Loqtorzi Dosage
Generic name: toripalimab 240mg in 6mL
Dosage form: injection
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
Medically reviewed by Drugs.com. Last updated on Oct 31, 2024.
Recommended Dosage
The recommended dosages of LOQTORZI are provided in Table 1. Administer as recommended.
Indication | Recommended Dosage of LOQTORZI | Duration of Treatment |
---|---|---|
First-line NPC | 240 mg every three weeks | Until disease progression, unacceptable toxicity, or up to 24 months. |
Recurrent NPC | 3 mg/kg every two weeks | Until disease progression or unacceptable toxicity. |
Dosage Modifications
No dose reductions of LOQTORZI are recommended. In general, withhold LOQTORZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue LOQTORZI 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 LOQTORZI for adverse reactions that require management different from these general guidelines are summarized in Table 2.
Adverse Reaction | Severity* | Dose Modification |
---|---|---|
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 | ||
|
||
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 |
Preparation and Administration
Preparation for Intravenous Infusion
- Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
- Withdraw the required volume of LOQTORZI and inject slowly into a 100 mL or 250 mL infusion bag containing 0.9% Sodium Chloride Injection, USP. Mix diluted solution by gentle inversion. Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 3 mg/mL.
- Discard any unused portion left in the vial.
Storage of Diluted Solution for Infusion
LOQTORZI does not contain a preservative.
If the diluted solution is not administered immediately, store either:
- At room temperature, 20°C to 25°C (68°F to 77°F), for no more than 8 hours from the time of dilution to the completion of the infusion. Discard diluted solution stored at room temperature after 8 hours.
Or - Refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of dilution to the completion of the infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Discard the refrigerated diluted solution after 24 hours.
Do not freeze.
Administration
- Administer diluted solution 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, LOQTORZI should be administered prior to chemotherapy.
- Refer to the Prescribing Information for cisplatin and gemcitabine for recommended dosing information.
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