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Imfinzi
durvalumab
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-844-275-2360 or www.imfinzi.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
non-small cell lung CA
- [resectable dz, neoadjuvant tx, <30 kg]
- Dose: 20 mg/kg/dose IV q3wk for up to 4 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen
- [resectable dz, neoadjuvant tx, >30 kg]
- Dose: 1500 mg IV q3wk for up to 4 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen
- [resectable dz, adjuvant tx, <30 kg]
- Dose: 20 mg/kg/dose IV q4wk for up to 12 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations
- [resectable dz, adjuvant tx, >30 kg]
- Dose: 1500 mg IV q4wk for up to 12 cycles; Info: for pts w/ tumor >4cm or node-positive dz w/ no EGFR or ALK genomic tumor aberrations
- [stage III unresectable dz, <30 kg]
- Dose: 10 mg/kg/dose IV q2wk for up to 12mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT
- [stage III unresectable dz, >30 kg]
- Dose: 10 mg/kg/dose IV q2wk for up to 12mo; Alt: 1500 mg IV q4wk for up to 12mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT
- [metastatic dz, <30 kg]
- Dose: 20 mg/kg/dose IV q3wk x4 cycles on wk 0, 3, 6, 9, then 20 mg/kg/dose IV q4wk starting cycle 5 on wk 12; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen
- [metastatic dz, >30 kg]
- Dose: 1500 mg IV q3wk x4 cycles on wk 0, 3, 6, 9, then 1500 mg IV q4wk starting cycle 5 on wk 12; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; part of multi-drug chemo regimen
small cell lung CA
- [limited stage dz, <30 kg]
- Dose: 20 mg/kg/dose IV q4wk for up to 24mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT
- [limited stage dz, >30 kg]
- Dose: 1500 mg IV q4wk for up to 24mo; Info: for non-progressive dz after concurrent platinum-based chemo and XRT
- [extensive-stage dz, first-line tx, <30 kg]
- Dose: 20 mg/kg/dose IV q3wk x4 cycles as part of multi-drug chemo regimen, then 10 mg/kg/dose IV q2wk as monotherapy
- [extensive-stage dz, first-line tx, >30 kg]
- Dose: 1500 mg IV q3wk x4 cycles as part of multi-drug chemo regimen, then 1500 mg IV q4wk as monotherapy
biliary tract CA, locally advanced or metastatic
- [<30 kg]
- Dose: 20 mg/kg/dose IV q3wk for up to 8 cycles as part of multi-drug chemo regimen, then 20 mg/kg/dose IV q4wk as monotherapy
- [>30 kg]
- Dose: 1500 mg IV q3wk for up to 8 cycles as part of multi-drug chemo regimen, then 1500 mg IV q4wk as monotherapy
hepatocellular CA, unresectable
- [<30 kg]
- Dose: 20 mg/kg/dose IV x1 on day 1 of cycle 1 w/ tremelimumab, then 20 mg/kg/dose IV q4wk as monotherapy
- [>30 kg]
- Dose: 1500 mg IV x1 on day 1 of cycle 1 w/ tremelimumab, then 1500 mg IV q4wk as monotherapy
mismatch repair deficient endometrial CA, advanced or recurrent
- [<30 kg]
- Dose: 15 mg/kg/dose IV q3wk x6 cycles as part of multi-drug chemo regimen, then 20 mg/kg/dose IV q4wk as monotherapy
- [>30 kg]
- Dose: 1120 mg IV q3wk x6 cycles as part of multi-drug chemo regimen, then 1500 mg IV q4wk as monotherapy
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN: no adjustment; bilirubin >3x ULN: 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 x3mo after D/C
- caution: female pts of reproductive potential
- caution: thoracic XRT hx
- caution: transplant hx
- caution: transplant candidates
- caution: autoimmune disorder
- caution: HBV infection
- caution: HCV infection
- caution: HIV infection
- caution: TB infection, active
Drug Interactions .
Overview
durvalumab
PD-L1 blocking antibody
- immunomodulatory effects (other)
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 rxn
- pneumonitis
- interstitial lung dz
- hepatitis
- colitis
- diarrhea, severe
- hypothyroidism
- hyperthyroidism
- thyroiditis
- adrenal insufficiency
- diabetes mellitus, type 1
- hypophysitis
- hypopituitarism
- pancreatitis
- nephritis
- aplastic anemia
- hemolytic anemia
- pancytopenia
- thrombosis
- immune thrombocytopenia
- histiocytic necrotizing lymphadenitis
- hemophagocytic lymphohistiocytosis
- myocarditis
- pericarditis
- vasculitis
- meningitis
- encephalitis
- demyelination
- myasthenia gravis
- Guillain-Barre syndrome
- nerve paresis
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- myositis
- rhabdomyolysis
- polymyalgia rheumatica
- autoimmune neuropathy
- hypoparathyroidism
- infection, severe
- infusion rxn, severe
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug rxn w/ eosinophilia and systemic sx
Common Reactions
- pneumonitis
- cough
- fatigue
- rash
- dyspnea
- URI
- pneumonia
- diarrhea
- hypothyroidism
- pruritus
- fever
- abdominal pain
- appetite decr.
- dizziness
- nausea
- hyperthyroidism
- constipation
- dysphonia
- dysuria
- night sweats
- peripheral edema
- infection
- hepatitis
- pancreatitis
- infusion rxn
- colitis
- hyperglycemia
- hypocalcemia
- ALT or AST incr.
- hyponatremia
- hyperkalemia
- GGT incr.
- lymphopenia
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Cr, LFTs, TFTs at baseline, then periodically; glucose; s/sx infusion rxn
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of spontaneous abortion, stillbirth, and premature neonatal death, based on animal data at 6-20x recommended human dose 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 x3mo after D/C in female pts
Lactation
Clinical Summary
avoid breastfeeding during tx and x3mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: other; CYP450: unknown
Excretion: other; Half-life: 21 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
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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