- herpes infection
- immune-mediated reactions
- infants
- infection
- lymphoma
- murine protein hypersensitivity
- neonates
- neoplastic disease
- pregnancy
- psoriasis
- reproductive risk
- requires a specialized care setting
- requires an experienced clinician
- suicidal ideation
- vaccination
- varicella
- viral infection
Interactions
- Azathioprine
- Basiliximab
- Canakinumab
- Carboplatin
- Chlorambucil
- Cyclosporine
- Daunorubicin
- Doxorubicin
- Echinacea
- Infliximab
- Live Vaccines
- Melphalan
- Mycophenolate
- Natalizumab
- Ocrelizumab
- Sirolimus
- Tacrolimus
- Temozolomide
- Tocilizumab
- Upadacitinib