Overview
11 DESCRIPTION Toripalimab-tpzi is a programmed death receptor-1 (PD-1) blocking antibody. Toripalimab-tpzi is a humanized immunoglobulin G4 (IgG4) kappa immunoglobulin that has a predicted molecular weight of approximately 150 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) mammalian cell expression system.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Toripalimab-tpzi is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. 12.
Indications
- 1 INDICATIONS AND USAGE LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) 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 ( 1.2 ) 1.
Common Doses
- 240 mg
- 3 mg
- 10 mg
- 100 mL
Dosage
2 DOSAGE AND ADMINISTRATION In combination with cisplatin and gemcitabine: 240 mg intravenously every three weeks ( 2.1 ) As a single agent: 3 mg/kg intravenously every two weeks ( 2.1 ) First Infusion : Infuse over 60 minutes. Subsequent Infusions : If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes. 2.1 Recommended Dosage The recommended dosages of LOQTORZI are provided in Table 1. Administer as recommended [see Dosage and Administration (2.3) ].
Contraindications
- 4 CONTRAINDICATIONS None . None
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] LOQTORZI in Combination with Cisplatin and Gemcitabine The most common adverse reactions (≥ 20%) are nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.