Generic Name and Formulations:
Daclizumab 150mg/mL; soln for SC inj.
AbbVie and Biogen
Indications for ZINBRYTA:
Treatment of relapsing forms of multiple sclerosis.
Give as SC inj into the thigh, abdomen, or back of upper arm. 150mg once monthly. If AST/ALT >5×ULN or total bilirubin >2×ULN or ALT/AST ≥3–<5×ULN and total bilirubin >1.5–<2×ULN, interrupt or discontinue dose as appropriate (see full labeling).
<17yrs: not recommended.
Pre-existing hepatic disease or hepatic impairment, including ALT or AST ≥2×ULN. History of autoimmune hepatitis or other autoimmune condition involving the liver.
Risk of serious hepatic injury, including autoimmune hepatitis (discontinue if suspected) and other immune-mediated disorders (eg, skin reactions, lymphadenopathy, non-infectious colitis); may require systemic corticosteroids or immunosuppressants; consider discontinuing if serious immune-mediated disorders develop. History of skin conditions (eg, eczema, psoriasis). Evaluate and treat (if positive) for tuberculosis (esp. in high-risk patients) prior to initiation. Screen for hepatitis B/C prior to initiation. Tuberculosis or other severe active infection: avoid starting treatment until controlled. If serious infection develops, consider withholding until resolved. Obtain serum ALT/AST and total bilirubin prior to initiation, monthly, and before the next dose; follow LFTs monthly for 6 months after last dose. Depressive disorders. Monitor for new or worsening symptoms of depression and/or suicidal ideation; consider discontinuing if severe. Discontinue if anaphylaxis or other allergic reactions occur; do not restart. Pregnancy. Nursing mothers.
Avoid live virus vaccines during and up to 4 months after discontinuation. Caution with concomitant hepatotoxic drugs, including non-prescription products (eg, herbals, dietary supplements).
Interleukin-2 (IL-2) receptor blocking antibody.
Nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, bronchitis, eczema, lymphadenopathy, depression, increased ALT; hepatic injury, immune-mediated disorders, acute hypersensitivity.
Single-dose prefilled syringe—1