Recurrent unresectable or metastatic nasopharyngeal carcinoma

Active Ingredient: Toripalimab

Indication for Toripalimab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Toripalimab is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments:

3 mg/kg every 2 weeks until disease progression or unacceptable toxicity

For:

Dosage regimens

Intravenous, 3 milligrams toripalimab per kilogram of body weight, once every 2 weeks.

Detailed description

Recurrent NPC

Recommended dosage of toripalimab: 3 mg/kg every two weeks.

Duration of treatment: Until disease progression or unacceptable toxicity.

Dosage Modifications

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.

Dosage considerations

  • Administer intravenously via an infusion pump using an in-line aseptic filter (0.2 or 0.22 micron).
  • First infusion: Infuse over at least 60 minutes.
  • Subsequent infusions: If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes.
  • Do not co-administer other drugs through the same intravenous line.
  • When administered on the same day as chemotherapy, toripalimab should be administered prior to chemotherapy.
  • Refer to the Prescribing Information for cisplatin and gemcitabine for recommended dosing information.

Active ingredient

Toripalimab

Toripalimab is a recombinant humanized programmed cell death protein 1 (PD-1) monoclonal antibody that acts as a checkpoint inhibitor. Toripalimab is used for the treatment of melanoma and nasopharyngeal carcinoma.

Read more about Toripalimab

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