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Tevimbra (tislelizumab-jsgr)
tislelizumab
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
esophageal CA, unresectable or metastatic
- [PD-L1-expressing dz, first-line tx]
- Dose: 200 mg IV q3wk; Alt: 150 mg IV q2wk or 300 mg IV q4wk; Info: for pts w/ squamous cell carcinoma; part of multi-drug chemo regimen
- [previously treated dz]
- Dose: 200 mg IV q3wk; Alt: 150 mg IV q2wk or 300 mg IV q4wk; Info: for pts w/ squamous cell carcinoma who have received prior tx other than PD-1/PD-L1 inhibitor
HER2-negative PD-L1-expressing gastric CA, unresectable or metastatic
- [200 mg IV q3wk]
- Alt: 150 mg IV q2wk or 300 mg IV q4wk; Info: for pts w/ gastric or gastroesophageal junction adenocarcinoma; part of multi-drug chemo regimen
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 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 x4mo after D/C
- caution: pts of childbearing potential
- caution: thoracic XRT hx
- caution: transplant hx
- caution: transplant candidates
Drug Interactions .
Overview
tislelizumab
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
- pneumonia
- colitis
- hepatitis
- endocrinopathy
- adrenal insufficiency
- hypophysitis
- thyroiditis
- hyperthyroidism
- hypothyroidism
- hypoparathyroidism
- diabetes mellitus, type 1
- hypopituitarism
- nephritis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug rxn w/ eosinophilia and systemic sx
- exfoliative dermatitis
- myocarditis
- pericarditis
- vasculitis
- meningitis
- encephalitis
- demyelination
- myasthenia gravis
- Guillain-Barre syndrome
- nerve paresis
- autoimmune neuropathy
- arthritis
- polymyalgia rheumatica
- Sjogren's syndrome
- myositis
- rhabdomyolysis
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- pancreatitis
- hemorrhage
- anemia
- hemolytic anemia
- aplastic anemia
- hemophagocytic lymphohistiocytosis
- immune thrombocytopenic purpura
- infusion rxn, severe
Common Reactions
- anemia
- fatigue
- musculoskeletal pain
- weight decr.
- cough
- fever
- appetite decr.
- pneumonia
- constipation
- nausea
- diarrhea
- hypothyroidism
- rash
- hemorrhage
- dysphagia
- abdominal pain
- vomiting
- infusion rxn
- glucose incr.
- lymphocytes decr.
- sodium decr.
- albumin decr.
- alk phos incr.
- ALT or AST incr.
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 embryo-fetal toxicity, incl. spontaneous abortion and stillbirth, based on animal data w/ 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 pts 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: catabolism; CYP450: unknown
Excretion: other; Half-life: 24 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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