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Zynyz (retifanlimab-dlwr)
retifanlimab
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = retifanlimab-dlwr
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
squamous cell anal CA
- [first-line tx, combo tx]
- Dose: 500 mg IV q4wk for up to 12mo; Alt: 375 mg IV q3wk for up to 12mo; Info: for patients with inoperable locally recurrent or metastatic disease
- [platinum-refractory or intolerant disease, monotherapy]
- Dose: 500 mg IV q4wk for up to 24mo; Alt: 375 mg IV q3wk for up to 24mo; Info: for patients with locally recurrent or metastatic disease
Merkel cell carcinoma, recurrent locally advanced or metastatic
- [500 mg IV q4wk for up to 24mo]
renal dosing
- [see below]
- eGFR >26: no adjustment; eGFR <26: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x4mo after D/C
- caution: patients of childbearing potential
- caution: thoracic XRT history
- caution: transplant history
- caution: transplant candidates
Drug Interactions .
Overview
retifanlimab
PD-1 blocking antibody
- immunomodulatory effects
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- rabies vaccine
Monitor/Modify Tx
- anthrax vaccine
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Adverse Reactions .
Serious Reactions
- immune-mediated reaction
- pneumonitis
- colitis
- hepatitis
- endocrinopathy
- adrenal insufficiency
- hypophysitis
- thyroiditis
- hypothyroidism
- hyperthyroidism
- hypoparathyroidism
- diabetes mellitus, type 1
- hypopituitarism
- nephritis
- Stevens-Johnson syndrome
- drug reaction with eosinophilia and systemic symptoms
- toxic epidermal necrolysis
- myocarditis
- pericarditis
- vasculitis
- pancreatitis
- myositis
- rhabdomyolysis
- polymyalgia rheumatica
- meningitis
- encephalitis
- myelitis
- demyelination
- myasthenia gravis
- Guillain-Barre syndrome
- nerve paresis
- autoimmune neuropathy
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- hemolytic anemia
- aplastic anemia
- hemophagocytic lymphohistiocytosis
- systemic inflammatory response syndrome
- histiocytic necrotizing lymphadenitis
- sarcoidosis
- immune thrombocytopenic purpura
- infusion reaction, severe
- arrhythmia
- infection, serious
- hemorrhage
Common Reactions
- fatigue
- musculoskeletal pain
- diarrhea
- pruritus
- rash
- nausea
- fever
- hypothyroidism
- infection
- hemorrhage
- skin reaction
- constipation
- appetite decr.
- abdominal pain
- vomiting
- dyspnea
- cough
- hyperthyroidism
- headache
- weight decr.
- pneumonitis
- hepatitis
- Hgb decr.
- lymphocytes decr.
- ALT or AST incr.
- lipase incr.
- sodium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Cr, LFTs, TFTs at baseline, then periodically; glucose; signs/symptoms of infusion reaction
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of embryo-fetal toxicity, including spontaneous abortion and stillbirth, based on animal data with other PD-1/PD-L1 pathway inhibitors and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x4mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x4mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for retifanlimab: other; CYP450: unknown
Excretion: for retifanlimab: other; Half-life: 19 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
for retifanlimab: binds to PD-L1 on tumor cells and tumor-infiltrating immune cells, blocking PD-1/PD-L1 pathway-mediated inhibition of anti-tumor immune response, resulting in decreased tumor growth (monoclonal antibody)
Formulary .
No Formulary Selected
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