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Opdivo
nivolumab
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: not interchangeable w/ other nivolumab-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
melanoma
- [stage IIB, IIC, III, IV dz, adjuvant tx]
- Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for pts w/ completely resected dz
- [unresectable or metastatic dz, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic dz, combo tx]
- Dose: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy
non-small cell lung CA
- [resectable dz, neoadjuvant tx, combo tx]
- Dose: 360 mg IV q3wk x3 doses; Info: for pts w/ tumor >4cm or node-positive dz; use w/ platinum-doublet chemo; may give up to 4 doses prior to adjuvant nivolumab monotherapy in pts w/ no EGFR or ALK genomic tumor aberrations
- [resectable dz, adjuvant tx following neoadjuvant tx, monotherapy]
- Dose: 480 mg IV q4wk for up to 13 doses; Info: for pts w/ tumor >4cm or node-positive dz and no EGFR or ALK genomic tumor aberrations
- [metastatic PD-L1-expressing dz, combo tx]
- Dose: 360 mg IV q3wk for up to 2y; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; first-line tx; use w/ ipilimumab
- [metastatic or recurrent dz, combo tx]
- Dose: 360 mg IV q3wk for up to 2y; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; first-line tx; use w/ ipilimumab and 2 cycles of q3wk histology-based platinum-doublet chemo
- [metastatic dz, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for pts w/ progressive dz on or after platinum-based chemo
malignant pleural mesothelioma, unresectable
- [360 mg IV q3wk for up to 2y]
- Info: first-line tx; use w/ ipilimumab
renal cell CA, advanced
- [first-line tx, combo w/ cabozantinib]
- Dose: 240 mg IV q2wk for up to 2y; Alt: 480 mg IV q4wk for up to 2y
- [first-line tx, combo w/ ipilimumab]
- Dose: 3 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 3 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for pts w/ intermediate or poor risk dz
- [progressive dz]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: for pts who have received prior antiangiogenic tx
Hodgkin lymphoma, classical
- [240 mg IV q2wk]
- Alt: 480 mg IV q4wk; Info: for relapsed or refractory dz after autologous HSCT + brentuximab vedotin, or after at least 3 lines of tx, incl. autologous HSCT
squamous cell head/neck CA, recurrent or metastatic
- [240 mg IV q2wk]
- Alt: 480 mg IV q4wk; Info: for pts w/ dz progression on or after platinum-containing chemo
urothelial carcinoma
- [adjuvant tx]
- Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for pts w/ high recurrence risk after radical resection
- [unresectable or metastatic dz, first-line tx]
- Dose: 360 mg IV q3wk for up to 6 cycles w/ combo chemo, then 240 mg IV q2wk as monotherapy for up to 2y total; Alt: 360 mg IV q3wk for up to 6 cycles w/ combo chemo, then 480 mg q4wk as monotherapy for up to 2y total
- [locally advanced or metastatic dz, progressive dz]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk; Info: pts w/ dz progression on or after platinum-containing chemo
microsatellite instability-high or mismatch repair deficient colorectal CA
- [progressive metastatic dz, monotherapy]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic dz, combo tx]
- Dose: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy for up to 2y; Alt: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy for up to 2y
hepatocellular CA
- [1 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy]
- Alt: 1 mg/kg/dose IV q3wk x4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy; Info: for sorafenib refractory or intolerant dz
esophageal CA
- [adjuvant tx]
- Dose: 240 mg IV q2wk x1y; Alt: 480 mg IV q4wk x1y; Info: for pts w/ completely resected esophageal or gastroesophageal junction cancer w/ residual pathologic dz after receiving neoadjuvant chemoradiation
- [squamous cell carcinoma, first-line tx, combo w/ ipilimumab]
- Dose: 3 mg/kg/dose IV q2wk for up to 2y; Alt: 360 mg IV q3wk for up to 2y; Info: for pts w/ unresectable advanced or metastatic dz
- [squamous cell carcinoma, first-line tx, combo w/ fluoropyrimidine and platinum-containing chemo]
- Dose: 240 mg IV q2wk for up to 2y; Alt: 480 mg IV q4wk for up to 2y; Info: for pts w/ unresectable advanced or metastatic dz
- [squamous cell carcinoma, progressive dz]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q2wk; Info: for pts w/ unresectable advanced, recurrent or metastatic dz after prior fluoropyrimidine and platinum-based chemo
- [advanced or metastatic dz]
- Dose: 240 mg IV q2wk for up to 2y; Alt: 360 mg IV q3wk for up to 2y; Info: for pts w/ gastroesophageal junction CA or esophageal adenocarcinoma; part of multi-drug chemo regimen
gastric CA
- [240 mg IV q2wk for up to 2y]
- Alt: 360 mg IV q3wk for up to 2y; Info: for pts w/ advanced or metastatic gastric or gastroesophageal junction CA; part of multi-drug chemo regimen
small cell lung CA, relapsed (off-label)
- [240 mg IV q2wk]
- Info: for pts who have received prior tx other than immune checkpoint inhibitors w/ chemo-free interval <6mo
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
- Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: not interchangeable w/ other nivolumab-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
melanoma
- [stage IIB, IIC, III, IV dz, adjuvant tx, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk for up to 1y; Alt: 6 mg/kg/dose IV q4wk for up to 1y; Info: for pts w/ completely resected dz
- [stage IIB, IIC, III, IV dz, adjuvant tx, 12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk for up to 1y; Alt: 480 mg IV q4wk for up to 1y; Info: for pts w/ completely resected dz
- [unresectable or metastatic dz, monotherapy, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk; Alt: 6 mg/kg/dose IV q4wk
- [unresectable or metastatic dz, monotherapy, 12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic dz, combo tx, 12 yo and older, <40 kg]
- Dose: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 3 mg/kg/dose IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 6 mg/kg/dose IV q4wk as monotherapy
- [unresectable or metastatic dz, combo tx, 12 yo and older, >40 kg]
- Dose: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy; Alt: 1 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy
microsatellite instability-high or mismatch repair deficient colorectal CA
- [progressive metastatic dz, monotherapy, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q2wk
- [progressive metastatic dz, monotherapy, 12 yo and older, >40 kg]
- Dose: 240 mg IV q2wk; Alt: 480 mg IV q4wk
- [unresectable or metastatic dz, combo tx, 12 yo and older, <40 kg]
- Dose: 3 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 3 mg/kg/dose IV q2wk as monotherapy for up to 2y; Alt: 3 mg/kg/dose IV q3wk for max 4 doses w/ ipilimumab, then 6 mg/kg/dose IV q4wk as monotherapy for up to 2y
- [unresectable or metastatic dz, combo tx, 12 yo and older, >40 kg]
- Dose: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 240 mg IV q2wk as monotherapy for up to 2y; Alt: 240 mg IV q3wk for max 4 doses w/ ipilimumab, then 480 mg IV q4wk as monotherapy for up to 2y
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- multiple myeloma
- avoid: breastfeeding during tx and x5mo after D/C
- caution: female pts of reproductive potential
- caution: transplant hx
- caution: transplant candidates
- caution: ipilimumab-associated immune toxicity, severe
- caution: autoimmune disorder
- caution: interstitial lung dz
- caution: thyroid disorder
- caution: HBV infection
- caution: HCV infection
- caution: HIV infection
Drug Interactions .
Overview
nivolumab
PD-1 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
- pleural effusion
- respiratory failure
- pulmonary embolism
- pneumonia
- sepsis
- infection, serious
- colitis
- hepatitis
- hepatotoxicity
- ascites
- esophageal varices
- hemorrhage
- pancreatitis
- diabetes mellitus, type 1
- diabetic ketoacidosis
- adrenal insufficiency
- hypophysitis
- hypopituitarism
- hypothyroidism
- hyperthyroidism
- heart failure
- renal failure
- nephritis
- encephalitis
- meningitis
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- blindness
- autoimmune neuropathy
- demyelination
- nerve paresis
- Guillain-Barre syndrome
- myasthenia gravis
- rhabdomyolysis
- myocarditis
- pericarditis
- myositis
- polymyalgia rheumatica
- vasculitis
- histiocytic necrotizing lymphadenitis
- aplastic anemia
- anemia
- neutropenia
- thrombocytopenia
- immune thrombocytopenic purpura
- lymphopenia
- hemophagocytic lymphohistiocytosis
- hemolytic anemia, autoimmune
- infusion rxn, severe
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- erythema multiforme
- exfoliative dermatitis
- drug rxn w/ eosinophilia and systemic sx
Common Reactions
- fatigue
- musculoskeletal pain
- rash
- diarrhea
- cough
- nausea
- pruritus
- URI
- appetite decr.
- arthralgia
- dyspnea
- constipation
- abdominal pain
- fever
- vomiting
- hypothyroidism
- headache
- dizziness
- UTI
- weight loss
- edema
- back pain
- vitiligo
- peripheral neuropathy
- hyperthyroidism
- lymphopenia
- ALT or AST incr.
- anemia
- hyponatremia
- alk phos incr.
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Cr, LFTs, TFTs at baseline, then periodically; glucose
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of spontaneous abortion and premature neonatal death, esp. in 2nd and 3rd trimesters, based on animal data at 9-42x systemic exposure 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 for at least 5mo after D/C in female pts
Lactation
Clinical Summary
avoid breastfeeding during tx and x5mo 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: 25 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
binds to PD-1 receptor on T-cells, blocking PD-1 pathway-mediated inhibition of anti-tumor immune response, resulting in decreased tumor growth (monoclonal antibody)
Formulary .
No Formulary Selected
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