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Yervoy
ipilimumab
Adult Dosing .
Dosage forms: INJ
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
melanoma
- [adjuvant tx]
- Dose: 3 mg/kg/dose IV q3wk for max 4 doses, then 3 mg/kg/dose IV q12wk for up to 4 doses; Info: for cutaneous dz w/ regional lymph nodes involvement that have undergone complete resection
- [unresectable or metastatic dz]
- Dose: 3 mg/kg/dose IV q3wk x4 doses; Max: 4 doses; Info: complete tx w/in 16wk after 1st dose; use as monotherapy or w/ nivolumab
renal cell CA, advanced
- [1 mg/kg/dose IV q3wk x4 doses]
- Max: 4 doses; Info: for pts w/ previously untreated intermediate or poor risk dz; first-line tx; use w/ nivolumab
microsatellite instability-high or mismatch repair deficient colorectal CA, unresectable or metastatic
- [1 mg/kg/dose IV q3wk x4 doses]
- Max: 4 doses; Info: use w/ nivolumab
hepatocellular CA
- [3 mg/kg/dose IV q3wk for up to 4 doses]
- Info: for sorafenib refractory or intolerant dz; use w/ nivolumab
non-small cell lung CA
- [metastatic PD-L1-expressing dz]
- Dose: 1 mg/kg/dose IV q6wk for up to 2y; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; first-line tx; use w/ nivolumab
- [metastatic or recurrent dz]
- Dose: 1 mg/kg/dose IV q6wk for up to 2y; Info: for pts w/ no EGFR or ALK genomic tumor aberrations; first-line tx; use w/ nivolumab and 2 cycles of q3wk histology-based platinum-doublet chemo
malignant pleural mesothelioma, unresectable
- [1 mg/kg/dose IV q6wk for up to 2y]
- Info: first-line tx; use w/ nivolumab
esophageal CA
- [1 mg/kg/dose IV q6wk for up to 2y]
- Info: for pts w/ unresectable advanced or metastatic esophageal squamous cell carcinoma; first-line tx; use w/ nivolumab
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
- Dosage forms: INJ
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
melanoma, unresectable or metastatic
- [12 yo and older]
- Dose: 3 mg/kg/dose IV q3wk x4 doses; Max: 4 doses; Info: complete tx w/in 16wk after 1st dose; use as monotherapy or w/ nivolumab
microsatellite instability-high or mismatch repair deficient colorectal CA, unresectable or metastatic
- [12 yo and older]
- Dose: 1 mg/kg/dose IV q3wk x4 doses; Max: 4 doses; Info: use w/ nivolumab
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x3mo after D/C
- caution: pts of childbearing potential
- caution: transplant hx
- caution: transplant candidates
Drug Interactions .
Overview
ipilimumab
CTLA-4 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
Caution Advised
- vemurafenib
Adverse Reactions .
Serious Reactions
- immune-mediated rxn
- colitis, severe
- diarrhea, severe
- hepatitis
- bullous dermatitis
- exfoliative dermatitis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug rxn w/ eosinophilia and systemic sx
- erythema multiforme
- endocrinopathy
- adrenal insufficiency
- diabetes mellitus, type 1
- hypogonadism
- hypothyroidism
- hyperthyroidism
- thyroiditis
- hypoparathyroidism
- hypopituitarism
- Cushing syndrome
- hypophysitis
- myasthenia gravis
- demyelination
- Guillain-Barre syndrome
- nerve paresis
- autoimmune neuropathy
- uveitis
- iritis
- Vogt-Koyanagi-Harada-like syndrome
- myositis
- rhabdomyolysis
- polymyalgia rheumatica
- nephritis
- pneumonitis
- meningitis
- encephalitis
- pericarditis
- myocarditis
- vasculitis
- pancreatitis
- ascites
- esophageal varices
- hemolytic anemia
- aplastic anemia
- hemophagocytic lymphohistiocytosis
- histiocytic necrotizing lymphadenitis
- sarcoidosis
- cytopenia
- infusion rxn, severe
- infection, serious
Common Reactions
- fatigue
- diarrhea
- rash
- pruritus
- nausea
- appetite decr.
- headache
- colitis
- musculoskeletal pain
- vomiting
- fever
- abdominal pain
- hypothyroidism
- cough
- dyspnea
- URI
- adrenal insufficiency
- arthralgia
- hepatitis
- endocrinopathy
- HTN
- weight decr.
- neuropathy
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; ACTH, Cr, LFTs, TFTs, chemistry profile at baseline and prior to each dose; glucose; s/sx infusion rxn
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of spontaneous abortion, stillbirth, and premature neonatal death, based on animal data and drug's mechanism of action
Pregnancy Registry
encourage pts to enroll in Yervoy Pregnancy Safety Surveillance Study at 1-844-593-7869
Individuals of Reproductive Potential
obtain pregnancy test prior to tx start; avoid pregnancy by using effective contraception during tx and x3mo after D/C in pts of childbearing potential
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: catabolism; CYP450: unknown
Excretion: other; Half-life: 15.4 days
Subclass: Immunotherapy, CTLA-4 Inhibitors ; Immunotherapy, Immune Checkpoint Inhibitors
Mechanism of Action
binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), blocking CTLA-4 interaction w/ CD80 and CD86, thereby restoring T-cell activation and proliferation, resulting in decr. tumor growth
Formulary .
No Formulary Selected
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