Zynyz Generic Name & Formulations
Single-dose vial (20mL)—1
Mechanism of Action
Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Retifanlimab-dlwr binds to the PD-1 receptor, blocks interaction with its ligands PD-L1 and PD-L2, and potentiates T-cell activity.
Metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
Zynyz Dosage and Administration
Give as IV infusion over 30mins. 500mg every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months. Dosage modifications: see full labeling.
Zynyz Boxed Warnings
Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection, hyperglycemia, or other signs of diabetes. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Consider premedication (antipyretic and/or antihistamine) if previous systemic reactions to therapeutic proteins. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and intervene promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
Geometric mean volume of distribution at steady state: 6.0 L.
Half-life: 19 days.
Zynyz Adverse Reactions
Fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, nausea, lab abnormalities; arrhythmia, pneumonitis.
Zynyz Clinical Trials
Zynyz Patient Counseling