LOQTORZI Solution for injection Ref.[107258] Active ingredients: Toripalimab

Source: FDA, National Drug Code (US) Revision Year: 2023

1. Indications and Usage

1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine

LOQTORZI 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).

1.2 Previously Treated Unresectable or Metastatic NPC

LOQTORZI 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.

2. Dosage and Administration

2.1 Recommended Dosage

The recommended dosages of LOQTORZI are provided in Table 1. Administer as recommended [see Dosage and Administration (2.3)].

Table 1. Recommended Dosage:

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.

2.2 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.

Table 2. Recommended Dosage Modifications for Adverse Reactions:

Adverse Reaction	Severity*	Dose Modification
Immune-Related Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	Withhold^†
Pneumonitis	Grades 3 or 4	Permanently discontinue
Colitis	Grade 2 or 3	Withhold^†
Colitis	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^†
Hepatitis with no tumor involvement of the liver	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^†
Hepatitis with tumor involvement of the liver^‡	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^†
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold^†
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grades 2, 3, or 4	Permanently discontinue
Neurological toxicities	Grade 2	Withhold^†
Neurological toxicities	Grade 3-4	Permanently discontinue
Other Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.2)]	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 LOQTORZI 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 LOQTORZI based on recommendations for hepatitis with no liver involvement.

2.3 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.
LOQTORZI is compatible with polypropylene infusion bags and infusion sets with 0.2 or 0.22 micron in-line filter.
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.

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 [see Dose Modifications (2.2)].
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.

16.2. Storage and Handling

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

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