Generic Name and Formulations:
Durvalumab 50mg/mL; soln for IV infusion after dilution; preservative-free.
Indications for IMFINZI:
Locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Give as IV infusion over 60mins. 10mg/kg every 2 weeks until disease progression or unacceptable toxicity.
Permanently discontinue if Grade 3/4 pneumonitis, AST or ALT >8×ULN or total bilirubin >5×ULN, concurrent AST or ALT >3×ULN and total bilirubin >2×ULN (with no other cause), Grade 3/4 colitis or diarrhea, creatinine ≥3×ULN, Grade 3/4 infusion-related reactions, or Grade 4 rash/dermatitis. Withhold for Grade 2 pneumonitis, AST or ALT >3–5×ULN or total bilirubin >1.5–3×ULN, AST or ALT ≤8×ULN or total bilirubin ≤5×ULN, Grade 2 colitis or diarrhea, Grade ≥2 hypophysitis/hypopituitarism, Grade ≥2 adrenal insufficiency, Grade ≥2 hyperthyroidism, Grade ≥2 type 1 diabetes, creatinine >1.5–3×ULN, Grade 3/4 infection, Grade 2 (if >1 week) or Grade 3 rash. Monitor for immune-related pneumonitis, hepatitis (obtain LFTs each cycle), colitis/diarrhea, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), rash, thrombocytopenia purpura, nephritis; see full labeling for adverse reaction management details. Monitor for signs/symptoms of infection and treat with anti-infectives for suspected or confirmed infections. Interrupt or slow the infusion rate in patients with mild or moderate infusion reactions. Embryo-fetal toxicity. Pregnancy. Females of reproductive potential should use effective contraception during therapy and for ≥3 months after final dose. Nursing mothers: not recommended (during and for ≥3 months after final dose).
Programmed death-ligand 1 (PD-L1) blocking antibody.
Fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, urinary tract infection; other immune-related reactions (eg, aseptic meningitis, hemolytic anemia), infusion-related reactions, lab abnormalities.
Single-dose vial (2.4mL, 10mL)—1