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Jemperli (dostarlimab-gxly)
dostarlimab
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = dostarlimab-gxly
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
endometrial CA
- [primary advanced or recurrent disease]
- Dose: 500 mg IV q3wk x6 doses as part of multi-drug chemo regimen, then 1000 mg IV q6wk as monotherapy for up to 3y
- [mismatch repair deficient, recurrent or advanced disease]
- Dose: 500 mg IV q3wk x4 doses, then 1000 mg IV q6wk; Info: for patients with disease progression on or after platinum-containing chemo not eligible for curative surgery or XRT
mismatch repair deficient solid tumors, recurrent or advanced
- [500 mg IV q3wk x4 doses, then 1000 mg IV q6wk]
- Info: for patients with progressive disease and no alternative tx options
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN or AST >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 x4mo after D/C
- caution: patients of childbearing potential
- caution: thoracic XRT history
- caution: transplant history
- caution: transplant candidates
Drug Interactions .
Overview
dostarlimab
PD-1 blocking antibody
- immunomodulatory effects
- myelosuppressive oncologic agent
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
- chloramphenicol
- cladribine oral
- deferiprone
- dexrazoxane
- fexinidazole
- ganciclovir
- palifermin
- penicillamine
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- valganciclovir
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- copper histidinate
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- deuruxolitinib
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- foscarnet
- fosfomycin injection
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mycophenolate mofetil
- mycophenolic acid
- olsalazine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- proguanil
- pyrimethamine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- zidovudine
Adverse Reactions .
Serious Reactions
- immune-mediated reaction
- pneumonitis
- colitis
- hepatitis
- endocrinopathy
- adrenal insufficiency
- hypophysitis
- thyroiditis
- hypothyroidism
- hyperthyroidism
- hypoparathyroidism
- diabetes mellitus, type 1
- hypopituitarism
- nephritis
- acute kidney injury
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug reaction with eosinophilia and systemic symptoms
- meningitis
- encephalitis
- myelitis
- demyelination
- myasthenia gravis
- Guillain-Barre syndrome
- nerve paresis
- autoimmune neuropathy
- myocarditis
- pericarditis
- vasculitis
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- pancreatitis
- myositis
- rhabdomyolysis
- hemolytic anemia
- aplastic anemia
- immune thrombocytopenia
- hemophagocytic lymphohistiocytosis
- histiocytic necrotizing lymphadenitis
- infusion reaction, severe
- anemia
- sepsis
Common Reactions
- fatigue
- anemia
- diarrhea
- nausea
- vomiting
- constipation
- rash
- pruritus
- cough
- appetite decr.
- fever
- ALT or AST incr.
- UTI
- hypothyroidism
- myalgia
- hyperthyroidism
- pneumonitis
- lymphocytes decr.
- albumin decr.
- alk phos incr.
- Cr incr.
- sodium decr.
- magnesium 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 dostarlimab: catabolism; CYP450: unknown
Excretion: for dostarlimab: other; Half-life: 23.5 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
for dostarlimab: 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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