Active Ingredient: Toripalimab
Toripalimab is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 240 milligrams toripalimab, once every 3 months, over the duration of 24 months.
Recommended dosage of toripalimab: 240 mg every three weeks.
Duration of treatment: Until disease progression, unacceptable toxicity, or up to 24 months.
No dose reductions of toripalimab are recommended. In general, withhold toripalimab for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue toripalimab for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
Dosage modifications for toripalimab for adverse reactions that require management different from these general guidelines are summarized in the following table.
Recommended dosage modifications for adverse reactions:
| Adverse reaction | Severity* | Dose modification |
|---|---|---|
| Immune-Related Adverse Reactions | ||
| Pneumonitis | Grade 2 | Withhold† |
| Grades 3 or 4 | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withhold† |
| Grade 4 | Permanently discontinue | |
| Hepatitis with no tumor involvement of the liver | AST/ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN | Withhold† |
| AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Hepatitis with tumor involvement of the liver‡ | Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN | Withhold† |
| Baseline AST or ALT is above the ULN and increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Endocrinopathies | Grades 3 or 4 | Withhold until clinically stable or permanently discontinue depending on severity† |
| Nephritis with Renal Dysfunction | Grade 2 or 3 increased blood creatinine | Withhold† |
| Grade 4 increased blood creatinine | Permanently discontinue | |
| Exfoliative Dermatologic Conditions | Suspected SJS, TEN, or DRESS | Withhold† |
| Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
| Myocarditis | Grades 2, 3, or 4 | Permanently discontinue |
| Neurological toxicities | Grade 2 | Withhold† |
| Grade 3-4 | Permanently discontinue | |
| Other Adverse Reactions | ||
| Infusion-related reactions | Grade 1 or 2 | Interrupt or slow the rate of infusion |
| Grade 3 or 4 | Stop infusion Permanently discontinue | |
ALT=alanine aminotransferase, AST=aspartate aminotransferase, DRESS=drug rash with eosinophilia and systemic symptoms, SJS=Stevens Johnson syndrome, TEN=toxic epidermal necrolysis, ULN=upper limit of normal.
* Based on National Cancer Institute (NCI) Common Terminology for Adverse
Events (CTCAE) version 5.0.
† Resume toripalimab in patients with complete or partial resolution to Grade 0-1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
‡ If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue toripalimab based on recommendations for hepatitis with no liver involvement.
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